Sleep Watch

The Sleep Watch is a wrist-worn activity monitor that tracks physical movement during sleep using accelerometry to estimate sleep quantity, quality, and circadian rhythms. It collects data from multiple sensors (accelerometer, gyroscope, PPG, temperature, light) and transmits processed results to a cloud platform for review by healthcare professionals. The device is intended for passive, noninvasive monitoring in home environments for children and older patients.

Both the Sleep Watch and predicate Wrist Actigraph use accelerometry-based algorithms to assess sleep and circadian rhythms. The Sleep Watch adds gyroscope, PPG, Bluetooth/WiFi connectivity, and rechargeable batteries, whereas the predicate used only accelerometry, a light sensor, and infrared data communication. Both are wristwatch-form-factor devices with Type BF protection and ISO 10993-1 biocompatibility compliance.

IEC 60601-1 (general electrical safety), IEC 60601-1-2 (electromagnetic disturbances), IEC 60601-1-11 (home healthcare environment), IEC 62304 (medical device software lifecycle), ISO 14971 (risk management), ANSI/UL 2900-2-1 (software cybersecurity), and ISO 10993-1 (biocompatibility).

Both devices are classified as LEL biofeedback devices with identical intended use (sleep/circadian monitoring via actigraphy in home settings for children and older patients). The core actigraphy algorithms and signal processing for sleep estimation remain functionally equivalent between devices. Additional sensors (gyroscope, PPG) and modern connectivity (Bluetooth/WiFi) represent technological enhancements that do not change the fundamental intended purpose or introduce new safety concerns; risk management and software validation confirm equivalent safety and effectiveness profiles.