(89 days)
The Flexible Tip Digital Thermometer is a non-sterile, reusable clinical thermometer intended for the determination of oral, rectal, and axillary body temperature determination of humans.
The Flexible Tip Digital Thermometer is a clinical thermometer intended for the determination of oral, rectal and axillary body temperature determination in humans. In terms of physical requirements and operating parameters, the thermometer conforms to ASTM E1112, "Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature".
The provided text describes a 510(k) submission for a Flexible Tip Digital Thermometer, which is a Class II medical device. However, the document provided does not contain the detailed study information regarding acceptance criteria and performance results that you requested.
The document primarily focuses on:
- The identification of the device and its manufacturer.
- Its classification and intended use.
- A notice of substantial equivalence to a predicate device (PolyMedica Corporation's Flexible Tip Digital Thermometer).
- The FDA's decision to clear the device for marketing.
- A statement that the device conforms to ASTM E1112, "Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature."
Therefore, I cannot provide the requested table and detailed study information as it is not present in the provided text.
To answer your questions, I would need a document that includes:
- Specific acceptance criteria (e.g., accuracy ranges for different measurement sites).
- Results from performance studies (e.g., clinical trials comparing the device to a reference thermometer).
- Details about the study design, sample sizes, ground truth establishment, expert qualifications, etc.
ASTM E1112, which the device conforms to, would contain the technical performance requirements (acceptance criteria) for such a device, and the submission would typically include data demonstrating compliance with that standard. However, the actual performance data and study details are not in this 510(k) summary document.
§ 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.