(247 days)
Nexus IR30 Thermometer is an electronic thermometer using an infrared sensor to detect human body temperature from the surface of human skin without contact. It is for use on people of all ages (infants, children, adolescents, and adults) in the homecare environment.
Nexus IR30 Thermometer 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.
The Nexus IR30 Thermometer is a clinical electronic thermometer using an infrared sensor to detect human body temperature from the surface of human skin without contact. It is intended for use by people of all ages in a homecare environment.
The provided document K122221 does not contain specific acceptance criteria or an explicit study proving the device meets said criteria in the format typically expected for medical device performance studies (e.g., a detailed clinical trial or rigorous bench test with statistical analysis against predefined thresholds). Instead, this 510(k) submission relies on demonstrating substantial equivalence to a predicate device.
Here's an analysis of the information related to performance and substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, the document does not explicitly state specific acceptance criteria such as accuracy ranges (e.g., +/- 0.2°C at certain temperatures) or clinical performance metrics (e.g., sensitivity, specificity for fever detection). Instead, the performance is
demonstrated by asserting substantial equivalence to its predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| System accuracy | Substantially equivalent to predicate device U-RIGHT TD-1240 Thermometer (K113159). |
| Software verification and validation | Confirmed performance, safety, and effectiveness are equivalent to the predicate device. |
| Safety tests | Confirmed performance, safety, and effectiveness are equivalent to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of a clinical study with human subjects. The verification and validation activities mentioned are typically bench tests and engineering analyses rather than clinical trials. Therefore, information on sample size and data provenance (e.g., country of origin, retrospective/prospective) for a clinical test set is not provided in this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This type of information is not relevant or provided in this 510(k) summary, as it does not describe a clinical study where expert consensus would establish ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The device is a thermometer, and MRMC studies are typically for imaging or diagnostic tools where human interpretation of complex cases is involved.
6. Standalone (Algorithm Only) Performance
The device itself is a standalone thermometer; there is no "algorithm only" performance separate from the human interaction of taking a temperature reading. The performance of the device (system accuracy) is assessed as a complete unit. The document states that "A comparison of system accuracy performance demonstrated that Nexus IR30 Thermometer and U-RIGHT TD-1240 Thermometer (cleared under K113159) are substantially equivalent." This implies that quantitative tests were performed on the device to show its accuracy and that the results were comparable to the predicate. However, detailed results of these tests (e.g., mean difference, standard deviation, bias) are not included in this summary.
7. Type of Ground Truth Used
For a thermometer, the "ground truth" for accuracy testing is typically established using reference temperature standards (e.g., blackbody radiators for infrared thermometers) that are calibrated to a known precise temperature. The document states that "Software verification and validation, performance and safety tests confirmed that the performance, safety and effectiveness of the Nexus IR30 Thermometer are equivalent to the predicate device." While not explicitly stated, it is inferred that these tests would involve comparing the device's readings to established metrological standards.
8. Sample Size for the Training Set
This information is not applicable. The Nexus IR30 Thermometer is not an AI/machine learning device that requires a "training set" in the conventional sense. Its function is based on infrared physics and sensor technology, not a learned model from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 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.