(294 days)
Infrared Thermometer is intended to detect body temperature from forehead in the population including infant (above 6 months), child, adolescent, and adult.
The proposed device, Infrared Thermometers, which includes model FR800 and FR850 are hand-held, reusable, battery powered device, which are intended to detect body temperature from forehead for infant (above 6 months), child, adolescent, and adult.
The proposed device is intended for non-contacting infrared temperature measurement. The distance of the measurement is 3cm~5cm.
The proposed device uses a temperature sensor, which can detect the object temperature [human body temperature], environment temperature and temperature of sensor itself; these temperatures are then transfer to electronic signal and amplified; and then it is transferred to digital signal by AD module in MCU of the proposed device. MCU will calculate the body temperature, and then transfer to screen for display.
The Infrared Thermometer, Models FR800 and FR850, underwent non-clinical and clinical testing to demonstrate its substantial equivalence to the predicate device, Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1 (K161728).
1. Acceptance Criteria and Reported Device Performance:
| Criteria | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accuracy | Proposed device accuracy: | Demonstrated compliance with ISO 80601-2-56 and ASTM E 1965-98 (R 2016). Specific accuracy data not provided in this summary, but the conclusion states "the clinical accuracy of the proposed device is not inferior to that of predicate device." |
| - | ±0.2°C at 35.0°C-42.0°C | |
| - | ±0.4°F at 95°F-107.6°F | |
| - | ±0.3°C at other temperatures | |
| - | ±0.5°F at other temperatures | |
| Measurement Range | Proposed device range: 32.0°C-42.9°C | Bench testing confirmed the proposed device can accurately measure within this wider range. |
| Electrical Safety | Compliance with IEC 60601-1 | Complied with AAMI / ANSI ES60601-1:2005/(R) 2012 and A1:2012, c1:2009/(R)2012 and A2:2010/(R)2012. |
| EMC | Compliance with IEC 60601-1-2 | Complied with IEC 60601-1-2:2014. |
| Performance Standard | Compliance with ISO 80601-2-56 and ASTM E 1965-98 (R 2016) | Complied with ISO 80601-2-56 First Edition 2009-10-01 and ASTM E 1965-98 (R 2016). |
| Biocompatibility | Compliance with ISO 10993-5 (in vitro cytotoxicity) and ISO 10993-10 (irritation and skin sensitization) | Complied with ISO 10993-5:2009 and ISO10993-10:2010. |
| Software V&V | Compliance with FDA guidance for software in medical devices. | Software verification and validation data was completed as recommended in the FDA guidance document. |
| Clinical Accuracy | Not inferior to predicate device (Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1). Clinical bias, clinical uncertainty, and clinical repeatability evaluated per clinical validation for infrared thermometer. | The clinical trial results verify that the clinical accuracy of the proposed device is not inferior to that of predicate device. Specific numerical results for clinical bias, uncertainty, or repeatability were not provided in this summary. |
| Intended Use | Detect body temperature from forehead in population including infant (above 6 months), child, adolescent, and adult. | Successfully demonstrated suitability for its stated intended use. Acknowledged that the subject device's user population (above 6 months) is a subset of the predicate's (all ages), concluding this difference does not raise new safety or effectiveness questions. |
2. Sample Size for Test Set and Data Provenance:
- Sample Size: Not explicitly stated in the provided text for the clinical study. It mentions "Controlled human clinical studies were conducted," but not the number of subjects.
- Data Provenance: Not explicitly stated (e.g., country of origin). The testing was conducted in accordance with ASTM E 1965-98(2003) which is an American standard, implying the study might adhere to practices commonly found in regions where this standard is adopted, but specific origin is not mentioned. The sponsor and correspondent are based in China, suggesting the possibility of data collection there or involvement of Chinese entities in the study.
3. Number of Experts and Qualifications:
- This information is not provided in the given document. The document refers to non-clinical and clinical testing, but does not detail the specific involvement or qualifications of experts for establishing ground truth within the clinical trial context.
4. Adjudication Method for the Test Set:
- This information is not provided in the given document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. The clinical testing focused on the standalone performance of the device ("clinical accuracy of the proposed device is not inferior to that of predicate device") rather than its effect on human reader performance.
6. Standalone Performance Study:
- Yes, a standalone (algorithm only without human-in-the-loop performance) study was done. The non-clinical tests (Electrical Safety, EMC, Performance standards, Biocompatibility, Software V&V) and the clinical accuracy evaluation directly assess the device's inherent performance. The clinical study evaluated the device's standalone ability to measure body temperature accurately, comparing it to the performance requirements in standards and to the predicate device.
7. Type of Ground Truth Used:
- For the clinical study, the ground truth was based on clinical validation for infrared thermometer following ASTM E 1965-98(2003). This standard typically involves comparing the device's readings against a highly accurate reference thermometer (e.g., a mercury-in-glass or electronic contact thermometer in a controlled environment), often with a core body temperature measurement as the gold standard. The document states "clinical bias, clinical uncertainty and clinical repeatability have been evaluated per clinical validation."
8. Sample Size for the Training Set:
- This information is not applicable as this device (Infrared Thermometer) is a hardware medical device that directly measures a physical parameter. It does not use algorithms that require a "training set" in the context of machine learning. The "software verification and validation" mentioned refers to traditional software engineering processes, not machine learning model training.
9. How Ground Truth for Training Set Was Established:
- This information is not applicable for the same reason as 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.