JOINSOON ELECTRONICS MFG CO. LTD HIGH SPEED DIGITAL THERMOMETER, MODEL TC-001

{0}------------------------------------------------ K101232 # JUL 2-1 2010 #### EXHIBIT #1 #### 510(k) Summarv This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. # Date prepared: April 29, 2010. - 1. Applicant: Joinsoon Electronics MFG. Co., Ltd. 19F., No. 79, Sec. 1. Sintai 5th Rd., Sijhih City, Taipei County 221, Taiwan, R.O.C. Phone: +886-2-2698-4882 Fax: +886-2-2698-4883 ## 2. Submitter: Mr. Jigar Shah Official Correspondent for Joinsoon Electronics MFG. Co., Ltd. mdi Consultants, Inc. 55 Northern Blvd., Suite 200 Great Neck, New York 11021 Tel: 516-482-9001 Fax: 516-482-0186 Jigar@mdiconsultants.com #### 3. Trade/proprietary Name: Joinsoon Electronics MFG. Co., Ltd. High Speed Digital Thermometer Model TC-001 # 4. Classification name: Common Name: Clinical Electronic Thermometer Requiation: 21 CFR Part 880.2910 - 5. Product Code: FLL - 6. Predicate Devices: TEMPTELLER - HIGH SPEED DIGITAL THERMOMETERS, MODELS DT-302. DT-312, DT-412, DT-502 Previously cleared 510(k) number: K042202 #### 7. Device Description The device Joinsoon Electronics MFG. Co., Ltd. High Speed Digital Thermometer Model TC-001 which is based on the 510(k) 042202 model DT-312 is designed to measure the human body temperature in the mouth or rectum. This device is used under the condition(s) or disease(s) to be screened, monitored, treated, or diagnosed: Fever - 1 {1}------------------------------------------------ - i Hypothermia The device is intended use at the following conditions: - Age: newborn to geriatric - - Weight: > 2.5 kg The device operating conditions is between 10°C to 40°C (50°F to 104°F). The Fundamental Scientific technology of the modified device remains the same as that of the 510(k) cleared device. ## 8. Intended Use: This device is an electronic clinical thermometer using a thermistor to detect body temperature from the oral, armpit and rectal in the neonatal pediatric and audit population used in the clinical and home testing. #### 9. Substantial Equivalence Discussion: The Joinsoon Electronics MFG. Co., Ltd. High Speed Digital Thermometer Model TC-001 is substantially equivalent to the original 510(K) 042202, Model DT-312 in all aspects, e.g., technological characteristics, modes of operation, performance characteristics, intended use, etc., The only differences in the predicate version of the Digital thermometer are PCB layout involving Performance Specifications and Housing for Ergonomics of the Patient-UI. The Fundamental Scientific technology of the modified device remains the same as that of the 510(k) cleared device. ## 10. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows: Compliance to applicable voluntary standards includes ASTM E1112-00, as well as IEC60601-1 and IEC60601-1-2 requirements. Guidance documents included the "FDA Guidance on the content of Premarket Notification (510(k)) Submissions for Clinical Electronic Thermometers". #### 11. Conclusion: The Joinsoon Electronics MFG. Co., Ltd. High Speed Digital Thermometer Model TC-001 has the same intended use and similar technological characteristics as the Predicate device. Moreover, bench testing contained in this submission supplied demonstrate that any differences in their characteristics do not raise any new questions of safety or effectiveness. Thus the Joinsoon Electronics MFG. Co., Ltd. High Speed Digital Thermometer Model TC-001, is substantially equivalent to the predicate device. {2}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Joinsoon Electronics Manufacturing Company, Limited C/O Mr. Jigar Shah MDI Consultants, Incorporated 55 Northern Boulevard, Suite 200 Great Neck, New York 11021 JUL 2-1 2010 # Re: K101232 Trade/Device Name: Joinsoon Electronics Manufacturing Company, Limited High Speed Digital Thermometer. Models TC-001 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: June 24, 2010 Received: June 25, 2010 #### Dear Mr. Shah: 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.Shah 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/ucml15809.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/ReportalProblem/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. Rh for 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}------------------------------------------------ Exhibit 3 ## Indications for Use Page 1 of of 1 510(k) Number (if known): Device Name: Joinsoon Electronics Mfg. Co., Ltd. High Speed Digital Thermometer. Models TC-001 #### Indications For Use: This device is an electronic clinical thermometer using a thermistor to detect body temperature from the oral, armpit and rectal in the neonatal pediatric and audit population used in the clinical and home testing. Prescription Use (Per 21 CFR 801 Subpart D) OR X Over-The Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices K101232 510(k) Number: