Empatica Health Monitoring Platform

K221282 · Empatica S.r.l. · DQA · Nov 20, 2022 · Cardiovascular

Device Facts

• Record ID: K221282
• Device Name: Empatica Health Monitoring Platform
• Applicant: Empatica S.r.l.
• Product Code: DQA · Cardiovascular
• Decision Date: Nov 20, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2

Intended 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.

Device Story

Wearable wrist-worn device (EmbracePlus) collects raw physiological data (SpO2, skin temperature, electrodermal activity, movement); transmits via Bluetooth Low Energy to smartphone 'Care App'. Care App (EmpaDSP module) computes physiological parameters; transmits data via cellular/Wi-Fi to 'Care Portal' cloud platform. Healthcare professionals/researchers access data via Care Portal for remote patient monitoring. Device supports circadian rhythm analysis and sleep activity assessment. Intended for home-healthcare environments; no physiological alarms. Benefits include continuous, non-invasive monitoring of physiological parameters in ambulatory adults.

Clinical Evidence

Clinical study in 13 healthy adult subjects with heterogeneous skin types evaluated SpO2 accuracy against arterial blood gas analysis (gold standard). Testing followed ISO 80601-2-61 and FDA 2013 Pulse Oximeter guidance. Results demonstrated 2.6% Arms accuracy across 70-100% SpO2 range. No adverse events reported. Bench testing validated biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and performance of temperature, EDA, and activity sensors.

Technological Characteristics

Wearable wrist device (EmbracePlus) with MEMS accelerometer, high-precision temperature sensor, and photoplethysmogram (PPG) sensors for SpO2 and EDA. Connectivity via Bluetooth LE to mobile app and Wi-Fi/cellular to cloud. Materials compliant with ISO 10993-1. Software includes mobile app (EmpaDSP module) and cloud portal. Powered by rechargeable Lithium-ion battery.

Indications for Use

Indicated for ambulatory individuals 18 years of age and older in home-healthcare environments for remote monitoring of physiologic parameters by trained healthcare professionals or researchers. Not indicated for SpO2 monitoring during motion or low perfusion.

Regulatory Classification

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.

Predicate Devices

• Loop System (K181352)
• Current Wearable Health Monitoring System (K191272)
• ActiGraph CentrePoint Insight Watch (K181077)
• Empatica E4 (N/A)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 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)

| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|

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

Image /page/3/Picture/1 description: The image shows the word "empatica" in a bold, sans-serif font. The color of the text is a dark pink or magenta. To the right of the word is a stylized logo that resembles a heart shape pointing to the right, also in the same dark pink color.

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 | [e-mail] |
| Address | Via Stendhal, 36 - 20144, Milan, Italy |
| Telephone Number | [phone] |
| 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<br>Regulation | Classification Name | Device<br>Class | Product<br>Code | Classification<br>Panel |
|------------------------------|---------------------|-----------------|-----------------|-------------------------|
| 870.2700 | Oximeter | Class II | DQA | Cardiovascular |

#### Secondary Product Codes:

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

#### lll. PREDICATE DEVICES

| Predicate<br>Device | Name | Submitter | Product Code(s) | 510(k) Number |
|---------------------|----------------------------------------------|------------------------|---------------------------------|---------------|
| Primary | Loop System | Spry Health,<br>Inc. | DQA<br>BZQ | K181352 |
| Secondary | Current Wearable Health<br>Monitoring System | Current Health<br>Ltd. | MSX<br>DQA<br>DRG<br>BZQ<br>FLL | K191272 |
| Secondary | ActiGraph CentrePoint Insight<br>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

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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".

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.

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