Oxehealth Vital Signs
Oxehealth LimitedOxehealth Vital Signs is a software medical device that uses video footage from fixed-installation cameras to noninvasively measure pulse rate and estimated breathing rate through analysis of chest wall movements. It is designed for use in single occupancy rooms within hospitals and secured environments where healthcare professionals periodically monitor patients. This technology enables spot checks of vital signs without physical contact, supporting clinical monitoring while minimizing patient disturbance and infection risk.
Intended Use
Noninvasive spot measurement of pulse rate and estimated breathing rate (chest wall movements) using software assessing video footage from a fixed-installation solution in single occupancy rooms within hospitals and secured environments with professional healthcare oversight.
Technology
Software-only medical device that runs on standard off-the-shelf computing hardware with off-the-shelf video cameras and infrared illuminators. It uses proprietary algorithms to extract pulse and breathing rate signals from the acquired video data. The device is designed for spot check measurements when the patient is still.
Performance
Performance testing was conducted through software verification and validation demonstrating measurement accuracy of pulse rate ±3 beats per minute over 50-130 bpm range and estimated breathing rate ±2 breaths per minute over 8-31 bpm range, with clinical evidence from prior clearances supporting safety and effectiveness. The device benefits from extensive clinical validation and human factors/usability assessments ensuring reliable operation in intended environments.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
3/28/2022
1 month - 2
FDA Approval
4/29/2022
Other devices from Oxehealth Limited
- Vital Signs2021 • 510K
- Oxehealth Vital Signs2021 • DE NOVO
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