Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)

The Reusable SpO2 Sensor is a finger clip pulse oximeter sensor that continuously and non-invasively monitors functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) in adult patients weighing more than 40 kg. It consists of a connector, cable, and sensor housing with two specific-wavelength LEDs and a photodetector, designed for use in hospital settings with compatible monitors (Nellcor N-595, Nihon Kohden OPV1500, or Datex Ohmeda).

The subject device uses 2-wavelength relative optical absorption with LEDs at either 660±10nm/905±10nm (BSA307-47) or 663±3nm/940±10nm (BSA109-50, BSA109-31O), with SpO2 accuracy of ±3% (70–100%) and pulse rate accuracy of ±3 bpm (30–250 bpm). Minor differences include cable length (2.9m or 1m vs. 1.1m), material composition (TPU instead of PVC for cable), and compatible monitor models, but measurement principles and accuracy specifications remain equivalent.

IEC 60601-1:2005+A1:2012+A2:2021, IEC 60601-1-2:2014+A1:2021, ISO 80601-2-61:2017, IEC 62471:2006, ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (skin sensitization), ISO 10993-23:2021 (irritation), and IEC TR 60601-4-2:2016 for electromagnetic immunity.

The subject device is substantially equivalent to predicate K153184 because both use identical 2-wavelength relative optical absorption methodology with the same SpO2 and pulse rate accuracy specifications (±3% for SpO2, ±3 bpm for PR). Although the subject device has different compatible monitors, cable materials, and cable lengths, safety and clinical testing confirmed it meets IEC 60601-1 and ISO 60601-2-61 standards with no safety or effectiveness concerns, and biocompatibility testing (ISO 10993-5/10/23) confirmed material safety.