(81 days)
The Basal Digital Thermometer is intended to measure the human body temperature for children and adults, especial for woman. It has precise digital display and be used in household environment and doctor in clinics as reference.
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This document is a 510(k) clearance letter for a "Basic Digital Thermometer, Model KD-2160." It formally states that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information regarding specific acceptance criteria, study details, or performance data for the device itself. It is a regulatory approval letter, not a study report. Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.
To answer your request, I would need a document detailing the performance study, such as a summary of safety and effectiveness, or a clinical study report submitted to the FDA during the 510(k) process.
§ 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.