(156 days)
The Infrared Forehead Thermometer is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead for people of all ages. The device is reusable for home use and clinical use.
The subject device Infrared Forehead Thermometer has three models: LFR30B, LFR50 and LFR60. The three modes have same operation principle. A thermopile sensor is employed to detect the infrared energy emitted from the surface of the skin of the forehead which is converted into temperature measurement with the unit of degree C or degree F. The results can be displayed on LCD. The measurement is non-contact with the patient. The measuring distance is 0~5 cm to the forehead and the measuring time is 1s. The Infrared Forehead Thermometer is battery powered.
Here's an analysis of the provided text to extract information about the acceptance criteria and the study that proves the device meets those criteria:
Device: Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60
1. Table of Acceptance Criteria and Reported Device Performance
The provided document refers to compliance with performance standards rather than explicitly listing acceptance criteria with numeric targets for all aspects. However, based on the discussions and the standards invoked, we can infer some key performance criteria.
| Acceptance Criteria Category | Specific Criteria (Target/Standard) | Reported Device Performance |
|---|---|---|
| Measurement Accuracy | ±0.3°C (±0.5°F) within 34.0 | The performance testing shows that the subject device complies with performance standard IEC 80601-2-56 and ASTM E 1965 for measuring accuracy. |
| Measuring Range | 32-43°C/89.6-109.4°F (as per IEC 80601-2-56) | The performance testing shows that the subject device complies with performance standard IEC 80601-2-56. |
| Measurement Distance | Ability to measure accurately within 0-5 cm (as per IEC 80601-2-56 and ASTM E1965) | The performance testing shows that the subject device complies with performance standard IEC 80601-2-56 and ASTM E 1965. |
| Operating Condition | Functionality within 5°C | The performance testing shows that the subject device complies with performance standard IEC 80601-2-56 and ASTM E 1965. |
| Storage/Transport Condition | Functionality within -20°C~+55°C, Relative Humidity |
§ 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.