Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)

The F&P Optiflow+ Nasal Cannula Range is a nasal cannula interface used with respiratory gas humidifiers to deliver high-flow warmed and humidified gases to spontaneously breathing pediatric (3 years and older) and adult patients. The OPT94x models are for hospital, sub-acute, and long-term care facility use by healthcare professionals, while the MYOPT9x models can also be used in the home by lay users under healthcare professional prescription.

The subject device is technologically identical to the predicate device (K162553) in design, materials, and physical characteristics. The only difference is more detailed and clarified labeling in the Indications for Use statement, which now specifies the patient population (pediatric 3 years and older to adult) and operating environments (hospital, sub-acute, long-term care, and home for certain models).

Not stated in this summary.

Substantial equivalence is established because: (1) the device is identical to the predicate in all technological characteristics, materials, and intended use as a nasal cannula patient interface; (2) no new performance or biocompatibility testing was needed since the design is identical; (3) the only modification is labeling clarification that reflects current state-of-the-art requirements without changing the device's actual function or safety profile; and (4) compatibility with specified respiratory gas humidifiers remains unchanged.