(146 days)
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No
The summary describes a standard infrared ear thermometer and lacks any mention of AI, ML, or related concepts like training/test sets or performance metrics typically associated with AI/ML devices.
No
The device is an infrared ear thermometer intended for intermittent measurement and monitoring of human body temperature, which is a diagnostic function, not a therapeutic one.
Yes
The device is an infrared ear thermometer, which measures body temperature. Measuring body temperature is a diagnostic process used to identify fever, a common symptom of various medical conditions.
No
The device description explicitly states "Infra-red ear thermometer model: ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J", indicating a physical hardware device that uses infra-red technology to measure temperature. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "intermittent measurement and monitoring of human body temperature from the auditory canal". This is a direct measurement of a physiological parameter within the body, not an analysis of a sample taken from the body (like blood, urine, or tissue).
- Device Description: It's described as an "Infra-red ear thermometer". Thermometers are generally considered medical devices, but not IVDs.
- Anatomical Site: The measurement is taken from the "auditory canal", which is a part of the human body.
- Lack of IVD Characteristics: The description doesn't mention any analysis of biological samples, reagents, or any other typical components or processes associated with in vitro diagnostics.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device directly measures a physical property (temperature) of the body itself.
N/A
Intended Use / Indications for Use
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.
Product codes
FLL
Device Description
Infra-red ear thermometer model:ET-100A、ET-100B、ET-100E、ET-100G、ET-100L、ET-100J
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
auditory canal
Indicated Patient Age Range
all ages
Intended User / Care Setting
consumers in the home
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
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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