WiZARD 520 Full Face Mask

The WiZARD 520 Full Face Mask is a non-continuous ventilator interface mask designed to deliver Continuous Positive Airway Pressure (CPAP) or bi-level therapy for treating obstructive sleep apnea in adults weighing ≥30 kg. The mask features a cushioned interface, exhalation vents to reduce CO2 rebreathing, wider visibility design, and fabric frame with 3D-shaped headgear. It connects to standard 22 mm breathing tubes and is available in small, medium, and large sizes for both home single-patient reuse and hospital multi-patient use.

The subject device shares equivalent product code (BZD), regulation (21 CFR 868.5905), classification (Class II), indications for use, patient population (adults ≥30 kg), environments (home/hospital), pressure range (4–40 cmH₂O), and connectivity (22 mm hose) with the predicate WiZARD 310/320 Series. Key differences include reduced dead space (L: 271 ml vs 328 ml; M: 228 ml vs 284 ml; S: 211 ml vs 223.8 ml) and extended use life claim (6 months or 30 disinfection cycles vs 6 months unpacking only). Performance metrics for exhaust flow, CO₂ rebreathing, resistance, anti-asphyxia valve, and sound all meet or exceed ISO 17510:2015 requirements.

ISO 17510:2015 (sleep apnea breathing therapy masks), ISO 10993 series (biocompatibility: cytotoxicity, skin irritation/sensitization, systemic toxicity, chemical characterization), ISO 18562 series (breathing gas pathway biocompatibility: particulate matter and volatile organic compounds), ISO 5356-1:2015 (conical connectors), IEC 62366-1:2015 (usability engineering), and ISO 14971:2019 (risk management).

The WiZARD 520 is substantially equivalent because it maintains identical intended use, patient population, clinical indication, environments, and fundamental operating principles (positive pressure mask interface with adjustable headgear) as the predicate device. Both are Class II non-continuous ventilator masks using the same product code and regulation. Performance testing demonstrates the subject device meets or complies with all applicable ISO 17510:2015 standards for CO₂ rebreathing, pressure-flow characteristics, resistance, anti-asphyxia valve function, and sound levels. The minor design improvements (reduced dead space, disinfection cycle tracking) represent refinements that enhance but do not fundamentally alter the intended use or safety/effectiveness profile.