Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U410-91)

The Unimed Reusable Finger Clip SpO2 Sensors (models U403-91 and U410-91) are non-invasive pulse oximetry sensors that continuously monitor functional oxygen saturation (SpO2) and pulse rate in adult patients weighing over 30 kg. These prescription-use sensors attach to a patient's finger and work with Philips Intellivue MP30 monitors.

Both subject and predicate devices use two-wavelength relative optical absorption with identical sensor architecture (Philips D8 connector, cable, LED/photodetector, finger clip). The subject device uses LEDs at 663/890 nm versus predicate at ~660/~890 nm. Both achieve ±3% saturation accuracy (70–100%) and ±3 bpm pulse rate accuracy (30–250 bpm). Subject device biocompatible materials (ABS, silicone, TPU) meet ISO 10993 standards.

IEC 60601-1 and IEC 60601-1-2 (electrical safety and electromagnetic compatibility); ISO 80601-2-61 (pulse oximeter performance); ISO 10993-5, 10993-10, and 10993-23 (biocompatibility: cytotoxicity, skin irritation, and sensitization). Clinical validation per ISO 80601-2-61 and FDA pulse oximeter guidance using hypoxia testing in 12 subjects including three with dark skin pigmentation (Fitzpatrick Type 5–6), collecting over 200 data points.

The devices are substantially equivalent because they share identical intended use (SpO2 and pulse rate monitoring in adult patients), identical principle of operation (two-wavelength optical absorption), identical structural composition, and overlapping performance specifications. The minor wavelength variance (663 nm vs. ~660 nm) and slightly tighter pulse rate accuracy specification on the subject device do not affect safety or effectiveness. Clinical data demonstrate comparable accuracy across a representative population including diverse skin pigmentation, meeting the same ISO standards as the predicate.