SoClean 3+

The SoClean 3+ is an ozone-generating device designed to reduce bacterial populations on CPAP masks and hoses after cleaning. It operates disconnected from the CPAP machine and uses a 90-minute cycle that produces humidified ozone to treat the mask and hose surfaces, demonstrating a 3-log (99.9%) bacterial reduction for eight specified bacteria species.

The subject device maintains identical operational principles, cycle profile, and ozone generation (270 ± 15 ppm) as the predicate DEN210037. Minor updates include a simplified humidifier drawer with vertical rail access instead of horizontal 4-bar linkage, and modularized humidifier components with integrated wick cage. All safety checks, specifications, and sensor requirements remain identical.

ISO 10993-12 for biocompatibility testing via exhaustive extraction and GC-MS analysis; 21 CFR 801.415 for ambient and residual ozone limits (<0.05 ppm). Additional nonclinical testing included relative humidity verification, ozone production validation, shelf life testing, use life testing, and human factors study.

The SoClean 3+ is substantially equivalent because it has the identical intended use, indications, and principles of operation as predicate DEN210037, with only minor manufacturing-focused design updates to the humidifier that do not alter safety or effectiveness. All nonclinical performance testing demonstrates the device functions as intended with results equivalent to or better than the predicate, and no new safety or effectiveness issues arise from the minor technological differences.