| K-number | K240700 |
| Device name | HomeSleepTest (HST, HST REM+) |
| Applicant | Somnomedics GmbH |
| Product code | OLV |
| Device class | Class II |
| Decision date | Dec 8, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 882.1400 |
The HomeSleepTest (HST, HST REM+) is a non-invasive, portable prescription device for home use that records physiological signals to help physicians diagnose sleep disorders, particularly sleep-related breathing disorders. It uses three frontal EEG electrodes, EOG, EMG, accelerometer, acoustic sensors, and an optional ComfortOxyRing pulse oximeter to measure sleep stages, oxygen saturation, heart rate, snoring, and body position, then calculates derived parameters like oxygen desaturation index and arousal index.
The HomeSleepTest is a lightweight (28g), compact device with a 36-hour battery life that transmits data via Bluetooth to a tablet and uploads to a secure cloud for analysis using DOMINO software. It records the same signal channels as the predicate (plethysmography, SpO2, EEG/EOG/EMG, snoring, activity, position) and employs equivalent electronic sensors. Key differences from the predicate SOMNOscreen plus include smaller size, longer battery life, cloud-based data storage instead of docking-station transfer, and mobile app control instead of device menu controls.
IEC 60601-1:2020 (medical electrical equipment general requirements), IEC 60601-1-2:2014 (electromagnetic disturbances), IEC 60601-1-11:2015 (home healthcare environment requirements), ISO 10993-5:2009 (biocompatibility cytotoxicity), ISO 10993-10:2021 (skin sensitization), IEC 62304:2006+A1:2015 (software lifecycle), and EN 60529:1991+A1:2000+A2:2013 (enclosure protection degrees).
The subject device shares identical indications for use, patient population (adults 21+), and intended use environment (home) with the predicate SOMNOscreen plus. Both devices record the same physiological signals and employ the same DOMINO analysis software. Clinical validation demonstrated 83% concordance with manually-scored polysomnography for sleep stages (kappa 0.77, exceeding the 82% pass criterion) and equivalent performance across all key sleep parameters (total sleep time, arousal index, oxygen desaturation metrics, snoring, pulse rate). Differences in form factor, battery capacity, and data transfer method do not introduce new safety or effectiveness concerns and are addressed by equivalent biocompatibility testing and compliance with IEC 60601-1-11 for home use.
View the full FDA submission: accessdata.fda.gov