Final Project Slides Buchheit Harings Hussein

CARDIOVASCULAR
MONITORING SYSTEM
(CMS)
510(K)
Scott Buchheit
Andrew Harings
Moe Hussein
1

Product Classification & Code
Class II medical device
Regulation 21 CFR 870.2770
Impedance plethysmograph
Device used to estimate peripheral blood flow by
measuring electrical impedance changes in a region
of the body such as the arms and legs.
Product code DSB
FDA Review Branch: Division of Cardiovascular Devices
Eligible for third party review
2

Device Description
General Description
Intended Use (Indications for Use)
Principle of Operation
3

General Description
Cardiovascular Monitoring System consists of:
Multipurpose Smart Technology finger monitor
Base monitor
Wireless data transmission
Physician programmer
 Compatible with Microsoft Excel
4

Intended Use
The Cardiovascular Monitoring System is indicated
for use for adults for in-home monitoring of
cardiovascular vital signs during exercise, during
rehab, after prescribed medication, and/or lifestyle
changes under the supervision of a licensed
healthcare practitioner. The device monitors and
displays systolic and diastolic blood pressure, heart
rate, and arterial blood oxygen saturation.
5

Principle of Operation
Non-invasively measures:
Blood pressure – systolic and diastolic
Blood arterial oxygen saturation (SPO2)
Heart rate
Data is transmitted wirelessly from the finger unit and
measurements are displayed on the base monitor
Remote programming by physician
Patient can transmit data to physician via internet
Display patient data using Microsoft Excel
6

Principle of Operation: Non-Invasive
Blood Pressure
Cardiovascular Monitoring System uses the Oscillometric
method to measure the blood pressure.
The Oscillometric method senses the vibrating signal via
the closed air pipe system and utilizes the microcomputer
to automatically sense the characteristics of the pulse
signal.
The use of a stethoscope is not needed to monitor the
Korotkov sound when deciding the systolic or diastolic
pressure.
7

Principle of Operation: Non-Invasive
Blood Pressure
Through a simple calculation, the reading can reflect
the accurate real blood pressure.
The Systolic pressure is defined as the pressure
when the cuff pressure oscillating amplitude begins to
increase.
Diastolic pressure is the pressure when the cuff
pressure oscillating amplitude stops decreasing
8

Principle of Operation: Pulse Oximetry
Arterial oxygen saturation is measured by passing
light of two different wavelengths through the patients
finger to a photo detector.
The changing absorbance at each of the
wavelengths is measured, allowing determination of
the absorbance due to the pulsing arterial blood.
9

Principle of Operation: Heart Rate
Heart rate is measured with electrical signal
detection technology and is displayed as a digital
read out.
10

Principle of Operation Cont.
The system includes wireless technology to transmit
data from the patient sensor to the base monitor for
storage, analysis and display.
Physician can download patient data and display
results graphically or in tabular form using Microsoft
Excel
The data can be uploaded for remote monitoring by
a healthcare professional
11

Physician programmer establishes individual exercise
goals for blood pressure, arterial blood saturation, and
heart rate for cardiovascular patients:
 during rehabilitation
 after prescribed medications
 lifestyle changes
12

The patient can send the data to the base monitor at
prescribed times as directed by the physician or the
physician can upload the data remotely for
monitoring/ interpretation of the data through the use
of wireless technology
Physician programmer will determine how downloaded
data will be displayed using Microsoft Office Excel, either
graphically, in tabular format or both
13

Substantial Equivalence
Three predicate devices
The Cardiovascular Monitoring System Finger Blood
Pressure Monitor, MDMouse (K081924)
MD300C1 Fingertip Pulse Oximeter (K093757)
Lifegard ICG Monitor (K041434)
Comparison table used to compare CMS to the
predicate devices
14

Comparison Table
15
Feature/Characteristic Cardiovascular
Monitoring System
MDMouse Finger Blood
Pressure Monitor
Fingertip Pulse
Oximeter
Lifegard ICG Monitor
Product Code DSB DXN DQA DSB
Intended Use In-home monitoring of
cardiovascular vital
signs in adult males and
females during exercise,
during rehab, after
prescribed medications,
and/or life-style
changes under the
supervision of a
licensed healthcare
practitioner.
Noninvasive blood
pressure measurement
system intended to
measure the systolic
and diastolic blood
pressures and pulse
rate of an adult
individual.
Portable non-invasive,
spot-check, oxygen-
saturation of arterial
hemoglobin (SpO2)
and pulse rate of
adult and pediatric
patient at home, and
hospital.
Monitor cardiac output
through the use of
Impedance
Cardiography (ICG) in
adult males and
females on adult and
pediatric patients in
hospital areas and
hospital-type facilities,
such as clinics.
Location of Use Home Home Home or hospital Hospital or clinic
Prescription/over the
counter
Prescription Over the counter Prescription Prescription
Device Design Finger unit, silicon
lining, inflatable,
wireless base monitor
Inflatable finger cuff,
silicon lining
Finger unit, silicon lining NIBP cuff, single lead
ECG, base monitor

Comparison Table
16
Monitoring System
Pressure Monitor
Fingertip Pulse
Oximeter
Indications for Use Non-invasively measure
systolic and diastolic
blood pressure, heart
rate, duration of
achieved maximum
heart rate, and arterial
blood oxygen saturation
in adults
Non-invasively measure
systolic and diastolic
blood pressure
arterial blood oxygen
saturation
ECG, heart rate, blood
pressure (NIBP),
functional arterial
oxygen saturation
(SpO2) respiration rate,
temperature and carbon
dioxide (CO2) on adult
and pediatric patients
Sterile/Non-sterile Non-sterile Non-sterile Non-sterile Non-sterile
Patient Contacting
Materials
Silicone
HDPE plastic
Silicone HDPE plastic N/A
Biocompatibility Testing ISO 10993-1 ISO 10993-1 ISO 10993-1 N/A
Inflation Mechanism Pneumatic Pneumatic N/A N/A
Blood Pressure
Measurement
Systolic and diastolic via
oscillometric method
Systolic and diastolic via
N/A Systolic and diastolic via
Systolic Blood Pressure
Measurement Range
90-200 mm Hg, 5 mm Hg
increments
60-240 mm Hg, 5 mm Hg
increments
N/A 60-240 mm Hg, 5 mm Hg
increments
Diastolic Blood Pressure
Measurement Range
50-140 mm Hg, 5 mm Hg
increments
40-180 mm Hg, 5 mm Hg
increments
N/A 40-180 mm Hg, 5 mm Hg
increments

Comparison Table
Monitoring System
Pressure Monitor
Fingertip Pulse
Oximeter
Pulse Oximetry
Measurement
Mechanism
Dual light source and
photo detector sensor
N/A Dual light source and
photo detector sensor
N/A
Pulse Oximetry
Measurement
The ratio of light
absorbed at systole and
diastole
N/A The ratio of light
absorbed at systole and
diastole
N/A
Arterial Oxygen
Saturation Measurement
Range
80-100%, in 2.5%
increments
N/A 80-100%, in 1%
increments
N/A
Heart Rate
Measurement
Mechanism
Dual light source and
photo detector
N/A Dual light source and
photo detector
N/A
Heart Rate
Measurement Range
60-180 beats/minute, 5
beats/minimum
increment
N/A 30-254 beats/minute, 1
beat/minimum
increment
30-250 beats/minute, 5
beats/minimum increment
Data transmission Wireless USB cable N/A USB cable
Cleaning Surface cleaning of
finger unit with IPA, as
necessary
N/A Surface cleaning as
needed
Surface cleaning with IPA
as necessary
17

Comparison Table
Monitoring System
Pressure Monitor
Fingertip Pulse
Oximeter
Base monitor Features On/off, keypad, display,
activate display button,
display menu
N/A N/A On/off, keypad, display,
alarm controls, graphical
and tabular data display
Monitor data storage Up to 90 days N/A N/A Up to 72 hours
Finger unit monitor
features
Digital read out display
of
N/A Digital read out display N/A
Software programs Physician programs,
calculation and read-
out, Microsoft Excel
compatible; EHR
compatible
Physician programs,
calculation, digital read-
out; EHR compatible
Calculation, digital read-
out
Physician (or other
programmer) programs,
calculation, read-out
Power type (1) 9.0 V battery USB connection to PC 2 AAA alkaline or
rechargeable batteries
AC or Internal sealed
lead-acid batteries
18

Substantial Equivalence Discussion
The CMS has the same intended use as the
predicate devices.
The CMS is substantially equivalent to the predicate
devices in terms of:
Design
Operation
Measurement methods and accuracy
19

No questions arise from the design, materials, or
technological characteristics that would affect the safety
and effectiveness of the device.
Performance test results show that the Cardiovascular
Monitoring System produces measurements as accurate
as predicates.
20

Differences
21
Monitoring System
Pressure Monitor
Fingertip Pulse
Oximeter
Location of Use Home Home Home or hospital Hospital or clinic
Prescription/over the
counter
Prescription Over the counter Prescription Prescription
Data transmission Wireless USB cable N/A USB cable
Monitor data storage Up to 90 days N/A N/A Up to 72 hours
Software programs Physician programs,
calculation and read-
out, Microsoft Excel
compatible; EHR
compatible
Physician programs,
calculation, digital read-
out; EHR compatible
Calculation, digital read-
out
Physician (or other
programmer) programs,
calculation, read-out

Differences
Prescription vs. over-the counter
Because the Cardiovascular Monitor has features that
require it be used under physician supervision, it is
appropriately only for prescription use.
In-home use
Prescription use only
Adequate IFU
Programming and monitoring by healthcare practitioner
22

Differences
Wireless data transmission from Multipurpose
Smart Technology finger monitor to base monitor
Uses radio waves
Technology similar to wireless internet and cellular
phones
Validated during device validation
Data storage in base monitor
Same technology as predicate, but the hardware
contains 20x data storage capacity
Validated during device validation
23

Differences
Use of Microsoft Excel to export and analyze
patient data
Well-known software from Microsoft
Guidance document: Guidance for Industry, FDA
Reviewers and Compliance on Off-The-Shelf Software
Use in Medical Devices
Validated for use with CMS
24

Summary of required standards
AAMI/ANSI/IEC 60601-2-27:2011 Medical
electrical equipment - Part 2-27: Particular
requirements for the basic safety and essential
performance of electrocardiographic monitoring
equipment
To compare the performance characteristics of different
products: in this case the base monitor which is
recording the continues monitoring of the cardiovascular
vital signs
AAMI/ANSI EC13:2002/(R) 2007 Cardiac monitors, heart
rate meters, and alarms
25

Summary of Required Standards
AAMI/ANSI EC57:1998/(R) 2008 Testing and
reporting performance results of cardiac rhythm
and ST-segment measurement algorithm
 Heart rate variability for CMS
ISO 9919:2005: Medical electrical equipment -
Particular requirements for the basic safety and
essential performance of pulse oximeter equipment
for medical use
26

Summary of Required Standards
 ISO 80601-2-61 First edition 2011-04-01 Medical
requirements for basic safety and essential
performance of pulse oximeter equipment
IEC 60601-1
the safety and effectiveness of medical electrical
equipment
IEC 60601-1-2
ISO 10993
27

Summary of applicable guidance
documents
Guidance for Industry and FDA Staff: Format for
Traditional and Abbreviated 510(k)s August 12,
2005
Refuse to Accept Policy for 510(k)s: Guidance for
Industry and Food and Drug Administration Staff
December 31, 2012
Guidance for the Content of Premarket
Submissions for Software Contained in Medical
Devices May 11, 2005
28

Summary of applicable guidance
documents
Device Labeling Guidance #G91-1 (blue book
memo) March 8, 1991
Draft Guidance for Industry and FDA Staff - Pulse
Oximeters - Premarket Notification Submissions
[510(k)s]
General Guidance Document: Non-Invasive Pulse
Oximeter
29

Bench Testing
Bench testing was performed on the device to
demonstrate the effectiveness and accuracy of
measurements.
A hand held pulse oximetery analyzer
manufactured by Fluke Biomedical called the
ProSim 8 Vital Signs Patient Simulator used to
compare the system’s pulse oximeter SPO2
readings with the simulator set points.
30

Bench Testing
Verification testing to verify accuracy of the systolic and
diastolic blood pressure measurements of the
Cardiovascular Monitoring System, measured in units of
mm Hg, and compare it side-by-side to the MDMouse
finger blood pressure monitor.
Compare the system’s pulse oximeter SPO2 readings
with the simulator set points and confirm accuracy of
measurement.
Heart Rate test
The study was conducted using patients during pre-
operative period with goal of capturing the heart rate in
the three different phases of preoperative,
intraoperative and postoperative.
31

Bench Testing Results:
32
The results of the Cardiovascular Conditioning Monitor
System testing shows that it meets all criteria for safety
and effectiveness as required by the FDA.
The Cardiovascular Monitoring System finger monitor
was tested at all data points for systolic and diastolic
pressure.
 All measurements had passing results for systolic and
diastolic pressure measurements for the Cardiovascular
Monitoring System.
Both the Cardiovascular Conditioning Monitor and the
Finger pulse oximeter averaged the same when it come to
the heart beat measurements

Bench Testing Results:
The Bench testing shows the CMS produces results
equivalent to the predicates.
33

Standards and Guidance documents
used for Bench testing
IEC 80601-2-30 Edition 1.0 2009-1 Medical
performance of automated non-invasive
sphygmomanometers
ISO 80601-2-61 First edition 2011-04-01 Medical
34

used for Bench Testing
AAMI/ANSI SP10 Non-automated
Sphygmomanometer (Blood Pressure Cuff)
Guidance Version
AAMI/ANSI/IEC 80601-2-30:2009 Medical
performance of automated noninvasive
sphygmomanometers
35

Clinical Testing
Test Protocol written, approved and executed for
Verification of Accuracy of Systolic and Diastolic
Blood Pressure Measurements for the
Cardiovascular Monitoring System.
Clinical testing was performed at the University
of Mississippi Medical center where an IRB -
approved protocol was performed.
36

Clinical Testing
The study was to compare the predicate devices –
The MDMouse Finger Blood Pressure Monitor cleared
under K081924,
The Fingertip Pulse Oximeter cleared under K093757
 The Lifegard ICG Monitor cleared under K041434 with
the Cardiovascular Monitoring System (CMS).
Verify real-time data to that of the Cardiovascular
Monitoring System (CMS).
37

Clinical Testing Results:
• All testing results show that the Cardiovascular Monitoring
System (CMS) is substantially equivalent to the predicate
devices.
38

used for Clinical testing
ISO 9919:2005: Medical electrical equipment -
Particular requirements for the basic safety and
essential performance of pulse oximeter equipment
for medical use
AAMI/ANSI SP10 Non-automated
Sphygmomanometer (Blood Pressure Cuff)
Guidance Version
ISO 80601-2-61 First edition 2011-04-01 Medical
39

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