Digital thermometer(with disposable thermometer cover)

K172861 · Hangzhou Hua'An Medical&Health Instruments Co.,Ltd · FLL · Dec 19, 2017 · General Hospital

Device Facts

• Record ID: K172861
• Device Name: Digital thermometer(with disposable thermometer cover)
• Applicant: Hangzhou Hua'An Medical&Health Instruments Co.,Ltd
• Product Code: FLL · General Hospital
• Decision Date: Dec 19, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The devices models DT-K11E, DT-11H, are electronic clinical thermometer intended to measure the human body temperature in regular mode orally, rectally or under the arm, the devices are reusable for clinical or home use on people of all ages.

Device Story

Electronic clinical thermometers (models DT-K11E, DT-11H) measure human body temperature. Devices utilize thermistor-based sensing technology to detect temperature changes; signal processed by internal circuitry to calculate temperature; result displayed on integrated LCD screen. Used in clinical or home settings by patients or healthcare providers. Provides rapid, reusable temperature monitoring for oral, rectal, or axillary sites. Output assists in clinical decision-making regarding fever management and patient health status.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing and design specifications consistent with clinical electronic thermometer standards.

Technological Characteristics

Electronic clinical thermometer; thermistor-based sensing; battery-powered; digital LCD display; reusable; water-proof (DT-11H); intended for oral, rectal, or axillary use. Embedded firmware for temperature calculation.

Indications for Use

Indicated for measuring human body temperature in people of all ages via oral, rectal, or axillary routes. Suitable for clinical or home use.

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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December 19, 2017

Hangzhou Hua'an Medical & Health Instruments Co., Ltd. Ahneo Yang RA & QA Manager Building 2, 1# Fuzhu Nan RD, Wuchang Town, Yuhang District Hangzhou, 310023 CHINA

Re: K172861

Trade/Device Name: Rapid digital thermometer DT-K11E Digital thermometer (Water-proof) DT-11H Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: November 24, 2017 Received: November 27, 2017

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.

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

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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 medical devices and radiation-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,

Image /page/1/Figure/6 description: The image shows the name "Tara A. Ryan - S" in large font on the left side of the image. On the right side of the image, there is a digital signature by Tara A. Ryan - S. The signature includes the date 2017.12.19 14:03:38-05'00' and other information such as DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Tara A. Ryan -S, 0.9.2342.19200300.100.1.1=1300030749.

for 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) K172861

#### Device Name Rapid digital thermometer DT-K11E Digital thermometer(Water-proof) DT-11H

#### Indications for Use (Describe)

The devices models DT-K11E, DT-11H, are electronic clinical thermometer intended to measure the human body temperature in regular mode orally, rectally or under the arm, the devices are reusable for clinical or home 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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