(146 days)
The devices models ET-100A、ET-100D、ET-100E、ET-100G、ET-1001、ET-100J, are intended for the intermittent measurement and monitoring of human body temperature from the auditory canal by consumers in the home . they are intended for use on people of all ages.
Infra-red ear thermometer model: ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J
The provided text describes an FDA 510(k) clearance for an infra-red ear thermometer. It does not contain specific details about acceptance criteria, a comprehensive study report, or the methodology used to establish the device's performance against detailed acceptance criteria.
The document is a clearance letter, indicating that the device is substantially equivalent to legally marketed predicate devices. This implies that the manufacturer would have submitted data demonstrating this equivalence, but the details of that data and the specific acceptance criteria for performance are not explicitly in this letter.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present in the provided document.
- Sample sized used for the test set and the data provenance: This information is not present in the provided document.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present in the provided document.
- Adjudication method for the test set: This information is not present in the provided document.
- 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: This is an infra-red ear thermometer, not an AI diagnostic device. Therefore, this type of study is irrelevant and not mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is an infra-red ear thermometer, so "algorithm only" performance in the context of human interpretation is not applicable. Its performance is its direct measurement.
- The type of ground truth used: While the device measures body temperature, the specific "ground truth" methodology (e.g., comparison to rectal temperature, oral temperature, or a traceable reference thermometer) for the equivalence study is not detailed in this document.
- The sample size for the training set: This information is not present in the provided document.
- How the ground truth for the training set was established: This information is not present in the provided document.
The document primarily focuses on the regulatory aspects of the device's clearance and its intended use as an infra-red ear thermometer for intermittent measurement of human body temperature.
To get the detailed information you are looking for (acceptance criteria, study design, sample sizes, ground truth establishment, etc.), you would typically need to review the full 510(k) submission, which is not provided here, or a detailed clinical study report published by the manufacturer.
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February 13, 2018
Hangzhou hua'an medical & Health Instruments Co. Ltd Ahneo Yang RA&QA Manager Building 2, 1# Fuzhu Nan RD, Wuchang Town Yuhang District, Hangzhou, Zhejiang 310023 CHINA
Re: K172870
Trade/Device Name: Infra-red ear thermometer model: ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: January 8, 2018 Received: January 16, 2018
Dear Ahneo Yang:
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 (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. 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.
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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 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tina
Kiang-S
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172870
Device Name
Infra-red ear thermometer model:ET-100A、ET-100B、ET-100E、ET-100G、ET-100L、ET-100J
Indications for Use (Describe)
The devices models ET-100A、ET-100D、ET-100E、ET-100G、ET-1001、ET-100J, are intended for the intermittent measurement and monitoring of human body temperature from the auditory canal by consumers in the home . they are intended for use on people of all ages.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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§ 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.