Vital Signs

Vital Signs is a software-only medical device that performs non-contact measurement of pulse rate and breathing rate from video footage captured by fixed cameras in hospital rooms and care facilities. The device is intended for use by trained staff on patients 18 years or older who do not require critical care or continuous monitoring, and it is not intended as the sole method for checking patient health.

The device uses proprietary software algorithms to derive heart rate and breathing rate data from video analysis of patients in single-occupancy rooms without requiring any contact devices. The key difference from the predicate device (K211906) is that it runs on Ubuntu operating system rather than CentOS for improved security and vulnerability protection.

The device applied consensus standards including ISO 14971:2019 (risk management), IEC 62304:2006 (software life cycle), IEC 82304-1:2016 (health software), IEC 80001-1:2021 (IT network risk management), IEC 81001-5-1:2021 (health software security), AAMI BS 34971:2022 (AI/ML risk management), IEC 62366-1:2015 (usability), and ISO 15223-1:2021 (labeling symbols). The firm also performed penetration and vulnerability testing per FDA cybersecurity guidance.