Masimo O3 Regional Oximeter

The Masimo O3 Regional Oximeter is a noninvasive device that continuously measures regional hemoglobin oxygen saturation (rSO2) in tissue beneath applied sensors. It provides absolute and trending measurements for adults, pediatrics, and neonates across cerebral and non-cerebral sites, plus hemoglobin-related parameters (ΔO2Hb, ΔHHb, ΔcHb) for monitoring relative hemoglobin changes.

The device uses multi-distance diffusion spectroscopy to analyze light at different wavelengths and path lengths through tissue, detecting oxygenated and deoxygenated hemoglobin states. No hardware or software changes were made from the predicate device K214072; the only difference is expanded indications for delta features to include pediatric and neonatal populations on both cerebral and non-cerebral sites.

IEC 60601-1 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility), and accuracy specifications measured in ARMS (average root mean square) for rSO2 trending (3%) and absolute measurements (4-5% depending on population and site).

The subject device has identical intended use, principle of operation, mechanism of action, and components as the predicate K214072. Since no hardware or software changes were made, all prior bench testing, biocompatibility, electrical safety, and usability testing remain valid. The only substantive change is expanded indications for delta features across pediatric and neonatal populations and non-cerebral sites; this is supported by two clinical studies (25 and 29 subjects respectively) demonstrating equivalent performance and strong correlation for the delta features in these new populations.