(102 days)
The Infrared Thermometer is intermittent measurement of ear and forehead temperature at home or hospital. It can be used for anybody, such as infants, children and adults.
Infrared thermometer, model:HW-1
This FDA 510(k) clearance letter for the Dongguan SIMZO Electronic Technology Co. Ltd. Infrared Thermometer, Model: HW-1, does not contain the detailed information required to fill out the acceptance criteria and study information as requested.
The document indicates that the device is an Infrared Thermometer for intermittent measurement of ear and forehead temperature at home or in a hospital for all ages. It mentions the regulation number (21 CFR 880.2910) and regulation name (Clinical Electronic Thermometer), and its regulatory class (Class II).
However, the letter does not provide details such as:
- A table of specific acceptance criteria (e.g., accuracy ranges, precision) or reported device performance against these criteria.
- Sample size used for a test set, its provenance, or retrospective/prospective nature.
- The number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
- Whether standalone performance was evaluated.
- The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
- The sample size for the training set or how its ground truth was established.
This document is a formal communication of FDA's substantial equivalence determination, not a summary of the underlying verification and validation studies. Such detailed study information would typically be found in the 510(k) submission itself, which is generally proprietary until redacted and released, or in a separate marketing or technical document from the manufacturer.
§ 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.