DYNAMIC ECG SYSTEM MODEL TLC5000

{0}------------------------------------------------ Exhibit #1 510(k) Summary ## SEP 3 0 2011 11 ﺗ 1 | This 510(k) Summary is prepared per the request of 21 CFR 807.92. | | |-------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date of Preparation | 25 AUG 2011 | | Assigned 510(k) #. | K101273 | | Sponsor | Contec Medical Systems Co., Ltd Establishment Registration Number: 3006979678 | | | No. 24, Huanghe West Road, Economic & Technical Development Zone | | | Qinhuangdao, Hebei, 066004, China | | Correspondent | Ms. Diana Hong / Mr. Lee Fu | | | Shanghai Mid-Link Business Consulting Co., Ltd | | | Suite 5D, No. 19, Lane 999, Zhongshan Road (S-2), Shanghai, 200030, China | | Proposed Device | Dynamic ECG Systems, TLC5000 | | Classification | Electrocardiograph, ambulatory, with analysis algorithm; MLO; 870.2800; Class II | | Intended Use | Dynamic ECG System, TLC5000, is intended to continuously acquire ambulatory ECG data for up to<br>twelve leads. It can record the ECG data for at most twenty four hours. The ECG data obtained will be<br>stored in the recorder first and then download to PC for analysis, reviewing and printing by a trained<br>physician in health facilities. | | Device Description | Dynamic ECG System, TLC5000, mainly consists of two parts: a recorder, analysis software and<br>accessories. The recorder is designed to acquire, display and record ECG signals from patient body<br>surface by ECG electrodes. After been amplified, filtered and analyzed, the ECG signals waveforms, as<br>well as the patient information will be displayed and stored in the memory of the recorder. The<br>information stored can be downloaded to PC; the ECG signal then can be analyzed by the analysis<br>software. The analysis results are only used as advisory basis. The accessories contain disposable<br>electrodes, cables, USB connecting line. | | Testing | The following tests were performed to evaluate the safety and effectiveness of the proposed devices:<br>> Electrical Safety Test per IEC 60601-1:1988+A1:1991+A2:1995;<br>> EMC Test per IEC 60601-1-2:2001+A1:2004;<br>> Performance Test Report per IEC 60601-2-47:2001;<br>> Biocompatibility Test per ISO 10993 series standards:<br>> Automatic analysis function verification per AAMI EC 57.<br>The test results complied with FDA recognized standards and be evaluated to determine it was<br>acceptable, therefore, safety and effectiveness were demonstrated substantially equivalent (SE) to the<br>predicate device. | | Predicate Device | Matrix Holter System, K051730 | | SE Conclusion | The proposed device, Dynamic ECG System, TLC5000 is substantially equivalent (SE) to the predicate<br>device, Matrix Holter System, K051730. | {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Contec Medical System Co., Ltd. c/o Diana Hong Shanghai Midlink Business Consulting Co., Ltd. Suite 5D No 19, Lane 999 Zhongshan No.2 Roads Shanghai. China 200030 SEP 3 0 2011 Re: K101273 Trade/Device Name: Dynamic ECG Systems, TLC5000 Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II (two) Product Code: MLQ Dated: September 15, 2011 Received: September 16, 2011 Dear Ms. Hong: 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. 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 {2}------------------------------------------------ Page 2 - Ms. Diana Hong 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 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. Bram D. Zuckerman, M.D. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ K101273 1/1 Premarket Notification Section 510(k) Submission Report SN: SHA0202009091IFDA Indication for Use Statement ## Exhibit #1 Idication for Use Statement 510(k) Number: K101273 Device Name: Dynamic ECG System, TLC5000 Indication for Use: Dynamic ECG System, TLC5000, is intended to continuously acquire ambulatory ECG data for up to twelve leads. It can record the ECG data for at most twenty four hours. The ECG data obtained will be stored in the recorder first and then download to PC for analysis, reviewing and printing by a trained physician in health facilities. Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) . Page _J_ of __ ا_ا_ (Division Sign-Off) Division of Cardiovascular Devices 510(k) Number K10/273 ll-1