Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a device for data acquisition and transmission, with no mention of AI/ML algorithms for analysis or interpretation of the collected physiological data. The performance studies focus on data capture, connectivity, and hardware performance, not algorithmic performance.

Therapeutic

No.
The device is intended to record, display, and store physiological data to aid in diagnosis and treatment. It is a diagnostic monitoring technology, not a therapeutic one.

Diagnostic

Yes
The "Intended Use / Indications for Use" section states, "The device is intended for use when the clinician decides to evaluate the physiologic signals as an aid to diagnosis and treatment." Additionally, the "Device Description" explicitly refers to the device as "the next generation diagnostic monitoring technology."

SaMD (Software as a Medical Device)

No

The device description clearly outlines three hardware components: the SimpleSENSE Garment with embedded sensors, the SimpleSENSE Signal Acquisition Unit (SAU) for data acquisition and transmission, and the SimpleSENSE Mobile Application. The performance studies also include verification and testing of these hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, the SimpleSENSE System is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
SimpleSENSE Function: The SimpleSENSE System directly measures physiological signals (ECG, respiration, heart sounds, activity) from the patient's body using sensors embedded in a garment. It does not analyze specimens taken from the body.
Intended Use: The intended use describes the device as recording, displaying, and storing physiological data as an aid to diagnosis and treatment. This is consistent with a physiological monitoring or recording device, not an IVD.

Therefore, the SimpleSENSE System falls under the category of a physiological monitoring or recording device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The SimpleSENSE System is intended for use at home, or at a healthcare facility, under the direction of a licensed medical professional, to record, display and store the following physiological data: a) 2 leads of Electrocardiogram; b) Respiration rate measured through thoracic impedance; c) Heart Sounds; and d) Activity including posture. The device is intended for use when the clinician decides to evaluate the physiologic signals as an aid to diagnosis and treatment. The SimpleSENSE System is intended to be used by patients at rest and not performing any activities or movements. ECG recordings are indicated for the manual assessment of cardiac rhythm disturbances. The device does not produce alarms and is not intended for active patient monitoring (real-time). The device is not intended for use as life supporting equipment on high-risk patients such as critical care patients. The device is not intended for use in the presence of a pacemaker.

Product codes (comma separated list FDA assigned to the subject device)

DXH, DSB, BZQ, DPS, DQD

Device Description

The Nanowear SimpleSENSE device is the next generation diagnostic monitoring technology that captures electrocardiographic (ECG) signals, respiration rate though thoracic impedance, heart sounds, activity including posture with sensors embedded on a wearable textile garment. The signals are stored and wirelessly transmitted to a smartphone, and forwarded to a medical professional for review.
The garment is designed to be unobtrusive to everyday activity and provide an easy and efficient means of capturing ECG, respiration rate, heart sounds and activity data from patients.
The garment is designed to be unobtrusive to everyday activity and provide an easy and efficient means of capturing ECG data from patients. The device consists of three (3) components:

The SimpleSENSE Garment: an integrated network of nanosensor electrodes for measuring ECG and respiratory rate from thoracic impedance, and incorporating a MEMS microphone for measuring heart sounds.
The SimpleSENSE Signal Acquisition Unit (SAU): data acquisition, storage, and transmission to an iPhone 7 using iOS 13.4. Incorporates an accelerometer to measure activity.
The SimpleSENSE Mobile Application: mobile application for to start/stop a recording and to forward the test report to the medical professional.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

adult patients

Intended User / Care Setting

Home, or at a healthcare facility, under the direction of a licensed medical professional

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance testing for the SimpleSENSE device included the following:
• Verification of multiparametric data capture
• Verification of Bluetooth and iPhone connectivity
• Verification of encryption of acquired data
• Battery safety and charging status indication
• SAU performance and durability
• Durability, capacity, and data storage testing of the microSD card
• Battery charger verification
• Biocompatibility of the garment
• Electrocardiograph sensor performance
• Electrical current requirements for transthoracic impedance sensor
• MEMS microphone testing
• Garment conductive inlays testing for flexibility and electrical performance
• Garment compression requirements
• Garment fastening mechanisms
• Use cycles for the base garment
• Shelf life
• Equivalency testing against predicate/reference devices
Performance testing demonstrated performance to design specifications.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K161431 SimplECG

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K160981, K151319

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 870.2920 Telephone electrocardiograph transmitter and receiver.

(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of a human figure, and the text on the right is in blue. The text is arranged in three lines, with "FDA" on the first line, "U.S. FOOD & DRUG" on the second line, and "ADMINISTRATION" on the third line.

November 6, 2020

Nanowear Inc. % Melissa Walker President & CTO Graematter, Inc. 1324 Clarkson Clayton Ctr, #332 St Louis, Missouri 63011

Re: K201669

Trade/Device Name: SimpleSENSE Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter And Receiver Regulatory Class: Class II Product Code: DXH, DSB, BZQ, DPS, DQD Dated: October 4, 2020 Received: October 6, 2020

Dear Melissa Walker:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

1

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jennifer Shih Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201669

Device Name Simple SENSE

Indications for Use (Describe)

The SimpleSENSE System is intended for use at home, or at a healthcare facility, under the direction of a licensed medical professional, to record, display and store the following physiological data: a) 2 leads of Electrocardiogram; b) Respiration rate measured through thoracic impedance; c) Heart Sounds; and d) Activity including posture. The device is intended for use when the clinician decides to evaluate the physiologic signals as an aid to diagnosis and treatment. The SimpleSENSE System is intended to be used by patients at rest and not performing any activities or movements. ECG recordings are indicated for the manual assessment of cardiac rhythm disturbances. The device does not produce alarms and is not intended for active patient monitoring (real-time). The device is not intended for use as life supporting equipment on high-risk patients such as critical care patients. The device is not intended for use in the presence of a pacemaker.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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K201669 510(k) Summary

Submitter's information

Nanowear, Inc. 53 Boerum Pl, Suite 3F Brooklyn, NY 11201 United States 718-637-4815

Contact: Venk Varadan 53 Boerum Pl, Suite 3F Brooklyn, NY 11201 United States Phone: 718-637-4815 Date: June 15 2020

Classification The classification for the new device is shown in the table below.

| 21 CFR
Reference | Product
Code | Class | Trade Name | Classification Name |
|---------------------|-----------------|-------|-------------|--------------------------------------------------------------|
| §870.2920 | DXH | 2 | | Transmitters and Receivers,
Electrocardiograph, Telephone |
| §870.2770 | DSB | 2 | SimpleSENSE | Plethysmograph, Impedance |
| §868.2375 | BZQ | 2 | SimpleSENSE | Monitor, Breathing Frequency |
| §870.2340 | DPS | 2 | SimpleSENSE | Electrocardiograph |
| §870.1875 | DQD | 2 | SimpleSENSE | Stethoscope, Electronic |

Predicate The predicate device is: devices · K161431 SimplECG cleared on 11/30/2016 from Nanowear, Inc. The following devices are considered as reference devices: • K160981 Patient Monitor, models elite V5, elite V6 and elite V8 cleared on 12/22/2016 from Edan Instruments, Inc. • K151319 Eko Electronic Stethoscope System cleared on 5/18/2015 from Eko Devices, Inc. The SimpleSENSE System is intended for use at home, or at a healthcare facility, under Indications for use the direction of a licensed medical professional, to record, display and store the following physiological data: a) 2 leads of Electrocardiogram; b) Respiration rate measured through thoracic impedance; c) Heart Sounds; and d) Activity including posture. The device is intended for use when the clinician decides to evaluate the physiologic signals of adult patients as an aid to diagnosis and treatment. The SimpleSENSE System is intended to be used by patients at rest and not performing any activities or movements. ECG recordings are indicated for the manual assessment of cardiac rhythm disturbances. The device does not produce alarms and is not intended for active patient monitoring (real-time). The device is not intended for use as life supporting equipment on high-risk patients such as critical care patients. The device is not intended for use in the presence of a pacemaker.

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Device The Nanowear SimpleSENSE device is the next generation diagnostic description monitoring technology that captures electrocardiographic (ECG) signals, respiration rate though thoracic impedance, heart sounds, activity including posture with sensors embedded on a wearable textile garment. The signals are stored and wirelessly transmitted to a smartphone, and forwarded to a medical professional for review.

The garment is designed to be unobtrusive to everyday activity and provide an easy and efficient means of capturing ECG, respiration rate, heart sounds and activity data from patients.

The garment is designed to be unobtrusive to everyday activity and provide an easy and efficient means of capturing ECG data from patients. The device consists of three (3) components:

The SimpleSENSE Garment: an integrated network of nanosensor electrodes for measuring ECG and respiratory rate from thoracic impedance, and incorporating a MEMS microphone for measuring heart sounds.
The SimpleSENSE Signal Acquisition Unit (SAU): data acquisition, storage, and transmission to an iPhone 7 using iOS 13.4. Incorporates an accelerometer to measure activity.
The SimpleSENSE Mobile Application: mobile application for to start/stop a recording and to forward the test report to the medical professional.

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Characteristics	The table below provides a comparison of the New Device with the predicate and reference devices.
Characteristic	Nanowear Inc.
SimpleSENSE - New
Device
Current Submission	Nanowear Inc. SimplECG
K161431	Edan Instruments, Patient
Monitor, models elite V5,
elite V6 and elite V8
K160981	Eko Devices Inc. Eko
Electronic
Stethoscope System
K151319	Comparison
Indications for
Use Statement	The SimpleSENSE system is
intended for use at home,
or healthcare facility, under
the direction of a licensed
medical professional, to
record, display and store
the following physiological
data: a) 2 leads of
Electrocardiogram b)
Respiration rate measured
through thoracic
impedance; c) Heart
Sounds; and d) Activity
including posture. The
device is intended for use
when the clinician decides
to evaluate the physiologic
signals of adult patients as
an aid to diagnosis and
treatment. The
SimpleSENSE System is
intended to be used by
patients at rest and not
performing any activities or
movements. ECG	The SimplECG is intended
to aid in the diagnostic
evaluation of patients, 21
years of age and above, on
the order of a physician,
who experience transient
symptoms which may
suggest the need for
monitoring to manually
assess their cardiac rhythm
disturbance. ECG data is
recorded, stored,
transferred and displayed
wirelessly for review by a
physician who is skilled in
rhythm interpretation.	The monitors are intended
to be used for monitoring,
storing, and reviewing of,
and to generate alarms for,
multiple physiological
parameters of adults,
pediatrics and neonates.
The monitors are intended
for use by trained
healthcare professionals in
hospital environments. The
monitored physiological
parameters include: ECG,
respiration (RESP),
temperature (TEMP),
oxygen saturation of
arterial blood (SpO2), pulse
rate (PR), non-invasive
blood pressure (NIBP),
invasive blood pressure
(IBP), carbon dioxide
(CO2), cardiac output
(C.O.), anesthetic gas (AG),
bispectral index (BIS),
respiration mechanics (RM)	The Eko Electronic
Stethoscope System is
intended to be used as
a part of a physical
assessment of a
patient by healthcare
professionals for
diagnostic decision
support in clinical
settings. Eko is
intended for use on
pediatric and adult
patients. It can
electronically amplify,
filter and transfer
sounds to the
accompanying mobile
application for storage
and sharing. It can
used to record heart
sounds and cardiac
murmurs, bruits,
respiratory sounds and
abdominal sounds
during physical	The SimpleSENSE offers
the same ECG measures
as the SimplECG; heart
sounds as in the Eko
device, and a subset of
the measures included in
the Edan Patient Monitor
device.
The absence of the
measures does not affect
the substantial
equivalence of the New
Device.
Characteristic	Nanowear Inc.
SimpleSENSE - New
Device
Current Submission	Nanowear Inc. SimplECG
K161431	Edan Instruments, Patient
Monitor, models elite V5,
elite V6 and elite V8
K160981	Eko Devices Inc. Eko
Electronic
Stethoscope System
K151319	Comparison
	recordings are indicated for
the manual assessment of
cardiac rhythm
disturbances. The device
does not produce alarms
and is not intended for
active patient
monitoring(real-time). The
device is not intended for
use as life supporting
equipment on high-risk
patients such as critical care
patients. The device is not
intended for use in the
presence of a pacemaker.		and impedance
cardiography (ICG). BIS is
intended for use on adult
and pediatric patients.
ICG monitoring is intended
for use on adults only. The
arrhythmia detection and
ST Segment analysis are
intended for adult patients.
The monitors are
additionally intended for
use during patient
transport inside hospitals.
The monitors are not
intended for MRI
environments.	examination in normal
patients or those with
suspected diseases of
the cardiac, vascular,
pulmonary or
abdominal organ
systems.
Product Code(s)	DXH, DPS, DQD, DSB, BZQ	DXH	MHX, DSI, DRT, CBQ, DXN,
DSK, CBR, DQA, NHO, CBS,
NHQ, NHP, CCK, DSB, CCL,
BZQ, BZK, DPS, FLL, DRG,
MLD	DQD	Similar
Characteristic	Nanowear Inc.
SimpleSENSE - New
Device
Current Submission	Nanowear Inc. SimplECG
K161431	Edan Instruments, Patient
Monitor, models elite V5,
elite V6 and elite V8
K160981	Eko Devices Inc. Eko
Electronic
Stethoscope System
K151319	Comparison
Acquired Data	Electrocardiogram
(EKG/ECG)
Respiration Rate derived
from thoracic impedance
Heart Sounds	Electrocardiogram
(EKG/ECG)	ECG, Respiration Rate,
Temperature SpO2, pulse
rate non-invasive blood
pressure (NIBP), invasive
blood pressure (IBP),
carbon dioxide (CO2),
cardiac output (C.O.),
anesthetic gas (AG),
Bispectral Index (BIS),
respiration mechanics (RM)
Impedance Cardiography
(ICG).	Heart Sounds	Same measures as those
found in the predicate &
reference devices. The
New Device captures the
ECG signal in the same
way as the SimplECG
predicate. The New
Device captures some of
the measures in the Edan
reference and the heart
sounds as in the Eko
reference. The absence of
some measures does not
affect the substantial
equivalence of the
SimpleSENSE device.
	Electrocardiogram
(EKG/ECG): Textile-based
Nanosensors	Electrocardiogram
(EKG/ECG): Textile-based
Nanosensors	Not Applicable	Not Applicable	Same sensors as in the
SimplECG device are used
to capture signals
Sensor
Technology	Respiration Rate: Textile-
based Nanosensors
measure thoracic
impedance and
respiration is derived
from thoracic impedance	Not Applicable	Thoracic
Impedance/Impedance
Cardiogram (ICG), ECG:
Disposable Silver or
Silver/Silver Chloride
electrode.
Respiration Rate: derived
from thoracic impedance	Not Applicable	Both the New Device and
the Edan reference
measure and derive
respiration rate using
thoracic impedance
captured via a sensor.
The sensors in the two
devices are different,
however both types of
sensors are used for
Characteristic	Nanowear Inc.
SimpleSENSE - New
Device
Current Submission	Nanowear Inc. SimplECG
K161431	Edan Instruments, Patient
Monitor, models elite V5,
elite V6 and elite V8
K160981	Eko Devices Inc. Eko
Electronic
Stethoscope System
K151319	Comparison
				physiologic signal capture
in other cleared devices.
	Heart Sound:
Microelectromechanical
(MEMS) microphone	Not Applicable	Not Applicable	Heart Sound: Uses a
standard stethoscope
diaphragm. Method of
transduction and
digitization of sound
waves is not Available	The SimpleSENSE device
uses a different sensor
than the Eko reference.
However, the signal
acquisition and location
used in both the
SimpleSENSE device and
the Eko reference are
similar.
	Electrocardiogram
(EKG/ECG): Standard
Bipolar lead
instrumentation amplifier
and Sigma-Delta Analog
to Digital Converter.	Electrocardiogram
(EKG/ECG): Standard
Bipolar lead
instrumentation amplifier
and Sigma-Delta Analog to
Digital Converter	Not Applicable	Not Applicable	The signal acquisition
method in the New Device
for capturing ECG signal is
the same as the SimplECG
predicate.
Signal
acquisition
method	Respiration rate: Thoracic
Impedance is measured
using four-point probe
using low amplitude
current applied to the
body and impedance
measured from voltage
drop derived from
thoracic impedance.
(Respiration Rate
detection range 6 - 22	Not Applicable	Thoracic
Impedance/Impedance
Cardiograph: four-point
probe using low amplitude
current applied to the body
and impedance measured
from voltage drop.
Respiration Rate: derived
from thoracic impedance	Not Applicable	The signal acquisition
method for capturing
thoracic impedance is the
same as the Edan
reference.
Characteristic	Nanowear Inc.
SimpleSENSE - New
Device
Current Submission	Nanowear Inc. SimplECG
K161431	Edan Instruments, Patient
Monitor, models elite V5,
elite V6 and elite V8
K160981	Eko Devices Inc. Eko
Electronic
Stethoscope System
K151319	Comparison
	breaths per minute (BPM)
with accuracy ± 2 BPM)
	Heart Sound: solid state
Microelectromechanical
(MEMS) microphone
embedded in garment
and located near Apex of
heart.	Not Applicable	Not Applicable	Heart Sound: sensor
embedded in a
standard stethoscope
attachment that can
amplify, digitize and
transmit data.	The signal acquisition
method for detecting
heart sounds is similar to
the Eko reference. Both
devices are placed in
similar locations to detect
and capture heart
sounds.
Display Type	No on-device display.	No on-device display.	On Device Display of
waveforms acquired and
derived parameters is
available. Data can be
downloaded from the
device through an Ethernet
connection or a USB
connection.	No on-device display.
Display of data is
available on a
smartphone through a
smartphone app or on
the web using web
services.	Data display for the New
Device is the same as the
SimplECG predicate and
the Eko reference that
rely on wireless
transmission and display
on a smartphone or web-
based display.
Display
Requirement	User provided display
hardware for a
healthcare professional
to view the recorded
data. A general-purpose
PC/Laptop/Desktop or
mobile device may be
used.	User provided display
hardware for a healthcare
professional to view the
recorded data. A general-
purpose
PC/Laptop/Desktop may be
used.	No requirement for
additional user provided
hardware for display	Display available
through User provided
smartphone or tablet.
Display also available
through Web browser
on any
Laptop/PC/Desktop.	The Edan reference
includes a display
(hardware) while the New
Device, the SimplECG, and
the Eko reference all
display the data on the
user's hardware and via
web based display.
Power Source	Internally powered using
Li-Ion rechargeable
battery	Single Use Lithium AA type
batteries	Rechargeable Lithium-Ion
Battery and AC Mains
supported.	Internally powered
using Li-Ion
rechargeable battery	All of the devices are able
to operate on battery
power. The Edan
reference has an option
Characteristic	Nanowear Inc.
SimpleSENSE - New
Device
Current Submission	Nanowear Inc. SimplECG
K161431	Edan Instruments, Patient
Monitor, models elite V5,
elite V6 and elite V8
K160981	Eko Devices Inc. Eko
Electronic
Stethoscope System
K151319	Comparison
Internal
Memory/data	Removeable MicroSD
card	Removeable MicroSD card	Solid state memory non-
removeable.	Solid state memory
non-removeable	All devices use memory
devices to store the data
collected. The New
Device and the SimplECG
predicate use removeable
cards while the Edan and
Eko references use non-
removable memory
devices.
Communication
Interface	Wireless transceiver
using Bluetooth	Wireless transceiver using
Bluetooth	USB connection or Ethernet
connection	Wireless transceiver
using Bluetooth	The New Device uses the
same communication
interface as the SimplECG
predicate and Eko
reference. The Edan
reference uses a non-
wireless interface.
Access to
recorded data	Data is transferred to the
iPhone, which is then
shared with the
healthcare professional.
For redundancy,
encrypted data is also
stored in the removeable
storage medium.	Data is transferred to the
iPhone, which is then
shared with the healthcare
professional. For
redundancy, encrypted
data is also stored in the
removeable storage
medium. Data is
transferred from the device
to a web server and a Web
interface is used to access
the data.	Trends data can be
downloaded using
proprietary clinical
management software.	Data is transferred
and stored in .wav
format and can be
retrieved from a web
interface	Access to the data output
for the New Device is the
same as the SimplECG and
similar to the Eko
reference. The Edan
reference uses proprietary
software to manage their
downloadable data.

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| Discussion -
similarities | The similarities of the New Device to one or more of the predicate/references are:
• Sensor technology is the same as the SimplECG predicate device sensor |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | • Same measures as those found in the predicate and reference devices. |
| | • Same sensors as in the SimplECG device are used to capture signals (except heart
sounds) |
| | • Both the New Device and the Edan reference measure and derive respiration rate
using thoracic impedance captured via a sensor. |
| | • The signal acquisition method for capturing ECG signal is the same as the
SimplECG predicate. |
| | • The signal acquisition method for capturing thoracic impedance is the same as
the SimplECG predicate. |
| | • The signal acquisition method for detecting heart sounds is similar to the Eko
reference. Both devices are placed in similar locations to detect and capture
heart sounds. |
| | • Data display for the New Device is the same as the SimplECG predicate and Eko
reference that rely on wireless transmission and display on a smartphone or web-
based display. |
| | • The Edan reference includes a display (hardware) while the New Device, the
SimplECG predicate, and the Eko reference displays the data on the user's
hardware or via web based display. |
| | • All of the devices are able to operate on battery power. The Edan reference has
an additional option for use with an AC Main. |
| | • All of the devices listed use memory devices to store the data collected. The New
Device and the SimplECG predicate use removeable cards while the Edan and Eko
reference devices use non-removable memory devices. |
| | • The New Device uses the same communication interface as the SimplECG
predicate and Eko reference device. |
| | • Access to the data output for the New Device is the same as the SimplECG and
similar to the Eko reference. |
| Discussion -
differences | The differences between the New Device and the predicate/reference
devices are: |
| | • The New Device does not capture all of the measures in the Edan reference. |
| | • The sensors in the new device and Edan reference are different, however both
types of sensors are used for physiologic signal capture in other cleared devices. |
| | • The SimpleSENSE device uses a different sensor than the Eko reference.
However, the signal acquisition and location used in both the SimpleSENSE
device and the Eko reference are similar types of sensors. |
| | • The Edan reference uses a wired interface. |
| | • The Edan reference uses proprietary software to manage their downloadable
data. |

13

| Performance
testing | Performance testing for the SimpleSENSE device included the following:
• Verification of multiparametric data capture
• Verification of Bluetooth and iPhone connectivity
• Verification of encryption of acquired data
• Battery safety and charging status indication
• SAU performance and durability
• Durability, capacity, and data storage testing of the microSD card
• Battery charger verification
• Biocompatibility of the garment
• Electrocardiograph sensor performance
• Electrical current requirements for transthoracic impedance sensor
• MEMS microphone testing
• Garment conductive inlays testing for flexibility and electrical performance
• Garment compression requirements
• Garment fastening mechanisms
• Use cycles for the base garment
• Shelf life
• Equivalency testing against predicate/reference devices
Performance testing demonstrated performance to design specifications. |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion | The performance data provided demonstrate that the SimpleSENSE device is
substantially equivalent to the indicated predicate device. |