CONTEC ELECTROCARDIOGRAPH

K131900 · Contec Medical System Co., Ltd. · DPS · Mar 5, 2014 · Cardiovascular

Device Facts

• Record ID: K131900
• Device Name: CONTEC ELECTROCARDIOGRAPH
• Applicant: Contec Medical System Co., Ltd.
• Product Code: DPS · Cardiovascular
• Decision Date: Mar 5, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2

Intended Use

CONTECTM Electrocardiographs, ECG100G/ECG300G/ECG1200G, are intended to acquire ECG signals from adult patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.

Device Story

Device acquires 12-lead ECG signals from adult patients via body surface electrodes; signals amplified and filtered; waveforms displayed on LCD screen and recorded via thermal printer. Models ECG100G, ECG300G, and ECG1200G support automatic, manual, and rhythm (ECG300G/1200G only) recording modes. Used in healthcare facilities by physicians or trained professionals. Output provides ECG waveforms and data for clinical analysis and heart disease diagnosis. Device includes internal memory for storage of patient information and ECG records.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25, and ANSI/AAMI EC11 standards verified design specifications and safety.

Technological Characteristics

12-lead ECG acquisition; 1/3/12 channel display/print; frequency response 0.05-150Hz; input impedance >50MΩ; patient leakage current <10μA. Thermal printer output; LCD display. Powered device. No automated measurement or analysis algorithms.

Indications for Use

Indicated for adult patients requiring ECG signal acquisition via body surface electrodes to assist in the diagnosis of heart disease. Used in healthcare facilities by doctors or trained healthcare professionals.

Regulatory Classification

Identification

An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.

Predicate Devices

• Electrocardiographs (K113485)
• Digital Electrocardiographs (K122712)

Submission Summary (Full Text)

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K131900 Page 1 of 4

# 510(k) Summary

ﺮ

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: _ K131900

1. Date of Submission: Jun 21, 2013

Sponsor Identification 2.

> Contec Medical System Co., Ltd No. 24, Huanghe West Road, Economic & Technical Development Zone, Qinhuangdao, Hebei, 066004, China

Establishment Registration Number: 3006979678

Contact Person: Mr. Xueyong Li Position: Quality Manager Tel: [phone] Fax: [phone] Email: [e-mail]

Submission Correspondent 3.

> Ms. Diana Hong& Mr. Tarzan Wang Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: [phone] Fax: [phone] Email: [e-mail]

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#### 4. Proposed Device Identification

Proposed Device Name: CONTECTM Electrocardiograph Proposed Device Common Name: Digital Electrocardiograph

Regulatory Information: Classification Name: Electrocardiograph Classification: II; Product Code: DPS Regulation Number: CFR 870.2340 Review Panel: Cardiovascular

Intended Use Statement:

CONTECTM Electrocardiographs, ECG100G/ECG300G/ECG1200G, are intended to acquire ECG signals from adult patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.

## న్నా Predicate Device Identification

510(k) Number: K113485 Predicate Device: Electrocardiographs Product Model: ECG-1101G(1), ECG-1103G(1) and ECG-1112 Manufacturer: Shenzhen Carewell Electronics Co., Ltd

510(k) Number: K122712 Predicate Device: Digital Electrocardiographs Product Model: iE 3S and iE 12 Manufacturer: Shenzhen Biocare Electronics Co., Ltd

#### 6. Device Description

The proposed device, CONTECTM Electrocardiograph, has three models: ECG100G, ECG300G and ECG1200G.

The three models all have three design modules, which are power module, signal acquisition and processing module and control module.

The proposed devices acquire ECG signal via twelve leads simultaneously, display or print waveform of E3-2

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ECG signal via single channel/ three channel/ twelve channel.

The proposed device, model ECG100G, has two recording modes, including automatic mode and manual mode; the other two models, ECG300G and ECG1200G have three recording modes, including automatic mode, manual mode and rhythm mode.

The proposed devices are designed to acquire, process, display and record ECG signals from patient body surface by ECG electrodes. After been amplified and filtered, the ECG signal waveforms are displayed on the LCD screen and recorded on the paper through thermal printer. ECG data, waveform and patient information could be stored in the memory of the device;

## 7. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

IEC 60601-1:1988+ A1:1991+ A2:1995, Medical electrical equipment, Part 1: General requirements for safety.

IEC 60601-1-2: 2007, Medical electrical equipment, Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests

IEC 60601-2-25:1993+A1:1999, Medical electrical equipment, Part 2-25: Particular requirements for the safety of electrocardiographs.

ANSI/AAMI EC11:1991/(R) 2007, Diagnostic electrocardiographic devices

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## 8. Substantially Equivalent (SE) Conclusion

The following table compares the DEVICE to the predicate devices with respect to intended use, technological characteristics and product function, etc.

| ITEM | Proposed Device | Predicate Device | Predicate Device |
|--------------------------------------|-------------------------------------------------------------------------------|----------------------------------------|---------------------------|
| | CONTECTM Electrocardiograph | K113485 | K122712 |
| Model | ECG100G/ECG300G/ECG1200G | ECG-1101G(I)/ECG-1103G(I)/<br>ECG-1112 | iE 3S/ iE 12 |
| Code | DPS | SAME | SAME |
| Regulation No. | CFR 870.2340 | SAME | SAME |
| Channel | 1/3/12 channel | SAME | SAME |
| Acquisition mode | Simultaneous 12-lead acquisition | SAME | SAME |
| Recording mode | ECG100G: Automatic / Manual<br>ECG300G/ECG1200G: Automatic /<br>Manual/rhythm | Automatic / Manual/rhythm | Automatic / Manual/rhythm |
| Patient leak<br>current | <10μA | SAME | SAME |
| Frequency<br>response | 0.05~150Hz | SAME | SAME |
| Noise level | <15μVp-p | SAME | SAME |
| CMRR | >60 dB<br>>100 dB (with AC filter) | SIMILAR | SIMILAR |
| Measurement/<br>Analysis<br>Function | No | Yes | No |
| Input CIR current | <50nA | SAME | SAME |
| Input impedance | >50M Ω | SAME | SAME |

| Table 3-1 Comparison of Technology Characteristics | |
|----------------------------------------------------|--|
|----------------------------------------------------|--|

The proposed device, CONTECTM Electrocardiograph, is determined to be Substantially Equivalent (SE) to the predicate devices, Electrocardiographs (K113485) and Digital Electrocardiographs (K122712), in respect of safety and effectiveness.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wavy lines extending from its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

March 5. 2014

Contec Medical System Co., Ltd. c/o Ms. Diana Hong Regulatory Consultant P.o. Box 120-119 Shanghai, 200120 CHINA

Re: K131900

> Trade/Device Name: Contec electrocardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: January 16, 2014 Received: January 24, 2014

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. 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.

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

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Page 2 - Ms. Diana Hong

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely vours

for 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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K131900

Page l of

510(k) Number (if known):

Device Name: CONTEC Electrocardiograph

Indications For Use: CONTEC Electrocardiographs, ECG100G/ECG300G/ECG1200G, are intended to acquire ECG signals from adult patients through body surface ECG electrodes. The obtained ECG records can help users to analyze and diagnose heart disease. Digital Electrocardiographs shall be used in healthcare facilities by doctors and/or trained healthcare professionals.

(19) FASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) for Bram Zuckerman

Prescription Use_ X (Per 21 CFR 801.109)

OR

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Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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