Digital Electrocardiograph

K152384 · Shenzhen Biocare Bio-Medical Equipment Co., Ltd. · DPS · Dec 18, 2015 · Cardiovascular

Device Facts

• Record ID: K152384
• Device Name: Digital Electrocardiograph
• Applicant: Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
• Product Code: DPS · Cardiovascular
• Decision Date: Dec 18, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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

Device Story

Digital Electrocardiograph (ECG-2000) acquires ECG signals via body surface electrodes; signals filtered and amplified by acquisition box; data transferred via USB to workstation (PC) running ECG-2000 software. System displays and records ECG signals for clinical analysis and diagnosis of heart disease. Used in healthcare facilities by physicians or trained professionals. Provides standard 12-lead ECG; supports various gain settings (1.25 to 20 mm/mV) and 1000Hz sampling rate. Benefits include standardized cardiac signal acquisition for diagnostic support.

Clinical Evidence

No clinical data. Bench testing only, including verification of compliance with IEC 60601-2-25:2011 for basic safety and essential performance.

Technological Characteristics

12-lead ECG system; acquisition box powered via USB; chest electrodes (metal) and limb electrodes (ABS). Sampling rate 1000Hz. Complies with IEC 60601-1 (electrical safety) and IEC 60601-1-2 (EMC). Software-based signal processing on PC workstation.

Indications for Use

Indicated for adult and pediatric patients requiring ECG signal acquisition 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 Electrocardiograph, ECG-2000 (K133985)

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 and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with a flowing design element below them.

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

December 18, 2015

Shenzhen Biocare Bio-medical Equipment Co., Ltd. % Diana Hong General Manager Mid-link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CHINA

Re: K152384

Trade/Device Name: Digital Electrocardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: November 6, 2015 Received: November 9, 2015

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 of medical device

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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 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,

Mitchell Stein

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

Enclosure

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# Indications for Use

510(k) Number (if known) K152384

Device Name Digital Electrocardiograph, ECG-2000

Indications for Use (Describe)

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

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# Tab #7 510(k) Summary

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

The assigned 510(k) Number:

- 1. Date of Preparation: 08/04/2016
- 2. Sponsor Identification

Shenzhen Biocare Bio-Medical Equipment Co., Ltd. Room A735, Floor 7, Tower A, Shenzhen Famous Industrial Products 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. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Mr. Lee Fu (Alternative Contact Person)

## 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. Identification of Proposed Device

Trade 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:

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

Device Description

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 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.

#### ર . Identification of Predicate Device(s)

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

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Predicate device 2 510(k) Number: K133985 Product Name: Digital Electrocardiograph, ECG-2000 Manufacturer: Shenzhen Biocare Bio-Medical Equipment Co., Ltd.

- 6. Non-Clinical Test Conclusion
This submission is filed for extension of intended use, the device, including its hardware and software, has not been changed from the one cleared in the previous submission, K133985; therefore, only the following standard was tested to verify that the device can meet its additional intended use:

IEC 60601-2-25: 2011, Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs.

- 7. Clinical Test Conclusion
No clinical study is included in this submission.

- Substantially Equivalent (SE) Comparison 8.

| Item | Proposed Device | Predicate<br>Device1 | Predicate<br>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<br>disease. Digital Electrocardiograph<br>shall be used in healthcare facilities<br>by doctors and/or trained healthcare<br>professionals. | Same | Similar |
| 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 |

### Table 1 Comparison of Technology Characteristics

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| Input circuit current | $\leq$ 0.1 μA | Similar | Same |
|-----------------------|---------------------------|---------|------|
| Noise level | $<15\mu$ Vp-p | Similar | Same |
| Electrical Safety | Comply with IEC 60601-1 | Same | Same |
| EMC | Comply with IEC 60601-1-2 | Same | Same |
| Patient-contact | Chest Electrode: Metal | Same | Same |
| Material | Limb Electrode: ABS | Same | Same |

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.

- Substantially Equivalent (SE) Conclusion 9.
The proposed device, Digital Electrocardiograph EG-2000, is determined to be Substantially Equivalent (SE) to the predicate devices, PC ECG (K092010) and Digital Electrocardiographs ECG-2000 (K133985), in respect of safety and effectiveness.