(23 days)
The Pro Check™ Digital Pacifier Thermometer, is a non-sterile, re-usable clinical thermometer intended for the determination of oral body temperature in infants to children five years of age.
The Pro Check™ Digital Pacifier Thermometer, is a battery-powered, liquid crystal display device using a thermometer embedded in the nipple. The patient contact portion is composed of medical silicone rubber. The body is of ABS plastic. This device is reusable and no components are disposable. This device is not intended for use with other sheaths or devices.
The Pro Check™ Digital Pacifier Thermometer relies on previously performed clinical testing for predicate devices (Pasi-Temp Pacifier Digital Thermometer and Basis® Temp Pacifier Digital Thermometer) to demonstrate substantial equivalence. Therefore, the information provided focuses on the predicate devices' performance.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (from predicate devices) |
|---|---|
| Conformance to ASTM® #1112 "Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature" physical requirements and operating parameters. | The Pro Check™ Digital Pacifier Thermometer conforms to ASTM® #1112, based on the predicate devices. |
| Compliance with EPA requirements for nitrosamines. | The Pro Check™ Digital Pacifier Thermometer meets EPA requirements for nitrosamines, based on the predicate devices. |
| Compliance with CPSC 1511 requirements for Baby Pacifiers (choking hazards). | The Pro Check™ Digital Pacifier Thermometer meets CPSC 1511 requirements, based on the predicate devices. |
Study Details (Inferred from Predicate Device Information)
Since the Pro Check™ Digital Pacifier Thermometer directly references clinical testing from its predicate devices, the specifics below apply to those predicate devices and are attributed to the Pro Check™ by reference.
- Sample size used for the test set and the data provenance: Not explicitly stated in the provided document. The document only mentions "Clinical testing previously performed."
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not explicitly stated.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a digital thermometer, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a standalone thermometer, meaning its performance is measured directly, not as an algorithm assisting human interpretation. The clinical testing likely evaluated its accuracy in measuring temperature.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated, but for a thermometer, the ground truth would typically be a highly accurate reference thermometer (e.g., a calibrated laboratory thermometer) against which the device's temperature readings are compared.
- The sample size for the training set: Not applicable, as this is a traditional medical device not employing machine learning that requires a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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.