PCrompton_510(k)

. AneurysmClip –Traditional 510(k)
Medstrong Inc [Traditional] PremarketNotification
CONFIDENTIAL
Table of Contents
Refuse to Accept Checklist ..................................................................................................................1
1. User Fee Form (Form FDA 3601) ......................................................................................................2
2. CDRH Premarket Review Submission Cover Sheet.............................................................................3
3. 510(k) Notification Cover Letter.......................................................................................................8
4. Indicationsfor Use Statement........................................................................................................10
5. 510(k) Summary............................................................................................................................11
a. Device Information................................................................................................................11
b. Date Summary Prepared........................................................................................................11
c. Description of Device.............................................................................................................12
1. Viceroy Aneurysm Clip Description .....................................................................................12
2. Marquis Aneurysm ClipApplier Description.........................................................................12
d. Indications for Use.................................................................................................................12
e. Comparison to Predicate Device.............................................................................................12
f. Summary of Supporting Data..................................................................................................13
6. Truthful and Accuracy Statement...................................................................................................14
7. Class III Summary and Certification ................................................................................................15
8. Financial Certification or Disclosure Statement...............................................................................16
9. Declarations of Conformity and Summary Reports..........................................................................17
10. Executive Summary.....................................................................................................................20
a. Device Information................................................................................................................20
b. Date Summary Prepared........................................................................................................20
c. Description of Device.............................................................................................................21
1. Clinical context of use of the device........................................................................................21
2. Relevant device specific guidance, special controls and/or consensus standards applied ...........21
3. Descriptionof the principal of operationandmechanismof actionforachievingthe intended
therapeutic/diagnostic effect.....................................................................................................23
4. Conditions for use..............................................................................................................23
5. Engineering drawings, schematics, and/orillustrations ........................................................24
d. Indications for Use.................................................................................................................25

CONFIDENTIAL
e. Comparison to Predicate Device.............................................................................................25
f. Summary of Supporting Data..................................................................................................28
11. Device Description ......................................................................................................................30
a. Description............................................................................................................................30
1. Viceroy Aneurysm Clip / Marquis Clip Applier Description....................................................30
b. Indications for Use.................................................................................................................35
c. Substantial Equivalence .........................................................................................................35
12. Substantial Equivalence Discussion ..............................................................................................36
a. Tabular Comparison to Predicate Device.................................................................................36
b. Textual Comparison to Predicate Device.................................................................................38
c. 510(k) Flowchart Comparison to Predicate Device...................................................................40
d. Summary of Supporting Data..................................................................................................41
13. Proposed Draft Labeling..............................................................................................................42
a. Marquis Aneurysm ClipApplier..............................................................................................43
1. Draft – Instructions for Use.................................................................................................43
2. Draft – Package Label.........................................................................................................47
1. Draft – Instructions for Use.................................................................................................49
2. Draft – Package Label.........................................................................................................52
14. Sterilization and Shelf Life............................................................................................................54
a. Description: Sterilization Method ...........................................................................................54
b. Description: Sterile Packaging.................................................................................................54
c. Sterility Assurance Level (SAL)................................................................................................54
d. Description: Sterilization Site..................................................................................................54
e. Non-Pyrogenicity of Device....................................................................................................54
f. Radiation Sterilization Dose....................................................................................................55
g. Sterilization by User...............................................................................................................55
h. Expiration Date......................................................................................................................55
15. Biocompatibility..........................................................................................................................56
16. Software.....................................................................................................................................59
17. Electromagnetic Compatibility and Electrical Safety ......................................................................60
18. Performance Testing - Bench.......................................................................................................61

CONFIDENTIAL
19. Performance Testing - Animal......................................................................................................66
20. Performance Testing - Clinical......................................................................................................68
21. Design Control Activities..............................................................................................................69
Appendix A – Biocompatibility Test Results........................................................................................70
Tab 1 – Conformance Lab Documentation..........................................................................................70
Tab 2 – 2 Year Accelerated Shelf Life Report.......................................................................................70
Tab 3 – Misc. Forms..........................................................................................................................70
Tab 4 – Biocompatibility Reports.......................................................................................................70

CONFIDENTIAL Section1, Pg.1
Refuse to Accept Checklist

1. User Fee Form (Form FDA 3601)

2. CDRH Premarket Review Submission Cover Sheet
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CDRH PREMARKET REVIEW SUBMISSION COVER SHEET
Form Approval
OMB No. 0910-0120
Expiration Date: December 31 , 2013
See OMB Statement on page 5.
Date of Submission User Fee Payment ID Number FDA Submission Document Number (if known)
xxXXXxxxx XXXXXXXXX XXXXXXX
SECTION A TYPE OF SUBMISSION
PMA PMA & HDE Supplement PDP 510(k) Meeting
Original Submission
Pre market Report
Modular Submission
Amendment
Report
Report Amendment
Licensing Agreement
Regular (180 day)
Special
Panel Track (PMA Only)
30-day Supplement
30-day Notice
135-day Supplement
Real-time Review
Amendment to PMA & HDE
Supplement
Other
Original PDP
Notice of Completion
Amendment to PDP
x Original Submission:
x Traditional
Special
Abbreviated (Complete
section I, Page 5)
Additional Information
Third Party
Pre-510(K) Meeting
Pre-IDE Meeting
Pre-PMA Meeting
Pre-PDP Meeting
Day 100 Meeting
Agreement Meeting
Determination Meeting
Other (specify):
IDE Humanitarian Device Exemption
(HDE)
Class II Exemption Petition Evaluation of Automatic Class III
Designation
(De Novo)
Other Submission
Original Submission
Amendment
Supplement
Original Submission
Amendment
Supplement
Report
Report Amendment
Original Submission
Original Submission
513(g)
Other
(describe submission):
Have you used or cited Standards in your submission?  Yes No (If Yes, please complete Section I, Page 5)
SECTION B SUBMITTER, APPLICANT OR SPONSOR
Company / Institution Name Establishment Registration Number (if known)
Medstrong Inc. XXXXXXX
Division Name (if applicable) Phone Number (including area code)
N/A (XXX)-XXX-XXXX
Street Address FAX Number (including area code)
12345 False Ave. (XXX)-XXX-XXXX
City State / Province ZIP / Postal Code Country
Lafayette AL 55555 USA
Contact Name
Philip Crompton
Contact Title Contact E-mail Address
Regulatory Affairs Specialist pcrompton@medstrong.com
SECTION C APPLICATION CORRESPONDENT (e.g. consultant, if different from above)
Company / Institution Name Establishment Registration Number (if known)
City State / Province ZIP / Postal Code Country
Contact Name
Contact Title Contact E-mail Address

SECTION D1 REASON FOR APPLICATION - PMA, PDP, OR HDE
New Device
Withdrawal
Additional or Expanded Indications
Request for Extension
Post-approval Study Protocol
Request for Applicant Hold
Request for Removal of Applicant Hold
Request to Remove or Add Manufacturing Site
Change in design, component, or specification:
Software / Hardware
Color Additive
Material
Specifications
Other (specify below)
Location change:
Manufacturer
Sterilizer
Packager
Report Submission:
Annual or Periodic
Post-approval Study
Adverse Reaction
Device Defect
Amendment
Process change:
Packaging
Sterilization
Labeling change:
Indications
Instructions
Performance Characteristics
Shelf Life
Trade Name
Change in Ownership
Change in Correspondent
Change of Applicant Address
Response to FDA correspondence:
Other Reason (specify):
SECTION D2 REASON FOR APPLICATION - IDE
New Device
New Indication
Addition of Institution
Expansion / Extension of Study
IRB Certification
Termination of Study
Withdrawal of Application
Unanticipated Adverse Effect
Notification of Emergency Use
Compassionate Use Request
Treatment IDE
Continued Access
Change in:
Correspondent! Applicant
Design / Device
Informed Consent
Manufacturer
Manufacturing Process
Protocol - Feasibility
Protocol - Other
Sponsor
Response to FDA Letter Concerning:
Conditional Approval
Deemed Approved
Deficient Final Report
Deficient Progress Report
Deficient Investigator Report
Disapproval
Request Extension of Time to Respond
to FDA
Request Meeting
Request Hearing
Report submission:
Current Investigator
Annual Progress Report
Site Waiver Report
Final
SECTION D3 REASON FOR APPLICATION – 510(k)
 New Device Additional or Expanded Indications Change in Technology
FORM FDA 3514 ( 12/10) Page 2 of 5 Pages

SECTION E ADDITIONAL INFORMATION ON 510(K) SUBMISSIONS
Product codes to which substantial equivalence is claimed
Summary of, or statement concerning,
safety and effectiveness information
 510 (k) summary attached
510 (k) statement
1 HCH HCI 4
5 6 7 8
Information on devices to which substantial equivalence is claimed (if known)
510(k) Number Trade or Model or Proprietary Name Manufacturer
1 K131500 1 Yasargil Aneurysm Clips and Clip Appliers 1 Aesculap
2
3
SECTION F PRODUCT INFORMATION - APPLICATION TO ALL APPLICATIONS
Common or usual name or classification name
Clip, Aneurysm / Applier, Aneurysm Clip
Trade or Proprietary or Model Name for This Device Model Number
1 Viceroy Aneurysm Clip 1 See Section 11 of this submission for model number information.
2 Marquis Aneurysm Clip Appliers 2 See Section 11 of this submission for model number information.
3 3
4 4
5 5
FDA Document Numbers of all prior related submissions (regardless of outcome)
1 2 3 4 5 6
7 8 9 10 11 12
Data Included in Submission
 Laboratory Testing  Animal Trials
SECTION G PRODUCT CLASSIFICATION - APPLICATION TO ALL APPLICATIONS
Product Code C.F.R Section (if applicable) Device Class
HCH / HCI 21 CFR 882.5200 / 21 CFR 882.4175  Class II
Classification Panel
Neurology
Indications (from labeling)
The Medstrong Viceroy Aneurysm Clips are intended for the occlusion of cerebral aneurysms for both temporary and permanent applications. The Viceroy clips are applied
with Marquis Aneurysm Clip Appliers, which possess device specific hooks for gripping and actuating the clips.

Note: Submission of this information does not affect the need to submit a 2891 or 2891a
Device Establishment Registration form.
FDA Document Number (if known)
SECTION H MANUFACTURING / PACKAGING / STERILIZATION SITES RELATING TO A SUBMISSION
 Original Facility Establishment Identifier (FEI) Number Manufacturer  Contract Sterilizer
Relabeler
XXXXXX
Company I Institution Name Establishment Registration Number
E-Beam Inc. XXXXXX
N/A (XXX)-XXX-XXXX
555 Fake St. (XXX)-XXX-XXXX
City State I Province ZIP Code I Country
Lafayette AL 55555 USA
Contact Name Contact Title Contact E-mail Address
James E. Beam Sterilization Specialist JBeam@ebeam.com
 Original Facility Establishment Identifier (FEI) Number  Contract Sterilizer
Facility Establishment Identifier (FEI) Number

SECTION I UTILIZATION OF STANDARDS
Note: Complete this section if your application or submission cites standards or includes a "Declaration of Conformity to a Recognized
Standard" statement.
1
Standards No. Standards
Organization
Standards Title Version Date
5832-3 ISO Implants for surgery – Metallic Materials – Part 3: Wrought Titanium 6-Aluminium 4-
Vanadium Alloy
First 1996
2
Organization
5832-9 ISO Implants for surgery – Metallic Materials – Part 9: Wrought High Nitrogen Stainless
Steel
Second 2007
3
Organization
10993-1 ISO Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk
management process
Fourth 2009
4
Organization
10993-3 ISO Biological evaluation of medical devices – Part 3: Tests for genotoxicity,
carcinogenicity and reproductive toxicity
Third 2014
5
Organization
10993-5 ISO Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity Third 2009
6
Organization
10993-6 ISO Biological evaluation of medical devices – Part 6: Tests for local effects after
implantation
Second 2007
Please include any additional standards to be cited on a separate page.
Public reporting burden for this collection of information is estimated to average 0.5 hour per response, including the time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of
information, including suggestions for reducing this burden to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
1350 Piccard Drive, Room 400
Rockville, MD 20850
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

3. 510(k) Notification Cover Letter
Category Comments
Date of Submission xxXXXxxxx
Device CommonName AneurysmClip/ AneurysmClipApplier
Sponsor MedstrongInc.
12345 False Ave.
Lafayette,AL55555
Tel:(XXX) – XXX – XXXX
CorrespondentContactInformation PhilipCrompton
Address
Phone #
ConfidentialityPreference The informationcontainedinthisnotificationandour
intenttomarketthisdevice isconsideredconfidential
commercial informationandwe requestthatthe FDA
consideritas such (per21 CFR 807.95) the companyhas
takenreasonable precautionstoprotectthis
confidentiality.
Device ClassificationRegulation&Name 21 CFR 882.4175 – AneurysmClipApplier
21 CFR 882.5200 – AneurysmClip
Device Class &Product Code AneurysmClipApplier:
ProductCode – HCI
Device Class – 2
AneurysmClip:
ProductCode – HCH
Device Class – 2
Panel Neurological Devices
PriorFDA DocumentNumbers None
Basisof Submission New Design
KitDescription None
Numberof DevicesinSubmission Two

Question YES NO
Is the device intendedforprescriptionuse (21CFR801 SubpartD)? X
Is the device intendedforover-the-counteruse (21CFR 807 Subpart C)? X
Doesthe device containcomponentsderivedfromatissue orother biologicsource? X
Is the device (AneurysmClipApplier)provided sterile? X
Is the device (AneurysmClip) providedsterile? X
Is the device (AneurysmClipApplier)intendedforsingle use? X
Is the device (AneurysmClip) intendedforsingleuse? X
Is the device areprocessedsingleuse device? X
If yes,does thisdevice type require reprocessedvalidationdata? X
Doesthe device containa drug? X
Doesthe device containa biologic? X
Doesthe submissioninclude clinical information? X
Is the device (AneurysmClip) implanted? X
Is the device (Aneurysm ClipApplier)implanted? X

4. Indications for Use Statement
510(k) Number:TBD
Device Name: ViceroyAneurysmClipandMarquisAneurysmClipApplier
IndicationsFor Use:
The MedstrongViceroyAneurysmClipsare intendedforocclusionof cerebral aneurysmsinforboth
temporaryandpermanentapplications. Theyare appliedwithMarquisAneurysmClipAppliers,which
possessspecializedhooksmade fromtitaniumalloyforactuatingthe clips.
Type of Use:
_X_ PrescriptionUse (Part21 CFR 801 SubpartD)
_ _ Over-The-CounterUse (Part21 CFR 801 Subpart C)
To Reviewer: FDA Form# 3881 is includedinthe “MiscForms”Tab of thissubmission (Tab3).

5. 510(k) Summary
a. Device Information
Category Comments
12345 False Ave.
Lafayette,AL55555
Address
Phone #
Device Common Name AneurysmClip/AneurysmClipApplier
Device ClassificationNumber 21 CFR 882.4175 – AneurysmClipApplier
Device Class&Product Code AneurysmClipApplier:
ProductCode – HCI
Device Class – 2
AneurysmClip:
ProductCode – HCH
Device Class – 2
Device ProprietaryName ViceroyAneurysmClip/MarquisClipApplier
Predicate Device
Predicate Device Manufacturer Aesculap,Inc.
Predicate Device CommonName AneurysmClip/AneurysmClipApplier
Predicate Device PremarketNotification# K131500
Predicate Device Classification 21 CFR 882.4175 – AneurysmClipApplier
Predicate Device Class&ProductCode AneurysmClipApplier:
ProductCode – HCI
Device Class – 2
AneurysmClip:
ProductCode – HCH
Device Class – 2
b. Date Summary Prepared
Date Submitted

c. Description of Device
1. Viceroy Aneurysm Clip Description
The MedstrongViceroyAneurysmClipare designedforthe temporaryorpermanentocclusionof
vesselsduringneurosurgical procedures. The clipiscomprisedof ahead,consistingof twoclipheads
and a spring,anda tail withtwoopeningsdesignedtocatchon the MarquisAneurysmClipApplier.
Usingthe mechanical force of a calibratedspring,the twoclampheadscome togetherwhenactivated
throughthe use of the appliertoperformthe occlusive function. The Viceroyclipsare designedtobe
usedexclusivelywiththe MarquisAneurysmClipApplier.Theyare constructedwithanindustry
standardimplantable metalsaccording toISO5832, specifically: Wroughttitanium6-aluminium4-
vanadiumalloy(ISO5832-3). The clipisavailable inacurvedand straightformat,withsizesinthe range
of 2 mm to 10 mm.
2. Marquis Aneurysm Clip Applier Description
The MedstrongMarquis AneurysmClipApplierisdesignedtoboth:aidinthe positioningof the Viceroy
clip,andtightenandrelease the Viceroyclip. The applieriscomprisedof ahollow tube containinga
winch,connectedtosteel cabling,thatistoggledbyawheel atthe base of the applier. The cabling
togglesa springwhichconnectstotwohookswhichare intendedtolatchontothe Viceroyclip. The
applierissoldasa non-sterile item,andisdesignedtobe usedexclusivelywithViceroyAneurysmClips.
The body,cablingand springare manufacturedfromstainlesssteel. The hooksare manufacturedfrom
wroughttitanium6-aluminium4-vanadiumalloyperISO5832-3. The applierisavailableinthe standard
lengthof 90 mm, witha straightshape.
d. Indications for Use
The MedstrongViceroyAneurysmClipsare intendedforocclusionof cerebral aneurysms forboth
temporaryandpermanentapplications. The Viceroyclips are appliedwithMarquisAneurysmClip
Appliers,whichpossess devicespecifichooksforgrippingandactuatingthe clips.
e. Comparison to Predicate Device
The MedstrongViceroy AneurysmClipsandMarquisClipAppliersare equivalentinindicationsforuse,
mode of action andmaterialstothe Yasargil AneursmClipandClipAppliers(K131500). Both devices
utilize mechanical actionthroughclipsforthe occlusionof cerebral aneurysms. Bothdevicesuse
titaniumalloy(wroughttitanium6-aluminium4-vanadiumalloy) forthe constructionof the clipsandthe
graspingportionsof the clipapplier. Both devicesemploye-beam(radiation) inordertosterilize the
clips. The devicesdifferindesignwithregardstothe mechanismthroughwhichopeningandclosingof
the clipis effectuated. The testingdescribedinsections 18and 19 demonstratesthatthe differencesin
the devicesdonotraise any unresolvedissuesof safetyorefficacy. Medstrongconcludesthatthe
devicesare substantiallyequivalent.

f. Summary of Supporting Data
Biocompatibilitydatademonstratesthatthe device isincompliance withISO10993.
Benchtestingof the ViceroyAneurysmClipandthe MarquisAneurysmClip Applierhasyieldedthe
followingresults:
 The device isincompliance withISO9713 withregardsto clipclosingforce tolerance.
 The appliedforce tothe weldwhichbindsthe springtothe clipis beyondexpectedintracranial
forces.
 The presence of magneticresonance hasnoimpacton clipperformance.
Animal testingof the ViceroyAneurysmClipandthe MarquisAneurysmClipApplierhasyieldedthe
followingresults:
 The 2mm clips(curvedandstraight) performadequately in vivo inregardsto the clip’s occlusive
properties.
 The Marquis AneurysmClipApplierisfunctional forall applicationspertinenttoa90 mm
aneurysmclipapplier.

6. Truthful and Accuracy Statement
NOTE: This statementis requiredper21 CFR 807.87(k)
I certifythat,inmy capacityas the Chief Executive Officerof MedstrongInc.,Ibelieve tothe bestof my
knowledge,thatall dataand informationsubmittedinthe premarketnotificationare truthful and
accurate and thatno material facthas beenomitted.
_ _
(Signature)
_ _
(TypedName)
_ _
(Date)
_ _
*(PremarketNotification[510(k)] Number)
*For a newsubmission,leave the 510(k) numberblank.
Must be signedbya responsible personof the firm requiredtosubmitthe premarketnotification[e.g.,
not a consultantforthe 510(k) submitter].

7. Class III Summary and Certification
Thisdevice isa ClassII device;thissectiondoesnotapply.

8. Financial Certification or Disclosure Statement
There isno clinical studysupportingthisapplication;thissectiondoesnotapply.

9. Declarations of Conformity and Summary Reports
Standard
Body/ #
StandardName Standard
Version
FDA
Consensus#
Self-
Declared?
ISO5832-3 Implantsforsurgery – Metallic
Materials– Part 3: WroughtTitanium
6-Aluminium4-VanadiumAlloy
FirstEdition,
1996
8-58 No
Materials– Part 9: WroughtHigh
NitrogenStainlessSteel
SecondEdition,
2007
8-150 No
ISO10993-1 Biological evaluationof medical
devices –Part 1: Evaluationand
testingwithinarisk management
process
FourthEdition,
2009
2-156 No
ISO11137-1 Sterilizationof healthcare products –
Radiation – Part 1: Requirementsfor
development,validation,androutine
control of a sterilizationprocessfor
medical devices.
FirstEdition,
2006
14-428 No
Radiation – Part 2: Establishingthe
sterilizationdose
ThirdEdition,
2013
14-409 No
Radiation – Part 3: Guidance on
DosimetricAspects
FirstEdtion,
2006
14-330 No
ISO11607-1 Packagingforterminallysterilized
medical devices –Part1:
Requirementsformaterials,sterile
barriersystemsandpackaging
systems
FirstEdition,
2006
14-454 No
medical device –Part2: Validation
requirementsforforming,sealing
and assemblyprocesses
FirstEdition,
2006
14-455 No

Standard
Body/ #
Version
FDA
Consensus#
Self-
Declared?
ISO15223-1 Medical Devices –Symbolstobe
usedwithmedical devicelabels,
labellingandinformationtobe
supplied –Part 1: General
Requirements
SecondEdition,
2012
5-90 No
supplied –Part 2: Symbol
development,selectionand
validation.
FirstEdition,
2010
N/A No
ASTMD4169 StandardPractice for Performance
Testingof ShippingContainersand
Systems
2014 14-462 No
ASTMF1980 StandardGuide For Accelerated
Agingof Sterile BarrierSystems For
Medical Devices
2011 14-229 No
ASTMF2052 StandardTest Methodfor
Measurementof Magnetically
InducedDisplacementForce on
Medical Devicesinthe Magnetic
Resonance Environment
2014 8-381 No
ASTMF2119 Evaluationof MR Image Artifacts 2013 8-153 No
ASTMF2129 StandardTest Methodfor Conducting
CyclicPotentiodynamicPolarization
MeasurementstoDetermine
CorrosionSusceptibilityof Small
ImplantDevices
2008 8-177 No
ASTMF2182 Measurementof RadioFrequency
InducedHeatingDuringMagnetic
Resonance Imaging
2011 8-227 No
InducedTorque onMedical Devices
inthe MagneticResonance
Environment
2005 8-128 No
ASTMF88 StandardTest Methodfor Seal
Strengthof Flexible BarrierMaterials
2009 14-283 No
All coverlettersandreportsreceivedregardingthe outsideconformance labsusedforthissubmission
may be foundinTab 1.
The table belowincludesstandardsusedthatare not FDA recognized,butwere usedinthe submission.

Standard
Body/ #
Version
FDA
Consensus#
Self-Declared?
ISO9713 Neurosurgical implants –Self-
closingintracranial aneurysmclips
SecondEdition,
2002
N/A No

10. Executive Summary
a. Device Information
Category Comments
12345 False Ave.
Lafayette,AL55555
Address
Phone #
Device CommonName AneurysmClip/AneurysmClipApplier
Device ClassificationNumber 21 CFR 882.4175 – AneurysmClipApplier
Device Class&Product Code AneurysmClipApplier:
ProductCode – HCI
Device Class – 2
AneurysmClip:
ProductCode – HCH
Device Class – 2
Device Proprietary Name ViceroyAneurysmClip/MarquisClipApplier
Predicate Device
Predicate Device Manufacturer Aesculap,Inc.
Predicate Device CommonName AneurysmClip/AneurysmClipApplier
Predicate Device PremarketNotification# K131500
Predicate Device Classification 21 CFR 882.4175 – AneurysmClipApplier
Predicate Device Class&ProductCode AneurysmClipApplier:
ProductCode – HCI
Device Class – 2
AneurysmClip:
ProductCode – HCH
Device Class – 2
b. Date Summary Prepared
Date submitted.

c. Description of Device
1. Clinical context of use of the device
clip,andtightenandrelease the ViceroyAneurysmClip. The MedstrongViceroyAneurysmClipare
designedforthe temporaryorpermanentocclusionof vesselsduringneurosurgicalprocedures.
Aneurysmsrefertoaballoon-like bulge of abloodvessel. Ananeurysmmayresultinthe thinningand
weakeningof the vessel,whichmayleakorrupture,releasingbloodintothe spacesaroundthe brain.
Thisis otherwise knownasa subarachnoidhemorrhage (SAH). Usedappropriately,ananeurysmclipwill
preventbloodflowtothe bulge,preventinganSAHfromoccurring.
2. Relevant device specific guidance, special controls and/or consensus standards applied
Belowisa full table of the guidance usedinthissubmission.
Standard
Body/ #
Version
FDA
Consensus#
Self-Declared?
Materials– Part 3: Wrought
Titanium6-Aluminium4-Vanadium
Alloy
FirstEdition,
1996
8-58 No
Materials– Part 9: WroughtHigh
NitrogenStainlessSteel
SecondEdition,
2007
8-150 No
devices –Part 1: Evaluationand
testingwithinariskmanagement
process
FourthEdition,
2009
2-156 No
devices –Part 3: Testsfor
genotoxicity,carcinogenicityand
reproductive toxicity
ThirdEdition,
2014
2-117 No
devices –Part 5: Testsfor invitro
cytotoxicity
ThirdEdition,
2009
2-153 No
devices –Part 6: Testsfor local
effectsafterimplantation
SecondEdition,
2007
2-120 No
irritationandskinsensitization
ThirdEdition,
2010
2-118 No

Standard
Body/ #
Version
FDA
Consensus#
Self-Declared?
systemictoxicity
SecondEdition,
2006
2-176 No
ISO11137-1 Sterilizationof healthcare products
– Radiation –Part 1: Requirements
for development, validation,and
routine control of a sterilization
processfor medical devices.
FirstEdition,
2006
14-428 No
– Radiation –Part 2: Establishing
the sterilizationdose
ThirdEdition,
2013
14-409 No
– Radiation –Part 3: Guidance on
DosimetricAspects
FirstEdtion,
2006
14-330 No
medical devices –Part1:
Requirementsformaterials,sterile
barriersystems andpackaging
systems
FirstEdition,
2006
14-454 No
medical device –Part2: Validation
requirementsforforming,sealing
and assemblyprocesses
FirstEdition,
2006
14-455 No
supplied –Part 1: General
Requirements
SecondEdition,
2012
5-90 No
labellingandinformationto be
supplied –Part 2: Symbol
development,selectionand
validation.
FirstEdition,
2010
N/A No
ASTMD4169 StandardPractice for Performance
Testingof ShippingContainersand
Systems
2014 14-462 No

Standard
Body/ #
Version
FDA
Consensus#
Self-Declared?
2014 8-381 No
Resonance Imaging
2011 8-227 No
Environment
2005 8-128 No
ASTMF88 StandardTest Methodfor Seal
Strengthof Flexible Barrier
Materials
2009 14-283 No
3. Description of the principal of operation and mechanism of action for achieving the intended
therapeutic/diagnostic effect
The Marquis AneurysmClipApplieriscomprisedof ahollow,stainlesssteel tubecontainingawinch,
connectedtostainlesssteelcabling,thatistoggledbyawheel atthe base of the applier. The cabling
togglesa springwhichconnectstotwohookswhichare intendedtolatchontothe ViceroyAneurysm
Clip. The ViceroyAneurysmClipiscomprisedof atitaniumalloyhead,consistingof twoclipheadsanda
spring,anda tail withtwoopeningsdesignedtocatch on the MarquisAneurysmClipApplier. Using the
mechanical force of a calibratedspring,the twoclampheadscome togetherwhenactivatedthroughthe
use of the appliertoperformthe occlusive function.
4. Conditions for use
Like all aneurysmclipsandappliers,the ViceroyAneurysmClipandMarquisAneurysmClipApplier
require brainsurgerytouse for theirintendedocclusive function. Generally,acraniotomy,orbone flap,
mustbe createdforthe physiciantoaccessthe aneurysm. The MarquisAneurysmClipApplieris
designedtoworkspecificallywiththe ViceroyAneurysmClip. The clipsare soldsterile,inpacksof four
units. Each unitis independentlysterile,andthe use of one will notcompromisethe sterilityof the
others.

5. Engineering drawings, schematics, and/or illustrations
6. Note: Onlythe straight clip is shownin this drawing.
7. FigA: Marquis applier
8. FigB: Attachmenthooks - applier
9. FigC: Viceroyclips
10. FigD: Tensionedspring
11. FigE: Attachmenthooks - clip

d. Indications for Use
The MedstrongViceroyAneurysmClipsare intendedforocclusionof cerebral aneurysmsforboth
temporaryandpermanentapplications. The Viceroyclipsare appliedwithMarquisAneurysmClip
Appliers,whichpossessdevicespecifichooksforgrippingandactuatingthe clips.
e. Comparison to Predicate Device
The MedstrongViceroyAneurysmClipsandMarquisAneurysmClipApplierissubstantiallyequivalentin
indicationsforuse,operatingprincipal,varietaldesign,mechanical design,materials,principal operator,
use location,use type andsterilizationtothe predicate device K131500.
 ProductCodeEquivalence
Both the ViceroyAneurysmClips/MarquisAneurysmClipApplierandthe Yasargil Aneurysmclipsand
clipappliershave identical productcodes: HCH(clip,aneurysm) andHCI(applier,aneurysmclip).
Medstrongconcludesthatthe product codesof the submittedandpredicate devicesare substantially
equivalent.
 IndicationsforUseEquivalence
Both devicesare intendedforthe occlusionof cerebral aneurysmsineithera temporaryor permanent
mannerthroughthe use of the appropriate applier. Medstrongconcludesthatthe indicationsforuse of
the submittedandpredicate devicesare substantiallyequivalent.
 Operating Principle Equivalence
Both devicesutilizeaspring clipto produce the mechanical clampingaction. Medstrongconcludesthat
the operatingprinciple of the submittedandpredicatedevicesare substantiallyequivalent.
 VarietalDesign Equivalence
Withtwo exceptions,the varietiesof clipandappliersubmittedbythe predicate device containall of
the varietiescontainedwithinthissubmission.The exceptionscontainedinthissubmissionrefertothe
2mm curvedand straightViceroyAneurysmClips. Benchandanimal testing(see section18and 19)
prove the safetyandefficacyof the smallersize,andthereforeMedstrongconcludesthatthe varietal
designof the submittedandpredicate devicesare substantiallyequivalent.
 MechanicalDesign Equivalence
Both the Yasargil and the Viceroyclipsutilize the same mechanical designforactuatingthe clipbyusing
a tensionedspringwithsufficientforce toocclude ananeurysm. The predicate applieruseshinged
tongswhichrequiresaforce of gripon the tong handlestoactuate the clip. The submittedapplieruses
a tensionedspringconnectedtohookstowhichistoggledbya wheel onthe applier. Althoughthe
mechanical designbetweenthe twoisdifferent,the ultimatemode of action(i.e.clampingthe clip
throughmechanical action) isfunctionallyidentical. Benchandanimal testing(see sections18and 19)
showthat safetyandefficacyof the device isunaffectedbytechnological characteristics. Medstrong

concludesthatthe mechanical designsof the submittedandpredicate devicesare substantially
equivalent.
 MaterialsEquivalence
The materials,titaniumalloyandstainlesssteel,usedinthe constructionof the submittedclipandclip
applierare listedasa material usedinthe constructionof the predicate clipandclipapplier. Medstrong
concludesthatthe materialsof the submittedandpredicate device are substantiallyequivalent.
Giventhe explanationsabove,Medstrongconcludesthat the devicesare substantiallyequivalent.
The tablesbelowallowforaconvenientcomparisonbetweenthe predicate andsubmissiondevice.

Yasargil AneruysmClips
and ClipAppliers
MedstrongViceroyClips
and Marquis Applier
Discussion
K# K131500 TBD N/A
Indications
for Use
The Yasargil Aneurysm
Clipsare intendedfor
occlusionof cerebral
aneurysms ineithera
temporaryor permanent
manner. Theyare applied
withAesculapclipappliers,
whichcontaintitanium
alloworphynox jaws.
The MedstrongViceroy
AneurysmClipsare
intendedforocclusionof
cerebral aneurysmsfor
bothtemporaryand
permanentapplications.
The Viceroyclipsare
appliedwithMarquis
AneurysmClipAppliers,
whichpossessdevice
specifichooksforgripping
and actuatingthe clips.
Thougha special
reference ismade tothe
appropriate clipappliers
(Marquis),Medstrong
believesthatthe overall
contentof both
indicationsforuse are
functionallyidentical.
FDA Product
Code(s)
Clip,Aneurysm: HCH
Applier,AneurysmClip:HCI
Clip,Aneurysm: HCH
Identical
Operating
Principle
Mechanical actionusinga
springclip.
Mechanical actionusinga
springclip.
Identical
Varietal
Design
Cliptypes:Straight,curved,
angled,bayonet,T-bar,
offsetT-bar,convex T-bar,
concave T-bar, fenestrated
and non-fenestratedstyles.
Clipsizes:between3mm
and 40 mm
Appliertypes:straight,
angledandbayonet.
Appliersizes: 50mm,
90mm and110mm
Cliptypes: Straightand
curved.
ClipSizes:2mm, 4mm,
6mm, 8mm, 10mm.
Appliertypes:Straight
Appliersizes:90mm
Medstrong’ssubmitted
clipsandappliershave
the possessthe same
sizesandtypesas the
predicate device. The
exceptiontothisisthe
2mm straightand curved
Viceroyclips. Benchand
animal testingproves
these tobe as safe and
effectiveasthe other
sizesoffered(see section
18 and 19 of this
document).

and ClipAppliers
and Marquis Applier
Discussion
Mechanical
Design
Clip:Tensionedspringwith
sufficientforce toocclude
aneurysm.
Applier: Hingedtongsthat
allowa physicianto
position andactuate the
clip.
aneurysm.
Applier: Tensionedspring
connectedtohooksthat
allow a physicianto
positionandactuate clip.
The submittedand
predicate device clips
operate withthe same
mechanical design. A
difference exists
betweenthe submitted
and predicate applier,
the ultimate mode of
action(i.e.the togglingof
the clipthrough
mechanical action) is
Benchand animal testing
(see sections18and 19)
show that the safetyand
efficacyof the submitted
device isacceptable.
Materials
Clip: Titaniumalloy(ISO
5832/3) or phynox (ISO
5832/7)
Applier: StainlessSteel
withtitaniumalloyor
phynox jaws.
5832/3)
Applier: Stainlesssteel
withtitaniumalloyjaws.
Medstrong’sclipandclip
appliermaterialsare
containedwithinthe
predicate devices
material list.
Principal
Operator
Surgeon Surgeon Identical
Use Location Operatingroom Operatingroom Identical
Use Type
Single use (permanentor
temporary)
temporary)
Identical
Sterilization E-beamsterilization E-beamsterilization Identical
f. Summary of Supporting Data
Benchtestingof the ViceroyAneurysmClipandthe MarquisAneurysmClipApplierhasyieldedthe
followingresults:
 The appliedforce tothe weldwhichbindsthe springto the clipis beyondexpectedintracranial
forces.

followingresults:
 The 2mm clips(curvedandstraight) performadequately in vivo inregardsto the clip’socclusive
properties.
 The Marquis AneurysmClipApplierisfunctional forall applicationspertinenttoa90 mm

11. Device Description
a. Description
1. Viceroy Aneurysm Clip / Marquis Clip Applier Description
1.1 Clinical contextof useof thedevice
clip,andtightenandrelease the ViceroyAneurysmClip. The MedstrongViceroyAneurysmClipare
designedforthe temporaryorpermanentocclusionof vesselsduringneurosurgicalprocedures.
Aneurysmsrefertoaballoon-like bulge of abloodvessel. Ananeurysmmayresultinthe thinningand
weakeningof the vessel,whichmay leakorrupture,releasingbloodintothe spacesaroundthe brain.
Thisis otherwise knownasa subarachnoidhemorrhage (SAH). Usedappropriately,ananeurysmclipwill
preventbloodflowtothe bulge,preventinganSAHfromoccurring.
1.2 Relevantdevice specific guidance, specialcontrolsand/orconsensusstandardsapplied
See the table below foracomplete listof consensusstandardsused inthissubmission.
Standard
Body/ #
Version
FDA
Consensus#
Self-
Declared?
2014 8-381 No
ASTMF2129 StandardTest Methodfor Conducting
CyclicPotentiodynamicPolarization
MeasurementstoDetermine
Corrosion Susceptibilityof Small
ImplantDevices
2008 8-177 No
Resonance Imaging
2011 8-227 No
Environment
2005 8-128 No

1.3 Description of theprincipalof operation &mechanismofaction forachieving the intended
therapeutic/diagnosticeffect
The Marquis AneurysmClipApplieriscomprisedof ahollow tube containingawinch,connectedtosteel
cabling,thatis toggledbya wheel atthe base of the applier. The cablingtogglesaspringwhich
connectsto twohookswhichare intendedtolatchontothe ViceroyAneurysmClip. The Viceroy
AneurysmClipiscomprisedof ahead,consistingof twoclipheadsanda spring,anda tail withtwo
openingsdesignedtocatchon the Marquis AneurysmClipApplier. Titaniumalloy(wroughttitanium6-
aluminium4-vanadiumalloy) isusedforthe constructionof the clipsandthe graspingportionsof the
clipapplier. Usingthe mechanical force of a calibratedspring,the twoclampheadscome together
whenactivatedthroughthe use of the appliertoperformthe occlusive function. See below for
drawings detailingthe mechanismof action.

Note: Onlythe straight clip is shownin this drawing.
FigA: Marquis Applier
FigB: Attachmenthooks - applier
FigC: Clipblades
FigD: Tensionedspring
FigE: Attachmenthooks – clip
 The hooksshownon FigE attach to the hookson FigB, whichallow the appliertoactuate the
tensionedspring(FigD).

FigF: This illustrationshowsthe applier
connectingwiththe clip.
FigG: Thisillustrationshowsthe wheel,which
will maneuverthe applierhooks(see FigF) and
actuate the clip.
1.4 Conditionsforuse
Like all aneurysmclipsandappliers,the ViceroyAneurysmClipandMarquisAneurysmClipApplier
require brainsurgerytouse for theirintendedocclusive function. Generally,acraniotomy,orbone flap,
mustbe createdforthe physiciantoaccessthe aneurysm. The MarquisAneurysmClipApplieris
designedtoworkspecificallywiththe ViceroyAneurysmClip. The clipsare soldsterile,inpacksof four

units. Each unitis independentlysterile,andthe use of one will notcompromisethe sterilityof the
others.
1.5 Engineering drawings, schematicsand/orillustrations
1.6 Materials, energy source, andotherdetailspertinentto theSubstantialEquivalencediscussion
The submitteddevicesrequirenoexternal energysource.
Belowisa table of the materialsusedforthe submitteddevices.
Device Material ISO Standard # Body Contact Contact Duration
Viceroy
Aneurysm
Clip
Titanium 6-
aluminium 4-
vanadium alloy
5832-3
Implant Device –
Tissue/Bone
Permanent (> 30
days)
Marquis
Aneurysm
Clip Applier
High Nitrogen
Stainless Steel
(Grade 316)
5832-9
External Communicating
Device –
Tissue/Bone/Dentin
Limited (< 24 hr)
Note:The Marquis ClipApplieremploysHigh NitrogenStainlessSteel (Grade 316) for both the body
and the hooks.
The materialsusedhere are alsousedinthe predicate device (Yasargil AneurysmClipandClipAppliers –
Submission#K131500).
1.7 Modellist
ViceroyAneurysmClip Model List
Model Name Blade Length Clip Type
Viceroy2
2 mm
Straight
Viceroy2C Curved
Viceroy4
4 mm
Straight
Viceroy4C Curved
Viceroy6
6 mm
Straight
Viceroy6C Curved
Viceroy8
8 mm
Straight
Viceroy8C Curved
Viceroy10
10 mm
Straight
Viceroy10C Curved
Marquis AneurysmClipApplierModel List

Medstrongcurrentlyoffersonlyone size of the MarquisAneurysmClipApplier. The applierisavailable
inthe standardlengthof 90 mm, witha straight and angled shape. The model name forthe straight
variant: Marquis 90-S. The model name forthe curvedvariant: Marquis 90-C
1.8 Description of devices to be marketed with theapplication device
Currently,nodevice isintendedtobe marketedalongsidethe submitted devices.
b. Indications for Use
c. Substantial Equivalence
The MedstrongViceroy AneurysmClips andMarquis ClipAppliers are equivalentinindicationsforuse,
mode of action andmaterialstothe Yasargil AneursmClipandClip Appliers (K131500). Both devices
utilize mechanical actionthroughclipsforthe occlusionof cerebral aneurysms. Bothdevicesuse
titaniumalloy(wroughttitanium6-aluminium4-vanadiumalloy) forthe constructionof the clipsandthe
graspingportionsof the clipapplier. Both devicesemploye-beam(radiation) inordertosterilize the
clips. The devicesdifferindesignwithregardstothe mechanismthroughwhichopeningandclosingof
the clipis effectuated. The testingdescribedinsections 18and 19 demonstratesthatthe differencesin
the devicesdonotraise any unresolvedissuesof safetyorefficacy. Medstrongconcludesthatthe

12. Substantial Equivalence Discussion
a. Tabular Comparison to Predicate Device
Yasargil AneruysmClipsand Clip
Appliers
MedstrongViceroy
Clipsand Marquis
Applier
Discussion
K# K131500 TBD N/A
Indications
for Use
The Yasargil AneurysmClipsare
intendedforocclusionof cerebral
aneurysmsineitheratemporary
or permanentmanner. Theyare
appliedwithAesculapclip
appliers,whichcontaintitanium
alloworphynox jaws.
The MedstrongViceroy
AneurysmClipsare
intendedforocclusion
of cerebral aneurysms
for bothtemporary
and permanent
applications. The
Viceroyclipsare
appliedwithMarquis
AneurysmClip
Appliers,which
possessdevice specific
hooksfor grippingand
actuatingthe clips.
Thougha special
reference ismade tothe
appropriate clip appliers
(Marquis), Medstrong
believesthatthe overall
contentof both
indicationsforuse are
Also,the predicate and
applicationdevice
intendtotreat the same
patientpopulationand
disease condition.
FDA Product
Code(s)
Clip,Aneurysm: HCH
Clip,Aneurysm: HCH
Applier,AneurysmClip:
HCI
Identical
Operating
Principle
Mechanical actionusinga spring
clip.
Mechanical action
usinga springclip.
Identical
Varietal
Design
Cliptypes:
 Straight
 Curved
 Angled
 Bayonet
 T-bar
 offsetT-bar
 convex T-bar
 concave T-bar,
Cliptypes:
 Straight
 Curved
Medstrong’ssubmitted
clipsandappliers are a
subsetof the same sizes
and types offeredin
predicate device. The
exceptiontothisisthe
2mm straightand
curvedViceroyclips.
Benchand animal
testingprovesthese to
be as safe and effective
as the othersizes
offered(see section18
and 19 of this
document).
Clipsizes:
 Between3mmand40 mm.
ClipSizes:
 2mm
 4mm
 6mm
 8mm
 10mm
Appliertypes:
 Straight
 Angled
 Bayonet.
Appliertypes:
 Straight
 Angled
Appliersizes: 50mm, 90mm and
110mm
Appliersizes:90mm

and ClipAppliers
and Marquis Applier
Discussion
Mechanical
Design
aneurysm.
Applier: Hingedtongsthat
allowa physicianto
positionandactuate the
clip.
aneurysm.
Applier: Tensionedspring
connectedtohooksthat
allow a physicianto
positionandactuate clip.
The submittedand
predicate device clips
operate withthe same
mechanical design. A
difference exists
betweenthe submitted
and predicate applier,
the ultimate mode of
action(i.e.the togglingof
the clipthrough
mechanical action) is
Benchand animal testing
(see sections18and 19)
show that the safetyand
efficacyof the submitted
device isacceptable.
Materials
5832/3) or phynox (ISO
5832/7)
Applier: StainlessSteel
withtitaniumalloyor
phynox jaws.
5832/3)
Applier: Stainlesssteel
withtitaniumalloyjaws.
Medstrong’sclipandclip
appliermaterialsare
containedwithinthe
predicate devices
material list.
Principal
Operator
Surgeon Surgeon Identical
Use Location Operatingroom Operatingroom Identical
Use Type
temporary)
temporary)
Identical
Sterilization E-beamsterilization E-beamsterilization Identical

b. Textual Comparison to Predicate Device
The MedstrongViceroyAneurysmClipsandMarquis AneurysmClipApplierissubstantiallyequivalentin
indicationsforuse,operatingprincipal,varietaldesign,mechanical design,materials,principal operator,
use location,use type andsterilizationtothe predicate device K131500.
 ProductCodeEquivalence
Both the Viceroy AneurysmClips/Marquis AneurysmClipApplierandthe Yasargil Aneurysmclipsand
clipappliershave identical productcodes: HCH(clip,aneurysm) andHCI(applier,aneurysmclip).
Medstrongconcludesthatthe product codesof the submittedandpredicate devicesare substantially
equivalent.
 IndicationsforUseEquivalence
Both devices are intendedforthe occlusionof cerebral aneurysmsineitheratemporaryor permanent
mannerthroughthe use of the appropriate applier. Medstrongconcludesthatthe indicationsforuse of
the submittedandpredicate devicesare substantiallyequivalent.
 Operating Principle Equivalence
Both devicesutilizeaspringclipto produce the mechanical clampingaction. Medstrongconcludesthat
the operatingprinciple of the submittedandpredicatedevicesare substantiallyequivalent.
 VarietalDesign Equivalence
Withtwo exceptions,the size and varietiesof clipandapplier of the applicationdevice are asubsetof
the predicate device.The exceptionscontainedinthissubmissionrefertothe 2mm curvedand straight
Viceroy Clips. Benchandanimal testing(seesection18 and19) prove the safetyandefficacyof the
smallersize,andtherefore Medstrongconcludesthatthe varietal designof the submittedandpredicate
 MechanicalDesign Equivalence
Both the Yasargil and the Viceroyclipsutilize the same mechanical designforactuatingthe clipbyusing
a tensionedspringwithsufficientforce toocclude ananeurysm. The predicate applieruseshinged
tongswhichrequiresaforce of gripon the tong handlestoactuate the clip. The submittedapplieruses
a tensionedspringconnectedtohookstowhichistoggledbya wheel onthe applier. Althoughthe
mechanical designbetweenthe twoisdifferent,the ultimatemode of action(i.e.clampingthe clip
throughmechanical action) isfunctionallyidentical. Benchandanimal testing(see sections18and 19)
showthat safetyandefficacyof the device isunaffectedbytechnological characteristics. Medstrong
concludesthatthe mechanical designsof the submittedandpredicate devicesare substantially
equivalent.

 MaterialsEquivalence
The materials,titaniumalloyandstainlesssteel,usedinthe constructionof the submittedclipandclip
applierare listedasa material usedinthe constructionof the predicate clipandclipapplier. Medstrong
concludesthatthe materialsof the submittedandpredicate device are substantiallyequivalent.
 Principal OperatorEquivalence
Both deviceslistaphysicianasthe principal operatorof the device. Medstrongconcludesthatthe
principal operatorof the submittedand predicate device is substantiallyequivalent.
 UseLocation Equivalence
Both deviceslistthe operatingroomasthe use locationof the device. Medstrongconcludesthatthe
use locationof the submittedandpredicate device issubstantiallyequivalent.
 UseType Equivalence
Both devicesindicate the aneurysmclipistobe usedone time asa permanentortemporarydevice.
Medstrongconcludesthatthe use type of the submittedandpredicate device issubstantially
equivalent.
 Sterilization Equivalence
Both devicesutilizee-beamsterilization(irradiation) tosterilize the device. Medstrongconcludesthat
the sterilizationof the submittedandpredicate device issubstantiallyequivalent.
Giventhe explanationsabove,Medstrongconcludesthat the devicesare substantiallyequivalent.

c. 510(k) Flowchart Comparison to Predicate Device
 Is the predicatedevice legally marketed?
o YES. The predicate device wasclearedunderpremarketnotificationK131500
 Do the deviceshavethe sameintended use?
o YES. Though the language differs,boththe applicationdevice andthe predicate device
are indicatedforthe occlusionof cerebral aneurysms. Giventhatthe indicationsforuse
are analogous,the intendedusescanbe assumedtobe identical.
 Do the deviceshavethe sametechnologicalcharacteristics?
o NO. Bothdeviceshave identical fundamental technologybyusing atensionedspringto
effectthe occlusion. The submissionandpredicatedifferinthattheyuse different
modesof actionto actuate the clip throughthe applier. Consequentially,the assembly
of the submitteddevice differsfromthe predicate device.
 Do the devicesraise differentquestionsof safety and effectiveness?
o NO. The deviceshave the same intendeduse,are intendedforthe same patients,and
the differencesof the technologyandthe sizesof the clipdonotraise different
questionsof safetyandefficacy. Additionally, the benchandanimal testingperformed
(see section18 and19) showsequivalence tothe safetyandefficacyof the predicate
device.
 Are the testing methodsacceptable?
o YES. Acceptedstandardsare usedwiththe attendingacceptedtestingmethodology.
See sections18 and 19 forsupportingevidence. Belowisalistof the standards:
 ISO9713: Neurosurgical implants –Self-closingintracranial aneurysmclips
 ASTMF2119: Evaluationof MR Image Artifacts
 ASTMF2182: Measurementof RadioFrequencyInducedHeatingDuring
MagneticResonance Imaging
 ASTMF2213: Qualitative Measurementof MagneticallyInducedTorque inthe
MagneticResonance Environment
 ASTMF2052: Measurementof MagneticallyInducedDisplacementForce on
Medical Devicesinthe MagneticResonance Environment
 In addition,acustomtensile testwasperformedtomeasure the tensile strength
at critical parts of the clipandapplier. The methodwasvalidatedperthe ICH
guideline: Q2(R1). See section18for details.
 Does thedatademonstrateequivalenceand supporttheindications?
o YES. All mechanical testing(closingforce testingand weldfailure tensile testing)and
magneticresonance testing(magneticresonance heating,torque anddisplacement
testing) demonstrate thatthe Viceroyaneurysmclipandthe Marquisapplieris
adequate foritsintendeduse.

d. Summary of Supporting Data
Benchtestingof the ViceroyAneurysmClipandthe MarquisAneurysmClipApplierhasyieldedthe
followingresults:
 The appliedforce tothe weldwhichbindsthe springtothe clipis beyondexpectedintracranial
forces.
followingresults:
 The 2mm clips(curvedandstraight) performadequately in vivo inregardsto the clip’socclusive
properties.
 The Marquis aneurysmclipapplierisfunctional forall applicationspertinenttoa 90 mm
 .

13. Proposed Draft Labeling
Thisdevice qualifiesforthe exemptionfromissuingdirectionsforuse forthe lay personunder21 CFR
801 SubpartD. The device willonlybe inthe possessionof apractitionerlicensedbylaw touse or order
the device.
Medstronghas metall the labelingrequirementsdescribedindevice-specificguidance,specialcontrols
or regulationsthatinclude:
- HHS PublicationFDA 89-420 – “Labeling - Regulatory RequirementsforMedicalDevices”.
- 21 CFR 801 – “Labeling”
- ISO15223-1:2012 – “Medical Devices – Symbolsto be used with medicaldevice labels, labelling and
information to besupplied – Part1: General Requirements.
- ISO15223-2:2012 – “Medical Devices – Symbolsto be used with medicaldevice labels, labelling and
information to besupplied – Part2: SymbolDevelopment,selection and validation.”
Beloware the proposedinstructionsforuse andlabelingforthe MarquisAneurysmClipapplierand
Viceroy AneurysmClip,separatedintosub-sectionsforclarityandconvenience.

a. Marquis Aneurysm Clip Applier
1. Draft – Instructions for Use
Medstrong Inc.
Marquis Aneurysm Clip Applier
Catalog #: 3122-01
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
Carefully read all instructions prior to use. Observe all contraindications, warnings and precautions
noted in these directions. Failure to do so may result in patient complications.
Instructions for Use
 Thispackage contains1 (one) Marquis AneurysmClipAppliersheathedinaprotective plastic
casing.
o Remove the protective casingbefore use.
 The Marquis ClipApplierisdesignedtobe usedexclusivelywiththe ViceroyAneurysmClip
(Catalog#: 3100-01 through3100-12). Use of thisproductwithotheraneurysmclipsmayresult
inpatientcomplications.
 The Marquis ClipApplierisnotSterile outof the package.
 The Marquis ClipAppliermaybe steamsterilized.
 The Marquis ClipAppliermaybe sterilizedusingaliquidchemical germicide,butmustbe
thoroughlyrinsedwithwaterpriortouse.
 The Marquis ClipApplierisintendedtobe usedina hospital operatingroombya licensed
physician.
Indicationsfor Use:
Precautions:
 Carefullyinspectthe package priortouse for any breachof the seal or damage to the contents.
If the package has beenopenedandcontentsdamaged,DONOTUSE and contact a Medstrong
representative.

 Thisitemisdesignedforrepeateduse,thoughitisnon-sterile. Cleaningandsterilizingthe
Marquis AneurysmClipApplieris stronglyrecommended.
 Thisitemismade from High-NitrogenStainlessSteel(grade 316). Patientsallergictothe
followingmetalsmayreacttothisproduct:
o Chromium
o Magnesium
o Nickel
o Iron
Directionsfor Use:
1) Inspectthe package for damage or disfigurement. Donotuse thisproduct if the packagingseal
has been breached,orthe productappearsdamaged.
2) Thisitemis non-Sterileoutof the package;cleandevice withone of the methodsbelow suitable
for high-nitrogenstainlesssteel:
a. SteamSterilization
b. LiquidChemical Sterilization

3) The distal endpossessthe specializedhooksforgrabbingthe Viceroyclips. The proximal end
possessesthe wheel fortogglingthe hooks. See the picture below formore detail:
4) Toggle the wheel towardthe distal endof the clipappliertoclose the attachedaneurysmclip.
5) Toggle the wheel towardthe proximal endof the clipappliertoopenthe attachedaneurysm
clip.
Complications:
The followingpotentialrisksordiscomfortsmaybe associatedwithocclusive proceduresperformed
withthisdevice. The frequencyandseverityof these eventscanvary,and may necessitateadditional
medical intervention,includingsurgery. Strictadherence tothe instructionsbefore use will helpto
reduce the incidence of complications:
Allergic reaction, Arrhythmias, Cardiac or respiratory arrest, Damage to brain, Death, Embolus Hemorrhage,
Infection, Stroke, Tamponade, Thrombosis, Vasovagalreaction.
Inspection,cleaning,disinfection,sterilization:
Thisproduct issold non-Sterile,anditisstronglyrecommendedthatthe productiscleanedprior touse.
Steamand chemical sterilizationsafe forstainlesssteel isappropriateforthisfunction.
Storage:
Store in a cool and dry place.

Servicingand Repair:
For any questions,concerns,ortoreceive servicingonthisproduct. Please call MedstrongCustomer
Service ((XXX)–XXX – XXXX) oremail custservice@medstrong.com
Warranty and Limitations:
TBD
Distributor/Rep Contact:
TBD
Manufactured By:
MedstrongInc.
12345 False Ave.
Lafayette,AL55555
Website:www.medstrong.com

2. Draft – Package Label
Medstrong Inc.
Marquis Aneurysm Clip Applier – Marquis 90-S
‡This package contains one (1), 90 mm, straight aneurysm clip applier
‡h Model Name: Marquis 90-S
‡g Lot #
‡H Use by date
Y See package insert for detailed description and instructions.
Do not use if the packaging is damaged.
Rx: Federal (USA) law restricts the device to sale by or on the order of a physician or other
licensed practitioner.
‡C
‡M Manufacturer: ‡Authorized Representative
Company Medstrong, Inc.
Street Address 12345 False Ave.

Lafayette, AL 55555
Tel: (XXX) – XXX – XXXX
City, State, Mail Code, Country Lafayette, AL 55555
Tel: Tel: (XXX) – XXX – XXXX
Fax: Fax: (XXX) – XXX – XXXX
Website: www.medstrong.com
The instructionsforuse and labelingdraftbelow refertothe ‘Marquis90-S’ model (straight, 90 mm). All
information,exceptforthe productreferencecodes,are identical foreachvariant.

1. Draft – Instructions for Use
Medstrong Inc.
Viceroy 2:
2 mm Aneurysm Clip, Straight
Catalog #: 3122-01
Caution: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
Carefully read all instructions prior to use. Observe all contraindications, warnings and precautions
noted in these directions. Failure to do so may result in patient complications.
Instructions for Use
 Thispackage contains 2 (two) boxesof straight,2mm aneurysmclips.
o Each box contains6 (six) individuallysealedaneurysmclips
 The ViceroyAneurysmClip isdesignedtobe usedexclusivelywiththe MarquisClipApplier
(Catalog#: 3122-01). Use of thisproduct withotheraneurysmclips appliers mayresultin
patientcomplications.
 The ViceroyAneurysmClip isSterile outof the package.
o Each clipis sealedinaself-contained,sterile casing.
o A breachof a seal overa clipcompromisesthe sterilityof thatcliponly. The otherclips
may be usedat any othertime withinthe shelf-life of the device (2years)
 The ViceroyAneurysmClip isintendedtobe usedina hospital operatingroombya licensed
physician.
Indicationsfor Use:
Precautions:
 Carefullyinspectthe package priortouse for any breachof the seal or damage to the contents.
If the package has beenopened andcontentsdamaged,DONOTUSE and contact a Medstrong
representative.
 Thisitemisdesignedforone-time use only,andissold Sterile.

 Thisitemismade from wroughttitanium6-aluminum4-vandiumally. Patientsallergictothe
followingmetalsmay reacttothisproduct:
o Titanium
o Aluminium
o Vanadium
Directionsfor Use:
1) Inspectthe package for damage or disfigurement. Donotuse thisproduct if the packagingseal
has beenbreached,orthe productappearsdamaged.
2) Each clipis ina self-containedcapsuleinpacksof 6 andis Sterile unlessthe seal isbreached.
3) Puncture the topof the capsule containingthe clipwiththe distal endof the Marquis Aneurysm
ClipApplier. The packagingisdesignedtoacceptthe applierinaspecificorientation. See the
picture belowfordetails:
Alignthe distal endof the MarquisAneurysmClip
Applierwiththe blue circle,andpushthroughto
puncture the sterile barrierandattachthe cliptothe
applier.
4) Once the clipis attachedto the applier,itisrecommendedthatthe operatoractuate the clipto
ensure properattachment. See the Marquisclipapplierinstructionsforfurtherdetail.
Complications:
The followingpotentialrisksordiscomfortsmaybe associatedwithocclusive proceduresperformed
withthisdevice. The frequencyandseverityof these eventscanvary,and may necessitateadditional
medical intervention,includingsurgery. Strictadherence tothe instructionsbefore use will helpto
reduce the incidence of complications:
Allergic reaction, Arrhythmias, Cardiac arrest, Damage to brain, Death, Embolus Hemorrhage,
Infection, Stroke, Tamponade, Thrombosis, Vasovagalreaction.
Inspection,cleaning,disinfection,sterilization:
Thisproduct issold Sterile forone-time use. DONOT REUSE thisproduct.

Storage:
Store in a cool and dry place.
Servicingand Repair:
For any questions,concerns,ortoreceive servicingonthisproduct. Please call MedstrongCustomer
Service ((XXX)–XXX – XXXX) oremail custservice@medstrong.com
Warranty and Limitations:
Thisproduct isgood fortwo yearsafterthe date of manufacture. Refertothe productlabel forthe date
of manufacture.
Distributor/Rep Contact:
TBD
Manufactured By:
MedstrongInc.
12345 False Ave.
Lafayette,AL55555
Website:www.medstrong.com

2. Draft – Package Label
Medstrong Inc.
Viceroy Aneurysm Clip – Viceroy 2
‡This package contains four (4), 2mm, straight clips
‡h Model Name: Viceroy 2
‡g Lot #
‡H Use by date
Y See package insert for detailed description and instructions.
D Single Use device. Do not reuse or resterilize
‡I
Do not use if the packaging is damaged.
Rx: Federal (USA) law restricts the device to sale by or on the order of a physician or other
licensed practitioner.
‡C
‡M Manufacturer: ‡Authorized Representative
Company Medstrong, Inc.
Street Address 12345 False Ave.

Lafayette, AL 55555
Tel: (XXX) – XXX – XXXX
City, State, Mail Code, Country Lafayette, AL 55555
Tel: Tel: (XXX) – XXX – XXXX
Fax: Fax: (XXX) – XXX – XXXX
Website: www.medstrong.com

14. Sterilization and Shelf Life
Medstrongsterilizeseveryvariantof the Viceroy AneurysmClipusingelectron-beamsterilization
(radiation). The MarquisAneurysmClipApplierisnotprovidedsterile,andmustundergoadisinfection
processdescribedinthe package insertprovidedwith everyapplier.
Listedbeloware the responsestothe requirementssetforthbythe FDA draft guidelinesdatedJanuary
21, 2016: SubmissionandReviewof SterilityInformationinPremarketNotification(510(k)) Submissions
for DevicesLabeledasSterile.
a. Description: Sterilization Method
Validationof the sterilizationcycle wasconductedinaccordance with ISO11137-1:2006: Sterilization of
healthcare products – Radiation – Part 1: Requirementsfordevelopment,validation and routinecontrol
of a sterilization processformedical devices. VDmax (VerificationDose Maximum) isthe specific
methodusedforthe validation. The Viceroyaneurysmclipsrequire 20kGy of radiationbasedonthis
methodasdeterminedthroughthe use of ISO11137-2:2013: Sterilization of health care products –
Radiation – Part 2: Establishing the sterilization dose andISO 11137-3:2006: Sterilization of health care
products – Radiation – Part 3: Guidanceon dosimetricaspects.
b. Description: Sterile Packaging
Packagingandsterilizationof the device meetsthe conditionssetforthbythe FDA consensusstandards
for sterile devices,AAMI/ANSI/ISO11607-1 and 2: 2006: Packaging forterminally sterilized medical
devices. Packagingisdesignedtobe compatible withsterilizationmethodtoretainsterile integrityof
the product andavoiddamage to the devicesuntil opened. Additionally,the entire shipping
configurationwillbe testedtobe inaccordance withASTMD4169: PerformanceTesting of Shipping
Containers and Systems andASTMF88-99: Standard TestMethod forSealStrength of Flexible Barrier
Materials. The devicesare packagedin Tyvek.
c. Sterility Assurance Level (SAL)
The SAL for the ViceroyAneurysmClipswill be 10-6
or better. The probabilityof anorganismsurvivinga
givencycle will notbe more thanone out of one million.
d. Description: Sterilization Site
Electronbeamradiationisthe sterilizationmethodusedforthe Viceroy AneurysmClips. Below isthe
contract sterilizerused.
Contract Sterilizer:E-BeamInc.
Contact Person:JamesE.Beam:
Address: 555 Fake St.,Lafayette,AL55555
Tel.:555-555-5555
e. Non-Pyrogenicity of Device
The Viceroy aneurysmclipwill be labeledasnon-pyrogenicdue tothe LAL testingperformed. Fora
detaileddescription of the methodandresultsused,seesection16(Biocompatibility)of thisdocument.

f. Radiation Sterilization Dose
>20 kGy
g. Sterilization by User
The Viceroy Aneurysmclipissingleuse onlyandshouldnotbe resterilizedbythe user. The Marquis
AneurysmClipappliermaybe steamsterilized.
h. Expiration Date
The expirationdate withregardstothe sterilityof the ViceroyAneurysmclipswill be 2yearsafter the
manufacture date baseduponthe resultsof a 2 yearacceleratedshelf-life studyperformedperASTM
F1980: Accelerated Aging of Sterile Medical Device Packages. Thisstudyhasbeencompleted;the report
isincludedinTab2 of thissubmission. Thisstudyincludesthe storage of packageddevicesat55°C for
155 days. The companyanticipatesthatitwill validate5yearsof shelf lifepriortocommercialization. A
copy of the expirationdate protocol isavailable uponrequest. A real-time shelf life studywas also
initiatedconcurrentlywiththe acceleratedshelf life study.

15. Biocompatibility
The biocompatibilityof the ViceroyAneurysmClipandthe Marquis AneurysmClipApplierwasassessed
accordingto ISO 10993-1: Biological Evaluation of Medical Devices Part1: Evaluation and Testing.
Belowisa table containingthe materialsandthe scope of theircontactas indicatedbyISO10993-1 -
Annex A.
Device Material ISO # Body Contact Contact Duration
Viceroy
Aneurysm
Clip
Titanium 6-
aluminium 4-
vanadium alloy
5832-3
Implant Device –
Tissue/Bone
Permanent (> 30
days)
Marquis Clip
Applier
High Nitrogen
Stainless Steel
(Grade 316)
5832-9
External Communicating
Device –
Tissue/Bone/Dentin
Limited (< 24 hr)
WithISO 10993-1 – Annex A as a reference (seepg. 52 of thisdocument), the materialslistedinthe
table above shouldbe subjectedtothe followingbiocompatibilitytestslistsbelow. The materialstested
were comprisedof whole devicesthathadundergone all manufacturingprocessesincluding
sterilization.
Titanium 6-aluminium 4-vandium alloy
Test Methodology Result
Cytotoxicity ISO 10993-5:2009 Pass
Sensitization ISO 10993-10:2010 Pass
IrritationorIntracutaneousReactivity ISO 10993-10:2010 Pass
Systemic Toxicity ISO 10993-11:2006 Pass
Subchronic Toxicity ISO 10993-11:2006 Pass
Genotoxicitiy ISO 10993-3:2014 Pass
Implanatation ISO 10993-6:2007 Pass
High Nitrogen Stainless Steel – Grade 316
Test Methodology Result
Cytotoxicity ISO 10993-5:2009 Pass
Sensitization ISO 10993-10:2010 Pass
IrritationorIntracutaneousReactivity ISO 10993-10:2010 Pass
Note:All biocompatibilityreportsmay be foundin Tab 4 ofthis submission

The ViceroyAneurysmClipandMarquisClipApplierpassedall ISO10993 testing. Copiesof the original
reportscan be foundin AppendixA of thisdocument. The materials usedforthe ViceroyAneurysmClip
and MarquisClipApplierare commoninmedical devices,andhave beenspecificallyusedinthe
predicate device (K131500). ISO 5832-3 details the characteristicsand correspondingtestmethodsfor
the titanium6-aluminium4-vandiumalloy. ISO5832-9 detailsthe characteristicsandcorrespondingtest
methodsforhighnitrogenstainlesssteel. The presence of these ISOs,biocompatibilitytestresults
(appendix A),and the presence of the relevantmaterialsinthe predicate device,allow Medstrongto
conclude thatthe medical communityissatisfiedthatthe benefitsof these materialsoutweighthe risks
of patientinteractions. Noadditional warningsare necessarytomitigate anyinteractionrisks. Itcan be
concludedthatthe materialsinthe ViceroyAneurysmClipandthe MarquisClipAppliersdonotpose a
riskof negative interactionwiththe device’sprospectivepatients.

 ISO 10993-1 – AnnexA

16. Software
Thissectiondoesnotapply. Thisdevice hasno software.

17. Electromagnetic Compatibility and Electrical Safety
Thissectiondoesnot apply. Thisdevice hasno electrical components.

18. Performance Testing - Bench
Medstronghas followedthe recommendationsfor collectingperformance dataoutlinedinthe device-
specificguidelines whenappropriate. The guideline below specificallyaddressesthe occlusivefunction
of the clip.
 ISO9713:2002 (Neurosurgical Implants–Self-ClosingIntracranial AneurysmClips)
o Thisdocumentdetailsthe methodologyusedforthe measurementof closingforce of a
clip.
The guidelinesbeloware usedtoassessif the clip maycause injurywithinamagneticresonance
environment.
 ASTMF2119 (Evaluationof MR Image Artifacts)
o Thisdocumentdetailsthe methodologyforcharacterizingthe distortionandsignal loss
artifactsproducedina magneticresonance image bya passive implant.
 ASTMF2182 (Measurementof RadioFrequencyInducedHeatingDuringMagneticResonance
Imaging)
o Thisdocumentdetailsthe methodologyformeasuringradiofrequencyinducedheating
on or nearas passive medical implantanditssurroundingsduringmagneticresonance
imaging(MRI).
 ASTMF2213 (StandardTestMethodfor Measurementof MagneticallyInducedTorque on
Medical Devicesinthe MagneticResonance Environment)
o Thisdocumentdetailsthe methodologyformeasuringthe magneticallyinducedtorque
producedbya staticmagneticfieldinthe magneticresonance environmentcompared
to the torque appliedbythe gravitational force of the implant.
 ASTMF2052 (StandardTestMethodfor Measurementof MagneticallyInducedDisplacement
Force on Medical Devicesinthe MagneticResonance Environment)
o Thisdocumentdetails the methodologyformeasuringthe magneticallyinduced
displacementforce producedbystaticmagneticfieldgradientsonmedical devices
comparedto the weightof the medical device.
 ASTMF2129 (StandardTetMethod forConductingCyclicPotentiodynamicPolarization
MeasurementstoDeterminethe CorrosionSusceptibilityof Small ImplantDevices)
o Thisdocumentdetailsthe methodologyformeasuringthe corrosionpotentialof small,
metallicimplantdevicesthroughcyclicpotentiodynamicpolarization.
In additiontothe available device-specificguidelines,Medstronghas developedamethod totest
specificparameterssurroundingthe clipandclipapplier. These methodsare listedand summarized
below.
 TM1357 (TensileStrengthof the CliptoWire Weld)
o The purpose of thistest isto characterize the strengthof the weldbetweenthe clipand
the springwire.

The tablesbelowdetail the summaryof the device-specificguidelines.
Table 18.1: ISO 9713:2002 (Neurosurgical Implants – Self-Closing Intracranial Aneurysm Clips
Item StandardSpec
Location
SpecificationName orDescription
or Test Purpose
Methodof
Verification
Acceptance
Criteria
Pass/
Fail?
Report
Numberor
Location
Comments
1 8.2 Tolerance onNominal Closing
Force
Test ±7.5% of
Nominal
ClosingForce
(200 N)
Pass TR2011 Each of the Viceroyclip
varietalswaswithin
7.5% of the nominal
closingforce. See
Appendix IIforthe full
report.
2 8.3 Degradationof ClosingForce Test < 10% load
reductionafter
1000 cycles
Pass TR2013 Each of the Viceroyclip
varietalsshowed a
degradationof closing
force at < 10% after
1000 cycles. See
report.
Table 18.2: ASTM F2119 (Evaluation of MR Image Artifacts)
Item StandardSpec
Location
or Test Purpose
Methodof
Verification
Acceptance
Criteria
Pass/
Fail?
Report
Numberor
Location
Comments
3 6.1 Quantificationof Image Artifact
Production
Test < 5 unitsper
clip
Pass TR1266 Each of the viceroyclip
varietalspossessed<5
units. See Appendix II
for the full report

Table 18.3: ASTM F2182 (Measurement of Radio Frequency Induced Heating During Magnetic Resonance Imaging
Item StandardSpec
Location
or Test Purpose
Methodof
Verification
Acceptance
Criteria
Pass/
Fail?
Report
Numberor
Location
Comments
4 7.1 Temperature Change Test < 2°C after4
hoursexposure
Pass TR1333 The smallestandlargest
Viceroyclipvarietals
were assayedusingthis
guidance.See Appendix
II forthe full report.
Table 18.4: ASTM F2213 (Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic
Resonance Environment)
Item Standard
Spec
Location
SpecificationName or
DescriptionorTest
Purpose
Methodof
Verification
Acceptance
Criteria
Pass/ Fail? Report
Numberor
Location
Comments
5 7.1 Torque Measurement Test Magnetically
Induced
Torque ≤
Gravitational
Torque
Pass TR2555 Gravitational Torque isassumed
at the worstcase by takingthe
weightof the largestclipand
multiplyingitbyit’sweight.
Onlythe Viceroy10/10C clips
were tested. See Appendix IIfor
the full report

Table 18.5: ASTM F2052 (Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the
Magnetic Resonance Environment)
Item StandardSpec
Location
DescriptionorTest
Purpose
Methodof
Verification
Acceptance Criteria Pass/
Fail?
Report
Numberor
Location
Comments
6 8.1 DeflectionMeasurement Test MagneticallyInduced
Deflection≤45°
Pass TR5311 Since the deflectionis
partiallyafunctionweight,
onlythe Viceroy10/10C
clipswere tested. See
report.
Table 18.6: ASTM F2129 (Standard Tet Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the
Corrosion Susceptibility of Small Implant Devices)
Item StandardSpec
Location
DescriptionorTest
Purpose
Methodof
Verification
Acceptance Criteria Pass/
Fail?
Report
Numberor
Location
Comments
7 8.1 Potentiodynamic
Polarization(Cyclic,
Forward)
Test °> 30 SI Pass TR5398 Since largerdevicesare
more effectivein
measuringthe corrosion
potential, onlythe Viceroy
10/10C clipswere tested.
See AppendixIIforthe full
report.
8 9.1 Potentiodynamic
Polarization(Cyclic,
Reverse)
Test °> 30 SI Pass TR5398

TR1357-01 – Tensile Strength of Clip to Wire Weld
Purpose: To characterize the strengthof the weldbetweenthe clipandthe springwire throughtensile
strengthtesting. Figure Dbelowgivesagraphical representationof the areawhere the springmeets
the clip.
Acceptance Criteria: The predicate device (K131500) reportedthatthe weldto springwire can
withstand30 N of force. Therefore,the Viceroyclipmustexhibitaweldstrengthof ≤ 30N. The data
possessa95% confidence ratingwitha90% reliability. Therefore,the distributionmustfall betweenthe
meanplusor minusthe standarddeviationmultipliedby1.697. The data mustpossessa normal
distributionasdeterminedbythe Anderson-darlingnormalitytest.
Methodsand Materials: 40 Viceroyclips(2mm) pulledrandomlyfrom10differentlots were affixedto
the tensile testingapparatusatconsistentpointsalongthe clip,andwere pulledtofailure. The max
loadwas extrapolatedfromthe instrument,andrecorded.
Results:
Sample # –
Lot #
Max Load
(N)
Average Standard Deviation Standard Deviation *
1.697
Pass/Fail
1 – 132211 33.45
32.76 2.02 3.43 Pass
2 – 132312 31.89
3 - 148864 29.76
Etc. Etc.
Anderson-DarlingNormalityTest: Usingminitab,the Anderson-DarlingNormalitytestwasperformed.
The p-value wascalculatedto0.87; therefore, the dataisnormal.
Conclusions:
The average max load metthe acceptance criteria. Additionally,everydatapointwaswithinthe limits
requiredfora 95% confidence /90% reliability. The cliptospringwire weldstrengthisequivalenttothe
predicate device (K131500).

19. Performance Testing - Animal
The ViceroyAneurysmClip/MarquisClipAppliersystemutilizesasecondaryspringmechanism, toggled
by a wheel onthe applier,inordertoactuate the clip. This methodof clampingisdifferentthanthe
traditional clipappliermodel,whichreliesonthe operatortoapplythe appropriate tensiontothe clip
applierhandle. Because of thismode of operation, Medstrongperformedanimaltestingtoevaluate the
feasibilityof the procedure technique priortohumanuse as well asevaluate potentialperformance
issuesassociatedwithmechanicallyinducedclipactuation. The testingwasperformedperthe Animal
TestingProtocol 431. A summaryof the protocol and the resultsfollow.
Animal Testing Protocol 431: Feasibility of Viceroy Aneurysm Clip and Marquis Clip Applier
Purpose:
The objectof thisstudyisto collectdata onthe ease of use associatedwiththe ViceroyAneurysmClip
and MarquisClipApplier. Thisincludes: Navigatingthe clipandapplierina surgical setting,applyingthe
clipperthe intentionsof the operator,andremovingthe clipperthe intentionsof the operator.
Acceptance Criteria:
Thisstudywas initiatedtogauge the ease andaccuracy of use as definedbythe operator. Anequivalent
or favorable comparisonof the ViceroyAneurysmClip/MarquisClipAppliertoa traditional mode of
clipapplication(Yasargil AneurysmClipandClipappliers) will be usedasthe acceptance criteriaforthe
purposesof thisstudy.
Methodsand Materials:
1. The brown rat (rattusnorvegicus) waschosenforthisstudy.
2. A total of three operatorswere employedforthisstudy. Each operatorreceivedthreeratswith
indicationstoinsert,andsubsequentlyremove,ananeurysmclipin orondifferentlocationsof
the animal.
a. Each rat isanaesthetizedand treatedashumanelyaspossibleforthisprocedure.
3. A recorderispresentduringeachoperationinordertoannotate the operator’scomparative
thoughtswithregardsto the clipand clipappliersystems.
4. The appropriate incisionwasmade asnecessaryby the operatorinorderto place the clipas
directed. The locationsforeachrat are as follows:
a. Applyandremove aclipon the tip of the specimen’stail. Performthisstepusingeach
of the clipand clipappliersystems.
b. Create an approximately5cm subdermal incisiononthe rat’sthigh. Applythe clip
betweenthe epidermalanddermal layersandthe remove.
c. Create an appropriatelysizedincisioninthe animal’sabdominal regioninordertoapply
and subsequentlyremove,the cliponthe rat’slowerintestine.

Results:
The resultsof the testingare organizedinthe table below. A keyisbelow the table forreference:
Operator ClipArea Observation Overall
Impressions
LC
Tail
Both the YCS and VMwere able toclipontothe tipof the
tail accurately. Both systemswere easytoposition
Comparable
Thigh Dermal
Both the YCS and VMwere able toclipbetweenthe
dermal andsubdermal layersaccurately. Bothsystems
were easyto position.
Comparable
Lower Intestine
The wheel associatedwiththe VMallowedthe operator
to focuson positioningandnotmaintainingthe
appropriate pressure onthe clipappliersutilizedbythe
YCS.
VM
Favorable
PF
Tail
Both the YCS and VMwere able toclip ontothe tipof the
Comparable
Thigh Dermal
Comparable
Lower Intestine
YCS.
VM
Favorable
JS
Tail
Both the YCS and VMwere able toclipontothe tipof the
Comparable
Thigh Dermal
Comparable
Lower Intestine
YCS.
VM
Favorable
YCS = Yagarsil ClipandClipApplierSystem
VM= ViceroyClipandMarquisClipApplierSystem
Conclusion:
The animal testingshowedthatthe ease of use andpositioningaccuracyassociatedwiththe Viceroy
ClipandMarquis ClipApplieriscomparable tothe predicate device.

20. Performance Testing - Clinical
Thissectiondoesnotapply. Nohuman testingwasnecessarytodemonstrate substantialequivalenceor
to demonstrate thatthe device canmeetitslabelingclaims.
In accordance withthe FDA’sGuidance,Form3674 “Certification of ComplianceUnder42 U.S.C. §
282(j)(5)(B),withRequirementsof ClinicalTrials.gov Data Bank(42 U.S.C. § 282(j))”is not necessaryfor
thispremarketnotificationsince noclinicaltrialswere conductedtosupportthissubmission.

21. Design Control Activities
Designcontrol activitiesare notapplicabletothissubmission.

Appendix A – Biocompatibility Test Results
Tab 1 – Conformance Lab Documentation
Tab 2 – 2 Year Accelerated Shelf Life Report
Tab 3 – Misc. Forms
Tab 4 – Biocompatibility Reports

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