AViTA Pulse Oximeter (SP62B)

The AViTA Pulse Oximeter (SP62B) is a fingertip device that non-invasively measures blood oxygen saturation (SpO2) and pulse rate in adults during stationary finger placement in professional care settings. It is battery-powered, displays results on a two-color OLED screen, and is intended for spot-checking rather than continuous monitoring. The device is for prescription use only.

The proposed device uses spectrophotometry with red and infrared light wavelengths to measure oxygen saturation through a fingertip sensor. It is software-driven with Bluetooth 4.2 connectivity (versus Bluetooth 5.0 in predicate), uses one AAA battery (versus predicate's one AAA), has automatic power on/off, visual indicators, and display rotation. The main operational difference is the addition of Bluetooth capability, which is treated as an independent function module that does not affect core oximetry performance.

ISO 80601-2-61 (pulse oximeter equipment), IEC 60601-1 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility), IEC 60601-1-11 (home healthcare), ISO 10993-1 (biocompatibility), ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), and ISO 10993-23 (irritation). Clinical validation per ISO 80601-2-61 demonstrated SpO2 accuracy of 1.89% ARMS in the 70-100% range on healthy adult volunteers.

The proposed device shares identical intended use, patient population (adults), application site (finger), operating principle (spectrophotometry), classification (Class II), and performance specifications (SpO2 range 0-100% with ±2% accuracy, pulse rate 30-250 bpm) with predicate K223399. Both use same wavelength measurement method, biocompatible materials (ABS, PMMA, PET), and achieve equivalent safety/effectiveness per harmonized standards. The Bluetooth 4.2 addition does not affect core oximetry function and is treated as independent firmware operating on the same device platform, thus creating no new safety or effectiveness questions compared to the non-Bluetooth predicate.