November 20, 2022
Empatica S.r.l.
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 theenclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, theenactment date of the Medical Device Amendments, or to devices that have been reclassified in accordancewith the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of apremarket approval application (PMA). You may, therefore, market the device, subject to the generalcontrols provisions of the Act. Although this letter refers to your product as a device, please be aware thatsome cleared products may instead be combination products. The 510(k) Premarket Notification Databaselocated 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 andadulteration. 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 besubject to additional controls. Existing major regulations affecting your device can be found in the Code ofFederal 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
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID# 04017.05.02

2K221282 - Alberto Poli

Page801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (seehttps://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 531542 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 Part803), please go to https://www.fda.gov/medical-devices/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 theDivision of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
the DICE website (https://www.fda.gov/medical-devices/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,

James J. Lee -SJames J. Lee, Ph.D.
Director
DHT1C: Division of Sleep Disordered
Breathing, Respiratory andAnesthesia Devices
OHT1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
EnclosureDEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023

Indications for Use

See PRA Statement below.

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 paired mobile and cloud-based software platform
intended to be used by trained healthcare professionals or researchers to remotely monitor physiologic parameters inambulatory 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 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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including thetime to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspectof this information collection, including suggestions for reducing this burden, to:Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov“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 number.”
FORM FDA 3881 (6/20)

Page 1 of 1

PSC Publishing Services (301) 443-6740

EFEmpatica Srl
Traditional 510(k)Empatica Health Monitoring Platform

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
5.1

Empatica Srl
Traditional 510(k)Empatica Health Monitoring Platform
510(k) SummaryI.

SUBMITTER

Company Name
Establishment Registration Number
Contact Person
Contact Person email
Address
Telephone Number
Date prepared

II.

Empatica Srl
3012933969
Alberto Poli, Regulatory Affairs & Quality Manager
apo@empatica.com
Via Stendhal, 36 - 20144, Milan, Italy+39 02 36165068
April 29, 2022

DEVICE

Trade/Proprietary Name:
Common/Usual Name:

Empatica Health Monitoring Platform
Remote Patient Monitoring System

Primary Product Code:Classification Classification Name
Regulation
870.2700
OximeterDeviceClass
Class II

Product
Code
DQA

Classification
Panel
Cardiovascular

DeviceClass
Class II

Product
Code
DRG

Classification
Panel
CardiovascularClass IIClass IILEL
GZO

Neurology
Neurology

Class IIFLL

General Hospital

Product Code(s)510(k) Number

DQA
BZQ
MSX
DQA
DRG
BZQ
FLL
LEL

K181352GZO

N/ASecondary Product Codes:
Classification Classification Name
Regulation
870.2910
Transmitters and Receivers, PhysiologicalSignal, Radiofrequency
882.5050
Device, Sleep Assessment
882.1540
Galvanic skin response measurement
device880.2910
Thermometer, Electronic, Clinical

III.

PREDICATE DEVICES

PredicateDevicePrimary

Name
Loop System

Secondary Current Wearable
Monitoring System

Submitter
Spry Health,
Inc.
Health Current Health
Ltd.

Secondary ActiGraph CentrePoint Insight ActiGraph
Watch
Secondary Empatica E4
Empatica S.r.l.

K191272

K181077

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

Empatica Srl
Traditional 510(k)Empatica Health Monitoring PlatformIV.

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 theCare 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 skintemperature (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 physiologicalparameters:••••

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.

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 5.3

Empatica Srl
Traditional 510(k)Empatica Health Monitoring Platform
I.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

The application Empatica Health Monitoring Platform is substantially equivalent to the identified predicate devices. The devices have similar Indications forUse, features, technology, and accuracy.
Features

Common Name
DeviceManufacturer
DeviceClassification
510(k) number
Primary Product
Code
Secondary
Product CodeIntended
Use/Indications
for UseEmpatica Health
Monitoring
Platform (Subject
Device)Loop System

Current Wearable
Health Monitoring
SystemActiGraph
CentrePoint
Insight Watch

Empatica E4

Analysis ofdifferences

OximeterOximeter

System, Network andCommunication,
Physiological
Monitors

Sleep assessment
device (actigraphy)

Device, Galvanic
Skin Response
Measurement

N/A

Empatica S.r.l.

Spry Health Ltd.

Current Health Ltd.

ActiGraph, Inc.

Empatica S.r.l.

N/A

II

II

II

II

II (510(k) exempt)

N/A

N/A

K181352

K191272

K181077

N/A

N/A

DQA

DQA

MSX

LEL

GZO

N/A

DRG, GZO, LEL, FLL

BZQ

-

-

N/A

The Empatica
Health Monitoring
Platform is a
wearable device
and paired mobileand cloud-based
software platform
intended to be
used by trained
healthcare
professionals or

The Loop System isintended for adultpatients in the homeenvironment for
passive, noninvasive,intermittent datacollection ofphysiologicalparameters that will
later be transmitted toa web server for

The ActiGraph
CentrePoint Insight
Watch is a small
worn activity
monitor designed
for documenting
physical movement
associated withapplications inphysiologicalmonitoring. The

The Empatica E4 isintended for
passive, noninvasive
continuous
collection ofelectrodermal
activity that will belater transmitted
to a web server for
remote review by

The subject
deviceindication foruse includes themonitoring of asubset of thephysiologicalparameters of
all thepredicates.

FLL, DQA, BZQ, DRG,
BZG
The Current Wearable
Health Monitoring
System is intended forreusable bedside,mobile and central
multi-parameter,
physiologic patientmonitoring of adultpatients in professional
healthcare facilities,
such as hospitals or

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 5.4

Empatica Srl
Traditional 510(k)Empatica Health Monitoring Platform

FeaturesEmpatica Health
Monitoring
Platform (Subject
Device)researchers toremotely monitor
physiologic
parameters inambulatory
individuals 18 yearsof age and older inhome-healthcare
environments.
The device
supports
continuous datacollection formonitoring thefollowing
physiologicalparameters:• Peripheral skintemperature,• Electrodermal
activity,• Blood Oxygen
Saturation underno motion
conditions,• Activity associatedwith movement
during sleep

Loop System
remote review by aclinician. The Loop
System measures andrecords: • arterial
oxygen saturation(SpO2) • heart rate(HR) • respiration rate(RR) All of thesemeasurements are
made when no motion
is detected by the
System. The Loop
System device does
not provide
physiological alarms.

Current Wearable
Health Monitoring
SystemActiGraph
CentrePoint
Insight Watch

skilled nursing
facilities, or their own
home. It is intended formonitoring of patientsby trained healthcare
professionals. The
Current Wearable
Health Monitoring
System is intended toprovide visual andaudible physiologic
multi-parameter
alarms. The Current
Wearable Health
Monitoring System isintended fortemperaturemonitoring where
monitoring
temperature at theupper arm is clinicallyindicated. The Current
Wearable Health
Monitoring System isintended forcontinuous monitoringof the following
parameters indevice is intended
to monitor theactivity associatedwith movement
during sleep. The
Insight watch canbe used to analyze
circadian rhythms
and assess activity
in any instance
where quantifiable
analysis of physicalmotion isdesirable.

Empatica E4

Analysis ofdifferences

clinicians or
researchers.

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
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Empatica Srl
Traditional 510(k)Empatica Health Monitoring Platform

FeaturesEmpatica Health
Monitoring
Platform (Subject
Device)The Empatica
Health Monitoring
Platform can beused to analyze
circadian rhythms
and assess activity
in any instance
where quantifiable
analysis of physicalmotion is desirable.
The Empatica
Health Monitoring
Platform is notintended for SpO2
monitoring inconditions of
motion or low
perfusion.
The Empatica
Health Monitoring
Platform isintended for
peripheral skintemperaturemonitoring, where
monitoring

Loop System

Current Wearable
Health Monitoring
SystemActiGraph
CentrePoint
Insight Watch

Empatica E4

Analysis ofdifferences

adults:• Pulse rate
• Oxygen saturation• Temperature• Movement
The Current Wearable
Health Monitoring
System is intended forintermittent or spotcheck monitoring, inadults, of:• Respiration rate
• Non-invasive bloodpressure• Lung function &spirometry• Weight
The Current Wearable
Health Monitoring
System is not intended
for use in high-acuity
environments, such as
ICU or operatingrooms.
The Current Wearable
Health Monitoring
System is not intended

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
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Empatica Srl
Traditional 510(k)Empatica Health Monitoring Platform

FeaturesEmpatica Health
Monitoring
Platform (Subject
Device)temperature at thewrist is clinicallyindicated.

Loop System

Current Wearable
Health Monitoring
SystemActiGraph
CentrePoint
Insight Watch

Empatica E4

Analysis ofdifferences

Adult

The subject
device and thepredicates are
identical

for use on acutely ill
cardiac patients withthe potential todevelop life
threatening
arrhythmias e.g. very
fast atrial fibrillation.
For these patients,
they should bemonitored using adevice with continuous
ECG. The Current
Wearable Health
Monitoring System is
not a substitute for an
ECG monitor.
The Current Wearable
Health Monitoring
System is not intended
for SpO2 monitoring inconditions of highmotion or
low perfusion

TargetPopulation

Adult

Adult

Adult

Adult

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
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Empatica Srl
Traditional 510(k)Empatica Health Monitoring Platform
Empatica Health
Monitoring
Platform (Subject
Device)Loop System

Anatomical Site

Wrist

Wrist

Upper Arm

Wrist

Wrist

Over theCounter or Rx

Rx

Rx

Rx

Rx

Rx

Environment

Home

Home

Professional
Healthcare Facilities &Home

Professional
Healthcare
Facilities & Home

Professional
Healthcare
Facilities & Home

Features

Current Wearable
Health Monitoring
SystemActiGraph
CentrePoint
Insight Watch

Empatica E4

Analysis ofdifferences
Clinical testing
demonstrated
the equivalence
between thesubject device
and thepredicates. The
difference inwearing locationon the body
does not raise
new questionsofsafety or
efficacy.
The subject
device and thepredicates are
identical
The subject
device includes
a subgroup of
the predicates,
hence this does
not raise newquestions ofsafety or
efficacy.

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
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Empatica Srl
Traditional 510(k)Empatica Health Monitoring Platform
Empatica Health
Monitoring
Platform (Subject
Device)Loop System

Alarms

No

No

Yes

No

No

User Interface

Device screen,
Mobile device
application, andcloud software
platform

Central station

Mobile devices and acentral station

Device screen andMobile device
application

Mobile devices
and cloud software
platform

Features

Current Wearable
Health Monitoring
SystemActiGraph
CentrePoint
Insight Watch

Empatica E4

Analysis ofdifferences
This difference
does not raise
new questionsof safety or
efficacy since
the Empatica
HealthMonitoring
Platform is notintended, by
design, to
include alarms
to be used in asituation where
the presence ofalarms is arequirement forthe correct
patient care.
The differences
between thesubject device
and thepredicates do
not raise newquestions ofsafety or
efficacy

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
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Empatica Srl
Traditional 510(k)Empatica Health Monitoring Platform
Empatica Health
Monitoring
Platform (Subject
Device)Loop System

Energy Source

Battery

Battery

Battery

Battery

Battery

Battery Type

Rechargeable
Lithium-Ion

Rechargeable LithiumIon

Rechargeable LithiumIon

Rechargeable
Lithium-Ion

Rechargeable
Lithium-Ion

FeaturesWireless
Communication
Interface

Patient
contacting
materials

Bluetooth® Low
Energy (device tomobile device)
IEEE 802.11
WiFi/cellular to
Empatica cloudCompliant to ISO
10993-1

Current Wearable
Health Monitoring
SystemActiGraph
CentrePoint
Insight Watch

Empatica E4

Wireless (cellularconnection) via
charging station to
Spry Server.

IEEE 802.11 WiFi

Bluetooth® Low
EnergyBluetooth® Low
Energy (device tomobile device)
IEEE 802.11
WiFi/cellular to
Empatica cloudCompliant to ISO
10993-1

Compliant to ISO
10993-1

Compliant to ISO
10993-1

Compliant to ISO
10993-1

Analysis ofdifferences
The subject
device and thepredicates are
identical
The subject
device and thepredicates are
identical
All the devices
are designed totransmit theirdata toalternatedevices or sites.
The different
technologies
used do notraise newquestions ofsafety or
efficacy
The subject
device and thepredicates are
identical

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permission of Empatica, S.r.l. is prohibited. © Empatica S.R.L, 2022. All rights reserved
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Empatica Srl
Traditional 510(k)Empatica Health Monitoring Platform

FeaturesEmpatica Health
Monitoring Platform(Subject Device)

Technology

SpO2 relies on theprinciple that
hemoglobin at different
oxygenation states
absorbs light differently
based upon the
wavelength of light.

Technical and Performance Information for Blood Oxygen Saturation
Current Wearable
ActiGraph
Loop System
Health Monitoring
CentrePoint
SystemInsight Watch
SpO2 is measured by
SpO2 measured byanalyzing theanalyzing reflectance ofreflectance of certain
certain LED frequencies in
LED frequencies in aa photoplethysmogram
photoplethysmogram
N/A
design. The diodes aredesign. The diodes aremounted in the device
mounted in the device
such that they are insuch that they are incontact with the skincontact with the skin.

Empatica
E4

Analysis of differences

N/A

The subject device andthe predicates are
identical in that they all
use thephotoplethysmogram
technology

SpO2 Range

70-100%70-100%70-100%

N/A

N/A

SpO2
Resolution

1%

1%

1%

N/A

N/A

SpO2
Accuracy

2.6% Arms

3% Arms± 2 Digits

N/A

N/A

The subject device andthe predicates are
identical
The subject device andthe predicates are
identical
The subject device andthe predicates comply
with ISO 80601-261 as well as with FDA
Guidance for Pulse
Oximeters(2013)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
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Empatica Srl
Traditional 510(k)Empatica Health Monitoring Platform

Features
Technology
Temperature
Range
Temperature
Resolution
Temperature
Accuracy

Features

Technology

Empatica Health
Monitoring Platform(Subject Device)high-precision
temperature sensor

Technical and Performance Information for Temperature
Current Wearable
ActiGraph CentrePoint
Loop System
Health Monitoring
Insight Watch
SystemEmpatica
E4

N/A

In-Built Thermistor

N/A

N/A

0°C to 50°C

N/A

0°C to 50°C

N/A

N/A

0.1°C

N/A

0.1°C

N/A

N/A

± 0.1ºC within 30.0ºC 45.0ºC range

N/A±0.1°C

N/A

N/A

Technical and Performance Information for Electrodermal Activity
Current
Empatica Health
Wearable
ActiGraph
Loop
Monitoring Platform
HealthCentrePoint
Empatica E4
System(Subject Device)
Monitoring
Insight Watch
System
EDA is measured by
EDA is measured byanalyzing detected
analyzing detectedchanges in thechanges in the
N/A
N/A
N/A
conductivity of the
conductivity of thesuperficial layers of thesuperficial layers ofskin.
the skin.

EDA Range

0.01 μS – 100 μS

N/A

N/A

N/A

0.01 μS – 100 μS

EDA Resolution

1 digit ~ 55 pS

N/A

N/A

N/A

1 digit ~ 900 pS

Analysis of differences
The subject device and thepredicates are identical
The subject device and thepredicates are identical
The subject device and thepredicates are identical
The subject device and thepredicates are identical

Analysis of differences

The subject device and thepredicates are identical
The subject device and thepredicates are identical
This difference shall not raise
new concerns of device safety oreffectivenessThe 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
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Empatica Srl
Traditional 510(k)Empatica Health Monitoring Platform

FeaturesEmpatica Health
Monitoring Platform(Subject Device)

Technology

Accelerometer

Accelerometer
Type

Microelectromechanicalsystem(MEMS)-based integrated
circuitAccelerometer
Sampling Rate

Digital method, 26 Hz –208 HzAccelerometer
Dynamic Range
Accelerometer
Sensitivity

Technical and Performance Information for Activity and Sleep
Current Wearable
Loop
ActiGraph CentrePoint
Health Monitoring
SystemInsight Watch
SystemEmpatica
E4

Analysis of differences

N/A

Accelerometer

N/A

N/A

Microelectromechanicalsystem(MEMS)-based
integrated circuit

The subject device andthe predicate are
identical

N/A

The subject device andthe predicate are
identical

N/A

N/A

Digital method, 32 Hz –256 HzN/A± 16 g

N/A

N/A

±8g

N/A

0.488 milli-g per Least
Significant Bit

N/A

N/A

2.4 milli-g per Least
Significant Bit

N/A

N/A

N/A

This difference shall notraise new concerns ofdevice safety oreffectivenessThis difference shall notraise new concerns ofdevice safety oreffectivenessThis difference shall notraise new concerns ofdevice safety oreffectivenessThe 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
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Page 5.13

Empatica Srl
Traditional 510(k)Empatica Health Monitoring PlatformII.

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
Biocompatibility
testing

Test Description
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 "Useof 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 < 30 days)
Electrical safety The wearable device component of the Empatica Health Monitoring
testing
Platform, called EmbracePlus, was tested in accordance with
International Standard IEC 60601-1 for electrical safety
Electromagnetic The wearable device component of the Empatica Health Monitoring
compatibility
Platform, called EmbracePlus, was tested in accordance with(EMC) testing
International Standard IEC 60601-1-2 for EMC
Wireless Radio Empatica Health Monitoring Platform was tested to ensure it canCommunication communicate via wireless radio in its intended environment incompliance with FDA Radio Frequency Wireless Technology in
Medical Devices Guidance, issued August 2013
Usability testing The Empatica Health Monitoring Platform was assessed with regards
to usability for compliance with IEC 62366-1. The EmbracePlus was
also tested in accordance with International Standard IEC 60601-1-11
for Usability of medical devices.
Home-Use
The wearable device component of the Empatica Health Monitoring
testing
Platform, called EmbracePlus, was tested in accordance with
International Standard IEC 60601-1-6 for medical devices used inhome healthcare environments.
Cleaning
The wearable device component of the Empatica Health Monitoringvalidation
Platform, called EmbracePlus, was tested in accordance with
International Standard ISO 17664 and AAMI TIR 30 to assess device
cleaning procedure
ManualThe wearable device component of the Empatica Health Monitoring
disinfection
Platform, called EmbracePlus, was tested in accordance with ASTM
E1837:2014 and AAMI TIR 12 to assess device low-level disinfection
procedureTemperature
The Empatica Health Monitoring Platform was tested to confirm themeasurement
Skin temperature measurement accuracy and transient time complies
accuracy
with ISO 80601-2-56 Medical electrical equipment - Part 2-56:

Results
PassedPassedPassedPassedPassedPassedPassedPassedPassedThe 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
5.14

Empatica Srl
Traditional 510(k)Empatica Health Monitoring Platform
Test Name

Electrodermal
activity
measurement
ActivityCounts/Sleep

Test Description
Results
Particular requirements for basic safety and essential performance ofclinical thermometers for body temperature measurement.
[Including: Amendment 1 (2018)] to assess its accuracy.
The Empatica Health Monitoring Platform computed electrodermal Passed
activity (EDA) was tested to determine its equivalence to thepredicate device Empatica E4.
Bench testing has been performed to demonstrate the equivalence of Passed
the Empatica Health Monitoring Platform activity counts and sleep
detection with the predicate device.

Software Verification and Validation Testing
Software verification and validation testing were conducted. Documentation was provided asrecommended by the FDA's Guidance for Industry and FDA Staff, "Guidance for the Content ofPremarket Submissions for Software Contained in Medical Devices." All the Empatica Health
Monitoring Platform software components were considered a "moderate" level of concern since a
failure or latent flaw in the software could result in minor injury to the patient or operator.
Cybersecurity
Cybersecurity activities was conducted. Documentation was provided as recommended by the FDA's
Guidance for Industry and FDA Staff, " Content of Premarket Submissions for Management ofCybersecurity in Medical Devices." All the Empatica Health Monitoring Platform software components
underwent appropriate cybersecurity assessment and testing.
Animal study

No animal studies were conducted as part of the submission to prove substantial equivalence.
Clinical Study
A human clinical investigation study was conducted to demonstrate the performance of the Empatica
Health Monitoring Platform.
The clinical study investigated the accuracy of the blood oxygen saturation monitoring in 13 healthy
adult subjects with heterogeneous skin types. The Empatica Health Monitoring Platform wascompared to the gold standard, arterial blood gas analysis.
This testing was conducted in accordance with ISO 80601-2-61 Medical electrical equipment - Part 261: Particular requirements for basic safety and essential performance of pulse oximeter equipment
and in accordance with the FDA Guidelines for Pulse Oximeters – Premarket Notification Submissions[510(k)s]: Guidance for Industry and Food and Drug Administration Staff (2013).
The Empatica Health Monitoring Platform was found to be in compliance with both documents. This
testing demonstrated an accuracy of 2.6% Arms across the SpO2 range of 70-100%. This testing was notconducted in the presence of motion or low perfusion.
No adverse events related to the device were encountered during the execution of both studies. The
results of the clinical investigations demonstrate an effectiveness profile similar to the predicate
devices.
III.

CONCLUSION

Based on the information presented in this 510(k) premarket notifications, the Empatica Health
Monitoring Platform is substantially equivalent to the predicate devices. The Empatica Health
Monitoring Platform is as safe and effective as the currently marketed predicate devices.

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 5.15

Empatica Srl
Traditional 510(k)Empatica Health Monitoring Platform
Based on testing and comparison with the predicate devices, the Empatica Health Monitoring Platform
indicated no adverse indications or results. It is our determination that the Empatica Health
Monitoring Platform is safe, effective and performs within its design specifications, and is substantiallyequivalent to the predicate devices.

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 5.16