AcuPebble Ox (200)

AcuPebble Ox200 is a wearable device that records and analyzes biophysical signals to evaluate adults with suspected obstructive sleep apnea (OSA). It consists of a neck-worn acoustic/accelerometer sensor, a finger or forehead-worn PPG/accelerometer sensor, a mobile app for data collection, and cloud-based analysis software. The device is intended primarily for home use under direction of a healthcare professional.

AcuPebble Ox200 adds a new PPG/accelerometer sensor placeable on finger or forehead (versus fixed finger placement in predicate K222950), and extracts additional parameters including position, respiratory effort, and respiratory rate from the acoustic neck sensor. The OSA diagnostic algorithms derived from the neck sensor remain identical to the predicate. The finger/forehead sensor is smaller and lighter than the predicate's finger sensor.

EN 60601-1:2006+A11:2011+A1:2013+A2:2021, EN 60601-1-2(2015)/A1(2021), IEC 60601-1-11:2015, IEC 62366-1:2020, ISO 80601-2-61:2017 (pulse oximetry), ISO 14971:2019 (risk management), IEC 62304:2006/A1:2016 (software lifecycle).

The device shares identical indications for use, same regulatory classification (Class II, 868.2375), and the same core OSA diagnostic algorithms and neck sensor technology as predicate K222950. New outputs (respiratory rate, effort, position) derive from the neck sensor using substantially equivalent technologies and have been clinically validated at performance levels comparable to reference devices like Airmod and Huxley SANSA. The new PPG sensor placement option (forehead or finger) has been validated per ISO 80601-2-61 with comparable accuracy to the predicate. Biocompatibility uses the same materials as prior cleared devices. No new safety or effectiveness questions are raised.