(109 days)
The Infrared ear and forehead thermometer model YI-100 is a multi-function infrared thermometer intended for the intermittent measurement of human body temperature by Ear mode, or by Forehead mode (moving the mead from one temple to another temple for forehead measurement). The device can be used on people of one month old and above.
Infrared ear and forehead thermometer, model: YI-100
The provided text is a 510(k) clearance letter from the FDA for an infrared ear and forehead thermometer (model YI-100). It focuses on regulatory approval and substantial equivalence to predicate devices, rather than detailed performance study results with specific acceptance criteria, sample sizes, expert qualifications, or ground truth methodologies.
Therefore, many of the requested details about acceptance criteria and the study proving the device meets them are not present in this document. The document confirms that the device has been reviewed and cleared based on substantial equivalence, implying that its performance is considered acceptable relative to legally marketed predicate devices.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
This information is not available in the provided document. The FDA letter is a regulatory clearance, not a performance report. Performance data and acceptance criteria would be part of the predicate device's documentation or the manufacturer's submission which is not included here.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not available in the provided document.
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):
This information is not available in the provided document. For a thermometer, "ground truth" would typically involve comparison to a highly accurate reference thermometer, rather than expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not available in the provided document. Adjudication methods are usually relevant for subjective interpretations of medical images, not for objective measurements like temperature.
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:
This information is not available in the provided document. An MRMC study is not relevant for a thermometer, which is a standalone measurement device, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
For a thermometer, the device itself is the standalone performance. The document implies that the device's performance was evaluated against standards for clinical electronic thermometers (21 CFR 880.2910), but specific study details are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For a thermometer, the "ground truth" typically involves comparison to a highly accurate, calibrated reference thermometer (e.g., a mercury-in-glass thermometer or a highly precise electronic lab thermometer). This specific detail is not explicitly stated in the provided document, but it's the standard practice for validating thermometer accuracy.
8. The sample size for the training set:
This information is not available in the provided document. This device is an infrared thermometer, not a machine learning or AI device that would typically have a "training set" in the context of diagnostic algorithms.
9. How the ground truth for the training set was established:
This information is not available and not applicable, as this device does not utilize a "training set" in the context of an AI/ML algorithm.
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October 23, 2020
Wenzhou Yosun Medical Technology Co., Ltd. % Reanny Wang Manager Shenzhen Reanny Medical Devices Management Consulting Co. Ltd Room 1813#, Gebu Commercial Building, Hongxing Community, Songgang Street Shenzhen, Guangdong 518000 China
Re: K201843
Trade/Device Name: Infrared ear and forehead thermometer, model YI-100 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: September 21, 2020 Received: September 25, 2020
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 (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 located 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.
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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) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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.
for Payal Patel Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201843
Device Name
Infrared ear and forehead thermometer, model: YI-100
Indications for Use (Describe)
The Infrared ear and forehead thermometer model YI-100 is a multi-function infrared thermometer intended for the intermittent measurement of human body temperature by Ear mode, or by Forehead mode (moving the mead from one temple to another temple for forehead measurement). The device can be used on people of one month old and above.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Production Unit for OFF-Highway Engines |
|---|
| Own-The-Road Unit for OFF-Highway Engines |
| | 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.