DYNAMIC ECG SYSTEM MODEL TLC5000

K101273 · Contec Medical System Co., Ltd. · MLO · Sep 30, 2011 · Cardiovascular

Device Facts

• Record ID: K101273
• Device Name: DYNAMIC ECG SYSTEM MODEL TLC5000
• Applicant: Contec Medical System Co., Ltd.
• Product Code: MLO · Cardiovascular
• Decision Date: Sep 30, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2

Intended 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.

Device Story

Dynamic ECG System, TLC5000, is an ambulatory ECG monitor; records up to 12-lead ECG signals for up to 24 hours. System components: wearable recorder, disposable electrodes, cables, and PC-based analysis software. Recorder captures, amplifies, and filters ECG signals from patient body surface; stores data in internal memory. Data transferred to PC for review, analysis, and printing by trained physicians in clinical settings. Analysis software provides advisory results to assist clinical decision-making; intended to support diagnosis of cardiac conditions. Benefits include continuous cardiac rhythm monitoring in ambulatory patients.

Clinical Evidence

No clinical data provided. Safety and effectiveness demonstrated through bench testing, including electrical safety, EMC, performance testing per IEC 60601-2-47, biocompatibility per ISO 10993, and automatic analysis function verification per AAMI EC 57.

Technological Characteristics

Ambulatory ECG recorder; 12-lead capability; 24-hour recording duration. Connectivity: USB data transfer to PC. Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-47 (performance), ISO 10993 (biocompatibility), AAMI EC 57 (analysis verification).

Indications for Use

Indicated for patients requiring continuous ambulatory ECG monitoring for up to 24 hours using up to 12 leads. Intended for use in health facilities by trained physicians.

Regulatory Classification

Identification

A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.

Predicate Devices

• Matrix Holter System (K051730)

Submission Summary (Full Text)

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Exhibit #1 510(k) Summary

## SEP 3 0 2011

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| 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. |

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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

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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 [phone] or [phone] 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

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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)

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(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K10/273

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