Predicate Devices

Reference Devices

Philips MX100 ECG

AI/ML (Artificial Intelligence / Machine Learning)

Unknown
The document mentions "signal processing and algorithm" and "algorithm training and validation data," which are common in both traditional signal processing and AI/ML. However, it explicitly states "Mentions AI, DNN, or ML: Not Found." Without further information or a more detailed description of the "algorithm," it's impossible to definitively confirm the presence of AI/ML.

Therapeutic

No
The device is described as "not designed to treat patients" and its results "should complement, but not replace, the user's usual professional medical care and/or medication." This indicates it's a measurement tool, not a therapeutic intervention.

Diagnostic

Yes

The device measures pulse rate and advises users to consult a medical professional if abnormalities are detected, indicating its function in identifying potential health issues. Although it states it's not designed to treat patients, its role in providing objective health measurements that might lead to further medical consultation classifies it as diagnostic.

SaMD (Software as a Medical Device)

Yes

The device is described as an "SDK" (Software Development Kit) and "software" that is intended to be installed on commercial mobile devices/laptops/computers equipped with cameras. It processes video data from these existing hardware platforms to measure pulse rate, without including any dedicated hardware components of its own.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device function: The FH Vitals SDK measures pulse rate based on a facial video stream. This is a non-invasive method that analyzes external physiological signals, not samples taken from the body.
Intended Use: The intended use clearly states it measures pulse rate from a facial video stream and is for non-invasive spot measurements. It does not mention analyzing biological samples.

Therefore, while it is a medical device used for health monitoring, it does not fit the definition of an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The FH Vitals SDK is designed to measure the pulse rate based on the given facial video stream. It is intended for non-invasive spot measurements of pulse rate when the subject is still. This SDK is not intended for use in patients with known or suspected heart arrhythmias.

While the SDK can be used for general healthcare, it is not designed to treat patients. The pulse rate measurement results provided by the FH Vitals SDK should complement, but not replace, the user's usual professional medical care and/or medication. If abnormalities are detected during the measurement with the FH Vitals SDK, users are advised to consult a medical professional.

The FH Vitals SDK is indicated for use in humans 18 years of age or older who do not require critical care or continuous vital signs monitoring. This software should not be the primary or sole method for assessing an individual's health.

Product codes

QME

Device Description

FH vitals SDK is a video-based, non-contact pulse rate measurement software with a face recognition function designed to measure and real-time display the pulse rate of adults. This system uses cameras to detect the user's face and obtains the continuous face image data, with signal processing and algorithm to compute the pulse rate. The software is intended to be installed on commercial mobile devices/laptops/computers equipped with cameras. It can be deployed on Android, iOS platform and Windows platforms.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

video-based, non-contact, facial video stream

Anatomical Site

Face

Indicated Patient Age Range

18 years of age or older

Intended User / Care Setting

General healthcare / Not Found

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

Performance data is demonstrated by 1000-CSR-02-V2.0 clinical studies Report. The performance of the FH vitals SDK was tested in a clinical study of 527 participants, age 18 and older. The data showed that compared with Philips MX100 ECG, the pulse rate deviation of FH Vitals SDK installed on laptops with C920, iPhone 13 Pro, iPhone 13 Pro Max, Samsung S22 Ultra, and Samsung S22+ were within +3bpm, accounting for about 90.3, 95.4%, 95.4%, 93.7%, and 94.3% in 527 subjects, respectively. On average, about 93.8% of the 527 subjects.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance data is demonstrated by 1000-CSR-02-V2.0 clinical studies Report. The performance of the FH vitals SDK was tested in a clinical study of 527 participants, age 18 and older. The data showed that compared with Philips MX100 ECG, the pulse rate deviation of FH Vitals SDK installed on laptops with C920, iPhone 13 Pro, iPhone 13 Pro Max, Samsung S22 Ultra, and Samsung S22+ were within +3bpm, accounting for about 90.3, 95.4%, 95.4%, 93.7%, and 94.3% in 527 subjects, respectively. On average, about 93.8% of the 527 subjects.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Pulse rate deviation within +/- 3 bpm

Predicate Device(s)

K211906

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.2785 Software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate.

(a)
Identification. The device uses software algorithms to analyze video signal and estimate pulse rate, heart rate, breathing rate, and/or respiratory rate. This device is not intended to independently direct therapy.(b)
Classification. Class II (special controls). The special controls for this device are:(1) A software description and the results of verification and validation testing based on a comprehensive hazard analysis and risk assessment must include:
(i) A full characterization of the software technical parameters, including algorithms;
(ii) If required image acquisition hardware is not included with the device, full specifications of the hardware requirements and testing to demonstrate the specified hardware ensures adequate data for validated and accurate measurements;
(iii) A description of the expected impact of all applicable sensor acquisition hardware characteristics and associated hardware specifications;
(iv) A description of all mitigations for user error or failure of any subsystem components (including signal detection, signal analysis, data display, and storage) on output accuracy; and
(v) Software documentation must include a cybersecurity vulnerability and management process to assure software functionality.
(2) Clinical data must be provided. This assessment must fulfill the following:
(i) The clinical data must be representative of the intended use population for the device. Any selection criteria or sample limitations must be fully described and justified.
(ii) The assessment must demonstrate output consistency using the expected range of data sources and data quality encountered in the intended use population and environment.
(iii) The assessment must compare device output with a clinically accurate patient-contacting relevant comparator device in an accurate and reproducible manner.
(3) A human factors and usability engineering assessment must be provided that evaluates the risk of improper measurement.
(4) Labeling must include:
(i) A description of what the device measures and outputs to the user;
(ii) Warnings identifying sensor acquisition factors or subject conditions or characteristics (garment types/textures, motion, etc.) that may impact measurement results;
(iii) Guidance for interpretation of the measurements, including a statement that the output is adjunctive to other physical vital sign parameters and patient information;
(iv) The expected performance of the device for all intended use populations and environments; and
(v) Robust instructions to ensure correct system setup.

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The seal features a stylized depiction of a human figure, while the FDA part includes the acronym in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 1, 2023

FaceHeart Corp. Morris Chung AVP PO Box 309, Ugland House Grand Cayman, KY1-1104 Cayman Islands

Re: K223622

Trade/Device Name: FaceHeart Vitals Software Development Kit (FH vitals SDK) Regulation Number: 21 CFR 870.2785 Regulation Name: Software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate Regulatory Class: Class II Product Code: QME Dated: July 29, 2023 Received: July 31, 2023

Dear Morris Chung:

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.

1

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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Jennifer W. Shih -S

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

Enclosure

2

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K223622

Device Name

FaceHeart Vitals Software Development Kit (FH vitals SDK)

ndications for Use (Describe)

The FH Vitals SDK is designed to measure the pulse rate based on the given facial video stream. It is intended for non-invasive spot measurements of pulse rate when the subject is still. This SDK is not intended for use in patients with known or suspected heart arrhythmias.

While the SDK can be used for general healthcare, it is not designed to treat patients. The pulse rate measurement results provided by the FH Vitals SDK should complement, but not replace, the user's usual professional medical care and/or medication. If abnormalities are detected during the measurement with the FH Vitals SDK, users are advised to consult a medical professional.

The FH Vitals SDK is indicated for use in humans 18 years of age or older who do not require critical care or continuous vital signs monitoring. This software should not be the primary or sole method for assessing an individual's health.

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

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

| FaceHeart

510(k) Summary

[This summary is submitted according to the requirements of 21 CFR 807.92]

1. Submitter's Name, Address and Date prepared:

| Applicant | FaceHeart Corporation
PO Box 309, Ugland House, Grand Cayman, KY1-1104,
Cayman Islands. |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Correspondent | Name: Morris Chung
Address: Rm.1003, 10F., Jan Qi Biomedical Engineering Building,
No.75, Bo'ai St., East Dist., Hsinchu City 300,
Taiwan (R.O.C.)
Phone: +886-3-6591088
Email: |
| Date Prepared | August 31, 2023 |

2. Device Names and Classifications

Proposed Device

| Name of Proposed

Device	FH vitals SDK
Common Name:	Pulse Rate Measuring Software
Regulation Number	21 CFR 870.2785
Regulation Name	Software for optical camera-based measurement of pulse rate, heart rate,
breathing rate, and/or respiratory rate
Regulatory Class	Class II
Product Code	QME
Review Panel	Cardiovascular

Predicate Device

| Predicate

Manufacturer	Oxehealth Limited
---------------------------	-------------------

4

Heart

| Predicate Trade

Name	Oxehealth Vital Signs
Predicate 510 (k)	K211906

3. Device Description:

FH vitals SDK is a video-based, non-contact pulse rate measurement software with a face recognition function designed to measure and real-time display the pulse rate of adults. This system uses cameras to detect the user's face and obtains the continuous face image data, with signal processing and algorithm to compute the pulse rate. The software is intended to be installed on commercial mobile devices/laptops/computers equipped with cameras. It can be deployed on Android, iOS platform and Windows platforms.

It is the responsibility of the device manufacturer to integrate FH vitals SDK correctly and to obtain the necessary regulatory approval/clearance for the final device integrating FH vitals SDK. It is also the responsibility of the device manufacturer to ensure that their device or software application has the correct regulatory approvals and meets the required standards for their intended use. Any regulatory clearance and tests FH vitals SDK has do not apply to a device or software integrating FH vitals SDK. These processes and tests should be repeated at the system level.

4. Indications for Use:

The FH Vitals SDK is designed to measure the pulse rate based on the given facial video stream. It is intended for non-invasive spot measurements of pulse rate when the subject is still. This SDK is not intended for use in patients with known or suspected heart arrhythmias.

While the SDK can be used for general healthcare, it is not designed to treat patients. The pulse rate measurement results provided by the FH Vitals SDK should complement, but not replace, the user's usual professional medical care and/or medication. If abnormalities

5

e Heart

are detected during the measurement with the FH Vitals SDK, users are advised to consult a medical professional.

The FH Vitals SDK is indicated for use in humans 18 years of age or older who do not require critical care or continuous vital signs monitoring. This software should not be the primary or sole method for assessing an individual's health.

5. Technological Characteristics:

Similar to the predicate device, the FH vitals SDK is a software-only product that measures pulse rate through an optical camera-based mechanism.

This software intended to run on standard PCs, laptops, and mobile devices, analyzing video streams captured by compatible available video cameras to compute pulse rate.

This software is intended to analyze video collected by compatible cameras in stationary conditions. Users are instructed to keep the camera stationary (e.g., by using a stand or another suitable support). When integrating this software for use with camera signals from devices with accelerometers (e.g., smartphones), the manufacturer is instructed to use accelerometer data to only use this software with video collected when the camera is stationary.

6. Comparison with the Predicate Device (Substantial Equivalence):

	Subject Device	Predicate Device
510(k) Number	K223622	K211906
Device Name	FH vitals SDK	Oxehealth Vital Signs
Common Name	Pulse Rate Measuring Software	Vital Signs
Manufacturer	FaceHeart Corp.	Oxehealth Ltd
Indications for
Use	The FH Vitals SDK is designed to measure the pulse rate
based on the given facial video stream. It is intended for non-
invasive spot measurements of pulse rate when the subject is
still. This SDK is not intended for use in patients with
known or suspected heart arrhythmias.

While the SDK can be used for general healthcare, it is not
designed to treat patients. The pulse rate measurement
results provided by the FH Vitals SDK should complement,
but not replace, the user's usual professional medical care
and/or medication. If abnormalities are detected during the
measurement with the FH Vitals SDK, users are advised to
consult a medical professional.

The FH Vitals SDK is indicated for use in humans 18 years of
age or older who do not require critical care or continuous vital
signs monitoring. This software should not be the primary
or sole method for assessing an individual's health. | Non-invasive spot check
measurements of pulse rate
and breathing rate (chest
wall movements).

The Oxehealth Vital Signs
device is intended for
noninvasive spot
measurements of pulse rate
and estimated breathing
rate (chest wall
movements) when the
subject is still. It is software
assessing video footage
from a fixed-installation
solution for use within
single occupancy rooms
within hospitals, general
care, and secured
environments with
professional healthcare
oversight and where a
framework exists which
mandates periodic checks
by a trained professional to
ensure subject safety.

The Oxehealth system is
intended for use by
appropriately trained staff
with a duty of care and
should not be used by
untrained users.

The Oxehealth Vital Signs
device is indicated for use
on humans 18 years of age
for older who do not require
critical care or continuous
vital signs monitoring.

The device is not intended
to be the sole method of
checking the physical
health of a subject. | Similar.

Table 1. Substantial Equivalent (SE) Comparison Summary

6

F | Face Heart

7

F | Face Heart

| Pulse Rate
Measurement
Range | | 50-180 bpm | | | | | 50-130 bpm | Similar: FH
vitals SDK can
measure a
wider range of
pulse rate | |
|--------------------------------------------------------------|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-------------------------|-----------------------------------------------------|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|--|
| Performance
(Error Level) | | ±3 bpm | | | | | ±3 bpm | Same | |
| Measurement
Window | | 1 min | | | | | 9 seconds | Different | |
| Compatibility
with
Hardware-
computing | | The pulse rate measurement feature of FH Vitals SDK is a
software product that exclusively supports the following three
operating systems:

• Windows 10
• Android 12
• iOS 12 | | | | | Standard, off the shelf
computers and mobile
tablets, specified and
installed by Oxehealth, and
validated during
installation.

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FaceHeart

7. Clinical Performance Data

FH vitals SDK was verified and validated in accordance with the special controls for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate (21 CFR 870.2785-Reclassification Order of DEN200019). The testing demonstrated that the device performed according to its specifications and that the technological and performance criteria were comparable to the predicate device.

Performance data is demonstrated by 1000-CSR-02-V2.0 clinical studies Report. The performance of the FH vitals SDK was tested in a clinical study of 527 participants, age 18 and older. Study demographic characteristics are summarized in Table 2.

Sample size	N=527
Gender	Females: 314 subjects Males: 213 subjects
Age Group	18-39: 213 subjects 40-59: 184 subjects Above 60:
BMI	0-18.5: 29 subjects 18.5-24.9: 270 subjects 25-29.9: 149 subjects 30+: 79 subjects
Makeup	With: 44 subjects Without: 483 subjects
Glasses	With: 183 subjects Without: 344 subjects
Facial hair	With: 48 subjects Without: 419 subjects
Skin type
according to
Fitzpatrick Scale	Types I and II: The number of subjects was 34 Types III and IV: The number of subjects was 410 Types V and VI: The number of subjects was 83
Facial Shapes	Heart: 28 subjects Oblong: 169 subjects Oval: 58 subjects Round: 232 subjects Square: 40 subjects

Table 2. Clinical Validation Study subject demographic

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aceHeart

Disease History	Arrhythmia: 55 subjects Coronary Artery Disease (CAD): 90 subjects Heart Failure (HF): 23 subjects Hypertension: 125 subjects Other CVDs> 21 subjects
-----------------	-------------------------------------------------------------------------------------------------------------------------------------------------------

The data showed that compared with Philips MX100 ECG, the pulse rate deviation of FH Vitals SDK installed on laptops with C920, iPhone 13 Pro, iPhone 13 Pro Max, Samsung S22 Ultra, and Samsung S22+ were within +3bpm, accounting for about 90.3, 95.4%, 95.4%, 93.7%, and 94.3% in 527 subjects, respectively. On average, about 93.8% of the 527 subjects.

8. Non-Clinical Software Testing:

Our software underwent comprehensive non-clinical testing, as detailed in the "Full System Testing" report. Importantly, these tests were conducted on a system that integrates with our device and represents the final configuration. This testing approach encompassed both functionality tests and system performance tests.

. Device Compatibility:

The software's compatibility was verified on specific devices, ensuring that the final application functions correctly. The tested devices are as follows:

. Laptop (Asus Zenbook UX435EAL) with C920
. iPhone 13 Pro
iPhone 13 Pro Max
. Samsung S22+
Samsung S22

. Motion Impact on Performance Decay

According to our internal test, under the scenario of doing exercise or performing large movement, the mean absolute error of pulse rate measurement can range from 11.77 bpm to 42.06 bpm. Such error range indicates that motion has significant impact on the precision of pulse rate measurement.

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FaceHeart

. Software Functionality:

The software is designed to track only one face, even in scenarios where multiple faces are present within the image frames. All warning messages were also validated to ensure they are triggered appropriately.

Scenario	Software Response
There are multiple faces in camera view.	The software tracks only one face during the measurement.
Use a finger to cover the camera.	Warning message: Missing Face.
Use a hand to cover the face.	Warning message: Missing Face.
Turn off lights in the room to make the face unrecognizable.	Warning message: Missing Face.
Enlarge the camera focus to have a blurred face which is unrecognizable.	Warning message: Missing Face.
Wear a hat to block a large portion of the face.	Warning message: Missing Face.
Wear a facial mask.	Warning message: Missing Face.
Make the face outside Rectangle.	Warning message: Bad Face Position.
Make the face-camera distance larger than 1.5M.	Warning message: Bad Face Position.
Nod slightly.	Warning message: Motion.
Shake the head slightly.	Warning message: Motion.
Move back and forth.	Warning message: Motion.
Stand up suddenly.	Warning message: Motion.
Shake the camera.	Warning message: Motion.
Low camera frame rate.	Warning message: Low Frame Rate.

. System Performance Metrics:

For each device, the following performance metrics were observed:

| Device | Memory (MB) | CPU (%) | Average Image Frame
Processing Time:
Time Cost (ms/frame) |
|---------------------------------|-------------|---------|-----------------------------------------------------------------|
| C920 with Asus Zenbook UX435EAL | 155 | 10 | 4.09 |
| iPhone 13 Pro | 58.5 | 43 | 3.58 |
| iPhone 13 Pro Max | 46.3 | 40 | 3.91 |
| Samsung S22+ | 187 | 10 | 9.79 |
| Samsung S22 Ultra | 225 | 10 | 8.71 |

It's worth noting that the image processing speed of the software exceeds the frame rate of the camera, indicating that device performance meets real-time requirements.

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1 FaceHeart

9. Consideration of Special Controls Guidance

In combination with the general controls of the FD&C Act, the software for optical camerabased measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate (products submitted under 21 CFR 870.2785-Reclassification Order of DEN200019) is subject to the following special controls:

Special controls	Evidence of compliance
(1) A software description and the results of verification and
validation testing based on a comprehensive hazard analysis
and risk assessment must include:
(i)A full characterization of the software technical
parameters, including algorithms;
(ii)If required image acquisition hardware is not included
with the device, full specifications of the hardware
requirements and testing to demonstrate the specified
hardware ensures adequate data for validated and
accurate measurements.
(iii)A description of the expected impact of all applicable
sensor acquisition hardware characteristics and
associated hardware specifications;
(iv)A description of all mitigations for user error or
failure of any subsystem components (including signal
detection, signal analysis, data display, and storage) on
output accuracy; and
(v)Software documentation must include a cybersecurity
vulnerability and management process to assure software
functionality.	Software
documentation included
a description of
algorithm training and
validation data, a
discussion of the
specifications of
compatible hardware and
the impact of these
specifications on the
device, and testing of all
mitigations for user error.

Software documentation
also included
cybersecurity testing and
a vulnerability analysis. |
| (2) Clinical data must be provided. This assessment must
fulfill the following:
(i)The clinical data must be representative of the intended
use population for the device. Any selection criteria or
sample limitations must be fully described and justified.
(ii)The assessment must demonstrate output consistency
using the expected range of data sources and data quality
encountered in the intended use population and
environment.
(iii)The assessment must compare device output with a
clinically accurate patient-contacting relevant comparator
device in an accurate and reproducible manner. | Clinical validation study
is provided in Section 7
above. |
| (3) A human factors and usability engineering assessment
must be provided that evaluates the risk of improper
measurement. | A Use-Related-Risk-
Analysis was conducted
and A Human Factors
Validation Study was
conducted with 15 health
care providers and 15
patients that showed |
| | minimal user errors, close
calls, or use difficulties. |
| (4) Labeling must include:
(i) A description of what the device measures and outputs
to the user;
(ii) Warnings identifying sensor acquisition factors or
subject conditions or characteristics (garment
types/textures, motion, etc.) that may impact
measurement results;
(iii) Guidance for interpretation of the measurements,
including a statement that the output is adjunctive to
other physical vital sign parameters and patient
information;
(iv) The expected performance of the device for all
intended use populations and environments; and
(v) Robust instructions to ensure correct system setup.
In addition, this is a prescription device and must comply with
21 CFR 801.109. | Labeling requirements
are incorporated in the
user manuals. |

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Heart

10. Conclusion

In conclusion, the FH Vitals SDK shares a similar intended use to that of the already cleared predicate device, with its function encapsulating a subset of the features provided by the Oxehealth systems. Moreover, the proposed device aligns closely in technological characteristics and operational principles with the predicate device. The distinctions that do exist between the two devices do not introduce additional concerns regarding safety or performance. Consequently, we posit that the FH Vitals SDK is substantially equivalent to the predicate device.