Philips VSC-MEDlib
Philips Medical Systems Nederland B.V.Philips VSC-MEDlib is a software library intended to automatically and contactlessly measure respiration rate by analyzing video streams of a patient's torso during virtual consults or health screenings. It uses camera-captured images to detect torso motion and calculate breathing frequency, providing clinicians with an additional vital sign measurement to support patient assessment. It is designed for use in clinical or home environments under healthcare professional supervision.
Intended Use
Software library integrated into customer applications for automatic contactless spot checking of respiration rate during virtual consults or health screenings in patients aged 22 and older classified as ASA I. Used under supervision of a healthcare professional in home or clinical environments. Not for continuous monitoring or sole health check.
Technology
Philips VSC-MEDlib uses an algorithm to analyze video streams from an unobstructed camera view of the patient's torso to calculate respiration rate based on torso motion. Video duration is typically 60 seconds or less, capturing a spot measurement. The device is a software library intended for integration into other platforms and relies on video data from cameras like Samsung Galaxy A20e.
Performance
Non-clinical testing demonstrated compliance with FDA consensus standards for medical device software, risk management, usability, and cybersecurity. Software verification and validation included usability tests with healthcare professionals and lay users. Clinical testing involved a prospective study with 92 subjects measuring accuracy against manually annotated capnography, achieving an RMSE of 0.80 breaths per minute, meeting the primary endpoint threshold.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/9/2024
8 months - 2
FDA Approval
4/4/2025
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