F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size B (ONIV117B); F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size C (ONIV117C); F&P OptiNIV ONIV117-F Hospital Vented Full Face Mask with optional Expiratory Filter Compatible with Single-limb Circuits - Size A (ONIV117A-F); F&P OptiNIV ONIV117-F Hospital Vented Full

The F&P OptiNIV Vented Full Face Mask is an oro-nasal full face mask accessory for delivering non-invasive positive pressure ventilation (NPPV) therapy to spontaneously breathing adult patients (>30 kg) with respiratory insufficiency or respiratory failure. The device consists of a plastic shell with a soft seal and head straps, is single-patient use and non-sterile, and is available in three sizes (A, B, C). It is designed for use in hospital/institutional environments by trained medical practitioners.

The subject device operates at 4–30 cmH₂O pressure (compared to predicate's 4–40 cmH₂O), has mask dead space <200 cm³, anti-asphyxiation valve opening/closing pressures of 0.41/0.92 cmH₂O, flow resistance of 0.23 cmH₂O @ 50 L/min and 0.61 cmH₂O @ 100 L/min, uses single-limb breathing circuits with ISO 5356-1 22mm male connectors, is non-sterile, has a maximum mask duration of 14 days and filter duration of 48 hours, and a 3-year shelf life. All characteristics are equivalent or similar to the F&P Visairo NIV Mask predicate (K203449).

ISO 5356-1:2015 (conical connectors), ISO 17510:2020 (sleep apnea breathing therapy masks and accessories), ISTA 2A:2011 (packaging shock and vibration), IEC 62366-1:2015/AMD 1:2020 (usability engineering), ISO 10993-1:2018 (biocompatibility), ISO 18562-1:2024 and 18562-2:2024 and 18562-3:2024 (breathing gas pathway biocompatibility). Additional testing included shelf-life, venting leak, pressure waveform, humidity delivery, and product leak testing.

The subject device is substantially equivalent because it shares identical intended use, patient population (spontaneously breathing adults >30 kg), operating environment (hospital/institutional), and prescription-only status with the predicate. All major technological characteristics are equivalent or similar: pressure range, dead space, anti-asphyxiation valve function, breathing circuit type, connector standards, and durability specifications. Performance testing to applicable consensus standards confirms the device performs safely and effectively in the same manner as the predicate, with no new risks or different mechanism of action.