Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard ECG signal processing and analysis software without mentioning AI or ML. The performance studies focus on electrical safety, EMC, and standard ECG analysis function verification.

Therapeutic

No
The document states that the device is for acquiring, displaying, and recording ECG signals for analysis, and the analysis results are "only used as advisory basis." This indicates a diagnostic rather than therapeutic function.

Diagnostic

Yes

The device acquires ECG data and provides analysis results for a physician to use as an "advisory basis," indicating its role in informing a diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of a recorder (hardware) and analysis software, and the performance studies include electrical safety and EMC testing, which are relevant to hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs analyze samples taken from the human body. The description clearly states the device acquires ECG signals from the patient body surface using electrodes. This is a non-invasive measurement of electrical activity within the body, not an analysis of a sample taken from the body (like blood, urine, tissue, etc.).
The intended use is to acquire and analyze ECG data. This is a physiological measurement, not a diagnostic test performed on a biological sample.

Therefore, the Dynamic ECG System, TLC5000, falls under the category of a physiological monitoring or diagnostic device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications 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.

Product codes (comma separated list FDA assigned to the subject device)

MLO, MLQ

Device Description

Dynamic ECG System, TLC5000, mainly consists of two parts: a recorder, analysis software and accessories. The recorder is designed to acquire, display and record ECG signals from patient body surface by ECG electrodes. After been amplified, filtered and analyzed, the ECG signals waveforms, as well as the patient information will be displayed and stored in the memory of the recorder. The information stored can be downloaded to PC; the ECG signal then can be analyzed by the analysis software. The analysis results are only used as advisory basis. The accessories contain disposable electrodes, cables, USB connecting line.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained physician in health facilities.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The following tests were performed to evaluate the safety and effectiveness of the proposed devices: > Electrical Safety Test per IEC 60601-1:1988+A1:1991+A2:1995; > EMC Test per IEC 60601-1-2:2001+A1:2004; > Performance Test Report per IEC 60601-2-47:2001; > Biocompatibility Test per ISO 10993 series standards: > Automatic analysis function verification per AAMI EC 57. The test results complied with FDA recognized standards and be evaluated to determine it was acceptable, therefore, safety and effectiveness were demonstrated substantially equivalent (SE) to the predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Matrix Holter System, K051730

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 870.2800 Medical magnetic tape recorder.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

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Exhibit #1 510(k) Summary

SEP 3 0 2011

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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
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 Description	Dynamic ECG System, TLC5000, mainly consists of two parts: a recorder, analysis software and
accessories. The recorder is designed to acquire, display and record ECG signals from patient body
surface by ECG electrodes. After been amplified, filtered and analyzed, the ECG signals waveforms, as
well as the patient information will be displayed and stored in the memory of the recorder. The
information stored can be downloaded to PC; the ECG signal then can be analyzed by the analysis
software. The analysis results are only used as advisory basis. The accessories contain disposable
electrodes, cables, USB connecting line.
Testing	The following tests were performed to evaluate the safety and effectiveness of the proposed devices:

Electrical Safety Test per IEC 60601-1:1988+A1:1991+A2:1995;
EMC Test per IEC 60601-1-2:2001+A1:2004;
Performance Test Report per IEC 60601-2-47:2001;
Biocompatibility Test per ISO 10993 series standards:
Automatic analysis function verification per AAMI EC 57.
The test results complied with FDA recognized standards and be evaluated to determine it was
acceptable, therefore, safety and effectiveness were demonstrated substantially equivalent (SE) to the
predicate device. |
| Predicate Device | Matrix Holter System, K051730 |
| SE Conclusion | The proposed device, Dynamic ECG System, TLC5000 is substantially equivalent (SE) to the predicate
device, Matrix Holter System, K051730. |

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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

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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)

.

Page J of __ ا_ا_

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

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