(152 days)
The digital thermometer is intended for the measurement and monitoring of human body temperature through or axillary as the measurement site on people of all ages by doctor or user in the hospital or home.
Digital Thermometer, Model T28, T28L
The provided document is an FDA 510(k) clearance letter for a Digital Thermometer, Model T28, T28L. This device is a standard medical instrument for measuring body temperature and does not involve AI or complex algorithms requiring extensive studies as described in the prompt's request.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for AI/ML-driven medical devices, are not applicable to this specific product.
Here's a breakdown based on the characteristics of the device and the provided document:
1. A table of acceptance criteria and the reported device performance
- Not applicable in the context of AI/ML performance. For a digital thermometer, acceptance criteria would typically involve accuracy, precision, response time, and environmental operating limits, as defined by international standards (e.g., ISO 80601-2-56 for clinical thermometers). These technical performance specifications are usually provided in the device's design and testing documentation submitted to the FDA, but they are not detailed in this clearance letter. The letter confirms substantial equivalence, implying these technical specifications meet regulatory requirements.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for AI/ML performance. For a digital thermometer, testing would involve physical measurements on a range of test subjects or using calibrated thermal sources, not a "test set" of data in the AI sense. The document does not provide details on the sample sizes for these physical performance tests or their provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. "Ground truth" in the context of expert consensus is not relevant for a digital thermometer. Accuracy is typically validated against highly calibrated reference thermometers (e.g., in a metrology lab) or in clinical trials against established methods, not by expert consensus on data interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are used to resolve disagreements among multiple experts interpreting complex data, which is not relevant for the direct measurement function of a digital thermometer.
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 not an AI-assisted diagnostic tool. An MRMC study is completely irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not have an "algorithm only" component that operates independently for diagnosis or prediction. It's a measurement device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the context of expert consensus/pathology/outcomes data. For a digital thermometer, the "ground truth" for its accuracy and performance testing would be highly accurate reference measurements from certified calibration equipment or established clinical comparison methods, not subjective expert assessment.
8. The sample size for the training set
- Not applicable. This device does not use machine learning, therefore, there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, there is no ground truth to establish for it in this context.
In summary: The FDA 510(k) clearance letter for the Digital Thermometer, Model T28, T28L, indicates a device that does not leverage AI/ML algorithms. Therefore, the detailed questions about acceptance criteria, study design, and ground truth establishment specific to AI-driven devices are not applicable to the information provided in this document. The clearance signifies that the device has demonstrated substantial equivalence to a legally marketed predicate device based on its intended use and conventional performance standards for clinical thermometers.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, the FDA logo is displayed in blue, with the words "U.S. FOOD & DRUG" stacked above the word "ADMINISTRATION". The logo is clean and professional, reflecting the organization's role in regulating food and drugs.
January 31, 2024
Guangdong Genial Technology Co., Ltd. % Reanny Wang Manager Shenzhen Reanny Medical Devices Management Consulting Co.Ltd Room 1407, Jingting Building, Dongzhou Community, Guangming Street. Guangming District Shenzhen, Guangdong 518107 China
Re: K232678
Trade/Device Name: Digital Thermometer, Model T28, T28L Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: January 3, 2024 Received: January 3, 2024
Dear Reanny Wang:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
{1}------------------------------------------------
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Porsche Bennett
Porsche Bennett For David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn,
{2}------------------------------------------------
General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K232678
Device Name Digital Thermometer. Model T28, T28L
Indications for Use (Describe)
The digital thermometer is intended for the measurement and monitoring of human body temperature through or axillary as the measurement site on people of all ages by doctor or user in the hospital or home.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
§ 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.