DUTECK(MICHEALTH)DIGITAL CLINICAL THERMOMETER

{0}------------------------------------------------ # K132140 EEB - 4 2014 Duteck: micHealth Digital Clinical Thermometer 510(K) Submission # 510(K) Summary 807.92(C) Company Name: Duteck Industrial Co., Ltd Company Address: 3F-2, No 26, Ln513 Rui-Kuang Rd Taipei 114, Taiwan ROC Telephone number: 886-2-8797-5035. Fax number Contact person: Joseph Chan Summary preparation: June 11, 2013 Device name: 807.92(a)(2) Trade name: Duteck(micHealth) Digital Clinical Thermometer, DT2306 Regulation Name: Digital Clinical Thermometer Product Code: FLL Registration Number: 9616844 Regulation Number: 21 CFR 880.2910 Regulatory Class: II # Predicate device: 807 92(a)(3) Duteck Digital Clinical Thermometer (K992327) - Device description: 807.92(a)(4) Duteck (micHealth) Digital Clinical Thermometer, DT2306 series is hand-held, reusable, battery operated device that can measure human body temperature via the human oral and armpit. Device intended to use: 807.92(a)(5) Duteck (micHealth) Digital Clinical Thermometer, DT2306 series is electronic thermometer using a thermopile detector to detect body temperature from the oral or armpit. It intended {1}------------------------------------------------ Duteck: micHealth Digital Clinical Thermometer 510(K) Submission for the intermittent measurement of human body temperature in people of all ages. | ELEMENT<br>OF<br>COMPARISON | Duteck Digital<br>Thermometer | Clinical Duteck (micHealth) Digital Clinical<br>Thermometer, DT2306 series | |-----------------------------------|-------------------------------|----------------------------------------------------------------------------| | 510(K) Number | K992327 | New | | Displayed<br>Temperature<br>Range | 32°C~42.0°C(89.6.0°F~109.2°F) | 32.00°C~42.00°C(89.60°F~109.20°F) | | Operation<br>Environment | 16°C~40°C(60.8°F~104°F) | 16.00°C~40.00°C(60.80°F~104.00°F) | | Power<br>Requirement | LR41 1.5V batteries x1 | CR 1620 3V x1 | | Display<br>Resolution | ±0.1°C/°F | ±0.01°C/°F | | Display | TN LCD | TN LCD | | Response Time | 15 second | 4 second | # Comparison of technical characteristics: 807.92(a)(6) # Safety and effectiveness 807.92(b) The Duteck (micHealth) Digital Clinical Thermometer, DT2306, had been tested to the appropriate electrical tested standard and biocompatibility standards have been found safe for intended use. (As Appendix III) ## Conclusion: ## 807.92(b)(3) The Duteck (micHealth) Digital Clinical Thermometer is as same as the predicate device in intended use and technological characteristics. After analyzing performance and safety. testing, it is the conclusions of Duteck (micHealth) Digital Clinical Thermometer is as safe and effective as the predicate devices and introduce no new questions concerning safety and effectiveness. Sincerely Yours, oseph Chen 7 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 4, 2014 Duteck Industrial Company, Limited C/O Joseph Chen, President 3F-2, Number 26, Lane 513 Rui-Kuang Road Taipei 114 Taiwan R.O.C. Re: K132140 Trade/Device Name: Duteck (micHealth) Digital Clinical Thermometer, DT2306 series Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: January 7, 2014 Received: January 15, 2014 Dear Mr. Chen: 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. {3}------------------------------------------------ Page 2 - Mr. Chen 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely vours. Image /page/3/Picture/8 description: The image shows the name Kwame Ulmer in a stylized font. The letters are bold and black, and they are arranged in two rows. The first row contains the name Kwame, and the second row contains the name Ulmer. The letters are partially obscured by a geometric design that is made up of lines and shapes. The design is black and white, and it is placed behind the letters. for Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health ### Enclosure {4}------------------------------------------------ ### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K132140 ### Device Name micHealth Digital Clinical Thermometer, DT2306 series Indications for Use (Describe) Duteck (micHealth) Digital Clinical Thermometer, DT2306 series (product code FLL) is used to measure human body temperature with the following features: The device display body temperature in digital format at LCD The device make intended contact with patient in 2 ways (1) Surface contact: armpit. (2) Invasive contact: oral. The device is used and installed by patients, Nurses, doctors and people with the exception of handicapped people and children. The device is used in ENVIRONMENT of room temperature and normal environment condition. 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) ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Image /page/4/Picture/18 description: The image shows the name "Sajjad H. Syed -S" in large, bold font on the left side. To the right of the name is a digital signature with the same name, along with information such as "o=U.S. Government, ou=HHS, ou=FDA," and a date and time stamp of "2014.01.30 14:55:10 -05'00'." There are also some numbers included in the digital signature, such as "19200300.100.1.1=2000601742". Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page. {5}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."