AViTA Pulse Oximeter (SP61)

The AViTA Pulse Oximeter (SP61) is a non-invasive, prescription-use medical device that measures oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in adults, adolescents, and children in home and professional healthcare settings. It performs spot-check measurements on fingers between 0.8 cm and 2.3 cm thick under no-motion conditions using red and infrared light spectrophotometry.

The device uses dual-wavelength LEDs at 660 nm (red, 3.2 mW) and 905 nm (infrared, 2.4 mW) to measure SpO2 and pulse rate via spectrophotometry principles. It features a two-color OLED display, 4-directional key input, automatic on/off, visual-only indicators, and a single AAA alkaline battery. Key differences from the predicate include 905 nm infrared (vs. 940 nm), a 4-directional key interface, and visual-only warnings suitable for spot-checking.

ISO 80601-2-61:2017 (pulse oximeter essential performance), IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-1-11 (home healthcare environment), ISO 10993-1/-5/-10/-23 (biocompatibility), and FDA guidance for pulse oximeters. Clinical testing included a controlled desaturation study with 12 healthy volunteers representing diverse skin pigmentation.

The AViTA SP61 is substantially equivalent to the Leadtek predicate (K193350) because both are non-invasive spot-check pulse oximeters for adults and adolescents in home and professional settings with identical finger size ranges, measurement principles, classification, and performance specifications. While the subject device expands the population to include children and uses 905 nm infrared (matching the reference device MD300M), these differences are supported by bench testing, pediatric anthropometric validation, and compliance with ISO 80601-2-61, which establishes the fundamental measurement standard.