Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)

The sterile temperature probe is a single-use sensor that connects to the Mindray BeneVision N17 patient monitor to measure body or skin surface temperature in hospital settings. It is offered in three configurations: body cavity probe (esophageal, rectal, nasopharyngeal), skin contact probe, and ear cavity probe. The device is intended for use by qualified healthcare personnel to monitor temperature in adult and pediatric patients.

The device uses an NTC thermistor (2.252 KΩ@25°C) to sense temperature changes, with a rated output range of 25–45°C and accuracy of ±0.1°C. It comprises a plug, cable, and probe with wire set and thermistor enclosed in a tube or with adhesive cover (skin probe) or foam earplug (ear probe). The device is sterilized with ethylene oxide, packed individually in a sterile paper-plastic pouch, and is disposable. Operating conditions are 5–40°C, 0–95% RH, 86–106 kPa.

IEC 60601-1 (basic safety and essential performance), IEC 60601-1-2 (electromagnetic disturbances), ISO 80601-2-56 (clinical thermometers for body temperature measurement), ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin sensitization), ISO 10993-23 (irritation), ISO 11135 (sterilization validation), and ASTM D4169-22 (shipping container performance testing).

The subject device is substantially equivalent to the predicate (DeRoyal Temperature Monitoring Probe, K200631) because both operate on the same thermistor-based principle, measure temperature in the same range (25–45°C), are disposable single-use devices, comply with the same safety and performance standards (IEC 60601-1, ISO 80601-2-56), and have comparable design and construction. Differences in patient population coverage, material composition, accuracy (±0.1°C vs ±0.2°C), and sterilization status (ear cavity sterile vs predicate tympanic non-sterile) do not raise new safety or effectiveness questions because validation testing confirms compliance with applicable standards and biocompatibility requirements.