F&P Nova Nasal Mask

The F&P Nova Nasal Mask is a non-invasive positive airway pressure (PAP) therapy nasal mask designed for adults aged 22 and older weighing ≥66 lbs who have been prescribed CPAP or Bi-Level therapy by a physician. It features an over-the-nose cushion held in place by adjustable headgear straps and is available in single-patient home use (A-Model) or multi-patient clinical use with disinfection capability (SLA-Model).

The Nova mask operates at 4–30 cm H₂O pressure with three cushion sizes (Small, Medium, Large) versus the predicate's four sizes; it has two headgear sizes instead of one, and includes optional accessories (diffuser clip, tube clip, headgear pad) not in the predicate. Both use 22mm ISO Taper connectors, single inspiratory tube, and identical thermal disinfection methods; the Nova adds chemical disinfection (CIDEX OPA) and claims 5-year shelf-life versus the predicate's 1 year.

ISO 17510:2015 (sleep apnea breathing therapy masks), ISO 5356-1:2015 (conical connectors), ISO 10993 series (biocompatibility parts 1, 3, 5, 10, 11, 17, 18, 23), ISO 18562 series (breathing gas pathway biocompatibility), ISO 17664 series (reprocessing information), ISTA 2A:2011 (packaging stress), and ASTM F1980-16 (accelerated aging).

The Nova is substantially equivalent because it is indicated for the same patient population and intended use (PAP therapy delivery) as the predicate F&P Evora mask; both are Class II nasal masks with identical operating environment and disinfection principles. Although the Nova offers expanded cushion/headgear sizing options and optional accessories, these represent convenience enhancements rather than functional changes. Performance testing demonstrates equivalent resistance to flow, dead space, and sound profiles within acceptable tolerance, and non-clinical validation (cleaning, disinfection, mechanical integrity, biocompatibility) confirms safety and functionality parity with the predicate.