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 Story
Software-based system; analyzes video footage from fixed-installation cameras; estimates pulse rate and breathing rate (chest wall movements). Used in single-occupancy hospital rooms, general care, or secured environments; operated by trained healthcare staff. System requires subject to be still for measurement. Output provided to clinicians as adjunctive information for patient safety checks; not intended for continuous monitoring or sole health assessment. Benefits include non-contact vital sign measurement, reducing patient disturbance and staff workload during routine checks.
Clinical Evidence
Observational, uncontrolled study (n=60) of patients 18-81 years old, balanced for skin color, BMI, and age. Compared Oxehealth device to Somnoscreen (contact) system. Primary endpoints: root mean square difference (RMSD). Pulse rate RMSD: 1.81 bpm (97.5% CI 0-2.19 bpm). Breathing rate RMSD: 1.17 breaths/min (97.5% CI 0-1.33 breaths/min). Success rate for pulse: 58%; for breathing: 73%. Bench testing verified hardware specifications and software algorithm performance.
Technological Characteristics
Software for optical camera-based measurement of pulse rate and breathing rate. Utilizes fixed-installation video hardware. Requires software verification, validation, hazard analysis, and cybersecurity vulnerability management. Must meet special controls regarding sensor acquisition hardware specifications and mitigation of user error or subsystem failure.
Indications for Use
Indicated for humans 18 years or older who do not require critical care or continuous vital signs monitoring. Used for noninvasive spot measurement of pulse rate and estimated breathing rate (chest wall movements) when the subject is still.
Regulatory Classification
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.
Special Controls
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 is subject to the following special controls:
*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.
Submission Summary (Full Text)
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### DE NOVO CLASSIFICATION REQUEST FOR OXEHEALTH VITAL SIGNS
#### REGULATORY INFORMATION
FDA identifies this generic type of device as:
Software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate. The device uses software algorithms to analyze video signal and estimate pulse rate, heart rate, respiratory rate and/or breathing rates. This device is not intended to independently direct therapy.
NEW REGULATION NUMBER: 21 CFR 870.2785
CLASSIFICATION: Class II
PRODUCT CODE: QME
#### BACKGROUND
DEVICE NAME: Oxehealth Vital Signs
SUBMISSION NUMBER: DEN200019
DATE DE NOVO RECEIVED: March 27, 2020
#### SPONSOR INFORMATION:
Oxehealth Limited Magdalen Center North, the Oxford Science Park Oxford OX4 4GA
### INDICATIONS FOR USE
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.
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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.
### LIMITATIONS
The subject must be still for a vital sign to be detected. For a pulse rate to be measured, a sufficient area of exposed skin must be visible to the camera. For a breathing rate to be measured, the movement of the chest must be visible to the camera.
The device is not a continuous monitor and is only intended for spot-check measurements of pulse rate and estimated breathing rate (chest wall movements).
The Oxehealth system is intended for use by appropriately trained staff with a duty of care, and should not be used by untrained lay users.
The device is not intended to be the sole method of checking the physical health of a subject.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
### DEVICE DESCRIPTION
The device is a software algorithm that reads data collected using off-the-shelf cameras collecting images in the near-infrared spectrum. These images 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. Pulse rate is determined by monitoring pixel intensity changes for exposed skin. Breathing rate is determined with motion tracking of the patient's chest. 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 estimated breathing rates (chest wall movements) of the individual in the room. This allows vital monitoring without disturbing the patient either to allow for patient rest or to protect staff that would otherwise need to enter the room with a potentially dangerous patient.
Off-the-shelf components must meet specifications set by the sponsor in order to ensure they will provide adequate quality video capture for analysis by the medical device.
### SUMMARY OF NONCLINICAL/BENCH STUDIES
### SOFTWARE
The Oxehealth Vital Signs device has a Moderate Level of Concern (LOC). Appropriate documentation was provided to support the validation of the software for a Moderate
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LOC in accordance with FDA's 2005 guidance titled, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The sponsor provided details on how the software algorithm measures pulse and breathing rate. Also in order to ensure that the non-device components will provide adequate information for the software algorithm, the sponsor provided minimum specifications for non-device components. Rationale was provided for choice of the minimum hardware specifications to ensure appropriate functioning of the software algorithm. The workflow and software handling of hardware error or failures were demonstrated.
Because the device is network connected, appropriate documentation was provided in accordance with FDA's 2014 guidance titled "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" to support adequate cybersecurity measures have been taken and will be monitored and updated throughout the device life cycle.
# PERFORMANCE TESTING - BENCH
The majority of performance testing for the Oxehealth device are encapsulated in software section above and through validation of the overall system in clinical studies.
Additionally, system installation instructions require unit-by-unit verification of all hardware and environmental conditions to be installed at a customer site by Oxehealth as well as verifying adequate performance at maximum usage load of the solution before handover to the customer.
Adequate scientific rationale was provided to justify specifications of off-the-shelf components to ensure image quality would be appropriate for the software algorithm to have reliable performance.
# HUMAN FACTORS/USABILITY
A human factors study was conducted with 10 users, 8 of which were given the user manual for self-training and 2 of which received no training. These users were asked to operate the Oxehealth Vital Signs device for 30 minutes to repeatedly obtain pulse and breathing measurements on a subject mimicking behaviors expected of patients. The testing verified the critical tasks of (1) ensuring measurement is taken from a patient and (2) distinguishing historical measurements from current measurements. The testing provided adequate assurance that the critical tasks could be performed.
### SUMMARY OF CLINICAL INFORMATION
The sponsor provided a clinical study protocol and results to support the safety and effectiveness of the device. The clinical performance study design was an observational, uncontrolled study in patients 18 vears of age and older. Patient recruitment was setup to ensure collection on a complete range of skin color types, body mass indices, and ages according to US census data (min. n=6 per Fitzpatrick scale class, where each class includes 2 skin tvpes: 60 adult patients).
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Patient age ranged from 18 to 81 years of age. The study evaluated the Oxehealth device performance measuring pulse and breathing rate under a range of expected conditions. Pulse and breathing rate was compared to the Somnoscreen system (standard contact device) in a statistical non-inferiority test. The study also showed that the Oxehealth system provides measurements of pulse rate and estimated breathing rate (chest wall movements) on the majority of occasions on which measurements would be expected.
The primary objective of the study was to assess the accuracy of pulse rate and estimated breathing rate (chest wall movements) measurements made using the Oxehealth Vital Signs device, calculated as the root mean square difference (RMSD) across all measurements when compared to a standard contact device. The pulse rate RMSD was found to be significantly less than the study objective of three beats per minute. The breathing rate RMSD was found to be significantly less than the study objective of two breaths per minute.
One-sided 97.5% confidence intervals (Cls) were calculated for these two endpoints, using the bootstrap method. The pulse rate RMSD was found to be 1.81 bpm (CI 0 - 2.19 bpm). The estimated breathing rate (chest wall movements) RMSD was found to be 1.17 breaths/minute (CI 0 - 1.33) breaths/minute.
The study was not powered to demonstrate statistical significance in sub-groups of the 60 participants. However, RMSD point estimates and their one-sided 97.5% confidence intervals for sub-groups were calculated to ensure adequate performance throughout the expected patient demographics.
For measurements for which the device could be used within its label (that is, with the participant not moving at the time of measurement, and, in the case of pulse rate measurement, with skin visible), 58% (95% CI 51% - 65%) of measurement attempts resulted in a displayed pulse rate, and 73% (95% CI 68% - 79%) of measurement attempts resulted in a displayed breathing rate. The study was intended to be a worst case scenario, as the study protocol required a reading to be taken at the same specified time during all activities, including those activities where the likelihood of a valid measurement being taken was reduced. Experience with the device (user reported outcomes) outside the United States suggest that proposed device is more commonly used when patients are resting, sleeping, or are moribund.
# Pediatric Extrapolation
The Oxehealth Vital Signs device is indicated for patients age 18 and older. For medical devices, the FD&C Act defines patients before their 22nd birthday as pediatric patients. In this De Novo request, data from patients between 18-22 were used to support the use of the device in patients over the age of 18. It was appropriate to indicate the device for individuals 18 and older because of this data and patients aged 18 to 21 do not carry additional differences or risks relative to the patient population studied.
# LABELING
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The labeling includes a description of what the device measures and outputs to the user must be still in order for a measurement to be taken with adequate skin visible for pulse rate measurement and the motion of the chest visible for estimated breathing rate (chest wall movements) measurement. Importantly, the vital signs measured are pulse and breathing rate, which is distinct from heart rate and respiration rate. As certain cardiac arrhythmias may confound accurate readings, patients with known cardiac arrhythmias should not use this device. Further, clinical data used to support the safety and effectiveness of the device did not include subjects with elevated pulse rates, so accuracy may be reduced when the subject has a pulse rate greater than 110 beats per minute. Other patient conditions that may affect performance of the device are listed in the labeling. Certain room conditions may affect performance (bright lights, shower, etc.). If the Oxehealth Vital Signs device fails to respond as described, discontinue use until the situation has been corrected.
The device is not a continuous monitor and is only intended for spot-check measurements of breathing and pulse rate. The reported accuracy of the system is described for both measurements in accordance with what was measured in the clinical study. The device should not be used with any subject receiving critical care. The Oxehealth system is intended for use by appropriately trained staff with a duty of care, and should not be used by untrained lay users. The device is not intended to be the sole method of checking the physical health of a subject.
Installation will be carried out by an Oxehealth trained installer, according to installation instructions and verification procedures provided by Oxehealth.
# RISKS TO HEALTH
The table below identifies the risks to health that may be associated with use of software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate and the measures necessary to mitigate these risks.
| Identified Risks to Health | Mitigation Measures |
|---------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Delayed or incorrect treatment due to<br>erroneous output as a result of software<br>malfunction or algorithm error | Software verification, validation, and hazard<br>analysis |
| | Cybersecurity assessment |
| | Clinical data |
| | Labeling |
| Delayed or incorrect treatment due to user<br>misinterpretation | Human factors assessment |
| | Labeling |
| Delayed or incorrect treatment due to non-<br>device components failing to provide inputs for<br>software to adequately analyze | Software verification, validation, and hazard<br>analysis |
| | Clinical data |
| | Human factors assessment |
| | Labeling |
# SPECIAL CONTROLS
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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 is subject to the following special controls:
- (1) A software description and the results of verification and validation testing based on a comprehensive hazard analysis and risk assessment must include:
- A full characterization of the software technical parameters, including algorithms; (i)
- (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;
- A description of all mitigations for user error or failure of any subsystem (iv) components (including signal detection, signal analysis, data display, and storage) on output accuracy: and
- Software documentation must include a cybersecurity vulnerability and management (v) process to assure software functionality.
- (2) Clinical data must be provided. This assessment must fulfill the following:
- The clinical data must be representative of the intended use population for the (i) device. Any selection criteria or sample limitations must be fully described and iustified.
- The assessment must demonstrate output consistency using the expected range of (ii) data sources and data quality encountered in the intended use population and environment.
- The assessment must compare device output with a clinically accurate patient-(iii) 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:
- A description of what the device measures and outputs to the user: (i)
- Warnings identifying sensor acquisition factors or subject conditions or (ii) 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;
- The expected performance of the device for all intended use populations and (iv) environments; and
- Robust instructions to ensure correct system setup. (v)
# BENEFIT-RISK DETERMINATION
The risks of the device are based on data collected in a clinical study described above.
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The consequences of an incorrect reading would be a delay in the provision of care or unnecessary testing. The patient could suffer harm from the delay in providing care. However, the device has been validated to have clinically acceptable accuracy and the probability of a patient harm related to false results is minimum.
The probable benefits of the device are also based on data collected in a clinical study as described above.
The device can benefit the patient by minimizing intrusion due to regular bedside vital signs measurements. In certain settings and circumstances, the non-contact measurement method offers a more practical and safer alternative to the conventional way of vital signs measurements. The device is especially valuable in environments (e.g., isolation rooms. secure facilities, and psychiatric wards) where routine physical interaction with a patient may be risky for to both the patient and health care provider. Remote monitoring provided by the device can also minimize personnel exposure to the patient.
In situations where regular access to subjects is impractical or unsafe, there are few alternatives. While contact sensors may be considered, their use is often limited by poor compliance and device-associated physical discomfort. For basic vital sign monitoring in these settings, there is a high likelihood that the Oxehealth device can offer significant advantages over existing alternatives.
#### Patient Perspectives
Patient perspectives considered for the Oxehealth Vital Signs during the review include surveys from patients who had been checked with the Oxehealth system in an existing hospital installation outside. The results demonstrated preference for the contactless checks as it didn't disturb their sleep and may result in less complaints from patients.
#### Benefit/Risk Conclusion
In conclusion, given the available information above, for the following indication statement:
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.
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The device is not intended to be the sole method of checking the physical health of a subject.
The probable benefits outweigh the probable risks for the Oxehealth Vital Signs. The device provides benefits and the risks can be mitigated by the use of general controls and the identified special controls.
### CONCLUSION
The De Novo request for the Oxehealth Vital Signs device is granted, and the device is classified as follows:
Product Code: QME Device Type: Software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate Regulation Number: 21 CFR 870.2785 Class: II
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
