HVT 2.0

The HVT 2.0 is a respiratory gas humidifier system that delivers warmed and humidified high-flow gases to spontaneously breathing neonates, infants, pediatric, and adult patients in hospital and sub-acute facility settings. It operates at flow rates of 2 to 45 liters per minute and is not intended for field transport or patients unable to protect their airway.

The HVT 2.0 uses a blower-driven air compressor with semi-permeable polymer tubing technology for humidification, operating at temperatures of 33–39°C with ±2°C accuracy. It accepts wall, tank, or oxygen concentrator sources; delivers FiO2 from 0.21 to 1.00 with ±2% accuracy; features extensive audible and visual alarms; and is powered by 110–240 VAC with Li-Ion battery backup. These characteristics are identical or equivalent to the secondary predicate HVT 2.0 (K203357).

Testing complied with IEC 60601-1:2005 (electrical safety), IEC 60601-1-2:2014 (electromagnetic compatibility), IEC 60601-1-8:2006 (alarms), ISO 10993-1 (biocompatibility), ISO 18562 series (breathing gas pathway biocompatibility), ISO 80601-2-74 (high-flow nasal therapy devices), ISO 14971:2019 (risk management), and AIM 7351731 (RFID testing).

The subject device has the same intended use as the primary predicate (Precision Flow K072845) and is technologically identical or equivalent to the secondary predicate (HVT 2.0 K203357). The expansion in indications (adding neonates) falls within the already-cleared patient populations of the primary predicate, flow rate range is a subset of cleared specifications, and minor differences in technological characteristics do not raise different safety or effectiveness questions. Comprehensive performance and biocompatibility testing demonstrates substantial equivalence.