DIGITAL ELECTROCARDIOGRAPH

K133985 · Shenzhen Biocare Bio-Medical Equipment Co., Ltd. · DPS · Jan 22, 2015 · Cardiovascular

Device Facts

• Record ID: K133985
• Device Name: DIGITAL ELECTROCARDIOGRAPH
• Applicant: Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
• Product Code: DPS · Cardiovascular
• Decision Date: Jan 22, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2

Intended Use

Digital Electrocardiograph is 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 Electrocardiograph shall be used in healthcare facilities by doctors and/or trained healthcare professionals.

Device Story

Device (ECG-2000) acquires ECG signals from adult patients via body surface electrodes; consists of acquisition box, USB dongle, and PC-based software. Acquisition box filters/amplifies signals; transfers data to PC via USB. PC displays and records ECG signals. Used in healthcare facilities by physicians/trained professionals. Output assists clinicians in heart disease diagnosis. Benefits include standardized 12-lead ECG recording and analysis.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1 (safety), EN 60601-1-2 (EMC), and IEC 60601-2-25 (electrocardiograph performance) verified. Software verification testing performed to confirm functionality against intended use.

Technological Characteristics

12-lead ECG system; 1000Hz sampling rate. Materials: Metal (chest electrodes), ABS (limb electrodes). Powered via USB from PC. Connectivity: USB interface to PC workstation. Standards: IEC 60601-1, EN 60601-1-2, IEC 60601-2-25. Software-based signal processing.

Indications for Use

Indicated for adult patients requiring ECG signal acquisition via body surface electrodes for the analysis and 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

• PC ECG (K092010)
• Digital Electrocardiographs iE 12A (K123816)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.

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

January 22, 2015

Shenzhen Biocare Bio-Medical Equipment Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 CH

Re: K133985

> Trade/Device Name: Digital Electrocardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: December 3. 2014 Received: December 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 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

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related adverse events) (21 CFR 803): good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Melissa A. Torres -S

For

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

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# Indications for Use

510(k) Number (if known) K133985

Device Name

Digital Electrocardiograph ECG-2000

Type of Use (Select one or both, as applicable)

Indications for Use (Describe)

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

| <span> <span style="font-size: 12px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
|-----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
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# Tab #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.

The assigned 510(k) Number: K133985

- 1. Date of Submission: 01/07/2015
- 2. Sponsor Identification

Shenzhen Biocare Bio-Medical Equipment Co., Ltd Room A735, Floor 7, Tower A, Shenzhen Famous Industrial Procurement & Exhibition Center, No. 168 Baoyuan Road, Baoan, Shenzhen, 518102, P.R. China

Establishment Registration Number: 3008457078

Contact Person: Mr. Hongbo Zhong Position: Director Tel: [phone]-8856 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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- Proposed Device Identification 4.
Proposed Device Name: Digital Electrocardiograph Model: ECG-2000 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 Electrocardiograph is 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 Electrocardiograph shall be used in healthcare facilities by doctors and/or trained healthcare professionals.

- న్. Predicate Device Identification
Predicate Device 1 510(k) Number:K092010 Product Name: PC ECG Manufacturer: Edan Instruments, Inc.

Predicate device 2 510(k) Number: K123816 Product Name: Digital Electrocardiographs iE 12A Manufacturer: Shenzhen Biocare Electronics Co., Ltd

- Device Description 6.
Digital Electrocardiograph, ECG-2000, is 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.

It consists of the acquisition box, optional accessories, installation CD, and USB dongle. The acquisition box is connected with ECG electrodes, and intends to acquire ECG signals from patient. The acquired ECG signal is filtered and amplified, then transferred to the working station. The acquisition box is

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powered by the working station via a USB line. The working station is a Personal Computer installed with ECG-2000 Software, it intends to receive the processed ECG signal from the acquisition box, and further display and record the signals. Optional accessories include lead wires, limb electrodes and chest electrodes, and general-purpose printer (with USB interface, support PCL language, such as HP1010, P2035, and P2055d series). The CD contains Digital Electrocardiograph installer and dongle installation program module.

- 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 60601-1:2005 + CORR.1(2006) + CORR.2(2007) +AM1(2012), Medical electrical equipment - Part 1 : General requirements for basic safety and essential performance.

EN 60601-1-2:2007+AC:2010, 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: 2011, Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs.

Software Verification Test was performed to verify the software functions against its intended use.

- 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 | Predicate Device 1 | Predicate Device 2 |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|--------------------|
| Product Code | DPS | Same | Same |
| Regulation Number | 21 CFR 870. 2340 | Same | Same |
| Class | Class II | Same | Same |
| Intended Use | Digital Electrocardiograph is<br>intended to acquire ECG signals<br>from adult patients through body<br>surface ECG electrodes. The<br>obtained ECG records can help<br>users to analyze and diagnose heart | Similar | Similar |
| | disease. Digital Electrocardiograph | | |

Table 3-1 Comparison of Technology Characteristics

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| | shall be used in healthcare facilities<br>by doctors and/or trained healthcare<br>professionals. | | |
|-----------------------------|--------------------------------------------------------------------------------------------------|---------|------|
| Configuration | Chest Electrode and Limb Electrode | Same | Same |
| ECG Lead | Standard 12-lead | Same | Same |
| ECG Gain | 1.25, 2.5, 5, 10, 20, 10-5, 20-10<br>(mm/mV) | Similar | Same |
| Sampling rate | 1000Hz | Same | Same |
| Input circuit current | ≤0.1 μΑ | Similar | Same |
| Noise level | <15μ Vp-p | Similar | Same |
| Electrical Safety | Comply with IEC 60601-1 | Same | Same |
| EMC | Comply with IEC 60601-1-2 | Same | Same |
| Patient-contact<br>Material | Chest Electrode: Metal<br>Limb Electrode: ABS | Same | Same |

### SE Discussion

The proposed device provides more options for gains than those of the predicate device 1, therefore, this difference will not affect the safety and effectiveness;

The proposed device provides a wider range of bandwidth than that of the predicate device 1. Therefore, the difference will not affect the safety and effectiveness of the proposed device.

The noise level and input circuit current of the proposed and predicate device 1 are different, however both the specifications comply with IEC 60601-1.

## SE Conclusion

The proposed device, Digital Electrocardiograph EG-2000, is determined to be Substantially Equivalent (SE) to the predicate devices, PC ECG (K092010) and Digital Electrocardiographs iE 12A (K123816), in respect of safety and effectiveness.