Sunrise

The Sunrise Air is a non-invasive home care device that evaluates obstructive sleep apnea (OSA) in patients 18 years and older suspected of having sleep breathing disorders. It consists of a small wearable sensor placed on the chin and software that analyzes mandibular movement, respiratory effort, airflow, oxygen saturation, pulse rate, and snoring to generate sleep parameters and an apnea-hypopnea index (AHI) for healthcare provider interpretation.

The Sunrise Air adds two enhancements to the predicate Sunrise device: a microphone for snore detection and a rechargeable lithium-ion battery (~500 charging cycles) instead of a non-rechargeable coin cell. The optical module, thermistor, accelerometer, and gyroscope remain identical. The device retains cloud-based analysis of sleep parameters and the same physical footprint and wearable form factor worn on the chin with adhesive.

IEC 60601-1 (basic safety), IEC 60601-1-2 (electromagnetic compatibility), IEC 60601-1-11 (home healthcare environment use), and ISO 10993-1 (biocompatibility evaluation). Software verification and validation followed FDA guidance for device software functions; cybersecurity measures were documented per FDA cybersecurity guidance.

The Sunrise Air is substantially equivalent because it performs the same intended function as the predicate Sunrise device with identical core sensor technology (optical module, thermistor, accelerometer, gyroscope) and unmodified sleep analysis algorithms. The additions of a microphone and rechargeable battery are minor enhancements: microphone performance was validated as comparable to the reference device, and the rechargeable battery poses no safety or effectiveness concern. Bench testing confirmed signal equivalence, and PPG-derived SpO₂ and pulse rate accuracy met predicate-level performance (SpO₂ 1.91% rms error, pulse rate 2.73 bpm rms error).