Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal

K230457 · Empatica S.r.l. · MWI · Oct 30, 2023 · Cardiovascular

Device Facts

• Record ID: K230457
• Device Name: Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal
• Applicant: Empatica S.r.l.
• Product Code: MWI · Cardiovascular
• Decision Date: Oct 30, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Intended 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 for retrospective remote monitoring of physiologic parameters in ambulatory individuals 18 years of age and older in home-healthcare environments. As the platform does not provide real-time alerts related to variation of physiologic parameters, users should use professional judgment in assessing patient clinical stability and the appropriateness of using a monitoring platform designed for retrospective review. The device is intended for continuous data collection supporting intermittent review of the following physiological parameters: · Pulse Rate, - · Blood Oxygen Saturation under no-motion conditions, - · Respiratory Rate under no motion conditions, - · Peripheral Skin Temperature, - · Electrodermal Activity, - · 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 Empatica Health Monitoring Platform is not intended for Respiratory Rate monitoring in motion conditions. This device does not detect apnea and should not be used for detecting or monitoring cessation of breathing. The Empatica Health Monitoring Platform is not intended for Pulse Rate monitoring in patients with chronic cardiac arrhythmias, including atrial fibrillation and atrial/ventricular bigeminy. and is not intended to diagnose or analyze cardiac arrhythmias. The Empatica Health Monitoring Platform is not a substitute for an ECG monitor, and should not be used as the sole basis for clinical decision-making.

Device Story

Wearable wrist-worn device (EmbracePlus) collects raw physiologic data via sensors; transmits via Bluetooth Low Energy to mobile app (Care App). Care App module (EmpaDSP) computes physiologic parameters; transmits data via cellular/Wi-Fi to cloud (Empatica Cloud). Healthcare professionals/researchers access data via cloud-based portal (Care Portal) for retrospective review. Device provides no real-time alerts. Used in home-healthcare environments to support clinical decision-making; not a substitute for ECG monitoring. Benefits include continuous, non-invasive physiologic data collection for intermittent review.

Clinical Evidence

Three clinical studies (n=146) evaluated pulse rate accuracy vs. ECG reference: ≤3 bpm (no-motion), ≤5 bpm (motion). Four clinical studies (n=117) evaluated respiratory rate accuracy vs. capnography: ≤3 brpm (no-motion). Subgroup analyses confirmed performance across sex, skin tone, and clinical conditions. No adverse events reported.

Technological Characteristics

Wrist-worn wearable with MEMS accelerometer (±16g), optical PPG sensors, and high-precision temperature sensor. Connectivity: BLE to mobile, Wi-Fi/cellular to cloud. Materials compliant with ISO 10993-1. Battery: Rechargeable Li-ion. Software: EmpaDSP module for signal processing. Standards: IEC 60601-1, IEC 60601-1-2, ISO 80601-2-61, ISO 80601-2-56.

Indications for Use

Indicated for ambulatory individuals 18+ years old in home-healthcare environments for retrospective remote monitoring of pulse rate, SpO2 (no-motion), respiratory rate (no-motion), peripheral skin temperature, electrodermal activity, and sleep-related movement. Contraindicated for SpO2/RR monitoring during motion, apnea detection, or pulse rate monitoring in patients with chronic cardiac arrhythmias (e.g., atrial fibrillation, bigeminy, trigeminy).

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Predicate Devices

• Current Health Monitoring System Gen 2 (K210133)
• Empatica Health Monitoring Platform (K221282)
• Loop System (K181352)

Reference Devices

• Everion+ System (K213863)

Submission Summary (Full Text)

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October 30, 2023

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

Re: K230457

Trade/Device Name: Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, BZQ, DQA, DRG, FLL, GZO, LEL Dated: April 3, 2023 Received: September 29, 2023

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

Sincerely,

## Jennifer W. Shih -S

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

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### Indications for Use

Submission Number (if known)

K230457

Device Name

Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal

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 for retrospective remote monitoring of physiologic parameters in ambulatory individuals 18 years of age and older in home-healthcare environments. As the platform does not provide real-time alerts related to variation of physiologic parameters, users should use professional judgment in assessing patient clinical stability and the appropriateness of using a monitoring platform designed for retrospective review.

The device is intended for continuous data collection supporting intermittent review of the following physiological parameters:

· Pulse Rate,

- · Blood Oxygen Saturation under no-motion conditions,
- · Respiratory Rate under no motion conditions,
- · Peripheral Skin Temperature,
- · Electrodermal Activity,
- · 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 Empatica Health Monitoring Platform is not intended for Respiratory Rate monitoring in motion conditions. This device does not detect apnea and should not be used for detecting or monitoring cessation of breathing.

The Empatica Health Monitoring Platform is not intended for Pulse Rate monitoring in patients with chronic cardiac arrhythmias, including atrial fibrillation and atrial/ventricular bigeminy and trigeminy. and is not intended to diagnose or analyze cardiac arrhythmias. The Empatica Health Monitoring Platform is not a substitute for an ECG monitor, and should not be used as the sole basis for clinical decision-making.

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

> Prescription Use (Part 21 CFR 801 Subpart D)

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### Empatica Health Monitoring Platform

### 510(k) Summary

#### l. SUBMITTER

| Company Name | Empatica Srl |
|-----------------------------------|---------------------------------------------------------|
| Establishment Registration Number | 3012933969 |
| Contact Person | Alberto Poli, Director, Quality & Regulatory Compliance |
| Contact Person email | [e-mail] |
| Address | Via Stendhal, 36 - 20144, Milan, Italy |
| Telephone Number | [phone] |
| Date prepared | September 27, 2023 |

#### II. DEVICE

Trade/Proprietary Name: Common/Usual Name:

Empatica Health Monitoring Platform Remote Patient Monitoring System

### Primary Product Code:

| Classification Regulation | Classification Name | Device Class | Product Code | Classification Panel |
|---------------------------|--------------------------------------------------------------------------|--------------|--------------|----------------------|
| 870.2300 | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Class II | MWI | Cardiovascular |

#### Secondary Product Codes:

| Classificatio<br>n Regulation | Classification Name | Device<br>Class | Produc<br>t Code | Classification<br>Panel |
|-------------------------------|---------------------------------------------------------------------|-----------------|------------------|-------------------------|
| 870.2700 | Oximeter | Class II | DQA | Cardiovascular |
| 868.2375 | Monitor, Breathing Frequency | Class II | BZQ | Anesthesiology |
| 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<br>Hospital |

#### PREDICATE DEVICES lll.

| Predicate<br>Device | Name | Submitter | Product Code(s) | 510(k) Number |
|---------------------|-------------------------------------------|----------------------|----------------------------------------|---------------|
| Primary | Current Health Monitoring<br>System Gen 2 | Spry Health,<br>Inc. | MSX<br>DQA<br>DRG<br>BZQ<br>BZG<br>FLL | K210133 |
| Secondary | Empatica Health Monitoring<br>Platform | Empatica S.r.l. | DQA<br>DRG<br>LEL<br>FLL<br>GZO | K221282 |

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Empatica Health Monitoring Platform

| Predicate<br>Device | Name | Submitter | Product Code(s) | 510(k) Number |
|---------------------|-------------|----------------------|-----------------|---------------|
| Secondary | Loop System | Spry Health,<br>Inc. | DQA<br>BZQ | K181352 |

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

#### REFERENCE DEVICE IV.

| Name | Submitter | Product Code(s) | 510(k) Number |
|-----------------|-------------------------------|-----------------|---------------|
| Everion+ System | Biofourmis Singapore Pte. Ltd | MWI, MSX, BZQ | K213863 |

#### DEVICE DESCRIPTION V.

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 Empatica Health Monitoring Platform is intended for retrospective remote monitoring of physiological parameters in ambulatory adults in home-healthcare environments. It is designed to continuously collect data to support intermittent monitoring of the following physiological parameters and digital biomarkers by trained healthcare professionals or researchers: Pulse Rate (PR), Respiratory Rate (RR), blood oxygen saturation (SpO-), 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.

#### INDICATION FOR USE vi.

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 for retrospective remote monitoring of physiologic parameters in ambulatory individuals 18 years of age and older in home-healthcare environments. As the platform does not provide real-time alerts related to variation of physiologic parameters, users should use professional judgment in assessing patient clinical stability and the appropriateness of using a monitoring platform designed for retrospective review.

The device is intended for continuous data collection supporting intermittent retrospective review of the following physiological parameters:

• Pulse Rate,

- · Blood Oxygen Saturation under no-motion conditions,
- · Respiratory Rate under no motion conditions,
- · Peripheral Skin Temperature,
- · Electrodermal Activity,
- · Activity associated with movement during sleep

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Empatica Health Monitoring Platform

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 Empatica Health Monitoring Platform is not intended for Respiratory Rate monitoring in motion conditions. This device does not detect apnea and should not be used for detecting or monitoring cessation of breathing.

The Empatica Health Monitoring Platform is not intended for Pulse Rate monitoring in patients with chronic cardiac arrhythmias, including atrial fibrillation and atrial/ventricular bigeminy, and is not intended to diagnose or analyze cardiac arrhythmias. The Empatica Health Monitoring Platform is not a substitute for an ECG monitor, and should not be used as the sole basis for clinical decision-making.

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K230457

Empatica Health Monitoring Platform

#### I. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

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

| Features | Empatica Health<br>Monitoring Platform<br>(Subject Device) | Current Health Monitoring<br>System Gen 2 (K210133) | Empatica Health Monitoring<br>Platform (K221282) | Loop System (K181352) | Analysis of differences |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Monitor, Physiological,<br>Patient (Without<br>Arrhythmia Detection Or<br>Alarms) | System, Network and<br>Communication,<br>Physiological<br>Monitors | Oximeter | Oximeter | N/A |
| Device<br>Manufacturer | Empatica S.r.l. | Current Health Ltd. | Empatica S.r.l. | Spry Health Ltd. | N/A |
| Device<br>Classification | II | ll | ll | ll | N/A |
| 510(k) number | N/A | K210133 | K221282 | K181352 | N/A |
| Primary<br>Product Code | MWI | MSX | DQA | DQA | N/A |
| Secondary<br>Product Code | DQA, BZQ, DRG, GZO, LEL,<br>FLL | FLL, DQA, BZQ, DRG,<br>BZG | DRG, GZO, LEL, FLL | BZQ | N/A |
| Intended<br>Use/Indications<br>for Use | The Empatica Health<br>Monitoring Platform is a<br>wearable device and<br>paired mobile and<br>cloud-based software<br>platform intended to be<br>used by trained<br>healthcare professionals<br>or researchers for<br>retrospective remote<br>monitoring of physiologic<br>parameters in ambulatory | The Current Wearable<br>Health Monitoring System is<br>intended for reusable<br>bedside, mobile and central<br>multi-parameter, physiologic<br>patient monitoring of adult<br>patients in professional<br>healthcare facilities, such as<br>hospitals or skilled nursing<br>facilities, or their own home.<br>It is intended for monitoring<br>of patients by trained | The Empatica Health<br>Monitoring Platform is a<br>wearable device and paired<br>mobile and cloud-based<br>software platform intended<br>to be used by trained<br>healthcare professionals or<br>researchers to remotely<br>monitor physiologic<br>parameters in ambulatory<br>individuals 18 years of age<br>and older in | 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 a<br>web server for remote<br>review by a clinician. | The subject device<br>indication for use<br>includes the monitoring<br>of a subset of the<br>physiological parameters<br>monitored by the primary<br>predicate and additional<br>parameters compared<br>with the secondary<br>predicates. |
| Features | Empatica Health<br>Monitoring Platform<br>(Subject Device) | Current Health Monitoring<br>System Gen 2 (K210133) | Empatica Health Monitoring<br>Platform (K221282) | Loop System (K181352) | Analysis of differences |
| | individuals 18 years of age and older in home-healthcare environments. As the platform does not provide real-time alerts related to variation of physiologic parameters, users should use professional judgment in assessing patient clinical stability and the appropriateness of using a monitoring platform designed for retrospective review.<br>The device is intended for continuous data collection supporting intermittent retrospective review of the following physiological parameters:<br>• Pulse Rate,<br>• Blood Oxygen Saturation under no-motion conditions,<br>• Respiratory Rate under no motion conditions, | healthcare professionals.<br>The Current Wearable Health Monitoring System is intended to provide visual and audible physiologic multi-parameter alarms. The Current Wearable Health Monitoring System is intended for temperature monitoring where monitoring temperature at the upper arm is clinically indicated. The Current Wearable Health Monitoring System is intended for continuous monitoring of the following parameters in adults:<br>• Pulse rate<br>• Oxygen saturation<br>• Temperature<br>• Movement<br>The Current Wearable Health Monitoring System is intended for intermittent or spot-check monitoring, in adults, of:<br>• Respiration rate | home-healthcare environments.<br>The device supports the continuous monitoring of the following:<br>• Peripheral skin temperature,<br>• Electrodermal activity<br>• Blood Oxygen Saturation under no motion conditions<br>• Activity associated with movement during sleep<br>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.<br>The Empatica Health Monitoring Platform is not intended for SpO2 monitoring in conditions of motion or low perfusion.<br>The Empatica Health Monitoring Platform is intended for peripheral skin temperature monitoring, | The Loop System measures and records:<br>• arterial oxygen saturation (SpO2) • heart rate (HR) • respiration rate (RR) All of these measurements are made when no motion is detected by the System. The Loop System device does not provide physiological alarms. | |
| Features | Empatica Health<br>Monitoring Platform<br>(Subject Device) | Current Health Monitoring<br>System Gen 2 (K210133) | Empatica Health Monitoring<br>Platform (K221282) | Loop System (K181352) | Analysis of differences |
| | Peripheral Skin<br>Temperature, Electrodermal Activity, Activity associated with<br>movement during sleep The Empatica Health<br>Monitoring Platform can<br>be used to analyze<br>circadian rhythms and<br>assess activity in any<br>instance where<br>quantifiable analysis of<br>physical motion is<br>desirable.<br>The Empatica Health<br>Monitoring Platform is<br>not intended for SpO2<br>monitoring in conditions<br>of motion or low<br>perfusion.<br>The Empatica Health<br>Monitoring Platform is<br>intended for peripheral<br>skin temperature<br>monitoring, where<br>monitoring temperature | Non-invasive blood<br>pressure Lung function &<br>spirometry Weight The Current Wearable<br>Health Monitoring System is<br>not intended for use in<br>high-acuity environments,<br>such as ICU or operating<br>rooms.<br>The Current Wearable<br>Health Monitoring System is<br>not intended for use on<br>acutely ill cardiac patients<br>with the potential to<br>develop life threatening<br>arrhythmias e.g. very fast<br>atrial fibrillation. For these<br>patients, they should be<br>monitored using a device<br>with continuous ECG. The<br>Current Wearable Health<br>Monitoring System is not a<br>substitute for an ECG<br>monitor.<br>The Current Wearable<br>Health Monitoring System is | where monitoring<br>temperature at the wrist is<br>clinically indicated. | | |
| Features | Empatica Health<br>Monitoring Platform<br>(Subject Device) | Current Health Monitoring<br>System Gen 2 (K210133) | Empatica Health Monitoring<br>Platform (K221282) | Loop System (K181352) | Analysis of differences |
| | at the wrist is clinically<br>indicated. | not intended for SpO2<br>monitoring in conditions of<br>high motion or<br>low perfusion | | | |
| | The Empatica Health<br>Monitoring Platform is<br>not intended for<br>Respiratory Rate<br>monitoring in motion<br>conditions. This device<br>does not detect apnea<br>and should not be used<br>for detecting or<br>monitoring cessation of<br>breathing. | | | | |
| | The Empatica Health<br>Monitoring Platform is<br>not intended for Pulse<br>Rate monitoring in<br>patients with chronic<br>cardiac arrhythmias,<br>including atrial fibrillation<br>and atrial/ventricular<br>bigeminy and trigeminy,<br>and is not intended to<br>diagnose or analyze<br>cardiac arrhythmias. The<br>Empatica Health<br>Monitoring Platform is | | | | |
| Features | Empatica Health<br>Monitoring Platform<br>(Subject Device) | Current Health Monitoring<br>System Gen 2 (K210133) | Empatica Health Monitoring<br>Platform (K221282) | Loop System (K181352) | Analysis of differences |
| | not a substitute for an<br>ECG monitor, and should<br>not be used as the sole<br>basis<br>for<br>clinical<br>decision-making. | | | | |
| Target<br>Population | Adult | Adult | Adult | Adult | The subject device and<br>the predicates are<br>identical |
| Anatomical Site | Wrist | Upper Arm | Wrist | Wrist | Clinical testing<br>demonstrated the<br>equivalence between the<br>subject device and the<br>predicates. The<br>difference in wearing<br>location<br>on the body<br>does not raise new<br>questions of<br>safety or efficacy. |
| Over the<br>Counter or Rx | Rx | Rx | Rx | Rx | The subject device and<br>the predicates are<br>identical |
| Environment | Home | Professional Healthcare<br>Facilities & Home | Home | Home | The subject device<br>includes a subgroup of<br>the predicates, hence this<br>does not raise new<br>questions of safety or<br>efficacy. |
| Features | Empatica Health<br>Monitoring Platform<br>(Subject Device) | Current Health Monitoring<br>System Gen 2 (K210133) | Empatica Health Monitoring<br>Platform (K221282) | Loop System (K181352) | Analysis of differences |
| Alarms | No…