(39 days)
Intermittent temperature measurement of the neonatal, pediatric and adult population through the patient's auditory canal using a battery operated infrared sensor.
OMRON Tympanic Thermometer, Model MC-514N
The provided text is a 510(k) clearance letter from the FDA for the OMRON Tympanic Thermometer, Model MC-514N. It states that the device is substantially equivalent to legally marketed predicate devices. However, the letter and the accompanying "Indications for Use Statement" do not contain any information regarding specific acceptance criteria, study details, performance data, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot provide the requested table and detailed information based on the provided text. The document is solely an FDA clearance letter and not a technical study report.
§ 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.