NON-CONTACT FOREHEAD INFRARED THERMOMETER, MODEL DT-8806H, BODY INFRARED THERMOMETER, MODEL DT-8806 AND DIGITAL INFRARED

{0}------------------------------------------------ ## JUL - 6 -2010 FDA-IR-05 # K101736 # Chapter 05 ## PREMARKET NOTIFICATION 510(K) Summary Infrared Thermometer Model: DT-8806H/DT-8806/DT-886 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92 1.0 Submitter's Name: SHENZHEN EVERBEST MACHINERY INDUSTRY CO.,LTD | Address: | 19th BUILDING, 5th REGION, BAIWANGXIN INDUSTRIAL<br>PARK, SONGBAI RD, BAIMANG, XILI, NANSHAN<br>SHENZHEN CHINA | | | | | | | |-----------------------------------|----------------------------------------------------------------------------------------------------------------|-------------|--|-------------------------|--|--|--| | Phone: | +86 755 27353188 | | | | | | | | Fax: | +86 755 27653699 | | | | | | | | Contact: | Deng Aiguo | | | | | | | | E-mail: | dengaiguo@cem-meter.com.cn<br>dengag@126.com | | | | | | | | Date | Aug 18, 2009 | | | | | | | | 2.0 Device Information: | | | | | | | | | Name: | Infrared Thermometer | | | | | | | | Model: | DT-8806H/DT-8806/DT-886 | | | | | | | | 3.0 Classification: | | | | | | | | | Product Code: | FLL---Clinic electronic thermometer | | | | | | | | Reguilation: | 880.2910 | | | | | | | | Number: | | | | | | | | | Classification: | II | | | | | | | | Panel: | 80 | | | | | | | | 4.0 Predicate Device Information: | | | | | | | | | Company Name: | Famidoc Technology Co.,Ltd | | | | | | | | Address: | 3rd Floor, East Block4, Chegongmiao Anhua Industrial Zone<br>Shenzhen P.R.China | | | | | | | | Device: | Infrared Thermometer, Model :FDIR-V1 | | | | | | | | | It's 510(K) number is K052849 | | | | | | | | Code: FDA-001 | Version: A/0 | Page 1 of 2 | | Issuing Date: 2009-8-18 | | | | {1}------------------------------------------------ FDA-IR-05 ## K101736 5.0 Device Description Infrared Thermometer Model:DT-8806/DT-8806H/DT-886 ાંક ਰ hand-held.reusable.battery operated.The device that can measures human body temperature by ways: 1. on forehead,the skin temperature on one's forehead(DT-8806H/DT-8806); 2.In ear.The tympanic temperature in one's ear(DT-886). The operation principle is based on Infrared Sensor technology.IR Sensor can putout different signal when measuring different object temperature or in different ambient temperature. An ASIC can turn the signal from IR Sensor to a digital Value and display it by LCD. ### 6.0intended Use: Infrared Thermometer Model: DT-8806H/DT-8806 Non-contact body infrared thermometer is designed for body surface and forehead temperature measurement for infants and adults without contact to human body. The Digital Infrared Ear Thermometer Model: DT-886 can provide a stable, hear -interference -free reading with each measurement,The digital Infrared Thermometer is intended for the periodic measurement and monitoring of human body temperature, It is intended for use on people of all ages. The Infrared Thermometer can be used by consumers in household environment. It is manufactured in accordance with the ASTM 1965-1998 Standard specification for Infrared Thermometers for Intermittent Determination of Patient Temperature. ### 7.0 Performance Summary: The decice conforms to applicable standards included ASTM E1965-98(2003)、 IEC60601-1、IEC60601-1-2、ISO14971(DT-8806H/DT-8806/DT-886) and EN ISO10993-5、 EN ISO10993-10、 EN12470-5 (DT-886)。 8.0 Comparison to Predicate Devices and conclusions Our Infrared Thermometer Model DT-8806H/DT-8806/DT-886 is substantially equivalent to Infrared Thermometer, Model: FDIR-V1 whose 510(K) number is K052849. The two series devices are very similar in design principle, intended use, functions, material and the applicable standards. Only their outlook and some parameter such as measurement rang are different. However, the tests in this submission provide demonstration these small differences do not raise any new question of safety or effectiveness. Conclusions: the infrared thermometer model DT-8806H/DT-8806/DT-886 is substantially equivalent to the predicate devices. Code: FDA-001 Version: A/0 Page 2 of 2 ess. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Shenzhen Everbest Machinery Industry Company, Limited C/O Ms. Tamas Borsai Responsible Third Party Official TÜV Rheinland of North America, Incorporated 12 Commerce Road Newton, Connecticut 06470 **JUL-6 2010** Re: K101736 Trade/Device Name: Infrared Thermometer Model DT-8806H/DT-8806/DT-886 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: June 17, 2010 Received: June 21, 2010 Dear Ms. Borsai: 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- Ms. Borsai 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Swart Luannon Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health ### Enclosure {4}------------------------------------------------ ### Chapter 04 # PREMARKET NOTIFICATION Indications for Use # 510(k) Number (if known): Device Name: Infrared Thermometer Trade Model Name: Infrared Thermometer Model: DT-8806H/DT-8806/DT-886 Intended Use: Infrared Thermometer Model: DT-8806H/DT-8806 Non-contact body infrared thermometer is designed for body surface and forehead temperature measurement for infants and adults without contact to human body. The Digital Infrared Ear Thermometer Model: DT-886 can provide a stable, hear –interference ~free reading with each measurement, The digital Infrared Thermometer is intended for the periodic measurement and monitoring of human body temperature, It is intended for use on people of all ages. The Infrared Thermometer can be used by consumers in household environment. It is manufactured in accordance with the ASTM E1965-1998 Standard specification for Infrared Thermometers for Intermittent Determination of Patient Temperature. Infrared Thermometer Model: DT-8806H/DT-8806/DT-886 is medical instruments, used as an assistant device by normal people to evaluate, by the result of measurement, their decision for the next clinical step in order to protect human's health. The function for measuring human body's temperature with precision helps detect and observe human states of health, in case of any possible illness. Infrared Thermometer Model: DT-8806H/DT-8806 is a hand-held, non-sterile, reusable medical device, Use and alcohol swab or cotton tissue moistened with alcohol(70% Isopropyl) to clean, the Digital Infrared Ear thermometer(DT-886) casing and the measuring probe contact body. supplied by internal power. It is used for human beings, and it belongs personal use monitoring device. Code: FDA-001 {5}------------------------------------------------ FDA-IR-04 ## K101736 Infrared Thermometer Model: DT-8806H/DT-8806 is non-contact device. It can detect the temperature from human's forehead, DT-886 is Digital Infrared Ear thermometer ,It can detect the temperature from human's ear channel ,It takes only half second(DT-8806/DT-8806H) and one second(DT-886) for one times measurement. Valid scientific evidence of product testing reports, software verification, and substantial equivalence are provided to guarantee product function, safety, effectiveness, and biological compatibility, etc. The thermometer shall be cleaned before and after each use. Cleaning method and information are provided in the instructions for use. ( See Chapter 13 ) Do not bite, bend, drop or disassemble this thermometer and do not dispose this thermometer and battery into fire. Keep this thermometer away from direct sunlight, moisture, dirt, extreme temperature while use, store or transport. Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Mica (Division Sign-Off) vision of Anesthesiology, General Hospital ection Control, Dental Devices : : : 0(k) Number: ___ K/ o/ 736 Code: FDA-001 Version: A/0 Page 2 of 2 Issuing Date: 2009-8-18