The Oxehealth Vital Signs device is intended for noninvasive spot measurement 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 or 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.

Device Description

The modified Oxehealth Vital Signs device uses custom-designed software to read data collected using off-the-shelf cameras. Data collected in this manner can be used to act as a non-contact monitor of pulse and breathing rates for individuals aged 18 and older in single-subject room environments. Video is collected through video cameras installed in each room. When run through proprietary software- controlled algorithms, the software will allow a user to make spot checks for pulse and breathing rates of the individual in the room. Validation testing has demonstrated that the algorithms show pulse and breathing rates that are statistically non-inferior when compared to conventional methods and technology that determine pulse and breathing rates.

AI/ML Overview

The provided document is a 510(k) summary for the Oxehealth Vital Signs device, specifically for a modification to a previously cleared version. The core of the submission revolves around demonstrating substantial equivalence to the predicate device, meaning the new modification does not raise new questions of safety or effectiveness.

Therefore, the study proving the device meets acceptance criteria largely refers to the studies performed for the original predicate device (Oxehealth Vital Signs version 1.30.0, classified in DEN200019), as the modifications discussed in this 510(k) submission do not affect the fundamental principles of operation or performance in measuring pulse rate and estimated breathing rate.

Here's a breakdown of the information requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states the performance criteria that were established for the predicate device and are considered unchanged for the modified device.

Performance Metric	Acceptance Criteria (from predicate)	Reported Device Performance (from predicate, considered applicable)
Pulse Rate	50 to 130 beats per minute	Accuracy uses the RMSE criterion
Pulse Rate Accuracy	± 3 beats per minute (RMSE criterion)	May be reduced when the subject has a pulse rate greater than 110 beats per minute.
Pulse Rate Measurement Window	9 seconds	9 second measurement window
Estimated Breathing Rate (chest wall movements)	8 to 31 breaths per minute	Accuracy uses the RMSE criterion
Estimated Breathing Rate Accuracy	± 2 breaths per minute (RMSE criterion)	-
Estimated Breathing Rate Measurement Window	30 seconds	30 second measurement window
General	Statistically non-inferior when compared to conventional methods and technology that determine pulse and breathing rates.	Validated through testing (details not in this document, but referred to from DEN200019)

Note: The document explicitly states "No change" for performance regarding the modified device compared to the predicate, implying that the acceptance criteria and the performance demonstrated by the predicate are carried over.

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

The document refers to the clinical evidence provided and reviewed in the original DEN200019 submission. It states: "As that clinical evidence is still applicable now, no new clinical evidence is required".

Therefore, the specific sample sizes and data provenance for the test set are not detailed in this 510(k) summary, but would be found in the documentation for DEN200019. The summary only confirms that such data was provided for the predicate device and is considered sufficient for the modified device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not provide details about the number and qualifications of experts directly for this 510(k) summary. This information would have been part of the original DEN200019 submission, where the clinical evidence was initially reviewed.

4. Adjudication Method for the Test Set

The document does not provide details about the adjudication method used for the test set. This information would have been part of the original DEN200019 submission.

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

The document does not mention an MRMC comparative effectiveness study where human readers improve with AI vs. without AI assistance. The device's function is explained as "software assessing video footage from a fixed-installation solution for use within single occupancy rooms" to produce "spot check measurements." It's generally intended as a non-contact monitor, not as an AI-assistance tool for human interpretation in the sense of a diagnostic imaging study. The focus is on the device's ability to provide accurate measurements directly, not on enhancing human interpretation of complex data.

The validation testing demonstrated that "the algorithms show pulse and breathing rates that are statistically non-inferior when compared to conventional methods and technology that determine pulse and breathing rates." This implies a comparison against ground truth measurements, not a human-AI team performance study.

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

Yes, based on the description, the "Performance Data" section indicates that "As the modified Oxehealth Vital Signs device is solely software, performance testing is demonstrated through software validation." The prior validation (from DEN200019) compared the device's output to "clinically accurate patient-contacting relevant comparator device." This strongly suggests a standalone performance evaluation where the algorithm's output is directly compared to a reference standard, without human intervention in the measurement process.

7. The Type of Ground Truth Used

The document states: "The assessment must compare device output with a clinically accurate patient-contacting relevant comparator device in an accurate and reproducible manner."

This indicates that the ground truth was established using measurements from "clinically accurate patient-contacting relevant comparator device(s)". This would imply standard, validated medical devices (e.g., pulse oximeters, capnographs, or other physiological monitoring equipment) used as the reference standard for pulse and breathing rates.

8. The Sample Size for the Training Set

The document does not provide details on the training set sample size. The focus of this 510(k) is on the substantial equivalence of a modified device to a predicate device, and it states that the modifications "do not affect the algorithm or the functionality of the software." This implies that the core algorithm, which would have been trained based on a training set, remains unchanged from the predicate version. Information on the training set would have been part of the initial submission for the predicate device (DEN200019).

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

Similar to point 8, the document does not provide details on how ground truth for the training set was established. This information would have been part of the original DEN200019 submission. The current submission reiterates that the original clinical evidence, which included comparison to "clinically accurate patient-contacting relevant comparator device," is still applicable.

Summary

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July 20, 2021

Oxehealth Limited Hugh Lloyd-Jukes Chief Executive Officer Magdalen Centre North, The Oxford Science Park Oxford, OX4 4GA United Kingdom

Re: K211906

Trade/Device Name: Oxehealth Vital Signs 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: OME Dated: June 17, 2021 Received: June 21, 2021

Dear Hugh Lloyd-Jukes:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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542 of the Act); 21 CFR 1000-1050.

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-

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 Shih 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

Enclosure

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Indications for Use

510(k) Number (if known) K211906

Device Name Oxehealth Vital Signs

Indications for Use (Describe)

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 or 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.

Type of Use (Select one or both, as applicable)
✖ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

Oxehealth's modified Vital Signs software medical device

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Submitter's Name: Hugh Lloyd-Jukes Address: Magdalen Centre North The Oxford Science Park Oxford OX4 4GA UK
Phone: +44 1865 900599
Facsimile: None
Contact Person: Hugh Lloyd-Jukes
Date Prepared: June 17 2021

Name of Device and Name/Address of Sponsor:

Vital Signs

Oxehealth Limited (Address as above)

Common or Usual Name:

Vital Signs

Classification Name: QME, Software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate.
Predicate Devices: Oxehealth Vital Signs version 1.30.0 (classified in DEN200019)

Purpose of the Special 510(k) Notice:

The Oxehealth Vital Signs medical device is a modification to Oxehealth Vital Signs version 1.30.0.

Indications for Use: The modified Oxehealth Vital Signs is intended to be used for Non-invasive spot check measurements of pulse rate and breathing rate (chest wall movements).

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The modified Oxehealth Vital Signs is indicated for use are as follows:

"The Oxehealth Vital Signs device is intended for noninvasive spot measurement 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 or 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."

Device Description: The modified Oxehealth Vital Signs device uses custom-designed software to read data collected using off-the-shelf cameras. Data collected in this manner can be used to act as a non-contact monitor of pulse and breathing rates for individuals aged 18 and older in single-subject room environments. Video is collected through video cameras installed in each room. When run through proprietary software- controlled algorithms, the software will allow a user to make spot checks for pulse and breathing rates of the individual in the room. Validation testing has demonstrated that the algorithms show pulse and breathing rates that are statistically non-inferior when compared to conventional methods and technology that determine pulse and breathing rates.

Consideration of Special Controls Guidance:

The De Novo grant identified several special controls to be applied to products submitted under 21 CFR 870.2785. The following information assesses the special controls in light of the proposed modifications to the Oxehealth Vital Signs device.

(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.

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(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.

A complete set of software documentation, demonstrating that the software Special Controls are met, is described in section VIII (Software) of this submission and objective evidence appended in the identified attachments.

(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 evidence was supplied and reviewed in DEN200019. The proposed modifications discussed in this Special 510(k) submission do not affect any of the fundamental principles of operation or performance of the device in measuring pulse rate and estimating breathing rate (chest wall movements). As that clinical evidence is still applicable now, no new clinical evidence is required, and this Special Control is met.

(3) A human factors and usability engineering assessment must be provided that evaluates the risk of improper measurement.

Human factors and usability engineering assessments were provided and reviewed in DEN200019. The proposed modifications discussed in this Special 510(k) submission do not affect the manner in which the modified Oxehealth Vital Signs device is interfaced with, therefore no new human factors testing is required, and this Special Control is met.

(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

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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 complying with special controls are described in section V and the proposed instructions for use are provided in Attachment 01. Relevant information supporting the continued conformance with Special Controls are provided in more detail in Section V (labeling) and Section VIII (Software).

Technological Characteristics:

The technical specifications for the modified Oxehealth Vital Signs device are as reviewed in DEN200019; Oxehealth Vital Signs is a software only medical device, intended to run on standard, off the shelf computing hardware with an off the shelf video camera and infrared illuminator. The technological characteristics of the software are largely unchanged, with details provided in VIII (Software).

Performance Data: As the modified Oxehealth Vital Signs device is solely software, performance testing is demonstrated through software validation. Therefore this Special 510(k) notice is accompanied by software verification and validation testing described further below and provided in Attachment 04.
The special controls document additionally requires clinical and human factors evidence to demonstrate the safety and effectiveness of the device. Oxehealth has assessed the changes that are proposed for implementation in the US; as none of them affect the algorithm or the functionality of the software, the evidence supplied in support of DEN200019 is still applicable and does not need to be repeated.

Substantial Equivalence:

The modified Oxehealth Vital Signs device has the same intended use and similar indications, principles of operation, and technological characteristics as Oxehealth Vital Signs version 1.30.0. The minor differences in the modified Oxehealth Vital Signs do not raise any new questions of safety or effectiveness. Thus, the modified Oxehealth Vital Signs device is substantially equivalent to its predicate device.

	Oxehealth Vital Signs Predicate	Oxehealth Modified Device
Intended Use	Non-invasive spot checkmeasurements of pulse rate andbreathing rate (chest wallmovements).	No change.
Indications for Use	The Oxehealth Vital Signs device	No change.
	is intended for noninvasive spotmeasurement of pulse rate andestimated breathing rate (chestwall movements) when thesubject is still. It is softwareassessing video footage from afixed-installation solution for usewithin single occupancy roomswithin hospitals, general care andsecured environments withprofessional healthcare oversightand where a framework existswhich mandates periodic checksby a trained professional toensure subject safety.
	The Oxehealth system isintended for use by appropriatelytrained staff with a duty of care,and should not be used byuntrained users.
	The Oxehealth Vital Signs deviceis indicated for use on humans 18years of age or older who do notrequire critical care or continuousvital signs monitoring.
	The device is not intended to bethe sole method of checking thephysical health of a subject.
Population	Adults not requiring critical care	No change.
Where used	Single occupancy rooms withinhospitals, general care andsecured environments.	No change.
Human Factors	Operation of a software userinterface.	No change.
Design	Software medical devicedesigned to extract signals fromvideo to and measure pulse rateand breathing rate from a patient.Software user interface designedto allow users to take a spotcheck measurement of pulse rateand breathing rate, and to see	No change.
	previously obtainedmeasurements.
Performance	Pulse rate measurement 50 to130 ± 3 beats per minute, 9second measurement window.Estimated breathing rate (chestwall movements) measurement8 to 31 ± 2 breaths per minute,30 second measurement window.* Accuracy uses the RMSEcriterionPulse rate accuracy may bereduced when the subject has apulse rate greater than 110 beatsper minute.	No change.
User Interface	Web-based user interfaceaccessed by touch screenmonitor exclusively serving theOxehealth software	Web-based user interfaceaccessed by touch screenmonitor or mobile device providedand installed by Oxehealth,exclusively serving the Oxehealthsoftware.
Compatibility withHardware - computing	Standard, off the shelf computers,specified and installed byOxehealth, and validated duringinstallation.	Standard, off the shelf computersand mobile tablets, specified andinstalled by Oxehealth, andvalidated during installation.No change to standard computerspecifications, with newer makesand models included according tospecified minimum performancerequirements
Compatibility withHardware – camera &accessories	Standard, off the shelf machinevision camera and infraredilluminators, exact specificationdetermined by Oxehealth andvalidated during installation.	No change to specification, makeor models used.
Software	C++ and Node.js; use of thirdparty libraries.	C++ and Node.js; some minormodifications to third partylibraries as discussed in SoftwareInformation section VIII.

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Conclusions: In summary, the company's modified Oxehealth system has the same intended use as the previously cleared predicate device. In addition, the modified Oxehealth system has very similar indications, technological characteristics, and principles of operation as its predicates. Although there

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are minor differences between the modified Oxehealth system and its predicate devices as described above, those differences do not raise new questions of safety or efficacy. Thus, the modified Oxehealth system is substantially equivalent.

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.