(227 days)
The device model MT-101 is intended to measure the human body temperature in regular mode orally, rectally or under the arm(axillary). The device is reusable for clinical or home use on people of all ages.
Digital Thermometer Model MT-101
This request cannot be fulfilled by the provided document. The document is an FDA 510(k) clearance letter for a digital thermometer. It confirms that the device is substantially equivalent to a predicate device and can be marketed, but it does not contain any details about acceptance criteria, specific studies, performance data, sample sizes, expert qualifications, or ground truth methodologies.
The document primarily focuses on regulatory approval based on substantial equivalence, not on a detailed report of clinical study results or technical performance evaluations against specific criteria.
§ 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.