(662 days)
FMT Reusable Temperature Probes are intended to be used for monitoring temperature for multi-patient use. The temperature probes are reusable and designed for use with monitors of Biolight, GE, HP/Philips, Mindray, MTRE, S& W, Siemens/Drager, Tecotherm.
These devices are used by qualified medical professional only.
FMT Reusable Temperature Probes
The provided text is a 510(k) clearance letter from the FDA for "FMT Reusable Temperature Probes." It acknowledges the device's substantial equivalence to legally marketed predicate devices and outlines general regulatory compliance.
However, there is no information within the provided text regarding acceptance criteria, device performance studies, sample sizes, data provenance, expert qualifications, ground truth establishment, or any details about AI/ML algorithm validation.
This document is a regulatory approval, not a technical report detailing the performance evaluation of the device. Therefore, I cannot extract the requested information from the provided input.
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.