HFT750U

The HFT750U is a continuous ventilator providing ventilation and oxygen concentration for spontaneously breathing patients who need partial support due to respiratory failure or chronic insufficiency. It delivers heated and humidified gas in high-flow, CPAP, and bilevel modes for pediatric patients ≥12.5 kg to adult patients in hospitals and hospital transport, and is not intended for life support.

The HFT750U uses a blower-driven system with proportional oxygen control, microprocessor regulation, and an integrated heated humidifier—similar to the secondary predicate (Fisher & Paykel Airvo 3 NIV). Key differences from the primary predicate (Nihon Kohden NKV-330) include the integrated humidifier versus external attachment and fewer ventilator modes with fewer measured parameters, though the technology and control strategy remain substantially similar.

ISO 80601-2-12 Ed.3, ISO 80601-2-55 Ed.2, ISO 80601-2-61 Ed.2, ISO 80601-2-74 Ed.2, ISO 80601-2-90 Ed.1; IEC 60601-1 Ed.3.2, IEC 60601-1-2 Ed.4.1, IEC 60601-1-6 Ed.3.1, IEC 60601-1-8; IEC 62133-2 Ed.1 and IEC 62366-1 Ed.1 for electrical safety, EMC, and biocompatibility.

The HFT750U is substantially equivalent because it shares the same intended use, patient population (pediatric ≥12.5 kg to adult), clinical indications, and hospital environments as the predicates. The technology is functionally identical—blower-driven positive pressure with proportional oxygen control and integrated humidification. Design differences (integrated versus external humidifier, fewer modes) do not raise new safety risks and are addressed by the secondary predicate. All measured parameters and calculated indices (S/F, ROX) are derived from existing clinical measurements and do not drive therapy control, thus raising no new safety or effectiveness concerns.