(86 days)
The Ear Thermometer, models WL-320X are the battery-operated electronic devices with intended use of measuring body temperature from the auditory canal of a patient by means of an infrared sensor coupled with electronic signal amplification, conditioning and a digital LCD(display) unit. The device is a reusable and intended for home use on people at all ages.
battery-operated electronic devices with intended use of measuring body temperature from the auditory canal of a patient by means of an infrared sensor coupled with electronic signal amplification, conditioning and a digital LCD(display) unit. The device is a reusable and intended for home use on people at all ages.
The provided document is a 510(k) premarket notification letter from the FDA for an ear thermometer. It acknowledges substantial equivalence to a predicate device but does not contain any information regarding specific acceptance criteria, performance metrics, or study details such as sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document confirms that the device "is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices". This implies that the device's performance is deemed comparable to existing, legally marketed devices, but the technical details of how that equivalence was demonstrated (i.e., specific studies, metrics, and thresholds) are not present in this 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.