(64 days)
The devices are intended for use as a barrier that is used as an accessory to oral or rectal for digital thermometers. These sheaths are non-sterile and are intended for single patient use only.
The disposable thermometer sheaths are plastic coverings used for either oral or rectal for digital thermometer. The products and its packaging are non-sterile and latex-free.
The document provided is a 510(k) summary for the GOOD MEDY Disposable Thermometer Sheaths. It does not contain information about acceptance criteria or a study proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information. The document only states:
- The new devices are substantially equivalent to the predicate devices: Sanitherm Oral Disposable Thermometer Sheaths, K983406.
- The intended use of the two devices is the same, and the overall dimensions are similar.
- The two devices also had passed the biocompatibility test by ISO10993, same non-sterile and latex-free.
No specific performance metrics, test results, or study details are provided beyond the biocompatibility test.
§ 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.