(177 days)
Infrared Thermometer is intended for the intermittent measurement of body temperature from the forehead on people of all ages. It can be used by consumers in the household environment and by health care providers.
Infrared Thermometer is mainly composed of infrared probe components, main circuit board components, LCD display components and housing components. The Infrared Thermometer is intended for the intermittent measurement of body temperature from the forehead on people of all ages. Infants and children cannot operate the thermometer; it is recommended that adults take the measurement. The Infrared Thermometer can be used by consumers in the household environment and by healthcare providers. The operator should be an adult with relevant experience. The operator can replace the battery, transmit data, and measure temperature.
Here's an analysis of the acceptance criteria and study details for the Infrared Thermometer Model YJ600, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Infrared Thermometer Model YJ600 are primarily defined by the standards ISO 80601-2-56 and ASTM E1965-98. The 510(k) summary directly states that the device "meets the requirement of the standard" for these and other tests. The most critical performance criterion for a thermometer is its accuracy.
| Acceptance Criteria (from ISO 80601-2-56 and ASTM E1965-98) | Reported Device Performance (Model YJ600) |
|---|---|
| Maximum allowable error in temperature measurement | $\pm 0.3°C$ within the temperature display range of $22.0°C$ to $42.0°C$ (Pass) |
| Clinical repeatability for each age group | In the range of plus or minus 0.3°C (meets the clinical repeatability requirement ±0.3°C) |
| Resolution of the indication unit | $0.1°C$ ($0.1°F$) (Pass) |
| Temperature display range | $22.0°C~42.9°C$ (Pass) |
| Appearance and structure | Correct shape, smooth/clean surface, no scratches, sharp edges, burrs, or deformation (Pass) |
| Text and symbols clarity | Clear, accurate, and firm (Pass) |
| Control devices flexibility and reliability | Flexible and reliable, fasteners not loose (Pass) |
| Thermometer probe smoothness | Smooth with no burrs on edges (Pass) |
| Function key marking | Clearly marked and indicated (Pass) |
| Anti-drop test (1m to hard surface, 3 postures) | Requirements met (Pass) |
| Display reading value height | >4mm (Pass) |
| Prompt function for out-of-range temperatures | "LO" below 22.0°C, "HI" above 42.9°C with "Di di" sound twice (Pass) |
| Low voltage prompt | Icon flashes when battery |
§ 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.