(19 days)
The Philips Baby Thermometer Set is intended for determination of a baby's oral, rectal, or axillary temperature. The set contains three items: A pacifier thermometer to detect baby's oral temperature. An ordinary pacifier can be used as a daily use pacifier to help accustom the baby to the shape of the pacifier-thermometer. A digital flexible-tip thermometer to detect baby's rectal or underarm (axillary) temperature.
The Philips Baby Thermometer set allows parents to accurately and conveniently measure the baby's temperature. The baby thermometer set is designed for he baby's safety, comfort, well-being and, therefore, parents own peace of mind. The set contains three items: A soother thermometer to reliably measure baby's temperature. It is very convenient to use both for parents and baby. A digital flexible-tip thermometer that measures baby's body temperature rectally if parents want added reassurance.
The Philips Baby Thermometer Set (model SBC SC530) is the subject of this 510(k) summary. The acceptance criteria and the study proving the device meets these criteria are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical Requirements (ASTM1112, "Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature") | Conforms to ASTM1112 |
| Operating Parameters (ASTM1112, "Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature") | Conforms to ASTM1112 |
| EPA Requirements for Nitro-amines | Meets EPA requirements |
| Consumer Product Safety Commission (CPSC 1511) Requirements for Baby Pacifiers (choking hazards) | Meets CPSC 1511 requirements |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Clinical testing previously performed for the Paci-Temp and Pro-Flex also applies to the Philips Baby Thermometer Set." This indicates that no new clinical test set data was generated specifically for the Philips Baby Thermometer Set. Instead, the performance of the Philips device is asserted to be equivalent to the predicate devices based on non-clinical tests and the applicability of existing clinical data. Therefore, details regarding a specific sample size, country of origin, or retrospective/prospective nature of a new test set are not provided for this specific submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not provided in the document. As noted above, the submission relies on previous clinical testing for predicate devices and non-clinical testing for the current device.
4. Adjudication Method for the Test Set
This information is not provided in the document, as no specific clinical test set was generated for this device submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The device is a thermometer, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical thermometer.
7. The Type of Ground Truth Used
For the non-clinical tests, the ground truth was established by adherence to recognized industry standards (ASTM1112) and regulatory requirements (EPA, CPSC 1511) which specify performance benchmarks for physical characteristics and operating parameters. For the clinical aspects, the ground truth was based on the performance demonstrated by the predicate devices based on their own prior clinical testing.
8. The Sample Size for the Training Set
This information is not provided because, as mentioned, the clinical performance relies on previously established data from predicate devices, and the submission focuses on demonstrating substantial equivalence through non-clinical testing. New clinical data for a "training set" for an algorithm is not relevant to this device submission.
9. How the Ground Truth for the Training Set was Established
This information is not provided. The term "training set" typically refers to data used to train machine learning algorithms, which is not applicable to the Philips Baby Thermometer Set. For the non-clinical tests, the ground truth was established by the specifications defined in the relevant standards and regulations (ASTM1112, EPA, CPSC 1511). For the clinical performance, the ground truth was established through the original clinical studies performed on the predicate devices.
§ 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.