DIGITAL ELECTROCARDIOGRAPH

K131858 · Guangdong Biolight Meditech Co., Ltd. · DPS · Jun 11, 2014 · Cardiovascular

Device Facts

• Record ID: K131858
• Device Name: DIGITAL ELECTROCARDIOGRAPH
• Applicant: Guangdong Biolight Meditech Co., Ltd.
• Product Code: DPS · Cardiovascular
• Decision Date: Jun 11, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Digital Electrocardiographs 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 Electrocardiograph (models E30, E35, E40, E65, E70, E80) acquires electrical ECG signals from patient body surface via electrodes; signals amplified, filtered, and transferred; waveforms displayed on LCD and printed via thermal printer. Used in healthcare facilities by physicians or trained healthcare professionals to assist in heart disease diagnosis. Device components include chest/limb electrodes, cables, and batteries. Output provides visual ECG records for clinical review.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), AAMI/ANSI EC11 (diagnostic ECG performance), and ISO 10993 (biocompatibility: cytotoxicity, irritation, sensitization) verified design specifications and substantial equivalence.

Technological Characteristics

Materials: ABS, Copper Alloy. Sensing: Body surface ECG electrodes. Energy: AC/DC power. Output: LCD display, thermal printer. Standards: IEC 60601-1, IEC 60601-1-2, AAMI/ANSI EC11, ISO 10993-5, ISO 10993-10. Non-sterile, reusable.

Indications for Use

Indicated for adult and pediatric patients requiring ECG signal acquisition for heart disease analysis and diagnosis. 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

• Digital Electrocardiographs (K101876)

Submission Summary (Full Text)

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Section 3 510 Summary

Project #: M0202013 A

# Section 3 510(k) Summary

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.

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The assigned 510(k) Number:

- 1. Date of Submission: 6/11/2013
- 2. Sponsor Identification

Guangdong Biolight Meditech Co., Ltd Innovation First Road, Technology Innovation Coast Zhuhai, Guangdong, 519085, China

Establishment Registration Number: 3007305624

Contact Person: Ms. Liang, Jing Position: R&D Director Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. Submission Correspondent
Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: [phone] Fax: [phone] Email: [e-mail]

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### Premarket Notification 510(k) Submission

Project #: M0202013A

# 4. Proposed Device Identification

Proposed Device Name: Digital Electrocardiograph Models: E30, E35, E40, E65, E70 and E80 Proposed Device Common Name: Electrocardiograph

Regulatory Information: Classification Name: Electrocardiograph Classification: II; Product Code: DPS; Regulation Number: 21 CFR part 870.2340; Review Panel: Cardiovascular;

### Intended Use Statement:

Digital Electrocardiographs 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.

- 5. Predicate Device Identification
510(k) Number: K101876 Predicate Device Name: Digital Electrocardiographs Manufacturer: Shenzhen Biocare Electronics Co., Ltd

#### Device Description 6.

Digital Electrocardiographs, E30, E65, E70 and E80, 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. There is no specific contraindication identified for the proposed devices.

The proposed devices acquire ECG electrical signals from patient body surface by ECG electrodes. After been amplified, filtered and transferred, the ECG signal waveforms are displayed on the LCD and recorded on the paper through thermal printer.

The components of the proposed devices, Digital Electrocardiograph, include: (1) chest electrodes (2) limb electrodes, (3) cable and (4) Batteries;

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# 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:

- ア IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995;
- > IEC 60601-1-2 Edition 3:2007-03, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests.
- > AAMI / ANSI EC11:1991/(R)2007, Diagnostic electrocardiographic devices.
- A ISO 10993-5:2009, Biological Evaluation of Medical Devices - Part 5: Test for in vitro cytotoxicity;
- > ISO 10993-10:2002/A2006, Biological Evaluation of Medical Devices - Part 10: Tests for irritation and delayed-type hypersensitivity;
- Substantially Equivalent (SE) Conclusion 8.

The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.

| Item | Proposed Device(s) | Predicate Device(s) |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | DPS | DPS |
| Regulation Number | 870.2340 | 870.2340 |
| Intended Use | Digital Electrocardiographs are<br>intended to acquire ECG signals<br>from adult and pediatric patients<br>through body surface ECG<br>electrodes. The obtained ECG<br>records can help users to analyze<br>and diagnose heart disease. Digital<br>Electrocardiographs shall be used<br>in healthcare facilities by doctors<br>and/or trained healthcare<br>professionals. | Digital Electrocardiographs,<br>ECG-1210 / ECG-1230 / ECG-3010<br>/ECG-6010, are intended to acquire<br>ECG signals from adult and<br>pediatric patients through body<br>surface ECG electrodes. The<br>obtained ECG records can help<br>users to analyze and diagnose heart<br>disease. Digital Electrocardiographs<br>shall be used in healthcare facilities<br>by doctors and/or trained healthcare<br>professionals. |
| Patient Contact Material | ABS / Cooper Alloy | ABS / Tin Alloy |

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

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:

Section 3 510 Summary

Project #: M0202013 A

| Sterile | No | No |
|------------------|-----------------------------|-----------------------------|
| Single Use | No | No |
| Energy Source | AC Power / DC Power | AC Power / DC Power |
| Safety | IEC 60601-1 / IEC 60601-1-2 | IEC 60601-1 / IEC 60601-1-2 |
| Biocompatibility | Non-Cytotoxicity | Non-Cytotoxicity |
| | Non-Irritation | Non-Irritation |
| | Non-Sensitization | Non-Sensitization |
| Performance | AAMI EC11 | AAMI EC11 |
| Accessories | Limb Electrode | Limb Electrode |
| | Chest Electrode | Chest Electrode |
| | Battery | Battery |

The proposed devices, Digital Electrocardiographs, E30, E35, E70 and E80, are determined to be Substantially Equivalent (SE) to the predicate devices, Digital Electrocardiographs, ECG-120 / ECG-1230 / ECG-3010 /ECG-6010. .

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human figures. The image is black and white.

Public Health Service

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

June 11, 2014

Guangdong Biolight Meditech Co., Ltd. % Diana Hong Mid-Link Consulting Co., Ltd P.o. Box 120-119 Shanghai, 200120 CH

Re: K131858

> Trade/Device Name: Digital Electrocardiograph (E30, E35, E40, E65, E70, E80) Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: April 30, 2014 Received: May 5, 2014

Dear Diana 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

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Page 2 - Diana Hong

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 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/ResourcesforYowIndustry/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 yours,

Image /page/5/Picture/8 description: The image shows a logo with the letters FDA. The letters are stylized and have a bold, geometric design. There are lines drawn through the logo, possibly indicating that it is not valid or has been rejected. The logo is in black and white.

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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K131858 Page 1 of 1

# Section 2 Indications for Use

510(k) Number: Device Name: Digital Electrocardiograph Models: E30, E35, E40, E65, E70 and E80

Indications for Use:

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

| ☑PRESCRIPTION USE<br>(Part 21 CFR 801 Subpart D) | OR | ☐OVER-THE-COUNTER USE<br>(21 CFR 801 Subpart C) |
|--------------------------------------------------|----|-------------------------------------------------|
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Date
20.04.05.11
09.44.03 -04'00'

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