Onera STS 2 (ONERA STS 2)

The Onera STS 2 is a wearable, multi-sensor system for measuring physiological signals during sleep studies, including EEG, EOG, EMG, ECG, respiratory effort, oxygen saturation, activity, position, and sound. It records data on disposable sensors applied to the forehead, chest, abdomen, and legs, then transmits encrypted data via Bluetooth to a smartphone app and cloud platform for clinician review to diagnose sleep disorders in adults.

The Onera STS 2 uses wireless Bluetooth/cloud connectivity for data transfer, compared to the predicate's wired USB connection. The sensors are single-use disposable devices versus the predicate's reusable sensors. The measured parameters, sampling rates, resolution, accuracy, and conformance to safety/performance standards are identical. The SpO2 accuracy improved to ±2.5% (predicate was ±4%), and operating temperature range extended to 5–40°C (predicate 10–40°C).

IEC 60601-1 (basic safety and essential performance), IEC 60601-1-2 (EMC), IEC 60601-2-25 (electrocardiographs), IEC 80601-2-26 (electroencephalographs), IEC 60601-2-40 (electromyographs), ISO 80601-2-61 (pulse oximeters), ANSI/AAMI EC 12 (disposable electrodes), ISO 14971 (risk management), IEC 62366-1 (usability), and IEC 62304 (software development). SpO2 accuracy testing performed per ISO 80601-2-61 on 12 healthy subjects during induced hypoxia.

The Onera STS 2 is substantially equivalent because it measures identical physiological parameters with the same technical specifications and conformance to all applicable standards as the predicate Onera STS. The two key differences—wireless cloud connectivity versus wired extraction and single-use versus reusable sensors—do not raise new safety or effectiveness questions; wireless data transfer does not alter signal quality or diagnostic capability, and disposable sensors eliminate reuse-related contamination risks. The improved SpO2 accuracy and expanded operating temperature range represent enhancements that do not diminish safety. Clinical testing confirmed SpO2 accuracy meets ISO standards, and risk management per ISO 14971 found no novel hazards introduced by these design changes.