AF531 Oro-Nasal SE Face Mask

The AF531 Oro-Nasal SE Face Mask is a single-use patient interface mask covering the nose and mouth for delivering noninvasive ventilation (CPAP or positive pressure) in hospital/institutional settings. It treats respiratory failure, respiratory insufficiency, and obstructive sleep apnea. The mask is available in three sizes: Small (7 years and older, >20 kg), Medium (>30 kg), and Large (>30 kg).

The device features a polycarbonate faceplate with silicone cushion, click-style elbows (replacing the press-fit design of the secondary predicate), an elbow retention hub to secure the click-style elbow, compatible headgear options (CapStrap or four-point), and a separate exhalation device. Performance specifications include 4–40 cmH₂O pressure range, ≤15 SLPM leak at 4.0 cmH₂O, deadspace <350–650 mL depending on size, and NIVO nebulizer compatibility.

ISO 17510:2015 (sleep apnea masks), ISO 10993 series (biocompatibility: genotoxicity, cytotoxicity, skin sensitization, irritation, leachables), ISO 18562 series (breathing gas pathway biocompatibility and emissions), ISO 15223-1:2021 (medical device symbols), ISO 14971-1:2019 (risk management), and ISO 5356-1:2004 (conical connectors).

The subject device is substantially equivalent because it has identical intended use, product code (CBK), regulatory classification, indications, patient population, anatomical site, environment, and performance specifications as the predicate devices. The primary design difference—the click-style elbow mechanism—does not represent a technological change since the primary predicate (AF541 SE) already incorporates click-style elbows. Minor hub design modifications to accommodate the click mechanism are routine engineering changes. All performance testing met specifications identical to the predicates, and the device was designed per the same applicable ISO consensus standards.