Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J

K172870 · Hangzhou Hua'An Medical&Health Instruments Co.,Ltd · FLL · Feb 13, 2018 · General Hospital

Device Facts

• Record ID: K172870
• Device Name: Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J
• Applicant: Hangzhou Hua'An Medical&Health Instruments Co.,Ltd
• Product Code: FLL · General Hospital
• Decision Date: Feb 13, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Infra-red ear thermometer models (ET-100 series) measure human body temperature via the auditory canal. Device captures infrared energy emitted from the eardrum and surrounding tissue; converts signal into temperature reading. Used by consumers in home settings for intermittent monitoring of all age groups. Output displayed on device screen to assist users in tracking body temperature.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and comparison of technological characteristics.

Technological Characteristics

Infra-red sensing technology for non-contact or auditory canal temperature measurement. Device is a handheld electronic thermometer. Powered by internal battery. No specific materials or software algorithm details provided in the source text.

Indications for Use

Indicated for intermittent measurement and monitoring of human body temperature via the auditory canal. Intended for use by consumers in the home setting on patients of all ages.

Regulatory Classification

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.

Special Controls

(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.

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
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Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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