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

Based on the provided text, the Oxehealth Vital Signs device is a software-only medical device used for noninvasive spot measurement of pulse rate and estimated breathing rate. The document (K220899) is a Special 510(k) Notice, indicating modifications to a previously cleared device (Oxehealth Vital Signs version 1.47.0, K211906), rather than an initial submission. Therefore, the detailed clinical study data with sample sizes for test and training sets, ground truth establishment methods, expert qualifications, and detailed statistical results (like MRMC study effect sizes) are not explicitly present in this document, as it refers back to the original DEN200019 submission for clinical evidence.

However, based on the provided text, we can extract the following information regarding acceptance criteria and general study approach:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (from predicate's performance)	Reported Device Performance (as the modified device is stated to have "no change" in performance)
Pulse rate measurement	50 to 130 ± 3 beats per minute* (9-second measurement window)	50 to 130 ± 3 beats per minute* (9-second measurement window)
Estimated breathing rate (chest wall movements) measurement	8 to 31 ± 2 breaths per minute* (30-second measurement window)	8 to 31 ± 2 breaths per minute* (30-second measurement window)
Note on Accuracy	* Accuracy uses the RMSE criterion. Pulse rate accuracy may be reduced when the subject has a pulse rate greater than 110 beats per minute.	* Accuracy uses the RMSE criterion. Pulse rate accuracy may be reduced when the subject has a pulse rate greater than 110 beats per minute.

Note: The document explicitly states "no change" in performance for the modified device compared to the predicate, K211906, which in turn relied on clinical evidence from DEN200019. Therefore, the acceptance criteria and reported performance for the modified device are the same as its predicate.

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

Test Set Sample Size: This specific 510(k) submission (K220899) does not provide new sample sizes for a test set. It states: "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). ... The original clinical evidence is still considered applicable now, no new clinical evidence is required..." To find the specific sample sizes, one would need to refer to the DEN200019 submission.
Data Provenance: Not specified in this document. It would be in the original DEN200019 submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not specified in this document. This information would be in the original DEN200019 submission.

4. Adjudication Method for the Test Set

Not specified in this document. This information would be in the original DEN200019 submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size

This device is a standalone measurement device, not an AI-assisted diagnostic tool for human readers, so an MRMC comparative effectiveness study where human readers improve with AI vs. without AI assistance is not applicable to its stated function. The primary comparison is to "conventional methods and technology" for vital sign measurement (as stated in Device Description, page 5 of 11).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, this is a standalone device. The "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." (Device Description, page 5 of 11). The performance data listed in the table (50-130 ± 3 bpm, 8-31 ± 2 bpm) refers to the algorithm's direct output compared to a reference.

7. The Type of Ground Truth Used

The ground truth for the clinical evidence (from DEN200019) was established by comparison with "a clinically accurate patient-contacting relevant comparator device in an accurate and reproducible manner." (Clinical data requirement, page 6 of 11). This implies direct physiological measurement using established medical devices.

8. The Sample Size for the Training Set

Not specified in this document, as it refers back to the original DEN200019 submission for clinical evidence.

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

Not specified in this document, as it refers back to the original DEN200019 submission for clinical evidence. However, given that it's a device that measures vital signs by assessing video footage, it's highly probable that the ground truth for training would have been established by simultaneously recording vital signs using "clinically accurate patient-contacting relevant comparator devices" while the video footage was collected.

Summary

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April 29, 2022

Oxehealth Limited Iain Charlton Head of Engineered Compliance Magdalen Centre North, The Oxford Science Park Oxford. OX4 4GA United Kingdom

Re: K220899

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: QME Dated: March 14, 2022 Received: March 28, 2022

Dear Iain Charlton:

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.

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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.

for

Jennifer Shih 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

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Indications for Use

510(k) Number (if known) K220899

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

K220899 Oxehealth's modified Vital Signs software medical device

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

Address: Magdalen Centre North The Oxford Science Park Oxford OX4 4GA UK
lain Charlton
Phone: +44 1865 900599
Facsimile: None

Submitter's Name:

Contact Person: lain Charlton
Date Prepared: March 14 2022

Name of Device and Name/Address of Sponsor:

Oxehealth 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 1.47.0 ( K211906)

Purpose of the Special 510(k) Notice:

The Oxehealth Vital Signs medical device is a modification to Oxehealth Vital Signs version 1.47.0.

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). In addition, the proposed change to use more than one installation of the hardware to apply the software device to two separate, non-overlapping areas of a single room is not intended to change the types of rooms or patients on which the device is used, with the camera installation intended to have the same general positioning and orientation requirements; at a high level, with a broad field of view of the area in the patient is expected to occupy. The original clinical evidence is still considered 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 or used, with no new human factors or usability concerns introduced by the use of the software to observe separate, non-overlapping areas in the same room, therefore no new human factors testing is required, and this Special Control is met.

(4) Labeling must include:

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(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 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).

The labelling changes identified in Section V (labeling). include minor changes in response to risk analysis of the change to accomodate installations that may focus on a single occupancy area of a larger physical room. Installation and installation qualification instructions are described in Attachment 21, the Vital Signs-INS-Installation Instructions. 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 and K211906; 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 05.

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.

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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 1.47.0. The minor differences in the modified Oxehealth Vital Signs do not raise any new questions of safety or effectiveness as compared to the predicate. Thus, the modified Oxehealth Vital Signs device is substantially equivalent to its predicate device.

	Oxehealth Vital SignsPredicate	Oxehealth Modified Device	Equivalence
Intended Use	Non-invasive spot checkmeasurements of pulse rateand breathing rate (chestwall movements).	Non-invasive spot checkmeasurements of pulse rateand breathing rate (chestwall movements).	No change.
Indications forUse	The Oxehealth Vital Signsdevice is intended fornoninvasive spotmeasurement of pulse rateand estimated breathing rate(chest wall movements)when the subject is still. It issoftware assessing videofootage from afixed-installation solution foruse within single occupancyrooms within hospitals,general care and securedenvironments withprofessional healthcareoversight and where aframework exists whichmandates periodic checks bya trained professional toensure subject safety.The Oxehealth system isintended for use byappropriately trained staffwith a duty of care, andshould not be used byuntrained users.The Oxehealth Vital Signsdevice is indicated for use on	The Oxehealth Vital Signsdevice is intended fornoninvasive spotmeasurement of pulse rateand estimated breathing rate(chest wall movements)when the subject is still. It issoftware assessing videofootage from afixed-installation solution foruse within single occupancyrooms within hospitals,general care and securedenvironments withprofessional healthcareoversight and where aframework exists whichmandates periodic checks bya trained professional toensure subject safety.The Oxehealth system isintended for use byappropriately trained staffwith a duty of care, andshould not be used byuntrained users.The Oxehealth Vital Signsdevice is indicated for use on	No change.

	older who do not requirecritical care or continuousvital signs monitoring.	older who do not requirecritical care or continuousvital signs monitoring.
	The device is not intended tobe the sole method ofchecking the physical healthof a subject.	The device is not intended tobe the sole method ofchecking the physical healthof a subject.
Population	Adults not requiring criticalcare	Adults not requiring criticalcare	No change.
Where used	Single occupancy roomswithinhospitals, general care andsecured environments.	Single occupancy areaswithinhospitals, general care andsecured environments.Single occupancy areas areintended to be set up as ifthey are small rooms,separated physically withinlarger rooms, with camerascontinuing to be placed athigh level and oriented toobserve a wide area thepatient may move aroundand rest in. Installation inrooms occupied by morethan one patient is controlledby Oxehealth, ensuring thatsetup is as originallyintended, and withoutoccupied areas overlapping.	Substantially equivalent.
Human Factors	Operation of a software userinterface.	Operation of a software userinterface.	No change.
Design	Software medical devicedesigned to extract signalsfrom video to and measurepulse rate and breathing ratefrom a patient.Software user interfacedesigned to allow users totake a spot checkmeasurement of pulse rateand breathing rate, and tosee previously obtainedmeasurements.	Software medical devicedesigned to extract signalsfrom video to and measurepulse rate and breathing ratefrom a patient.Software user interfacedesigned to allow users totake a spot checkmeasurement of pulse rateand breathing rate, and tosee previously obtainedmeasurements.	No change.
Performance	Pulse rate measurement 50to $130 \pm 3$ beats per minute,9 second measurementwindow.Estimated breathing rate(chest wall movements)measurement$8$ to $31 \pm 2$ breaths perminute, 30 secondmeasurement window.* Accuracy uses the RMSEcriterionPulse rate accuracy may bereduced when the subjecthas a pulse rate greater than110 beats per minute.	Pulse rate measurement 50to $130 \pm 3$ beats per minute,9 second measurementwindow.Estimated breathing rate(chest wall movements)measurement$8$ to $31 \pm 2$ breaths perminute, 30 secondmeasurement window.* Accuracy uses the RMSEcriterionPulse rate accuracy may bereduced when the subjecthas a pulse rate greater than110 beats per minute.	No change.
User Interface	Web-based user interfaceaccessed by touch screenmonitor or mobile deviceprovided and installed byOxehealth, exclusivelyserving the Oxehealthsoftware.	Web-based user interfaceaccessed by touch screenmonitor or mobile deviceprovided and installed byOxehealth, exclusivelyserving the Oxehealthsoftware.	No change.
Compatibilitywith Hardware -computing	Standard, off the shelfcomputers and mobiledevices, specified andinstalled by Oxehealth, andvalidated during installation.	Standard, off the shelfcomputers and mobiledevices, specified andinstalled by Oxehealth, andvalidated during installation.Newer makes and modelsincluded according tospecified minimumperformance requirements.	No change.
Compatibilitywith Hardware -camera &accessories	Standard, off the shelfmachine vision camera andinfrared illuminators, exactspecification determined byOxehealth and validatedduring installation.	Standard, off the shelfmachine vision camera andinfrared illuminators, exactspecification determined byOxehealth and validatedduring installation.	No change.
Software	C++ and Node.js; use ofthird party libraries.	C++, Python and Node.js;use of third party libraries.	Substantially equivalent.

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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 technological characteristics,

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and principles of operation as its predicates. Although there 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 effectiveness as compared to the predicate. 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.