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.

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.

AI/ML Overview

This document describes the Empatica Health Monitoring Platform, a wearable device and cloud-based software, and its validation for FDA clearance. The primary focus of the performance data in this document is on the Blood Oxygen Saturation (SpO2) monitoring feature.

Here's a breakdown of the acceptance criteria and study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides specific performance criteria for several physiological parameters. For the SpO2 feature, a key acceptance criterion is its accuracy, which is compared to the predicate devices and relevant standards.

Feature / Parameter	Acceptance Criterion (Standard/Predicate)	Reported Device Performance (Empatica Health Monitoring Platform)
SpO2 Accuracy	- ISO 80601-2-61 compliance- FDA Guidance for Pulse Oximeters (2013) compliance- Predicate Loop System: 3% Arms- Predicate Current Wearable: ± 2 Digits	2.6% Arms (across 70-100% SpO2 range)
SpO2 Range	70-100% (Matches predicates)	70-100%
SpO2 Resolution	1% (Matches predicates)	1%
Temperature Accuracy	± 0.1°C within 30.0°C - 45.0°C range (Matches predicate Current Wearable, which has ± 0.1°C)	± 0.1°C within 30.0°C - 45.0°C range
Temperature Range	0°C to 50°C (Matches predicate Current Wearable)	0°C to 50°C
Temperature Resolution	0.1°C (Matches predicate Current Wearable)	0.1°C
EDA Range	0.01 µS – 100 µS (Matches predicate Empatica E4)	0.01 µS – 100 µS
EDA Resolution	Predicate Empatica E4: 1 digit ~ 900 pS	1 digit ~ 55 pS
Accelerometer Type	Microelectromechanical system (MEMS)-based integrated circuit (Matches predicate ActiGraph CentrePoint Insight Watch)	Microelectromechanical system (MEMS)-based integrated circuit
Accelerometer Sampling Rate	Predicate ActiGraph CentrePoint Insight Watch: Digital method, 32 Hz - 256 Hz	Digital method, 26 Hz - 208 Hz
Accelerometer Dynamic Range	Predicate ActiGraph CentrePoint Insight Watch: ± 8 g	± 16 g
Accelerometer Sensitivity	Predicate ActiGraph CentrePoint Insight Watch: 2.4 milli-g per Least Significant Bit	0.488 milli-g per Least Significant Bit

Note on "Analysis of differences" for EDA and Accelerometer: For EDA Resolution, Accelerometer Sampling Rate, Dynamic Range, and Sensitivity, the document explicitly states that the differences "shall not raise new concerns of device safety or effectiveness," implying that the reported performance, while numerically different, is still considered acceptable.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size for SpO2 Accuracy Test Set: 13 healthy adult subjects.
Data Provenance: The document does not explicitly state the country of origin but implies it was conducted by Empatica S.r.l., which is based in Milan, Italy. The study was a prospective clinical investigation, comparing the device to a gold standard.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

The ground truth for the SpO2 accuracy test was established using arterial blood gas analysis, which is a direct and objective physiological measurement and is considered the "gold standard." This method does not typically involve human experts for interpreting the ground truth itself, but rather trained medical professionals for collecting the samples and laboratory personnel for performing the analysis. The document does not specify the number or qualifications of these personnel.

4. Adjudication Method for the Test Set

Not applicable for the SpO2 accuracy study, as the ground truth was established by direct physiological measurement (arterial blood gas analysis), not expert consensus requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The study described is a direct comparison of the device's SpO2 measurements against a clinical gold standard (arterial blood gas analysis), focusing on the device's standalone accuracy rather than human-in-the-loop performance or improvement with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance study was done for SpO2 accuracy. The clinical study directly evaluated the performance of the Empatica Health Monitoring Platform (device and its algorithms) in measuring blood oxygen saturation against the ground truth, without an explicit human reader component. The device's output was compared to arterial blood gas analysis.

7. The Type of Ground Truth Used

Clinical Gold Standard / Outcomes Data (Physiological Measurement): For SpO2 accuracy, the ground truth was established through arterial blood gas analysis.

8. The Sample Size for the Training Set

The document does not provide information regarding the sample size of the training set for the device's algorithms. The clinical study described focuses on the validation of the device's performance, not its development or training data.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for any potential training set was established. The clinical study details focus solely on the method for validating the device's performance against a gold standard.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K221282

Device Name Empatica Health Monitoring Platform

Indications for Use (Describe)

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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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

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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:

ClassificationRegulation	Classification Name	DeviceClass	ProductCode	ClassificationPanel
870.2700	Oximeter	Class II	DQA	Cardiovascular

Secondary Product Codes:

ClassificationRegulation	Classification Name	DeviceClass	ProductCode	ClassificationPanel
870.2910	Transmitters and Receivers, PhysiologicalSignal, Radiofrequency	Class II	DRG	Cardiovascular
882.5050	Device, Sleep Assessment	Class II	LEL	Neurology
882.1540	Galvanic skin response measurementdevice	Class II	GZO	Neurology
880.2910	Thermometer, Electronic, Clinical	Class II	FLL	General Hospital

lll. PREDICATE DEVICES

PredicateDevice	Name	Submitter	Product Code(s)	510(k) Number
Primary	Loop System	Spry Health,Inc.	DQABZQ	K181352
Secondary	Current Wearable HealthMonitoring System	Current HealthLtd.	MSXDQADRGBZQFLL	K191272
Secondary	ActiGraph CentrePoint InsightWatch	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.

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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".

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.

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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 HealthMonitoringPlatform (SubjectDevice)	Loop System	Current WearableHealth MonitoringSystem	ActiGraphCentrePointInsight Watch	Empatica E4	Analysis ofdifferences
Common Name	Oximeter	Oximeter	System, Network andCommunication,PhysiologicalMonitors	Sleep assessmentdevice (actigraphy)	Device, GalvanicSkin ResponseMeasurement	N/A
DeviceManufacturer	Empatica S.r.l.	Spry Health Ltd.	Current Health Ltd.	ActiGraph, Inc.	Empatica S.r.l.	N/A
DeviceClassification	II	II	II	II	II (510(k) exempt)	N/A
510(k) number	N/A	K181352	K191272	K181077	N/A	N/A
Primary ProductCode	DQA	DQA	MSX	LEL	GZO	N/A
SecondaryProduct Code	DRG, GZO, LEL, FLL	BZQ	FLL, DQA, BZQ, DRG,BZG	-	-	N/A
IntendedUse/Indicationsfor Use	The EmpaticaHealth MonitoringPlatform is awearable deviceand paired mobileand cloud-basedsoftware platformintended to beused by trainedhealthcareprofessionals or	The Loop System isintended for adultpatients in the homeenvironment forpassive, noninvasive,intermittent datacollection ofphysiologicalparameters that willlater be transmitted toa web server for	The Current WearableHealth MonitoringSystem is intended forreusable bedside,mobile and centralmulti-parameter,physiologic patientmonitoring of adultpatients in professionalhealthcare facilities,such as hospitals or	The ActiGraphCentrePoint InsightWatch is a smallworn activitymonitor designedfor documentingphysical movementassociated withapplications inphysiologicalmonitoring. The	The Empatica E4 isintended forpassive, non-invasivecontinuouscollection ofelectrodermalactivity that will belater transmittedto a web server forremote review by	The subjectdeviceindication foruse includes themonitoring of asubset of thephysiologicalparameters ofall thepredicates.
Features	Empatica HealthMonitoringPlatform (SubjectDevice)	Loop System	Current WearableHealth MonitoringSystem	ActiGraphCentrePointInsight Watch	Empatica E4	Analysis ofdifferences
	researchers to	remote review by aclinician. The LoopSystem measures andrecords: • arterialoxygen saturation(SpO2) • heart rate(HR) • respiration rate(RR) All of thesemeasurements aremade when no motionis detected by theSystem. The LoopSystem device doesnot providephysiological alarms.	skilled nursingfacilities, or their ownhome. It is intended formonitoring of patientsby trained healthcareprofessionals. TheCurrent WearableHealth MonitoringSystem is intended toprovide visual andaudible physiologicmulti-parameteralarms. The CurrentWearable HealthMonitoring System isintended fortemperaturemonitoring wheremonitoringtemperature at theupper arm is clinicallyindicated. The CurrentWearable HealthMonitoring System isintended forcontinuous monitoringof the followingparameters in	device is intendedto monitor theactivity associatedwith movementduring sleep. TheInsight watch canbe used to analyzecircadian rhythmsand assess activityin any instancewhere quantifiableanalysis of physicalmotion isdesirable.	clinicians orresearchers.
	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 HealthMonitoringPlatform (SubjectDevice)	Loop System	Current WearableHealth MonitoringSystem	ActiGraphCentrePointInsight Watch	Empatica E4	Analysis ofdifferences
	The EmpaticaHealth MonitoringPlatform can beused to analyzecircadian rhythmsand assess activityin any instancewhere quantifiableanalysis of physicalmotion is desirable.The EmpaticaHealth MonitoringPlatform is notintended for SpO2monitoring inconditions ofmotion or lowperfusion.The EmpaticaHealth MonitoringPlatform isintended forperipheral skintemperaturemonitoring, wheremonitoring		adults:• Pulse rate• Oxygen saturation• Temperature• MovementThe Current WearableHealth MonitoringSystem is intended forintermittent or spot-check monitoring, inadults, of:• Respiration rate• Non-invasive bloodpressure• Lung function &spirometry• WeightThe Current WearableHealth MonitoringSystem is not intendedfor use in high-acuityenvironments, such asICU or operatingrooms.The Current WearableHealth MonitoringSystem is not intended
Features	Empatica HealthMonitoringPlatform (SubjectDevice)	Loop System	Current WearableHealth MonitoringSystem	ActiGraphCentrePointInsight Watch	Empatica E4	Analysis ofdifferences
	temperature at thewrist is clinicallyindicated.		for use on acutely illcardiac patients withthe potential todevelop lifethreateningarrhythmias e.g. veryfast atrial fibrillation.For these patients,they should bemonitored using adevice with continuousECG. The CurrentWearable HealthMonitoring System isnot a substitute for anECG monitor.The Current WearableHealth MonitoringSystem is not intendedfor SpO2 monitoring inconditions of highmotion orlow perfusion
TargetPopulation	Adult	Adult	Adult	Adult	Adult	The subjectdevice and thepredicates areidentical
Features	Empatica HealthMonitoringPlatform (SubjectDevice)	Loop System	Current WearableHealth MonitoringSystem	ActiGraphCentrePointInsight Watch	Empatica E4	Analysis ofdifferences
Anatomical Site	Wrist	Wrist	Upper Arm	Wrist	Wrist	Clinical testingdemonstratedthe equivalencebetween thesubject deviceand thepredicates. Thedifference inwearing locationon the bodydoes not raisenew questionsofsafety orefficacy.
Over theCounter or Rx	Rx	Rx	Rx	Rx	Rx	The subjectdevice and thepredicates areidentical
Environment	Home	Home	ProfessionalHealthcare Facilities &Home	ProfessionalHealthcareFacilities & Home	ProfessionalHealthcareFacilities & Home	The subjectdevice includesa subgroup ofthe predicates,hence this doesnot raise newquestions ofsafety orefficacy.
Features	Empatica HealthMonitoringPlatform (SubjectDevice)	Loop System	Current WearableHealth MonitoringSystem	ActiGraphCentrePointInsight Watch	Empatica E4	Analysis ofdifferences
Alarms	No	No	Yes	No	No	This differencedoes not raisenew questionsof safety orefficacy sincethe EmpaticaHealthMonitoringPlatform is notintended, bydesign, toinclude alarmsto be used in asituation wherethe presence ofalarms is arequirement forthe correctpatient care.
User Interface	Device screen,Mobile deviceapplication, andcloud softwareplatform	Central station	Mobile devices and acentral station	Device screen andMobile deviceapplication	Mobile devicesand cloud softwareplatform	The differencesbetween thesubject deviceand thepredicates donot raise newquestions ofsafety orefficacy
Features	Empatica HealthMonitoringPlatform (SubjectDevice)	Loop System	Current WearableHealth MonitoringSystem	ActiGraphCentrePointInsight Watch	Empatica E4	Analysis ofdifferences
Energy Source	Battery	Battery	Battery	Battery	Battery	The subjectdevice and thepredicates areidentical
Battery Type	RechargeableLithium-lon	Rechargeable Lithium-lon	Rechargeable Lithium-lon	RechargeableLithium-lon	RechargeableLithium-lon	The subjectdevice and thepredicates areidentical
WirelessCommunicationInterface	Bluetooth® LowEnergy (device tomobile device)IEEE 802.11WiFi/cellular toEmpatica cloud	Wireless (cellularconnection) viacharging station toSpry Server.	IEEE 802.11 WiFi	Bluetooth® LowEnergy	Bluetooth® LowEnergy (device tomobile device)IEEE 802.11WiFi/cellular toEmpatica cloud	All the devicesare designed totransmit theirdata toalternatedevices or sites.The differenttechnologiesused do notraise newquestions ofsafety orefficacy
Patientcontactingmaterials	Compliant to ISO10993-1	Compliant to ISO10993-1	Compliant to ISO10993-1	Compliant to ISO10993-1	Compliant to ISO10993-1	The subjectdevice and thepredicates areidentical

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Technical and Performance Information for Blood Oxygen Saturation
Features	Empatica HealthMonitoring Platform(Subject Device)	Loop System	Current WearableHealth MonitoringSystem	ActiGraphCentrePointInsight Watch	EmpaticaE4	Analysis of differences
Technology	SpO2 relies on theprinciple thathemoglobin at differentoxygenation statesabsorbs light differentlybased upon thewavelength of light.	SpO2 measured byanalyzing reflectance ofcertain LED frequencies ina photoplethysmogramdesign. The diodes aremounted in the devicesuch that they are incontact with the skin	SpO2 is measured byanalyzing thereflectance of certainLED frequencies in aphotoplethysmogramdesign. The diodes aremounted in the devicesuch that they are incontact with the skin.	N/A	N/A	The subject device andthe predicates areidentical in that they alluse thephotoplethysmogramtechnology
SpO2 Range	70-100%	70-100%	70-100%	N/A	N/A	The subject device andthe predicates areidentical
SpO2 Resolution	1%	1%	1%	N/A	N/A	The subject device andthe predicates areidentical
SpO2 Accuracy	$2.6% A_{rms}$	$3% A_{rms}$	± 2 Digits	N/A	N/A	The subject device andthe predicates complywith ISO 80601-2-61 as well as with FDAGuidance for PulseOximeters(2013)

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Technical and Performance Information for Temperature
Features	Empatica HealthMonitoring Platform(Subject Device)	Loop System	Current WearableHealth MonitoringSystem	ActiGraph CentrePointInsight Watch	EmpaticaE4	Analysis of differences
Technology	high-precisiontemperature sensor	N/A	In-Built Thermistor	N/A	N/A	The subject device and thepredicates are identical
TemperatureRange	0°C to 50°C	N/A	0°C to 50°C	N/A	N/A	The subject device and thepredicates are identical
TemperatureResolution	0.1°C	N/A	0.1°C	N/A	N/A	The subject device and thepredicates are identical
TemperatureAccuracy	$\pm$ 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 thepredicates are identical

Technical and Performance Information for Electrodermal Activity
Features	Empatica HealthMonitoring Platform(Subject Device)	LoopSystem	CurrentWearableHealthMonitoringSystem	ActiGraphCentrePointInsight Watch	Empatica E4	Analysis of differences
Technology	EDA is measured byanalyzing detectedchanges in theconductivity of thesuperficial layers of theskin.	N/A	N/A	N/A	EDA is measured byanalyzing detectedchanges in theconductivity of thesuperficial layers ofthe skin.	The subject device and thepredicates 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 thepredicates are identical
EDA Resolution	1 digit ~ 55 pS	N/A	N/A	N/A	1 digit ~ 900 pS	This difference shall not raisenew concerns of device safety oreffectiveness

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Technical and Performance Information for Activity and Sleep
Features	Empatica HealthMonitoring Platform(Subject Device)	LoopSystem	Current WearableHealth MonitoringSystem	ActiGraph CentrePointInsight Watch	EmpaticaE4	Analysis of differences
Technology	Accelerometer	N/A	N/A	Accelerometer	N/A	The subject device andthe predicate areidentical
AccelerometerType	Microelectromechanicalsystem(MEMS)-based integratedcircuit	N/A	N/A	Microelectromechanicalsystem(MEMS)-basedintegrated circuit	N/A	The subject device andthe predicate areidentical
AccelerometerSampling Rate	Digital method, 26 Hz -208 Hz	N/A	N/A	Digital method, 32 Hz -256 Hz	N/A	This difference shall notraise new concerns ofdevice safety oreffectiveness
AccelerometerDynamic Range	± 16 g	N/A	N/A	± 8 g	N/A	This difference shall notraise new concerns ofdevice safety oreffectiveness
AccelerometerSensitivity	0.488 milli-g per LeastSignificant Bit	N/A	N/A	2.4 milli-g per LeastSignificant Bit	N/A	This difference shall notraise new concerns ofdevice safety oreffectiveness

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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
Biocompatibilitytesting	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• IrritationThe EmbracePlus wearable device is considered surface contacting for a prolonged duration (>24 hours < 30 days)	Passed
	Electrical safetytesting	The wearable device component of the Empatica Health Monitoring Platform, called EmbracePlus, was tested in accordance with International Standard IEC 60601-1 for electrical safety	Passed
		Electromagneticcompatibility(EMC) testing	The wearable device component of the Empatica Health Monitoring Platform, called EmbracePlus, was tested in accordance with International Standard IEC 60601-1-2 for EMC	Passed
	Wireless RadioCommunication		Empatica Health Monitoring Platform was tested to ensure it can communicate via wireless radio in its intended environment in compliance with FDA Radio Frequency Wireless Technology in Medical Devices Guidance, issued August 2013	Passed
			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.	Passed
		Home-Usetesting		The wearable device component of the Empatica Health Monitoring Platform, called EmbracePlus, was tested in accordance with International Standard IEC 60601-1-6 for medical devices used in home healthcare environments.	Passed
				Cleaningvalidation	The wearable device component of the Empatica Health Monitoring Platform, called EmbracePlus, was tested in accordance with International Standard ISO 17664 and AAMI TIR 30 to assess device cleaning procedure
	Manualdisinfection				The wearable device component of the Empatica Health Monitoring Platform, called EmbracePlus, was tested in accordance with ASTM E1837:2014 and AAMI TIR 12 to assess device low-level disinfection procedure
			Temperaturemeasurementaccuracy		The Empatica Health Monitoring Platform was tested to confirm the Skin temperature measurement accuracy and transient time complies with ISO 80601-2-56 Medical electrical equipment - Part 2-56:
		Test Name			Test Description
				Particular requirements for basic safety and essential performance ofclinical thermometers for body temperature measurement.[Including: Amendment 1 (2018)] to assess its accuracy.
	Electrodermalactivitymeasurement	The Empatica Health Monitoring Platform computed electrodermalactivity (EDA) was tested to determine its equivalence to thepredicate device Empatica E4.	Passed
	ActivityCounts/Sleep	Bench testing has been performed to demonstrate the equivalence ofthe Empatica Health Monitoring Platform activity counts and sleepdetection with the predicate device.	Passed

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Empatica Health Monitoring Platform

Software Verification and Validation Testing

Software verification and validation testing were conducted. Documentation was provided as recommended by the FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket 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 of Cybersecurity 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 was compared to the gold standard, arterial blood gas analysis.

This testing was conducted in accordance with ISO 80601-2-61 Medical electrical equipment - Part 2-61: 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 not conducted 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.

lll. 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.

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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 substantially equivalent to the predicate devices.

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).