Oxehealth Vital Signs
Oxehealth Limited • Cardiovascular • 03/26/2021
Device Purpose
The Oxehealth Vital Signs system employs near-infrared video cameras combined with remote photoplethysmography and motion tracking algorithms to non-invasively measure patient pulse and respiratory rates. This technology aims to provide accurate, supplementary vital sign data with comparable performance to reference devices across diverse skin tones, while enhancing patient comfort and minimizing infection risks in hospital environments.
Summary
Oxehealth Vital Signs is an innovative system designed for non-contact vital sign monitoring in hospital rooms, specifically measuring patients' pulse and respiratory rates. The technology operates using near-infrared video cameras, which analyze subtle physiological changes; pulse rate is determined via remote photoplethysmography by detecting minute variations in skin color due to blood flow, while respiratory rate is assessed by tracking chest movements. This methodology allows for spot-check vital sign assessments without requiring any physical contact with the patient, thereby enhancing patient comfort and reducing the potential for cross-infection. Accuracy evaluations have shown that the system's measurements are generally within ±5% of those obtained from reference monitoring devices, a performance level consistently maintained across diverse skin tones, addressing a common challenge in optical sensing technologies. Functioning as a supplementary tool, Oxehealth Vital Signs aims to improve routine patient monitoring by providing a less intrusive method for vital assessment, contributing to both patient well-being and operational efficiency within healthcare settings by minimizing disturbances and infection risks associated with traditional contact-based methods.
AI Regulatory Concerns
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Keywords
Device Metadata
Relevant Clinical Questions
- Q1. How does the system's accuracy compare to continuous contact monitoring over extended periods, rather than just spot-checks?; What is the impact of ambient lighting variations and patient movement (e.g., restless sleep, agitation) on the reliability of the rPPG and motion tracking algorithms?; Are there specific patient conditions (e.g., low perfusion states, severe edema, tremors) or medications that might interfere with the accuracy of the optical measurements?; What are the data security and privacy measures implemented, considering the system uses video camera footage in patient rooms?; How easily can the system be integrated into existing hospital electronic health record (EHR) systems for automated data logging and clinician review?
Risk Classification
ESL AnalysisFDA Class II via De Novo pathway; IEC 62304 Class C (software safety classification); Authorized before §524B enforcement
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Powered by SBOMator™Based on AI-generated device summaries, not the full FDA submission. Items not detected here may still be present in the complete submission package.
Supply Chain BOM Evidence
Based on the CycloneDX / OWASP ECMA-424 xBOM ecosystem. Detection is from the AI-generated summary.
Analysis:
• Analysis is based on the AI-generated device summary, not the full FDA submission package. Click "Analyze Full FDA PDF" below to scan the actual submission document.
• Evidence of ML-BOM, SaaSBOM, HBOM, OBOM detected in AI-generated device summary.
• This device was authorized before §524B took effect. Cybersecurity evidence requirements were less prescriptive at the time.
• Not detected in AI-generated device summary: SBOM, CBOM, VDR/VEX. These may be present in the full FDA submission.
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