(59 days)
The disposable PACK & PROPER Ear-Thermometer Prove Cap is used to protect probe of ear thermometer and prevent cross-infection.
Pack & Proper, Ear-Thermometer Probe Cap
The provided text is a 510(k) clearance letter from the FDA for the Pack & Proper Ear-Thermometer Probe Cap. This document is a regulatory approval and does not contain the acceptance criteria and study details requested in your prompt.
The 510(k) process is used to demonstrate that a device is substantially equivalent to a legally marketed predicate device, meaning it has the same intended use and the same technological characteristics, or if different technological characteristics, that the device is as safe and effective as a legally marketed device and does not raise different questions of safety and effectiveness.
While the FDA's decision is based on a review of submitted information, the specific details of performance testing, acceptance criteria, sample sizes, ground truth establishment, or human reader studies are not typically included in the public 510(k) summary or the clearance letter itself. These details would have been part of the manufacturer's submission to the FDA.
Therefore, I cannot provide the requested information based on the input 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.