Vital Signs

Vital Signs is a software-only medical device that measures pulse rate and breathing rate non-invasively from video footage using off-the-shelf cameras installed in hospital and care facility rooms. It is intended for retrospective spot measurements in subjects aged 12 and older who do not require critical care monitoring, and must be operated by appropriately trained staff in single-occupancy rooms with professional healthcare oversight.

The device uses identical algorithms, machine learning techniques, and processing pipeline as its predicate device (K211906). Key improvements include: 24-hour vital sign trends reporting (new feature), expansion of intended age population from 18+ to 12+, and widened respiratory rate measurement range from 8-31 bpm to 8-39 bpm. Both are software-only medical devices (SaMD) using off-the-shelf camera hardware with proprietary software analysis running on standard computers.

ISO 14971:2019 (risk management), AAMI BS 34971:2022 (AI/ML device risk management), IEC 62304:2006 (software lifecycle), IEC 82304-1:2016 (health software), IEC 80001-1:2021 (IT-network risk management), IEC 81001-5-1:2021 (health software security), IEC 62366-1:2015 (usability risk management), ISO 15223-1:2021 and ISO 20417:2021 (device labeling symbols), plus FDA cybersecurity guidance via penetration and vulnerability testing.

The subject device is substantially equivalent because it uses the identical core algorithm and machine learning methods as the predicate, identical processing pipeline and hardware components, and identical intended use in the same clinical environment. The expanded age range (12+ vs. 18+) and widened respiratory rate measurement range (8-39 vs. 8-31 bpm) were clinically validated in 30 representative subjects against FDA-cleared reference standards (pulse oximeter and capnogram), meeting the stated accuracy targets (±3 bpm for heart rate, ±2 breaths/min for respiratory rate) across all demographic subgroups. The new 24-hour trends reporting feature presents no new safety or effectiveness concerns. Therefore, the device poses no new questions of safety and effectiveness.