Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)

This device is a set of temperature probes (reusable models T1306, T2306, T3306, T4306 and disposable models T5106, T6106) used to monitor patient body temperature in healthcare settings. The probes connect to patient monitors, including Mindray Model PM-8000 and other monitors compatible with YSI 400 series temperature probes, and are designed for use by qualified medical professionals only.

The subject devices use thermistor-based temperature sensing with a measurement range of 25–45°C and accuracy of ±0.1°C, identical to the predicate. Key differences include: the subject device offers both reusable and disposable models (predicate was reusable only); compatible monitors are limited primarily to Mindray PM-8000 versus the predicate's broader list; and materials differ (reusable: PVC, copper nickel plated, epoxy AB glue; disposable: PVC, foam, aluminum foil). The thermistor resistance is 2.25 kΩ @ 25°C versus the predicate's 2.252 kΩ.

IEC 60601-1:2005 (medical electrical equipment general safety), IEC 60601-1-2:2014 (electromagnetic compatibility), ISO 80601-2-56:2017+A1:2018 (clinical thermometer performance), IEC 60601-1 (electrical safety), ISO 10993-1 (biocompatibility framework), ISO 10993-5 and ISO 10993-10 (cytotoxicity and sensitization testing), and ISO 10993-23 (irritation testing).

The subject device is substantially equivalent because it performs the same temperature monitoring function using an identical thermistor-based operating principle with the same measurement range and accuracy as the predicate. Although the subject device adds disposable models and specifies different compatible monitors, these differences do not raise new safety or effectiveness concerns because reusable models are considered higher-risk and adequately cover both categories, and all monitors comply with YSI 400 series compatibility standards verified by bench testing. Biocompatibility testing confirms patient-contacting materials are safe, and compliance with the most recent FDA-recognized standards (ISO 80601-2-56) exceeds predicate requirements.