Predicate Devices

Reference Devices

No reference devices were used in this submission.

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of the data analysis mentions "EmpaDSP, which computes the user physiological parameters," suggesting traditional signal processing rather than AI/ML.

Therapeutic

No.
The device is intended for remotely monitoring physiologic parameters and providing data to healthcare professionals, not for providing direct therapy or treatment.

Diagnostic

No

The device is intended for remote monitoring of physiological parameters in ambulatory individuals and is explicitly stated as a "Health Monitoring Platform." While it collects physiological data, its stated purpose is monitoring and analysis of these parameters for use by healthcare professionals or researchers, not for diagnosing specific conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is composed of a "wearable medical device called EmbracePlus" in addition to the software components. This wearable device is a hardware component that collects data via sensors.

IVD (In Vitro Diagnostic)

Based on the provided information, the Empatica Health Monitoring Platform is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
Empatica Platform Function: The Empatica Health Monitoring Platform is a wearable device that collects physiological data directly from the user's body (in vivo) through sensors on the wrist. It monitors parameters like skin temperature, electrodermal activity, blood oxygen saturation, and movement.
No Sample Analysis: The device does not involve the collection or analysis of biological samples from the user.

Therefore, the Empatica Health Monitoring Platform falls under the category of a wearable physiological monitoring device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Empatica Health Monitoring Platform is a wearable device and cloud-based software platform intended to be used by trained healthcare professionals or researchers to remotely monitor physiologic parameters in ambulatory individuals 18 years of age and older in home-healthcare environments.

The device supports continuous data collection for monitoring the following physiological parameters:

Peripheral skin temperature,
Electrodermal activity,
Blood Oxygen Saturation under no motion conditions,
Activity associated with movement during sleep.

The Empatica Health Monitoring Platform can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.

The Empatica Health Monitoring Platform is not intended for SpO2 monitoring of motion or low perfusion.

The Empatica Health Monitoring Platform is intended for peripheral skin temperature monitoring temperature at the wrist is clinically indicated.

Product codes

DQA, DRG, FLL, LEL, GZO

Device Description

The Empatica Health Monitoring Platform is a wearable device and software platform composed by:

A wearable medical device called EmbracePlus,
A mobile application running on smartphones called "Care App",
A cloud-based software platform named "Care Portal".

The EmbracePlus is worn on the user's wrist and continuously collects raw data via specific sensors. These data are wirelessly transmitted via Bluetooth Low Energy to a paired mobile device where the Care App is up and running. The data received are analyzed by one of the Care App software modules, EmpaDSP, which computes the user physiological parameters. Based on the version of the Care App installed, the user can visualize a subset of these physiological parameters. The Care App is also responsible for transmitting, over cellular or Wi-Fi connection sensors' raw data, device information, Care App-specific information, and computed physiological parameters to the Empatica Cloud. On the Empatica Cloud, these data are stored, further analyzed, and accessible by healthcare providers or researchers via a specific cloud-based software called Care Portal.

The platform is intended to continuously monitor adult patient physiological parameters in homehealthcare environment. It is designed for monitoring patients by trained healthcare professionals or researchers. It is intended to continuously monitor blood oxygen saturation (SpO2), peripheral skin temperature (TEMP), and electrodermal activity (EDA). Activity sensors are used to detect sleep periods and to monitor the activity associated with movement during sleep.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Wrist

Indicated Patient Age Range

18 years of age and older

Intended User / Care Setting

Trained healthcare professionals or researchers / home-healthcare environments.

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)

Non-Clinical testing (Bench testing)
The following non-clinical (bench) testing was conducted to support a determination of substantial equivalence to the predicates and to demonstrate performance. The non-clinical bench tests included:

Biocompatibility testing: The wearable device component of the Empatica Health Monitoring Platform, called EmbracePlus, was tested in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" September 4, 2020, and International Standard ISO 10993-1:2018 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests: Cytotoxicity, Sensitization, Irritation. The EmbracePlus wearable device is considered surface contacting for a prolonged duration (>24 hours

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).

Summary

0

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November 20, 2022

Empatica S.r.1. Alberto Poli Regulatory Affairs & Quality Manager Via Stendhal. 36 Milan, 20144 Italy

Re: K221282

Trade/Device Name: Empatica Health Monitoring Platform Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA, DRG, FLL, LEL, GZO Dated: November 14, 2022 Received: November 14, 2022

Dear Alberto Poli:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

1

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 (QS) 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 medical devices and radiation-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).

Sincerelv.

James J. Lee -S

James J. Lee, Ph.D. Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K221282

Device Name Empatica Health Monitoring Platform

Indications for Use (Describe)

The Empatica Health Monitoring Platform is a wearable device and cloud-based software platform intended to be used by trained healthcare professionals or researchers to remotely monitor physiologic parameters in ambulatory individuals 18 years of age and older in home-healthcare environments.

The device supports continuous data collection for monitoring the following physiological parameters:

· Peripheral skin temperature,
· Electrodermal activity,
· Blood Oxygen Saturation under no motion conditions,
· Activity associated with movement during sleep.

The Empatica Health Monitoring Platform can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.

The Empatica Health Monitoring Platform is not intended for SpO2 monitoring of motion or low perfusion.

The Empatica Health Monitoring Platform is intended for peripheral skin temperature monitoring temperature at the wrist is clinically indicated.

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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3

Empatica Srl Traditional 510(k) Empatica Health Monitoring Platform

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Empatica Health Monitoring Platform – 510(k)

510(k) Summary

Version 3.0

The information contained in this document is confidential and is the property solely of Empatica, S.r.l.. Any reproduction in part or in whole without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2022. All rights reserved

4

Empatica Health Monitoring Platform

510(k) Summary

SUBMITTER l.

Company Name	Empatica Srl
Establishment Registration Number	3012933969
Contact Person	Alberto Poli, Regulatory Affairs & Quality Manager
Contact Person email	apo@empatica.com
Address	Via Stendhal, 36 - 20144, Milan, Italy
Telephone Number	+39 02 36165068
Date prepared	April 29, 2022

II. DEVICE

Trade/Proprietary Name:	Empatica Health Monitoring Platform
Common/Usual Name:	Remote Patient Monitoring System

Primary Product Code:

| Classification
Regulation | Classification Name | Device
Class | Product
Code | Classification
Panel |
|------------------------------|---------------------|-----------------|-----------------|-------------------------|
| 870.2700 | Oximeter | Class II | DQA | Cardiovascular |

Secondary Product Codes:

| Classification
Regulation | Classification Name | Device
Class | Product
Code | Classification
Panel |
|------------------------------|---------------------------------------------------------------------|-----------------|-----------------|-------------------------|
| 870.2910 | Transmitters and Receivers, Physiological
Signal, Radiofrequency | Class II | DRG | Cardiovascular |
| 882.5050 | Device, Sleep Assessment | Class II | LEL | Neurology |
| 882.1540 | Galvanic skin response measurement
device | Class II | GZO | Neurology |
| 880.2910 | Thermometer, Electronic, Clinical | Class II | FLL | General Hospital |

lll. PREDICATE DEVICES

| Predicate

Device	Name	Submitter	Product Code(s)	510(k) Number
Primary	Loop System	Spry Health,
Inc.	DQA
BZQ	K181352
Secondary	Current Wearable Health
Monitoring System	Current Health
Ltd.	MSX
DQA
DRG
BZQ
FLL	K191272
Secondary	ActiGraph CentrePoint Insight
Watch	ActiGraph	LEL	K181077
Secondary	Empatica E4	Empatica S.r.l.	GZO	N/A

None of these predicates have been subject to a design-related recall.

No reference devices were used in this submission.

The information contained in this document is confidential and is the property solely of Empatica, S.r.l.. Any reproduction in part or in whole without the written permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2022. All rights reserved Page 5.2

5

Empatica Health Monitoring Platform

IV. DEVICE DESCRIPTION

The Empatica Health Monitoring Platform is a wearable device and software platform composed by:

A wearable medical device called EmbracePlus, ●
A mobile application running on smartphones called "Care App", ●
A cloud-based software platform named "Care Portal".

The EmbracePlus is worn on the user's wrist and continuously collects raw data via specific sensors. These data are wirelessly transmitted via Bluetooth Low Energy to a paired mobile device where the Care App is up and running. The data received are analyzed by one of the Care App software modules, EmpaDSP, which computes the user physiological parameters. Based on the version of the Care App installed, the user can visualize a subset of these physiological parameters. The Care App is also responsible for transmitting, over cellular or Wi-Fi connection sensors' raw data, device information, Care App-specific information, and computed physiological parameters to the Empatica Cloud. On the Empatica Cloud, these data are stored, further analyzed, and accessible by healthcare providers or researchers via a specific cloud-based software called Care Portal.

The platform is intended to continuously monitor adult patient physiological parameters in homehealthcare environment. It is designed for monitoring patients by trained healthcare professionals or researchers. It is intended to continuously monitor blood oxygen saturation (SpO2), peripheral skin temperature (TEMP), and electrodermal activity (EDA). Activity sensors are used to detect sleep periods and to monitor the activity associated with movement during sleep.

V. INDICATION FOR USE

The Empatica Health Monitoring Platform is a wearable device and paired mobile and cloud-based software platform intended to be used by trained healthcare professionals or researchers to remotely monitor physiologic parameters in ambulatory individuals 18 years of age and older in homehealthcare environments.

The device supports continuous data collection for monitoring of the following physiological parameters:

Peripheral skin temperature,
Electrodermal activity
Blood Oxygen Saturation under no motion conditions,
Activity associated with movement during sleep.

The Empatica Health Monitoring Platform can be used to analyze circadian rhythms and assess activity in any instance where quantifiable analysis of physical motion is desirable.

The Empatica Health Monitoring Platform is not intended for SpO2 monitoring in conditions of motion or low perfusion.

The Empatica Health Monitoring Platform is intended for peripheral skin temperature monitoring, where monitoring temperature at the wrist is clinically indicated.

6

Empatica Health Monitoring Platform

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES l.

The application Empatica Health Monitoring Platform is substantially equivate devices. The devices have similar Indications for Use, features, technology, and accuracy.

| Features | Empatica Monitoring
Platform (Subject
Device) Health Monitoring
System CentrePoint
Insight Watch differences |----------------------------------------|-------------- | Common Name | Oximeter Communication,
Physiological
Monitors device (actigraphy) Skin Response
Measurement | Device
Manufacturer | Empatica S.r.l. | Device
Classification | II | 510(k) number | N/A | Primary Product
Code | DQA | Secondary
Product Code | DRG, GZO, LEL, FLL BZG | Intended
Use/Indications
for Use | The Empatica
Health Monitoring
Platform is a
wearable device
and paired mobile
and cloud-based
software platform
intended to be
used by trained
healthcare
professionals or intended for adult
patients in the home
environment for
passive, noninvasive,
intermittent data
collection of
physiological
parameters that will
later be transmitted to
a web server for Health Monitoring
System is intended for
reusable bedside,
mobile and central
multi-parameter,
physiologic patient
monitoring of adult
patients in professional
healthcare facilities,
such as hospitals or CentrePoint Insight
Watch is a small
worn activity
monitor designed
for documenting
physical movement
associated with
applications in
physiological
monitoring. The intended for
passive, non-
invasive
continuous
collection of
electrodermal
activity that will be
later transmitted
to a web server for
remote review by | The subject
device
indication for
use includes the
monitoring of a
subset of the
physiological
parameters of
all the
predicates. | Features | Empatica Monitoring
Platform (Subject
Device) Health Monitoring
System CentrePoint
Insight Watch differences | | researchers to clinician. The Loop
System measures and
records: • arterial
oxygen saturation
(SpO2) • heart rate
(HR) • respiration rate
(RR) All of these
measurements are
made when no motion
is detected by the
System. The Loop
System device does
not provide
physiological alarms. | skilled nursing
facilities, or their own
home. It is intended for
monitoring of patients
by trained healthcare
professionals. The
Current Wearable
Health Monitoring
System is intended to
provide visual and
audible physiologic
multi-parameter
alarms. The Current
Wearable Health
Monitoring System is
intended for
temperature
monitoring where
monitoring
temperature at the
upper arm is clinically
indicated. The Current
Wearable Health
Monitoring System is
intended for
continuous monitoring
of the following
parameters in | device is intended
to monitor the
activity associated
with movement
during sleep. The
Insight watch can
be used to analyze
circadian rhythms
and assess activity
in any instance
where quantifiable
analysis of physical
motion is
desirable. | clinicians or
researchers. | | remotely monitor | | physiologic | | parameters in | | ambulatory | | individuals 18 years | | of age and older in | | home-healthcare | | environments. | | The device | | supports | | continuous data | | collection for | | monitoring the | | following | | physiological | | parameters: | | • Peripheral skin | | temperature, | | • Electrodermal | | activity, | | • Blood Oxygen | | Saturation under | | no motion | | conditions, | | • Activity associated | | with movement | | during sleep | Features | Empatica Monitoring
Platform (Subject
Device) Health Monitoring
System CentrePoint
Insight Watch differences | | The Health Monitoring
Platform can be
used to analyze
circadian rhythms
and assess activity
in any instance
where quantifiable
analysis of physical
motion is desirable. Health
| Loop System | Current Wearable
| ActiGraph
| Empatica E4 | Analysis of
|
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Oximeter | System, Network and
| Sleep assessment
| Device, Galvanic
| N/A |
| Spry Health Ltd. | Current Health Ltd. | ActiGraph, Inc. | Empatica S.r.l. | N/A |
| II | II | II | II (510(k) exempt) | N/A |
| K181352 | K191272 | K181077 | N/A | N/A |
| DQA | MSX | LEL | GZO | N/A |
| BZQ | FLL, DQA, BZQ, DRG,
| - | - | N/A |
| The Loop System is
| The Current Wearable
| The ActiGraph
| The Empatica E4 is
|
Health
| Loop System | Current Wearable
| ActiGraph
| Empatica E4 | Analysis of
|
| remote review by a
| |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
Health
| Loop System | Current Wearable
| ActiGraph
| Empatica E4 | Analysis of
|
Empatica

The Empatica
Health Monitoring
Platform is not
intended for SpO2
monitoring in
conditions of
motion or low
perfusion.

The Empatica
Health Monitoring
Platform is
intended for
peripheral skin
temperature
monitoring, where
monitoring | | adults:
• Pulse rate
• Oxygen saturation
• Temperature
• Movement

The Current Wearable
Health Monitoring
System is intended for
intermittent or spot-
check monitoring, in
adults, of:
• Respiration rate
• Non-invasive blood
pressure
• Lung function &
spirometry
• Weight

The Current Wearable
Health Monitoring
System is not intended
for use in high-acuity
environments, such as
ICU or operating
rooms.

The Current Wearable
Health Monitoring
System is not intended | | | |
| Features | Empatica Health
Monitoring
Platform (Subject
Device) | Loop System | Current Wearable
Health Monitoring
System | ActiGraph
CentrePoint
Insight Watch | Empatica E4 | Analysis of
differences |
| | temperature at the
wrist is clinically
indicated. | | for use on acutely ill
cardiac patients with
the potential to
develop life
threatening
arrhythmias e.g. very
fast atrial fibrillation.
For these patients,
they should be
monitored using a
device with continuous
ECG. The Current
Wearable Health
Monitoring System is
not a substitute for an
ECG monitor.

7

8

9

10

11

12

13

Technical and Performance Information for Blood Oxygen Saturation
Features	Empatica Health
Monitoring Platform
(Subject Device)	Loop System	Current Wearable
Health Monitoring
System	ActiGraph
CentrePoint
Insight Watch	Empatica
E4	Analysis of differences
Technology	SpO2 relies on the
principle that
hemoglobin at different
oxygenation states
absorbs light differently
based upon the
wavelength of light.	SpO2 measured by
analyzing reflectance of
certain LED frequencies in
a photoplethysmogram
design. The diodes are
mounted in the device
such that they are in
contact with the skin	SpO2 is measured by
analyzing the
reflectance of certain
LED frequencies in a
photoplethysmogram
design. The diodes are
mounted in the device
such that they are in
contact with the skin.	N/A	N/A	The subject device and
the predicates are
identical in that they all
use the
photoplethysmogram
technology
SpO2 Range	70-100%	70-100%	70-100%	N/A	N/A	The subject device and
the predicates are
identical
SpO2 Resolution	1%	1%	1%	N/A	N/A	The subject device and
the predicates are
identical
SpO2 Accuracy	$2.6% A_{rms}$	$3% A_{rms}$	± 2 Digits	N/A	N/A	The subject device and
the predicates comply
with ISO 80601-2-
61 as well as with FDA
Guidance for Pulse
Oximeters
(2013)

14

Technical and Performance Information for Temperature
Features	Empatica Health
Monitoring Platform
(Subject Device)	Loop System	Current Wearable
Health Monitoring
System	ActiGraph CentrePoint
Insight Watch	Empatica
E4	Analysis of differences
Technology	high-precision
temperature sensor	N/A	In-Built Thermistor	N/A	N/A	The subject device and the
predicates are identical
Temperature
Range	0°C to 50°C	N/A	0°C to 50°C	N/A	N/A	The subject device and the
predicates are identical
Temperature
Resolution	0.1°C	N/A	0.1°C	N/A	N/A	The subject device and the
predicates are identical
Temperature
Accuracy	$\pm$ 0.1°C within 30.0°C -
45.0°C range	N/A	$\pm$ 0.1°C	N/A	N/A	The subject device and the
predicates are identical

Technical and Performance Information for Electrodermal Activity
Features	Empatica Health
Monitoring Platform
(Subject Device)	Loop
System	Current
Wearable
Health
Monitoring
System	ActiGraph
CentrePoint
Insight Watch	Empatica E4	Analysis of differences
Technology	EDA is measured by
analyzing detected
changes in the
conductivity of the
superficial layers of the
skin.	N/A	N/A	N/A	EDA is measured by
analyzing detected
changes in the
conductivity of the
superficial layers of
the skin.	The subject device and the
predicates are identical
EDA Range	$0.01 \mu S – 100 \mu S$	N/A	N/A	N/A	$0.01 \mu S – 100 \mu S$	The subject device and the
predicates are identical
EDA Resolution	1 digit ~ 55 pS	N/A	N/A	N/A	1 digit ~ 900 pS	This difference shall not raise
new concerns of device safety or
effectiveness

15

Technical and Performance Information for Activity and Sleep
Features	Empatica Health
Monitoring Platform
(Subject Device)	Loop
System	Current Wearable
Health Monitoring
System	ActiGraph CentrePoint
Insight Watch	Empatica
E4	Analysis of differences
Technology	Accelerometer	N/A	N/A	Accelerometer	N/A	The subject device and
the predicate are
identical
Accelerometer
Type	Microelectromechanical
system
(MEMS)-based integrated
circuit	N/A	N/A	Microelectromechanical
system
(MEMS)-based
integrated circuit	N/A	The subject device and
the predicate are
identical
Accelerometer
Sampling Rate	Digital method, 26 Hz -
208 Hz	N/A	N/A	Digital method, 32 Hz -
256 Hz	N/A	This difference shall not
raise new concerns of
device safety or
effectiveness
Accelerometer
Dynamic Range	± 16 g	N/A	N/A	± 8 g	N/A	This difference shall not
raise new concerns of
device safety or
effectiveness
Accelerometer
Sensitivity	0.488 milli-g per Least
Significant Bit	N/A	N/A	2.4 milli-g per Least
Significant Bit	N/A	This difference shall not
raise new concerns of
device safety or
effectiveness

16

Empatica Health Monitoring Platform

II. PERFORMANCE DATA

Non-Clinical testing (Bench testing)

The following non-clinical (bench) testing was conducted to support a determination of substantial equivalence to the predicates and to demonstrate performance. The non-clinical bench tests included:

Test Name	Test Description	Results
Biocompatibility
testing	The wearable device component of the Empatica Health Monitoring Platform, called EmbracePlus, was tested in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" September 4, 2020, and International Standard ISO 10993-1:2018 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:
• Cytotoxicity
• Sensitization
• Irritation
The EmbracePlus wearable device is considered surface contacting for a prolonged duration (>24 hours