Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)

The Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling is a nasal cannula designed to deliver respiratory gases to adult patients in hospitals. It includes a CO2 sampling tube for qualitative carbon dioxide monitoring at flow rates of 5–50 L/min in operating and procedure rooms, and can be used for pre-oxygenation and short-term supplemental oxygenation (up to 10 minutes) during intubation with anesthesia mask compatibility.

The subject device is identical to the predicate device (K234058) in most technological characteristics including flow range (5–70 L/min), patient population (adults), hospital environment, classification (Class II, 21 CFR 868.5450), and physical components. The key difference is the inclusion of a CO2 sampling tube and CO2 clip, which are identical to those previously cleared in the reference device (K201723).

ISO 10993-1:2018 (Biological evaluation of medical devices), ISO 5356-1:2015 (Anaesthetic and respiratory equipment—Conical connectors), and IEC 62366-1:2015 + A1:2020 (Application of usability engineering to medical devices).

Substantial equivalence is based on identical patient population, intended uses, and technological characteristics to the predicate device (K234058), combined with the fact that the CO2 sampling feature is identical to a previously cleared device (K201723). Performance testing demonstrates the device does not raise new safety or effectiveness questions and is substantially equivalent to the legally marketed predicate.