(87 days)
TF1265, TF1267 Forehead Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature fro the surface of human skin without contact. It is for use by people of all ages in the homecare environment.
The Forehead Thermometer TF1265, TF1267 is characterized by measuring human body temperature from the surface of human skin. It utilizes infrared technology to measure infrared energy emitted from the skin surface when making a temperature measurement.
This document describes the regulatory submission for the KINGTECH Forehead Thermometer, Models TF1265 and TF1267. It is a 510(k) summary, indicating that the device is seeking clearance based on substantial equivalence to a legally marketed predicate device.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific numerical acceptance criteria for clinical performance (e.g., accuracy against a gold standard) for the subject device. Instead, it relies on a claim of "entire identical specifications" and a direct comparison to a predicate device, K122221, "Nexus IR30 Thermometer, Model: TD-1265."
The performance tests mentioned are safety and electromagnetic compatibility (EMC) standards:
| Acceptance Criteria (Standard) | Reported Device Performance (Compliance) |
|---|---|
| IEC 60601-1 (Medical electrical equipment Part 1. General requirements for safety, 2005) | Compliant |
| EN/IEC 60601-1-2 (Medical electrical equipment, Part 2. Electromagnetic compatibility - Requirements and tests, 2007) | Compliant |
| EN12470 (Specific to clinical thermometers) | Compliant |
| ASTME 1965-98 (Standard Specification for Clinical Thermometers) | Compliant |
| ASTM E1112-00 (Standard Specification for Electronic Thermometers for Intermittent Determination of Patient Temperature) | Compliant |
Note: The document states, "This 510k submission only need change the application name of the predicate K122221 from 'Nexus IR30 Thermometer, TD-1265' to 'KINGTECH Forehead Thermometer, TF1265' there is the entire identical specifications and only need to separate into different 510k." This implies that the KINGTECH device's clinical performance is assumed to be identical to the predicate device's performance, as they share the same specifications. However, the performance metrics of the predicate device are not included in this summary.
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide information on a specific clinical test set for the KINGTECH device, nor does it specify sample size or data provenance. It explicitly states under "Clinical Tests:" followed by a blank entry, suggesting no new clinical testing was conducted for this 510(k) submission. Instead, the submission relies on the "entire identical specifications" to the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable or provided as no specific clinical test set for the KINGTECH device is described. The device's substantial equivalence is based on its identical specifications to the predicate device, not on new clinical data with an independent ground truth.
4. Adjudication Method for the Test Set
This information is not applicable or provided as no specific clinical test set requiring adjudication for the KINGTECH device is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improvement with AI vs. Without AI Assistance
This information is not applicable or provided. The device is an infrared thermometer, not an AI-assisted diagnostic tool requiring MRMC studies for human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable or provided. The device is a thermometer, not an algorithm. Its performance is measured directly, though the document defers to the predicate device's performance characteristics.
7. The Type of Ground Truth Used
This information is not applicable or provided for the subject device. For a thermometer, the "ground truth" for reported temperature accuracy would typically be a highly accurate reference thermometer measurement. However, since no new clinical testing is presented, the ground truth methodology for the predicate device is not detailed here.
8. The Sample Size for the Training Set
This information is not applicable or provided. The device is a hardware product (thermometer) and not a machine learning algorithm that requires a training set in the typical sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or provided. Refer to point 8.
§ 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.