(329 days)
Digital thermometers (Model: TP-100, TP-300, TP-300, TP-500, BT-A31A-BT) is intended for the measurement and monitoring of oral or axillary for adult , pediatric and infant temperature via thermistor by doctor or consumers in the hospital or home. The result of measurement and monitoring will be transmitted via Bluetooth enabled smart mobile device (cell phone, iPad) with GuardiAngel App installed.
The Digital Thermometer is a general purpose thermometer is intended for oral or axillary temperature measurements of the human body. The thermometer should be used with a smart phone or other Bluetooth smart device on which the GuadiAngel app is installed. The thermometer communicates with the user's device through a Bluetooth connection.
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets those criteria:
Device: Digital Thermometer (Models: TP-100, TP-300, TP-400, TP-500, BT-A31A-BT)
Manufacturer: Fudakang Industrial Co., Ltd.
K Number: K172121
Based on the provided text, the device is a Digital Thermometer intended for measuring and monitoring oral or axillary temperature in adults, pediatric patients, and infants. It transmits measurements via Bluetooth to a smartphone or iPad with the GuardiAngel App installed.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily derived from the performance specifications and the standards the device claims to meet. The reported device performance is directly stated or implied by the assertion of compliance with these standards and the comparison to predicate devices.
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Intended Use: Measurement and monitoring of oral or axillary temperature for adult, pediatric and infant via thermistor by doctor or consumers in the hospital or home. Transmission of results via Bluetooth (BLE) to a Bluetooth-enabled smart mobile device (cell phone, iPad) with GuardiAngel App installed. | The "Digital Thermometer (Model: TP-100, TP-300, TP-200, TP-500, TP-400, BT-A31A-BT) has similar indications for use and technological characteristics as the predicate device" (K152739), which includes measuring human body temperature orally and/or under arm for adult, pediatric and infant. Measures are transmitted via Bluetooth to a smart mobile device with GuardiAngel App. This indicates the device meets its stated intended use. |
| Measuring Range: 32.0-42.9℃ (89.6-109.2°F) | Device performance matches this range: 32.0-42.9℃ (89.6-109.2°F) |
| Accuracy: | |
| • ±0.1℃ for 35.0-39.0℃ (±0.2°F for 95.0-102.2°F) | |
| • ±0.2℃ for the rest of the range | Device performance matches this accuracy: |
| • ±0.1℃ for 35.0-39.0℃ (±0.2°F for 95.0-102.2°F) | |
| • ±0.2℃ for the rest of the range | |
| Wireless Connectivity: Connects to iOS and Android devices via Bluetooth. | The targeted device connects to iOS device and Android device through wireless method. "Risk analysis and associated verification (include cybersecurity test, FCC test and wireless verification) have been performed that the wireless feature is acceptable." This implies the device meets the functional requirements for wireless connectivity to both platforms. Specific standards for wireless communication (CFR 47 FCC PART 15 Subpart C section 15.247, ETSI EN301 489-1, ETSI EN 301 489-17, ETSI EN 300 328) were met. |
| Biocompatibility: Skin-contacting components (Housing, probe, tapes, holders, silicone patches) must be biocompatible. | "The biocompatibility test reports for the different materials have been provided to determine the biocompatibility of the subject device." Tested according to ISO 10993-5 (In Vitro Cytotoxicity) and ISO 10993-10 (Irritation and Skin Sensitization). The implication is that the device meets the biocompatibility requirements. |
| Electrical Safety: Compliance with general requirements for basic safety and essential performance. | Complies with IEC 60601-1 (Medical electrical equipment –Part 1: General requirements for basic safety and essential performance) and IEC 60601-1-11 (Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment). |
| Electromagnetic Compatibility (EMC): Compliance with EMC standards. | Complies with IEC 60601-1-2 (Collateral standard: electromagnetic compatibility). |
| Clinical Thermometer Specific Performance: Compliance with particular requirements for basic safety and essential performance of clinical thermometers. | Complies with 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). |
| Software Verification and Validation: Software requirements met; hazards mitigated. | "Software documentation consistent with moderate level of concern is submitted in this 510(k). System validation testing presented in this 510(k) demonstrates that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels." |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states "Clinical study: Not applicable." This indicates that no clinical study involving human subjects or a test set of data with specific sample sizes was conducted or reported for this 510(k) submission. The device's performance was evaluated through non-clinical studies and testing against established standards, as well as a comparison to predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given that no clinical study was performed, there was no test set with ground truth established by experts in the context of diagnostic accuracy. The "ground truth" for the non-clinical tests would be the established specifications and limits defined by the relevant international standards (e.g., ISO 80601-2-56 for accuracy) and internal design specifications. The experts involved would be the engineers and quality assurance personnel responsible for conducting these tests and verifying compliance. Their qualifications are not specified in this document.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication was used.
5. 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-powered diagnostic imaging system requiring human readers or interpretation of complex cases. Therefore, an MRMC study is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to the performance of the device itself (the algorithm) independent of human intervention. The non-clinical studies described, such as verification of accuracy, electrical safety, EMC, and compliance with ISO 80601-2-56 for clinical thermometers, are essentially standalone performance evaluations of the device and its internal software (algorithm). The device measures temperature and transmits it; the "algorithm" here is the embedded software that processes the thermistor data into a temperature reading. The document indicates that "all software requirement specifications are met and all software hazards have been mitigated."
7. The Type of Ground Truth Used
The ground truth used for the device's technical performance and safety was primarily based on:
- Established Standards: International and national standards (e.g., IEC 60601-1, ISO 80601-2-56, FCC regulations) that define acceptable performance limits, safety requirements, and electromagnetic compatibility.
- Design Specifications: Internal specifications set by the manufacturer for parameters like measuring range and accuracy.
- Predicate Device Performance: The performance of legally marketed predicate devices (K160308 and K152739) served as a benchmark for substantial equivalence, implying that the proposed device should perform at least as well in relevant aspects.
- Biocompatibility Testing: Chemical and biological assays (ISO 10993-5, ISO 10993-10) directly testing the device's materials for adverse reactions.
8. The Sample Size for the Training Set
Not applicable. As this device is a "Digital Thermometer" and not an AI/ML-driven diagnostic tool that learns from data, there is no "training set" in the conventional machine learning sense. The device's performance is based on its hardware design, thermistor technology, and pre-programmed software.
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.