Medscape Medical NewsAll articles

Oxehealth Vital Signs

Oxehealth Limited • Cardiovascular • 03/26/2021

De NovoIEC 62304 Class C
FDA Summary PDF

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

Powered byJev by TypeSafe AI

Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

Keywords

Oxehealth Vital SignsNear-infraredVideo camerasPulse rateRespiratory rateRemote photoplethysmographyMotion trackingNon-contact monitoringAccuracySkin tones

Device Metadata

Submission Number
DEN200019
Company
Oxehealth Limited
Panel
Cardiovascular
Product Code
N/A
Data Type
Images
Clinical Function
Assessment
AI Function
Analysis
AI Subclass
quantification/feature localization

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 Analysis
FDA Device ClassII

FDA Class II via De Novo pathway; IEC 62304 Class C (software safety classification); Authorized before §524B enforcement

Learn how Parasoft automates IEC 62304 compliance testing →

Cybersecurity Evidence

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.

Cyber Score55/100
SBOM Evidence⚠ Not mentioned in summary
Cyber Risk Assessment✓ Detected in Summary
Postmarket Plan✓ Detected in Summary
§524B ApplicableNo

Supply Chain BOM Evidence

Based on the CycloneDX / OWASP ECMA-424 xBOM ecosystem. Detection is from the AI-generated summary.

SBOMSoftware Bill of Materials
- Not detected
ML-BOMMachine Learning Bill of Materials(algorithm)
✓ Detected
SaaSBOMSoftware-as-a-Service Bill of Materials(remote)
✓ Detected
HBOMHardware Bill of Materials(camera)
✓ Detected
CBOMCryptography Bill of Materials
- Not detected
VDR/VEXVulnerability Disclosure Report / Vulnerability Exploitability eXchange
- Not detected
OBOMOperations Bill of Materials(environment, operational)
✓ Detected

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.

Preparing a similar submission?

ESL takes complete ownership of your software evidence work - SBOM & CVE remediation with SBOMator™, static analysis & unit testing with Parasoft, traceability, and full IEC 62304 lifecycle support.

Assess Your Readiness →Or contact ESL directly
Oxehealth Vital Signs - Oxehealth Limited | ESL FDA AI Device Intelligence