VPAP Pediatric Face Mask

The VPAP Pediatric Face Mask is a non-sterile, full-face patient interface mask designed for noninvasive ventilation in hospital and institutional settings. It provides CPAP or positive pressure ventilation for treating respiratory failure or insufficiency in pediatric patients aged 7 years or older (>40 lbs/20 kg). The mask is available in two sizes (L and XL) and is intended for single-patient use.

The device operates at 5–20 cmH₂O pressure (versus predicate's 4–20 cmH₂O), has lower dead space volumes (103–138 mL versus predicate's 245 mL), and higher flow resistance (0.7–2.9 cmH₂O versus predicate's 0.4–1.2 cmH₂O). It uses 22 mm ISO 5356-1:2015 connectors, polycarbonate frame, silicone cushion, and headgear materials including SBR, nylon, and thermoplastic polyurethane. The device offers two pediatric sizes (L and XL) versus the predicate's three sizes (S, M, L).

ISO 10993 series (cytotoxicity, sensitization, irritation, chemical characterization), ISO 18562 series (particulate matter and volatile organic compound emissions), ISO 9360-1 (dead space testing), ISO 17510 (noise testing), ISO 5356-1:2015 (connector standard), ISTA 2A (transportation), and internal standards for leakage and flow resistance.

The VPAP Pediatric Face Mask is substantially equivalent because it shares the same regulatory classification (Class II, Product Code CBK), intended use (noninvasive ventilation interface), patient population (pediatric ≥7 years), and use environment (hospital/institutional) as the predicate AF531 SE Full Face Mask. Minor technological differences (pressure range, dead space, flow resistance, size options) do not raise new safety or effectiveness questions, as comprehensive biocompatibility, emissions, and performance testing demonstrated comparable performance to the predicate across all parameters.