DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIES

K092447 · Hangzhou Hua'An Medical & Health Instruments Co., · FLL · Jan 7, 2010 · General Hospital

Device Facts

• Record ID: K092447
• Device Name: DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIES
• Applicant: Hangzhou Hua'An Medical & Health Instruments Co.,
• Product Code: FLL · General Hospital
• Decision Date: Jan 7, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The devices models DT Series (barring model DT-201A and DT-211A) 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. The device model DT-201A and DT-211A are electronic clinical thermometer with pacifier probe head intended to measure oral temperature. The device is reusable for clinical or home use for children under the age of four.

Device Story

Electronic clinical thermometers; measure human body temperature via thermistor sensor. Input: thermal energy from patient body site (oral, rectal, axillary, or pacifier-based oral). Processing: thermistor resistance change converted to digital temperature reading via internal circuitry. Output: visual display of temperature on LCD screen. Used in clinical or home settings by patients or caregivers. Provides objective temperature data to assist in fever monitoring and clinical decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electronic clinical thermometers utilizing thermistor sensing technology. Models include standard, waterproof, flexible, rapid-read, and pacifier-integrated form factors. Battery-powered. Digital LCD output. Reusable. No software algorithm complexity described; standard electronic temperature conversion circuitry.

Indications for Use

Indicated for measurement of human body temperature. Models DT-01A through DT-K111A (excluding pacifier models) are for oral, rectal, or axillary use in all ages. Models DT-201A and DT-211A (pacifier style) are for oral use in children under age four. Reusable for clinical or home settings.

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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Mr. Ji Bo General Manager Hangzhou Hua'an Medical & Health Instrument Company Limited Building 2, Baimiao Industrial Park, Economic Development Zone Wuchang Hangzhou Zhejiang JAN - 7 2010 P.R. CHINA 310023

K092447 Re:

> Trade/Device Name: Digital Thermometer, Digital Thermometer (Water-Proof), Digital Basal Thermometer, Digital Flexible Thermometer, Rapid Digital Thermometer, Rapid Digital Flexible Thermometer, Digital Pacifier Thermometer

Regulation Number: 21CFR 880.2910

Regulation Name: Clinical Electronic Thermometer

Regulatory Class: II

Product Code: FLL

Dated: December 15, 2009

Received: December 15, 2009

Dear Mr. Bo:

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.

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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Page 2- Mr. Bo

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Punner

Anthony D. Watson, BS, MS, MBA Director Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indication for Use

510(k) Number (if known): K092447

Device Name:

| Digital Thermometer | DT-01A, DT-01B, DT-01D, DT-01E, DT-01G, |
|------------------------------------|-----------------------------------------|
| Digital Thermometer (Water-proof) | DT-11A, DT-11B, DT-11D, DT-11E |
| Digital Basal Thermometer | DT-12 |
| Digital Flexible Thermometer | DT-101A, DT-111A, DT-101B, DT-111B |
| Rapid Digital Thermometer | DT-K01A, DT-K11A |
| Rapid Digital Flexible Thermometer | DT-K101A, DT-K111A |
| Digital Pacifier Thermometer | DT-201A, DT-211A |

Indication For Use:

The devices models DT Series (barring model DT-201A and DT-211A) 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.

The device model DT-201A and DT-211A are electronic clinical thermometer with pacifier probe head intended to measure oral temperature. The device is reusable for clinical or home use for children under the age of four.

Prescription Use _ (Part 21 CFR 801 Subpart D)

AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Anesthasiology, General Hospital Infection Control, Dental Devices

510(k) Number: KD92447