(420 days)
The Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701) is an electronic thermometer using an infrared sensor to detect human body temperature from forehead on people of one month old and above. The device is reusable for home and clinical use.
The Infrared thermometers are hand-held, battery powered devices designed to measure human body temperature from the central forehead. Its operation is based on measuring the natural thermal radiation from central forehead.
The thermometers use a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, a parabolic mirror to help focus the infrared energy emitted from the forehead, and an infrared distance sensor for detection of no-contact use and compensation of the temperature reading.
The device mainly consists of infrared sensor, microprocessor, embedded software (Identified Software version is No: V1), memory, electro-acoustic components, LED display and the device is powered by 2AAA alkaline batteries.
The non-contact infrared thermometer included WL-301, WL-501, WL-601, WL-701. They can be selected calibration mode, body temperature mode and surface mode.
Here's a breakdown of the acceptance criteria and study information for the Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701), based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Predicate) | Reported Device Performance (Subject Device) | Notes/Differences |
|---|---|---|
| Measurement Range: 34°C ~ 43°C | Measurement Range: 34°C ~ 42°C | Different, but stated to meet ISO 80601-2-56:2017/Amd.1:2018 |
| Accuracy: | Accuracy: | |
| ±0.2°C: 35.0°C ~ 42.0°C | ±0.3°C: 34°C~42°C | Different, but stated to meet ISO80601-2-56 and demonstrated through clinical trial |
| ±0.3°C: 34.0°C ~ 34.9°C, 42.1°C ~ 43°C | ||
| Response time: 1S | Response time: |
§ 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.