Somfit D

The Somfit D is a single-use, non-invasive prescription device for home-based sleep monitoring in adults aged 21+. It detects sleep-related breathing disorders, performs sleep staging (REM, N1, N2, N3, Wake), and measures snoring levels using forehead-mounted electrodes that acquire EEG, pulse oximetry, peripheral arterial tonometry, accelerometry, and acoustic data. The device reports clinical parameters including pAHI, ODI, sleep stages, and SpO2 to aid physician diagnosis, but is not intended as the sole basis for diagnosis or for use in intensive care settings.

Somfit D uses identical EEG and PPG data acquisition systems, electronic sensors (photodiode, oximeter front-end AFE4404, microphone, accelerometer, EEG amplification), and analysis outputs (pAHI, sleep stages, ODI, snoring level) as the predicate Somfit device. The primary difference is that Somfit D employs a non-rechargeable 225 mAh 3.0V Li-MnO2 (CR2032) battery with 9 hours continuous recording versus the predicate's rechargeable 120 mAh Li-Ion battery with 16 hours recording. Both devices apply to the forehead, use ARM (TI) microprocessors, and transmit data via Bluetooth to the Nexus360 cloud server.

IEC 60601-1:2005 (electrical safety); IEC 60601-1-2:2014 and EN 60601-1-2:2015 (electromagnetic compatibility); IEC 60601-1-11:2015 (home healthcare environmental testing); IEC 60601-2-26:2012 (EEG safety and performance); ISO 80601-2-61:2011 (pulse oximeter safety and performance with functional simulator); IEC 60086-4 (single-use lithium battery safety for the CR2032 battery).

Somfit D is substantially equivalent because it has identical intended use, principles of operation, and data acquisition systems as the cleared Somfit predicate device (K231546). The sole design difference—substitution of a non-rechargeable CR2032 battery for the predicate's rechargeable Li-Ion battery—does not raise safety or effectiveness questions since both are low-voltage (<4V) power sources with identical electrical safety profiles. Clinical validation data from the predicate device (oximetry, pAHI, ODI, sleep staging studies) directly apply to Somfit D because its EEG and signal processing hardware and algorithms remain unchanged; the battery change only affects operating time, not clinical performance or measurement accuracy.