U-RIGHT EAR THEMOMETER, MODELS TD-1115 AND TD-1118

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for TaiDoc Technology Corp. The logo features the company name in bold, black font, with three heart symbols underneath the "TaiDoc" portion. Below the company name, there is a tagline that reads "A Good Future of Health for People" in a smaller, italicized font. http://www.taidoc.com 6F, No. 127, Wugong 2nd Rd., Wugu, Taipei County 248, tel: +886-2-66258188 fax: +886-2-66 # Attachment 1. 510(k) Summary ## 510(K) SUMMARY This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. MAY 2,6 2010 The Assigned 510(k) number is: - l. Submitter's Identification: TaiDoc Technology Corporation 3F, 5F, No.127, Wugong 2nd Rd., Wugu Township, Taipei County, 248, Taiwan Correspondence: Nicky Pan Regulatory Affairs Specialist Tel: +886-2-6625-8188 #1196 Fax: +886-2-6625-0288 Email: nicky@taidoc.com.tw Date of submission: April 02, 2010 - 2. Device name: Proprietary name: U-RIGHT TD-1115 ear thermometer and U-RIGHT TD-1118 ear thermometer ### Regulatory information: - A. Regulation section: 21 CFR 880.2910 - B. Classification: Class II - FLL, Clinical electronic thermometer C. Product Code: - Panel: General Hospital (80) D. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for TaiDoc Technology Corp. The logo features the company name in bold, black font, with three heart symbols underneath the first word, TaiDoc. Below the company name and heart symbols is the tagline, "A Good Future of Health for People," written in a cursive font. - 3. Intended Use: The U-RIGHT TD-1115 ear thermometer and U-RIGHT TD-1118 ear thermometer are intended for the intermittent measurement and monitoring of human body temperature from ear canal. The device is indicated for use by people of all ages in the home. - 4. Device Description: The U-RIGHT TD-1115 ear thermometer and U-RIGHT TD-1118 ear thermometer are characterized by measuring human body temperature in the ear canal. It utilizes infrared technology to measure either infrared energy emitted from the eardrum and surrounding tissues when making a temperature measurement. Substantial Equivalence Information: A. Predicate device name: Fora ComfortScan Ear Thermometer, model TD-1261B - B. Predicate K number: K081445 #### C. Comparison with predicate: The modified U-RIGHT TD-1115 ear thermometer and U-RIGHT TD-1118 ear thermometer have the following similarities to the predicate device: - I same operating principle, - same fundamental scientific technology. - . incorporate the same basic circuit design, - 트 incorporate the same materials, - . same shelf life - packaged using the same materials, and - Manufactured by the same process. . {2}------------------------------------------------ Image /page/2/Figure/1 description: The image shows the logo for TaiDoc Technology Corp. The logo features the company name in bold, black font. Below the name are three black heart symbols, followed by the tagline "A Good Future of Health for People" in a cursive font. The modifications encompass: - a modification in the user interface - modification in the physical appearance - . labeling change due to the modifications - . Removed the data transmission function - 5. Test Principle: The ear thermometer measures temperature by reading infrared radiation emitting from eardrum tissue. The small con-shape end of the thermometer is inserted into the ear canal, where the eardrum (tympanic membrane) and surrounding tissues give off heat. The thermometer converts it into a temperature value. - 6. Performance Characteristics: U-RIGHT TD-1115 ear thermometer and U-RIGHT TD-1118 ear thermometer have the same performance characteristics as the predicate device. A comparison of system accuracy performance demonstrated that the U-RIGHT TD-1115 ear thermometer and U-RIGHT TD-1118 ear thermometer and the currently marketed Fora ComfortScan Ear Thermometer, TD-1261B (cleared under K081445) are substantially equivalent. Software verification and validation, performance and safety tests confirmed that the performance, safety and effectiveness of the U-RIGHT TD-1115 ear thermometer and U-RIGHT TD-1118 ear thermometer are equivalent to the predicate device. - 7. Conclusion: Based on the information provided in this submission, the U-RIGHT TD-1115 ear thermometer and U-RIGHT TD-1118 ear thermometer are substantially equivalent to the predicate FORA ComfortScan Ear Thermometer, model TD-1261B. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is a stylized image of a bird or abstract human figure. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Mr. Nicky Pan Specialist of Regulatory Affairs Taidoc Technology Corporation 3F, 5F, No. 127 Wugong 2nd Road, Wugu Township Taipei County China (Taiwan) 24888 MAY 2 6 2010 Re: K100942 Trade/Device Name: U-RIGHT TD-1115 Ear Thermometer and U-RIGHT TD-1118 Ear Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: April 27, 2010 Received: April 29, 2010 Dear Mr. Pan: 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. {4}------------------------------------------------ ### Page Mr. Pan 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/Resourcesfor You/Industry/default.htm. Sincerely yours, Susan Runyon 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 {5}------------------------------------------------ # Section 8. Indications for Use Indications for Use 510(k) Number: Device Name: U-RIGHT TD-1115 ear thermometer and U-RIGHT TD-1118 ear thermometer Indications for Use: . The U-RIGHT TD-1115 ear thermometer and U-RIGHT TD-1118 ear thermometer are intended for the intermittent measurement and monitoring of human body temperature from ear canal. The devices are indicated for use by people of all ages in the home. Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR Part 801 Subpart D) Over the Counter Use _________________________________________________________________________________________________________________________________________________________ And/Or (21 CFR Part 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) uns WARN Division Sign-Off Office of Device Evaluation (ODE) 510(k) Page 1 of ____________________________________________________________________________________________________________________________________________________________________