Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions data analysis and computation of physiological parameters but does not explicitly state the use of AI or ML algorithms for these processes. The performance studies focus on standard accuracy metrics rather than AI/ML-specific metrics.

Therapeutic

No
The device is intended for retrospective remote monitoring of physiological parameters and does not provide real-time alerts or therapeutic interventions. Its labeling states it is "not intended to diagnose or analyze cardiac arrhythmias" and "not a substitute for an ECG monitor."

Diagnostic

No

The document explicitly states that the device "is not intended to diagnose or analyze cardiac arrhythmias" and "is not a substitute for an ECG monitor, and should not be used as the sole basis for clinical decision-making." Its purpose is for retrospective remote monitoring of physiological parameters, not for providing a diagnosis itself.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the Empatica Health Monitoring Platform is composed of a wearable medical device (EmbracePlus), a mobile application, and a cloud-based software platform. The wearable device is a hardware component that collects raw data via sensors.

IVD (In Vitro Diagnostic)

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

Here's why:

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

Therefore, the Empatica Health Monitoring Platform falls under the category of a physiological monitoring device rather than an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Empatica Health Monitoring Platform is a wearable device and 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.

Product codes (comma separated list FDA assigned to the subject device)

MWI, BZQ, DQA, DRG, FLL, GZO, LEL

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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

photoplethysmogram

Anatomical Site

Wrist

Indicated Patient Age Range

18 years of age and older

Intended User / Care Setting

trained healthcare professionals or researchers for retrospective remote monitoring of physiologic parameters in ambulatory individuals ... in home-healthcare environments.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Pulse Rate:
The accuracy of the pulse rate values computed by the Empatica Health Monitoring Platform in motion and no-motion conditions, was investigated through the execution of three clinical studies on a total of 146 adult subjects. The Empatica Health Monitoring Platform was compared to a reference electrocardiogram.

The first study investigated the accuracy of the computed pulse rate values during no-motion conditions in 12 healthy adult subjects (Male=7, Female=5; Fitzpatrick I-IV=11, This testing demonstrated an accuracy of ≤3 bpm Am in no-motion conditions across a range of 24-240 beats per minute.

A second study investigated the accuracy of the computed pulse rate values in motion and no-motion conditions in 85 healthy adult subjects (Male=40, Female=45; Fitzpatrick I-IV=63, V-VI=22). This testing demonstrated an accuracy of ≤3 bpm Ame in no-motion conditions, and ≤5 bpm Am in motion conditions across the range of 24-240 beats per minute.

The third study investigated the accuracy of the computed pulse rate values in motion and no-motion conditions in 49 adult subjects across a range of clinical conditions (Male=22; Fitzpatrick I-IV=38, V-VI=11; Healthy=10, Subjects with PVCs=19, Subjects with other comorbidities=20). This testing demonstrated an accuracy of ≤3 bpm Am in no-motion conditions, and

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
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.(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym and name on the right. The FDA part of the logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

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).

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

2

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)

3

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4

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	apo@empatica.com
Address	Via Stendhal, 36 - 20144, Milan, Italy
Telephone Number	+39 02 36165068
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
n Regulation | Classification Name | Device
Class | Produc
t Code | Classification
Panel |
|-------------------------------|---------------------------------------------------------------------|-----------------|------------------|-------------------------|
| 870.2700 | Oximeter | Class II | DQA | Cardiovascular |
| 868.2375 | Monitor, Breathing Frequency | Class II | BZQ | Anesthesiology |
| 870.2910 | Transmitters and Receivers, Physiological
Signal, Radiofrequency | Class II | DRG | Cardiovascular |
| 882.5050 | Device, Sleep Assessment | Class II | LEL | Neurology |
| 882.1540 | Galvanic skin response measurement
device | Class II | GZO | Neurology |
| 880.2910 | Thermometer, Electronic, Clinical | Class II | FLL | General
Hospital |

PREDICATE DEVICES lll.

| Predicate

Device	Name	Submitter
Primary	Current Health Monitoring
System Gen 2	Spry Health,
Inc.	MSX
DQA
DRG
BZQ
BZG
FLL	K210133
Secondary	Empatica Health Monitoring
Platform	Empatica S.r.l.	DQA
DRG
LEL
FLL
GZO	K221282

5

Empatica Health Monitoring Platform

| Predicate

Device	Name	Submitter
Secondary	Loop System	Spry Health,
Inc.	DQA
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

6

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.

7

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
Monitoring Platform
(Subject Device) | Current Health Monitoring
System Gen 2 (K210133) | Empatica Health Monitoring
Platform (K221282) | Loop System (K181352) | Analysis of differences |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Monitor, Physiological,
Patient (Without
Arrhythmia Detection Or
Alarms) | System, Network and
Communication,
Physiological
Monitors | Oximeter | Oximeter | N/A |
| Device
Manufacturer | Empatica S.r.l. | Current Health Ltd. | Empatica S.r.l. | Spry Health Ltd. | N/A |
| Device
Classification | II | ll | ll | ll | N/A |
| 510(k) number | N/A | K210133 | K221282 | K181352 | N/A |
| Primary
Product Code | MWI | MSX | DQA | DQA | N/A |
| Secondary
Product Code | DQA, BZQ, DRG, GZO, LEL,
FLL | FLL, DQA, BZQ, DRG,
BZG | DRG, GZO, LEL, FLL | BZQ | N/A |
| Intended
Use/Indications
for Use | The Empatica Health
Monitoring Platform is a
wearable device and
paired mobile and
cloud-based software
platform intended to be
used by trained
healthcare professionals
or researchers for
retrospective remote
monitoring of physiologic
parameters in ambulatory | The Current Wearable
Health Monitoring System is
intended for reusable
bedside, mobile and central
multi-parameter, physiologic
patient monitoring of adult
patients in professional
healthcare facilities, such as
hospitals or skilled nursing
facilities, or their own home.
It is intended for monitoring
of patients by trained | 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 | The Loop System is
intended for adult
patients in the home
environment for
passive, noninvasive,
intermittent data
collection of
physiological
parameters that will
later be transmitted to a
web server for remote
review by a clinician. | The subject device
indication for use
includes the monitoring
of a subset of the
physiological parameters
monitored by the primary
predicate and additional
parameters compared
with the secondary
predicates. |
| Features | Empatica Health
Monitoring Platform
(Subject Device) | Current Health Monitoring
System Gen 2 (K210133) | Empatica Health Monitoring
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.
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, | healthcare professionals.
The Current Wearable Health Monitoring System is intended to provide visual and audible physiologic multi-parameter alarms. The Current Wearable Health Monitoring System is intended for temperature monitoring where monitoring temperature at the upper arm is clinically indicated. The Current Wearable Health Monitoring System is intended for continuous monitoring of the following parameters in adults:
• Pulse rate
• Oxygen saturation
• Temperature
• Movement
The Current Wearable Health Monitoring System is intended for intermittent or spot-check monitoring, in adults, of:
• Respiration rate | home-healthcare environments.
The device supports the continuous monitoring of the following:
• 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, | The Loop System measures and records:
• arterial oxygen saturation (SpO2) • heart rate (HR) • respiration rate (RR) All of these measurements are made when no motion is detected by the System. The Loop System device does not provide physiological alarms. | |
| Features | Empatica Health
Monitoring Platform
(Subject Device) | Current Health Monitoring
System Gen 2 (K210133) | Empatica Health Monitoring
Platform (K221282) | Loop System (K181352) | Analysis of differences |
| | 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 | Non-invasive blood
pressure Lung function &
spirometry Weight The Current Wearable
Health Monitoring System is
not intended for use in
high-acuity environments,
such as ICU or operating
rooms.
The Current Wearable
Health Monitoring System is
not intended for use on
acutely ill cardiac patients
with the potential to
develop life threatening
arrhythmias e.g. very fast
atrial fibrillation. For these
patients, they should be
monitored using a device
with continuous ECG. The
Current Wearable Health
Monitoring System is not a
substitute for an ECG
monitor.
The Current Wearable
Health Monitoring System is | where monitoring
temperature at the wrist is
clinically indicated. | | |
| Features | Empatica Health
Monitoring Platform
(Subject Device) | Current Health Monitoring
System Gen 2 (K210133) | Empatica Health Monitoring
Platform (K221282) | Loop System (K181352) | Analysis of differences |
| | at the wrist is clinically
indicated. | not intended for SpO2
monitoring in conditions of
high motion or
low perfusion | | | |
| | 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 | | | | |
| Features | Empatica Health
Monitoring Platform
(Subject Device) | Current Health Monitoring
System Gen 2 (K210133) | Empatica Health Monitoring
Platform (K221282) | Loop System (K181352) | Analysis of differences |
| | not a substitute for an
ECG monitor, and should
not be used as the sole
basis
for
clinical
decision-making. | | | | |
| Target
Population | Adult | Adult | Adult | Adult | The subject device and
the predicates are
identical |
| Anatomical Site | Wrist | Upper Arm | Wrist | Wrist | Clinical testing
demonstrated the
equivalence between the
subject device and the
predicates. The
difference in wearing
location
on the body
does not raise new
questions of
safety or efficacy. |
| Over the
Counter or Rx | Rx | Rx | Rx | Rx | The subject device and
the predicates are
identical |
| Environment | Home | Professional Healthcare
Facilities & Home | Home | Home | The subject device
includes a subgroup of
the predicates, hence this
does not raise new
questions of safety or
efficacy. |
| Features | Empatica Health
Monitoring Platform
(Subject Device) | Current Health Monitoring
System Gen 2 (K210133) | Empatica Health Monitoring
Platform (K221282) | Loop System (K181352) | Analysis of differences |
| Alarms | No | Yes | No | No | This difference does not
raise new questions of
safety or efficacy since
the Empatica Health
Monitoring Platform is
not intended, by design,
to include alarms for use
in situations where the
presence of alarms is a
requirement for
appropriate patient care. |
| User Interface | Device screen, Mobile
device application, and
cloud software platform | Mobile devices and a central
station | Device screen, Mobile device
application, and cloud
software platform | Central station | The differences between
the subject device and
the predicates do not
raise new questions of
safety or efficacy |
| Energy Source | Battery | Battery | Battery | Battery | The subject device and
the predicates are
identical |
| Battery Type | Rechargeable Lithium-Ion | Rechargeable Lithium-Ion | Rechargeable Lithium-Ion | Rechargeable
Lithium-Ion | The subject device and
the predicates are
identical |
| Wireless
Communication
Interface | Bluetooth® Low Energy
(device to mobile device)
IEEE 802.11 WiFi/cellular
to Empatica cloud | IEEE 802.11 WiFi | Bluetooth® Low Energy
(device to mobile device)
IEEE 802.11 WiFi/cellular to
Empatica cloud | Wireless (cellular
connection) via
charging station to Spry
Server. | All the devices are
designed to
transmit their data to
alternate
devices or sites. The
different technologies
used do not raise new |
| Features | Empatica Health
Monitoring Platform
(Subject Device) | Current Health Monitoring
System Gen 2 (K210133) | Empatica Health Monitoring
Platform (K221282) | Loop System (K181352) | Analysis of differences |
| | | | | | questions of safety or
efficacy |
| Patient
contacting
materials | Compliant to ISO 10993-1 | Compliant to ISO 10993-1 | Compliant to ISO 10993-1 | Compliant to ISO
10993-1 | The subject device and
the predicates are
identical |

8

Empatica Health Monitoring Platform

9

Empatica Health Monitoring Platform

10

Empatica Health Monitoring Platform

11

Empatica Health Monitoring Platform

12

Empatica Health Monitoring Platform

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Empatica Health Monitoring Platform

Technical and Performance Information for Pulse Rate
Features	Empatica Health
Monitoring Platform
(Subject Device)	Current Health Monitoring
System Gen 2 (K210133)	Empatica Health Monitoring
Platform (K221282)	Loop System (K181352)	Analysis of differences
Technology	PR measured by analyzing
cyclic variations in
the reflectance of certain
LED
frequencies in a
photoplethysmogram
design.
The diodes are mounted in
the device such that theyin contact with the skin.	PR measured by analyzing
cyclic variations in
the reflectance of certain
LED
frequencies in a
photoplethysmogram
design.
The diodes are mounted in
the device such that they are
in contact with the skin.	N/A	HR measured by
analyzing cyclic
variations in reflectance
of certain LED
frequencies in a
photoplethysmogram
design. The diodes are
mounted in the device
such that they are in
contact with the skin.	The subject device and
the predicates are
identical in that they all
use the
photoplethysmogram
technology
PR Range	24 – 240 beats per minute
(bpm)	30 – 240 beats per minute
(bpm)	N/A	25 – 250 beats per
minute (bpm)	Clinically equivalent. The
subject device and the
predicates
comply with ISO
80601-2-61
PR Resolution	1 bpm	1 bpm	N/A	1 bpm	The subject device and
the predicates are
identical

14

Empatica Health Monitoring Platform

| Features | Empatica Health
Monitoring Platform
(Subject Device) | Current Health Monitoring
System Gen 2 (K210133) | Empatica Health Monitoring
Platform (K221282) | Loop System (K181352) | Analysis of differences |
|-------------|------------------------------------------------------------|-----------------------------------------------------|--------------------------------------------------|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| PR Accuracy | (no-motion) 3 bpm Arms
(motion) 5 bpm Arms | (generic) ±3bpm | N/A | (no-motion) 3 bpm Arms | The subject device and
the predicates all meet
accuracy acceptance
criteria thresholds
recommended by FDA.
The difference in
accuracy does not impact
the clinical safety of the
product. |

Technical and Performance Information for Respiratory Rate
Features	Empatica Health
Monitoring Platform
(Subject Device)	Current Health
Monitoring System
Gen 2 (K210133)	Empatica Health
Monitoring Platform
(K221282)	Loop System
(K181352)	Everion+ System
(K213863)	Analysis of
differences
Technology	Respiration rate (RR)
data is continuously
collected by analyzing
cyclic variations in the
photoplethysmogram.
The diodes are mounted
in the device such that
they are in contact with
the skin	Not used for
substantial
equivalence	N/A	Respiration rate (RR)
is intermittently
collected by analyzing
cyclic variations in the
photoplethysmogram.
The diodes are
mounted in the
device such that they
are in contact with
the skin.	An optical sensor
allows reflective
photoplethysmography
(PPG) measurements
to be performed on the
skin and underlying
tissue	The core technology
of
photoplethysmograp
hy is identical
between the subject
device and the
predicate. Technical
differences are
limited to differences
in data collection
frequency, which
does not raise new
questions of safety or
effectiveness when
Technical and Performance Information for Respiratory Rate
Features	Empatica Health
Monitoring Platform
(Subject Device)	Current Health
Monitoring System
Gen 2 (K210133)	Empatica Health
Monitoring Platform
(K221282)	Loop System
(K181352)	Everion+ System
(K213863)	Analysis of
differences
						considering
performance of the
device. Adequacy of
performance using a
continuous data
sampling technology
is supported by the
reference device
legally marketed for
the same indication
for use under the
product code MWI,
BZQ.
RR Range	6 - 40 breaths per
minute (brpm)		N/A	4 - 40 respirations per
minute (RPM)	6 – 30 breaths per
minute (brpm)	The subject device
has a different lower
limit. The difference
does not impact the
clinical safety of the
product.
RR
Resolution	1 brpm		N/A	1 RPM		The subject device
and the predicates
are identical
RR
Accuracy	3 brpm Arms		N/A	3 RPM Arms	3 brpm Arms	The subject device
and the predicates
are identical
Technical and Performance Information for Blood Oxygen Saturation
Features	Empatica Health Monitoring
Platform (Subject Device)	Current Health
Monitoring System Gen
2 (K210133)	Empatica Health
Monitoring Platform
(K221282)	Loop System (K181352)	Analysis of differences
Technology	SpO2 relies on the principle
that hemoglobin at different
oxygenation states absorbs
light differently based upon
the wavelength of light.	SpO2 is measured by
analyzing the
reflectance of certain
LED frequencies in a
photoplethysmogram
design. The diodes are
mounted in the device
such that they are in
contact with the skin.	SpO2 relies on the
principle that
hemoglobin at different
oxygenation states
absorbs light differently
based upon the
wavelength of light.	SpO2 measured by
analyzing reflectance of
certain LED frequencies
in a
photoplethysmogram
design. The diodes are
mounted in the device
such that they are in
contact with the skin	The subject device and
the predicates are
identical in that they all
use the
photoplethysmogram
technology
SpO2 Range	70-100%	70-100%	70-100%	70-100%	The subject device and
the predicates are
identical
SpO2 Resolution	1%	1%	1%	1%	The subject device and
the predicates are
identical
SpO2 Accuracy	3% Arms	± 2 Digits	3% Arms	3% Arms	The subject device and
the predicates comply
with ISO 80601-2-
61 as well as with FDA
Guidance for Pulse
Oximeters
(2012)

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Empatica Health Monitoring Platform

16

Empatica Health Monitoring Platform

No changes to the computation of Blood Oxygen Saturation (SpO-) have been introduced in the Empatica Health Monitoring Platform presented in this 510(k) submission compared with the recently cleared K221282. No additional clinical data or documentation has been attached to this 510(k) submission.

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Empatica Health Monitoring Platform

Technical and Performance Information for Temperature
Features	Empatica Health Monitoring
Platform (Subject Device)	Current Health Monitoring
System Gen 2 (K210133)	Empatica Health
Monitoring Platform
(K221282)	Loop System (K181352	Analysis of differences
Technology	high-precision temperature
sensor	In-Built Thermistor	high-precision
temperature sensor	N/A	The subject device and
the predicates are
identical
Temperature Range	0°C to 50°C	0°C to 50°C	0°C to 50°C	N/A	The subject device and
the predicates are
identical
Temperature
Resolution	0.1°C	0.1°C	0.1°C	N/A	The subject device and
the predicates are
identical
Temperature
Accuracy	± 0.1ºC within 30.0ºC - 45.0ºC
range	±0.1°C	± 0.1ºC within 30.0ºC

45.0ºC range | N/A | The subject device and
the predicates are
identical |

No changes to the computation of Peripheral Skin Temperature (TEMP) have been introduced in the Empatica Heath Monitoring Platform presented in this 510(k) submission compared with the recently cleared K221282. No additional bench test or documentation have been attached to this 510(k) submission.

Technical and Performance Information for Electrodermal Activity
Features	Empatica Health Monitoring
Platform (Subject Device)	Current Health
Monitoring System Gen
2 (K210133)	Empatica Health Monitoring
Platform (K221282)	Loop System (K181352)	Analysis of differences
Technology	EDA is measured by analyzing
detected changes in the
conductivity of the superficial
layers of the skin.	N/A	EDA is measured by analyzing
detected changes in the
conductivity of the superficial
layers of the skin.	N/A	The subject device and
the predicates are
identical
EDA Range	0.01 μS – 100 μS	N/A	0.01 μS – 100 μS	N/A	The subject device and
the predicates are
identical

18

K230457

Empatica Health Monitoring Platform

Technical and Performance Information for Electrodermal Activity
Features	Empatica Health Monitoring
Platform (Subject Device)	Current Health
Monitoring System Gen
2 (K210133)	Empatica Health Monitoring
Platform (K221282)	Loop System (K181352)	Analysis of differences
EDA Resolution	1 digit ~ 55 pS	N/A	1 digit ~ 55 pS	N/A	The subject device and
the predicates are
identical

No changes to the computation of EDA (EDA) have been in the version of the Empatica Health Monitoring Platform presented in this 510(k) submission compared with the recently cleared K221282. No addition data or documentation have been attached to this 510(k) submission.

Technical and Performance Information for Activity and Sleep
Features	Empatica Health
Monitoring Platform
(Subject Device)	Current Health
Monitoring System
Gen 2 (K210133)	Empatica Health Monitoring
Platform (K221282)	Loop System
(K181352)	Analysis of differences
Technology	Accelerometer	N/A	Accelerometer	N/A	The subject device and the
predicate are identical
Accelerometer Type	Microelectromechanical
system
(MEMS)-based integrated
circuit	N/A	Microelectromechanical system
(MEMS)-based integrated
circuit	N/A	The subject device and the
predicate are identical
Accelerometer
Sampling Rate	Digital method, 26 Hz -
208 Hz	N/A	Digital method, 26 Hz – 208 Hz	N/A	The subject device and the
predicate are identical
Accelerometer
Dynamic Range	± 16 g	N/A	± 16 g	N/A	The subject device and the
predicate are identical
Accelerometer
Sensitivity	0.488 milli-g per Least
Significant Bit	N/A	0.488 milli-g per Least
Significant Bit	N/A	The subject device and the
predicate are identical

No changes to the computation of Activity during sleep (ACT and SLEEP) have been introduced in the version of the Empatica Health Monitoring Platform presented in this 510(k) submission compared with the recently cleared K221282. No additional bench test and validation data or documentation have been attached to this 510(k) submission

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Empatica Health Monitoring Platform

ll. PERFORMANCE DATA

Non-Clinical testing (Bench testing)

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

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