Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask

The Sleepnet Arie Full Face Vented Mask and Arie Nasal Vented Mask are interfaces designed to deliver pressurized air from CPAP or bi-level positive airway pressure devices to adult patients (>30 kg) for sleep apnea therapy. The masks seal over the nose and mouth (full face) or nose only (nasal) and are intended for single-patient multi-use in home, hospital, or institutional settings at pressures of 4 cm H₂O or above.

Both masks use a liquid silicone rubber (LSR) cushion design with medical-grade injection-molded thermoplastics and clear silicone rubber. Key performance features include exhaust flow characteristics, anti-asphyxia valve (AAV) pressure ratings, mask dead space, pressure drop across the interface, CO₂ rebreathing performance, and sound levels. The full face mask offers three sizes (Small, Medium, Large) with varying dead space and weight; the nasal mask also offers three sizes with lower dead space and weight than the full face variant.

ISO 17510 (sleep apnea breathing therapy masks and accessories), ISO 3744 (sound power and pressure levels), ISO 5356 (conical connectors), IEC 60068-2-31 (rough handling shocks), ISO 17664 (device processing information), ISO 10993 series (biological evaluation including cytotoxicity, skin sensitization, irritation, and chemical characterization), and ISO 18562 series (biocompatibility of breathing gas pathways).

The Arie masks are substantially equivalent to the AirFit F20 (full face, K153563) and AirFit N20 (nasal, K171212) because they have identical intended use, patient population, operating principles, anatomical application site, and therapy pressure ranges. Performance testing demonstrates comparable exhaust flow, AAV pressure characteristics, pressure drop, and CO₂ rebreathing performance. All devices use similar materials and construction methods, with the Arie masks meeting or exceeding relevant ISO 17510 acceptance criteria for mask performance.