Onera SleepMap (SLEEPMAP)

Onera SleepMap is a software-only medical device that analyzes polysomnography sleep study recordings from the Onera STS I device to aid physicians in diagnosing sleep and respiratory disorders in adults. The system automatically scores sleep stages, detects arousals, leg movements, desaturations, and obstructive apneas/hypopneas, with results subject to clinician verification. Respiratory event subtypes, RERA, Cheyne-Stokes breathing, snoring, and arrhythmia events require manual marking.

SleepMap is a native cloud-based browser application (vs. predicate's stand-alone PC application), derives heart rate from ECG signal (vs. predicate using pulse rate input), allows manual annotation editing within the application (vs. predicate requiring third-party viewer), and processes data from Onera STS I devices only (vs. predicate supporting multiple PSG systems). All differences are deemed non-clinically relevant.

Compliance verified with EN IEC 62304:2006/A1:2015, EN 82304-1:2017, EN ISO 20417:2021, and EN ISO 15223-1:2021. Documentation prepared per FDA Guidance for Software Contained in Medical Devices. Usability engineering process followed to mitigate usability risks.

SleepMap is substantially equivalent to EnsoSleep (K162627) because both are software-only devices with identical regulatory classification, identical indications for use, and identical operating principles (automated analysis, clinician review, report generation). The technological differences (cloud vs. desktop, ECG-derived vs. pulse rate heart rate, built-in vs. third-party annotation editing, single vs. multiple input device support) do not raise different safety or effectiveness questions. Clinical validation on 98 PSG studies with 2/3 majority expert scoring demonstrates comparable performance to the predicate device.