(158 days)
The Behind Ear Gentle Touch Thermometer (Models V980/BET 1000) is a non-sterile, reusable clinical thermometer intended for the intermittent determination of human body temperature using behind the earlobe as the measurement site on people of all ages.
The over-the-counter Behind Ear Gentle Touch Thermometer - Models V980/ BET 1000 is a hand-held, battery powered device designed to measure human body temperature by detecting heat flow on the skin directly behind the ear lobe as a measurement site, by using the heat conduction principal and prediction. The skin area over the posterior auricular artery passing behind the earlobe is the measurement site, which is very close to the cantharid artery. These arteries carry blood to the brain and therefore the site is the best external place to measure temperature. The Behind Ear Gentle Touch Thermometer is designed to calculate the maximum temperature of a probe in contact with the body site by heat transfer data and mathematical algorithm. The temperature reading range is from 95.0° F to 107.6° F (35°C to 42 °C) and the time of measurement is about 1 second.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by ASTM E1965-03) | Reported Device Performance (KAZ Behind Ear Gentle Touch Thermometer) |
|---|---|
| Bias |
§ 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.