AirFit F20 Mask System; AirFit F20 NM Mask System

The AirFit F20 and AirFit F20 NM Mask Systems are full-face masks for delivering pressurized air from CPAP or bi-level devices to patients with obstructive sleep apnea. Both come in home-use variants (single-patient reuse) and Sleep Lab variants (multi-patient reuse with reprocessing). They are intended for patients weighing over 66 lb (30 kg) prescribed non-invasive positive airway pressure therapy.

Both mask systems share the predicate's common design architecture with four main assemblies: cushion, elbow, frame, and headgear in multiple sizes. The AirFit F20 includes multi-hole and diffuser vents with magnetic clips; the AirFit F20 NM is identical except it replaces magnetic clips with non-magnetic clips. Both operate at 3–40 cmH₂O pressure and connect via ISO 5356-1 (22 mm) tubing. Reprocessing is validated for high-level thermal disinfection and sterilization.

ISO 17510:2015 (CO₂ rebreathing, exhaust flow, resistance to flow, anti-asphyxia valve, breathing resistance, vibration/noise); ISO 18562-1:2017 and ISO 18562-2/3/4:2017 (biocompatibility of breathing pathways); ISO 10993-1, 5, 10, 11, 12, 17, 18, 23:2021 (biological evaluation); ISO 17664-1/2:2021 (reprocessing validation); ST98:2022 (cleaning validation); AAMI TIR12:2020 (processing guidance).

The AirFit F20 and F20 NM systems have identical indications for use, intended patient population, and operating environment as the predicate AirFit F20 (K170924). Performance testing demonstrates equivalent exhaust flow, CO₂ rebreathing, resistance to flow, and breathing resistance across all clinically relevant pressures. The only design difference—replacement of magnetic with non-magnetic clips in the NM variant—does not affect functional safety or performance. Both variants meet all predetermined acceptance criteria in non-clinical testing and reprocessing validation.