Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29)

The Unimed Reusable SpO2 Sensors (models U410-48 and U410-29) are finger-clip pulse oximeter sensors for continuous, non-invasive monitoring of blood oxygen saturation (SpO2) and pulse rate in adult patients weighing over 30 kg in professional healthcare settings. The sensors use two-wavelength (660nm and 905nm) LED light absorption to measure oxygen saturation and are intended for prescription use only under no-motion conditions.

The subject devices operate via two-wavelength relative optical absorption, identical to the predicate. Key differences include connector pin configuration (6-pin for U410-29, 7-pin for U410-48), TPU cable jacket instead of PVC, and ISO10993-compliant patient-contacting materials instead of ABS/Silicone. Performance specifications for saturation accuracy (±3% at 70-100%), pulse rate accuracy (±3 bpm at 30-250 bpm), operating temperature (5-40°C), and humidity (10-85%) are identical to the predicate.

Non-clinical testing conformed to IEC 60601-1 (medical electrical equipment safety), IEC 60601-1-2 (electromagnetic disturbances), ISO 80601-2-61 (pulse oximeter equipment), and ISO 10993 parts 5, 10, and 23 (biocompatibility testing for cytotoxicity, skin sensitization, and irritation). Clinical testing followed ISO 80601-2-61 and FDA guidance for pulse oximeter premarket notifications, including hypoxia studies in 12 adult volunteers with diverse skin pigmentation.

The subject devices are substantially equivalent to predicate K142832 because they operate on identical principles, achieve identical performance specifications, are designed for the same finger application site, and have substantially equivalent sensor structure and materials. Although the intended patient population is narrower (adults >30 kg versus adults/pediatric/neonatal in predicate), biocompatibility and clinical accuracy testing confirm safety and effectiveness. Design differences in connectors and cable materials were validated through bench testing and clinical data.