(35 days)
The ThermoTek Q5 is intended for taking body temperature orally, rectally or under the arm.
The device is an electronic contact thermometer. It consists of a commercial thermistor in a stainless steel cap, a tip and rigid plastic housing that contains a PCBA, a LCD and two flexible buttons (On and Mode). The device is operated on a single 3V Lithium battery. Thanks to its small size, the thermistor reaches a thermal equilibrium with the measured subject in about 5 seconds in a bath and in oral and rectal modes, and in about 20 sec in axial mode.
This document is a 510(k) summary for the ThermoTek™ Q5 oral thermometer. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document states that "The ThermoTek Q5 was tested in a series of safety and performance tests, showing its compliance with the relevant standards, without raising any safety and/or effectiveness issues." However, no details about these tests, the specific acceptance criteria, or the results are provided.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study to prove they are met from the provided text.
§ 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.