Philips VSC-MEDlib

The Philips VitalSigns Camera Medical Library is a software library that measures respiration rate contactlessly from video of a patient's torso using computer vision analysis. It is intended for spot-check respiratory rate measurement during virtual consults or health screenings in healthy adults (ASA I classification, age 22+) under healthcare professional supervision, either in home or clinical settings. It is not for continuous monitoring or as the sole health assessment method.

Both the subject device and predicate (Thora-3Di Model T-01) use the same fundamental technology: analyzing video images from a digital camera to measure respiratory rate by detecting torso movement. The key difference is that Philips VSC-MEDlib is software-only for integration into customer applications, while Thora-3Di is a fully integrated system with a fixed camera installation. These structural differences do not affect safety or effectiveness.

IEC 62304 (medical device software lifecycle), IEC 62366-1 (usability engineering), ISO 14971 (risk management), plus FDA guidance documents on premarket software submissions, human factors/usability engineering, cybersecurity in medical devices, off-the-shelf software use, and the 510(k) program for evaluating substantial equivalence.

Both devices are intended for non-continuous, spot-check measurement of respiration rate in adults as an adjunct to clinical assessment—not as sole diagnostic method. Both employ the same algorithmic approach (torso motion analysis from video), measure in the same range with similar accuracy (±3 bpm vs ±2 bpm), and share the same intended measurement window (60 seconds). The subject device's restriction to healthy ASA I patients is a lower-risk subset of the predicate's broader adult population, and extension to home use is supported by reference device K223163. Clinical testing demonstrated RMSE of 0.80 bpm, meeting the ≤3 bpm endpoint.