DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010

K101876 · Shenzhen Biocare Electronics Co., Ltd. · DPS · Mar 1, 2011 · Cardiovascular

Device Facts

• Record ID: K101876
• Device Name: DIGITAL ELECTROCARDIOGRAPH, MODELS ECG-1210, ECG-1230, ECG-3010, ECG-6010
• Applicant: Shenzhen Biocare Electronics Co., Ltd.
• Product Code: DPS · Cardiovascular
• Decision Date: Mar 1, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Digital Electrocardiographs, ECG-1210 / ECG-1230 / ECG-3010 / ECG-6010, are intended to acquire ECG signals from adult and pediatric 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

Digital electrocardiographs (models ECG-1210, ECG-1230, ECG-3010, ECG-6010) acquire, display, and record ECG signals from patient body surfaces using electrodes. Device consists of power supply, signal collection, amplification, and control modules. Signals are amplified and filtered before being displayed on an integrated LCD and printed via a thermal printer. Patient data and ECG records are stored in device memory. Used in healthcare facilities by physicians or trained healthcare professionals to assist in heart disease diagnosis.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing was conducted to verify that the devices met design specifications and were substantially equivalent to the predicate device.

Technological Characteristics

System consists of four modules: power supply, signal collection, amplification, and control. Features integrated LCD display and thermal printer. Connectivity includes internal memory storage. Device is a digital electrocardiograph (21 CFR 870.2340).

Indications for Use

Indicated for adult and pediatric patients to acquire ECG signals via body surface electrodes to assist in the analysis and diagnosis of heart disease. For use 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

• Smart ECG (SE) Series Electrocardiograph, SE-12 (K091513)

Submission Summary (Full Text)

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Exhibit #1 510(k) Summary - K101876 Digital Electrocardiographs

Exhibit #1 510(k) Summary

MAR - 1 2010

| This 510(k) Summary is prepared per the request of 21 CFR 807.92. | |
|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Date | 19 JAN 2011 |
| Sponsor | Shenzhen Biocare Electronics Co., Ltd |
| | 5/F, Taohuayuan High-Tech Innovation Park, Baoan |
| | Shenzhen, Guangdong, 518102, 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 | Digital Electrocardiographs, ECG-1210 / ECG-1230 / ECG-3010 / ECG-6010 |
| Classification | Electrocardiograph; DPS; 21CFR870.2340; Class II |
| Intended Use | Digital Electrocardiographs, ECG-1210 / ECG-1230 / ECG-3010 / ECG-6010, are intended to acquire |
| | ECG signals from adult and pediatric 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 | Digital Electrocardiographs, ECG-1210 / ECG-1230 / ECG-3010 / ECG-6010, are designed to acquire, |
| Description | display and record ECG signals from patient body surface by ECG electrodes. After been amplified, |
| | filtered, the ECG signals waveforms are displayed in the LCD and recorded in the paper through thermal |
| | printer. ECG data and patient information could be stored in the memory of the device. |
| | All the models, ECG-1210 / ECG-1230 / ECG-3010 / ECG-6010, of the proposed device, Digital |
| | Electrocardiographs, follow the same design principle and same technical specifications: They consist of |
| | four modules, which are power supply module, signal collection module, amplification module, and |
| | control module. |
| Testing | Performance testing was conducted to validate and verify that the proposed devices met all design |
| | specifications and was substantially equivalent to the predicate device. |
| Predicate Device | Smart ECG (SE) Series Electrocardiograph, SE-12, K091513 |
| SE Conclusion | The proposed devices, Digital Electrocardiograph ECG-1210 / ECG-1230 / ECG-3010 / ECG-6010, are |
| | claimed to be Substantially Equivalent (SE) to the predicate device, Smart ECG (SE) Series |
| | Electrocardiograph, SE-12, in safety and effectiveness concerns. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name written around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized representation of human services.

## Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Shenzhen Biocare Electronics Co., Ltd c/o Ms. Diana Hong Shanghai Mid-Link Business Consulting Co., Ltd Suite 5D, No. 19, Lane 999, Zhongshan Road (S-2) Shanghai, 200030 CHINA

MAR - 1 2011

Re: K101876

Trade Name: Digital Electrocardiograph, Models ECG-1210, ECG-1230, ECG-3010, ECG-6010 Regulation Number: 21 CFR 870.2340

Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: February 20, 2011 Received: February 23, 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. 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.

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## Page 2 - Ms. Diana Hong

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/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,

W.M.S.

Bram Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exhibit #2 Indications for Use Statement

510(k) Number: K101876 Device Name: Digital Electrocardiographs Models: ECG-1210 / ECG-1230 / ECG-3010 / ECG-6010

Indications for Use:

Digital Electrocardiographs, ECG-1210 / ECG-1230 / ECG-3010 / ECG-6010, are intended to acquire ECG signals from adult and pediatric 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.

ZPRESCRIPTION USE (Part 21 CFR 801 Subpart D) □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)

W.M.P

n of Cardiovascular Devices

510(k) Number K101876

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