ProSomnus RPMO2 OSA Device (RPMO2 OSA)

The ProSomnus® RPMO2 OSA Device is a prescription, custom-fitted intraoral mandibular advancement device designed to reduce nighttime snoring and mild to moderate obstructive sleep apnea in adults. It features a fully embedded reflective pulse oximetry sensor that measures oxygen saturation (SpO2) and pulse rate during sleep, with data transmitted wirelessly to a mobile app and provider portal for remote monitoring.

The primary technological difference from the predicate device is replacement of a temperature-sensing micro-recorder with an embedded reflective pulse oximetry sensor for continuous SpO2 and pulse rate monitoring. Additional differences include Bluetooth Low Energy wireless transmission (vs. infrared), rechargeable lithium-ion battery (vs. non-rechargeable coin cell), up to 24 hours data storage (vs. six months wear-time data), and modified post design with upper guided posterior blocks. The oximeter is passive, does not deliver therapy, and does not influence mandibular positioning or device fit.

Standards cited include ISO 13485 (quality management), ISO 7405 and ISO 10993 series (biocompatibility), IEC 60601-1 and IEC 60601-1-2 (electrical safety), IEC 62304 (software lifecycle), IEC 62133-2 (battery safety), FCC Title 47 Parts 15 and 18 (radiofrequency), EN 50663:2017 (EMC), and ISO 80601-2-61 (pulse oximetry). Mechanical testing included ASTM D4169-16 and shear strength evaluation per predefined acceptance criteria.

The RPMO2 device shares the same therapeutic mechanism (mandibular advancement), anatomical site (oral cavity), patient population (adults), materials, and intended therapeutic use as the predicate ProSomnus® EVO device. The embedded oximeter is adjunctive, non-therapeutic, and does not alter mandibular positioning or clinical decision-making. Comprehensive bench testing, electrical safety evaluation, clinical performance data, and software verification demonstrate that the monitoring additions do not raise new safety or effectiveness questions and that the device maintains structural integrity and therapeutic equivalence to the predicate.