(273 days)
FMT Disposable and Autoclavable Temperature Probes are intended to be used with YSI 400, GE, HP/Philips. Mindray, S& W, and Siemens/Drager temperature monitors for body temperature measurements.
FMT Autoclavable Temperature Probes are reusable and autoclavable. FMT Disposable Temperature Probes are provided sterile and single use.
FMT Disposable and Autoclavable Temperature Probes are intended by qualified medical professionals only.
FMT Disposable and Autoclavable Temperature Probes are intended to be used with YSI 400, GE, HP/Philips. Mindray, S& W, and Siemens/Drager temperature monitors for body temperature measurements.
FMT Autoclavable Temperature Probes are reusable and autoclavable. FMT Disposable Temperature Probes are provided sterile and single use.
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (FMT Disposable and Autoclavable Temperature Probes). It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain the following information that you requested:
- A table of acceptance criteria and reported device performance.
- Details about a study proving the device meets acceptance criteria.
- Sample size for the test set or data provenance.
- Number or qualifications of experts for ground truth.
- Adjudication method for the test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect size.
- Information about a standalone (algorithm only) performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document focuses on regulatory clearance based on substantial equivalence, not on the detailed results of performance studies that would include the information you've asked for. Such details would typically be found in a separate performance study report submitted as part of the 510(k) application, but they are not included in this FDA clearance letter.
§ 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.