F&P Optiflow Air/Oxygen Flow Source

The F&P Optiflow Air/Oxygen Flow Source is a respiratory high-flow therapy device that generates and delivers a mixture of air and/or oxygen to patients in hospitals. It operates at flow rates between 0–70 L/min with selectable oxygen concentrations from 21% to 100%, and is intended for use by qualified healthcare professionals. The device is not for patients with bypassed upper airways, is not life-sustaining or life-supporting, and is not intended for apneic ventilation.

The subject device uses electronic flow and FiO₂ control with a touch-screen display, compared to the primary predicate's mechanical controls with rotary dial and push buttons. Both achieve ±10% flow meter accuracy and operate in similar temperature ranges (subject device 18–26°C). The subject device's oxygen control accuracy is ±5% per ISO 11195:2018 (gas mixer standard), versus the predicate's ±3%. The subject device includes alarms for oxygen supply pressure, FiO₂, disconnection, obstruction, and general faults—comparable to the predicates.

ISO 80601-2-90:2021 (respiratory high-flow therapy equipment), ISO 11195:2018 (stand-alone gas mixers), IEC 60601-1 series (medical electrical equipment safety), IEC 62304:2006 (software life cycle), IEC 62366-1:2015 (usability engineering), ISO 17664-2:2021 (device processing), and ANSI/AAMI ST98:2022 (cleaning validation).

The device is substantially equivalent because it performs the same intended function as the predicates—mixing and delivering high-flow respiratory gases in hospital settings—using the same classification, regulatory code (BZR), and indications for use. Although the subject device employs electronic controls with a touch screen rather than mechanical controls, this difference does not raise new safety or effectiveness questions and both control methods achieve comparable performance specifications (flow range, oxygen concentration, accuracy, and alarms). Testing to harmonized standards for high-flow therapy equipment and gas mixers confirms the device meets the same essential safety and performance requirements as the legally marketed predicates.