Hypnos (369054-200)

Hypnos is a software application for polysomnography (PSG) and clinical sleep studies that measures, records, displays, analyzes, and retrieves physiological signals during sleep and wake to assist in assessing sleep and diagnosing sleep disorders including sleep-related breathing disorders. It is intended for use by trained medical professionals in hospitals, sleep centers, and clinics for patients from neonate to adult, with computer-assisted analysis features limited to adults only.

Hypnos has equivalent technological characteristics to the predicate device, including the ability to acquire, display, store and archive PSG data; perform FFT analysis; detect respiratory events, sleep staging, arousals, limb movements, snore events, and oxygen desaturation; display heart rate, CO2, and oximetry data; and generate customizable reports following AASM scoring standards. Both the subject and predicate devices use mouse/keyboard input, receive data from separate acquisition hardware, and visualize signals and events in equivalent ways.

Software testing was conducted per IEC 62304:2015-06; risk management per ISO 14971:2019; usability testing per IEC 62366-1:2020-06; and user information per ISO 20417:2021-04. All verification, validation, and usability testing was performed per design requirements.

Hypnos presents no new questions of safety and effectiveness and is substantially equivalent to the predicate devices based on: (1) equivalent intended use for PSG analysis and sleep disorder diagnosis by trained professionals; (2) equivalent primary functions including opening studies, displaying data, manually and computer-assisted scoring, and report generation; and (3) clinical performance testing showing computer-assisted scoring achieves above 80% event annotation across all valid clinical event types with confidence intervals comparable to the reference predicate EnsoSleep.