Spo2 Sensor CSS032D

The SpO2 Sensor CSS032D is a fingertip pulse oximeter probe that measures arterial hemoglobin oxygen saturation and pulse rate in adult patients weighing over 40 kg within medical institutions. It connects to a compatible pulse oximeter monitor and is indicated for continuous non-invasive monitoring in hospital settings, but is prohibited for emergency transport, home care, long-term monitoring, mobile patients, and low perfusion conditions.

The device uses 2-wavelength relative optical absorption with red light LEDs (660-666 nm) and infrared LEDs (880-950 nm) to measure SpO2 in the 70-100% range with ±3% accuracy and pulse rate in the 30-250 bpm range with ±3 bpm accuracy. Materials include FEP plastic and silicone for the soft-tip design, differing slightly from the predicate's use of ABS, PVC, and TPU, but silicone is common to both.

IEC 60601-1 (medical electrical equipment general requirements), IEC 60601-1-2 (electromagnetic compatibility), IEC 60601-1-12 (emergency medical services), IEC 80601-2-61 (pulse oximeter equipment), and ISO 10993-1 (biocompatibility evaluation). Clinical testing per ISO 80601-2-61 and FDA guidance was conducted on 13 adult volunteers (ages 18-33, varying skin pigmentation including 3 darkly pigmented subjects).

The subject device is substantially equivalent because it has identical intended use, regulatory classification (Class II), product code (DQA), and technological characteristics (wavelengths, measurement ranges, and accuracy) as the predicate SpO2 Sensors from JKH USA. Minor material differences (FEP and silicone vs. other polymers) and connector design do not raise safety or efficacy concerns, as performance data demonstrates equivalent accuracy across diverse populations.