DIGITAL ELECTROCARDIOGRAPH

K141946 · Shenzhen Biocare Bio-Medical Equipment Co., Ltd. · DPS · Feb 13, 2015 · Cardiovascular

Device Facts

• Record ID: K141946
• Device Name: DIGITAL ELECTROCARDIOGRAPH
• Applicant: Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
• Product Code: DPS · Cardiovascular
• Decision Date: Feb 13, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.

Device Story

Digital electrocardiograph (models iE 3, iE 6, iE 12, iE 12A, iE 15, ECG-1210, ECG-3010, ECG-6010) acquires ECG signals from adult/pediatric patients via body surface electrodes. Device consists of power supply, signal collection, amplification, and control modules. Signals are amplified, filtered, and processed by the CardioPro analysis program; waveforms displayed on LCD and printed via thermal printer. Used in hospitals/healthcare facilities by physicians and trained professionals. Provides measurements and interpretive statements on an advisory basis to assist clinical diagnosis of heart disease.

Clinical Evidence

Bench testing only. Device performance verified against IEC 60601-1 (safety), IEC 60601-2-25 (electrocardiograph safety), IEC 60601-1-2 (EMC), and ISO 10993 (biocompatibility) standards. No clinical data provided.

Technological Characteristics

12/15-lead ECG acquisition; simultaneous acquisition; LCD display; thermal printer. Input impedance >50MΩ; frequency response 0.05~150Hz; CMRR >60dB (>100dB with AC filter). Biocompatibility per ISO 10993. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2; performance per IEC 60601-2-25.

Indications for Use

Indicated for adult and pediatric patients requiring ECG signal acquisition for the analysis and diagnosis of heart disease. Intended for use in hospitals or healthcare facilities by doctors and 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)
• Ascentia HeartStation™ ECG Management System (K050858)

Submission Summary (Full Text)

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Public Health Service

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

February 13, 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: K141946

> Trade/Device Name: Digital electrocardiograph Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: January 5, 2015 Received: January 15, 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. Isting 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

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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 devicerelated 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,

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

Enclosure

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# Indications for Use

510(k) Number (if known) KJ41946

Device Name Digital Electrocardiograph

## Indications for Use (Describe)

The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

- Over-The-Counter Use (21 CFR 801 Subpart C)

## PEEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IE NEEDED.

## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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## 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.

The assigned 510(k) Number: K141946

- 1. Date of Submission: July 04, 2014
- 2. Sponsor Identification

Shenzhen Biocare Bio-Medical Equipment Co.,Ltd. #A735, Shenzhen Mingyou Industrial Product Exhibition & Procurement Center, Bao'an, Shenzhen, Guangdong, 518102, China

Establishment Registration Number: 3008457078

Contact Person: Mr. Hongbo Zhong 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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### 4. Proposed Device Identification

Proposed Device Name: Digital Electrocardiograph; Models: iE 3, iE 6, iE 12, iE 12A, iE 15, ECG-1210, ECG-3010 and ECG-6010; Proposed Device Common Name: Electrocardiograph;

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

Intended Use Statement:

The intended use of electrocardiograph is to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.

### ર. Predicate Device Identification

510(k) Number: K091513 Product Name: Smart ECG (SE) Series Electrocardiograph, SE-12 Model: SE-12 Manufacturer: Edan Instruments, Inc

510(k) Number: K050858 Product Name: Ascentia HeartStation™ ECG Management System Manufacturer: Heartlab, Inc.

#### 6. Device Description

Digital Electrocardiograph, iE 3/ iE 6/ iE 12/ iE 12A/ iE 15/ ECG-1210/ ECG-3010/ ECG-6010, are intended to acquire ECG signals from adult and pediatric patients through body surface ECG electrodes. The electrocardiograph is only intended to be used in hospitals or healthcare facilities by doctors and trained healthcare professionals. The cardiogram recorded by the electrocardiograph can help users to analyze and diagnose heart disease. However the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only.

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All the proposed models, iE 3/ iE 6/ iE 12/ iE 12A/ iE 15/ ECG1210/ ECG3010/ ECG6010, follow the same design principle, main components, accessories and software; they 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.

They consist of four modules, which are power supply module, signal collection module, amplification module, and control module.

They can acquire ECG signal via twelve leads simultaneously, display or print waveform of ECG signal via three channel, six channel, twelve channel or fifteen channel.

The CardioPro analysis program is the analysis program used in this proposed device.

- Non-Clinical Test Conclusion 7.
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 60601-1:1990+ A1:1993+ A11:1993+ A12:1993+ A13:1996, Medical electrical equipment, Part 1: General requirements for safety.

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

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 teats.

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### 8. Substantially Equivalent (SE) Conclusion

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 | Predicate Device |
|----------------------------|-----------------------------------------------------------------------------------------------|--------------------------------------|------------------------------------------------|
| | | K091513 | K050858 |
| Model | iE 3/ iE 6/ iE 12/ iE 12A/ iE 15/ | | N.A. |
| | ECG-1210/<br>ECG-3010/ | SE-12 | |
| | ECG-6010 | | |
| Product Code | DPS | Same | Same |
| Regulation | | | |
| Number | 21CFR 870.2340 | Same | Same |
| Intended Use | | | HeartStation™<br>Heartlab<br>The<br>ECG |
| | The<br>intended<br>use<br>of | intended<br>The<br>use<br>of | Management System is a comprehensive data |
| | electrocardiograph is to acquire | electrocardiograph is to acquire | management solution which automates the |
| | ECG signals from adult and | ECG signals from adult and | processing,<br>and<br>storage<br>display<br>of |
| | pediatric patients through body | pediatric patients through body | electrocardiograms (ECGs)<br>throughout<br>a |
| | surface ECG electrodes. The | surface ECG electrodes. The | healthcare enterprise. HeartStation™ accepts |
| | electrocardiograph<br>is<br>only | electrocardiograph<br>is<br>only | standard 12-lead ECGs, which originate from |
| | intended to be used in hospitals | intended to be used in hospitals | any one of a variety of manufacturers' |
| | or healthcare facilities by doctors | healthcare<br>facilities<br>or<br>by | cardiographs and patient monitors, and |
| | and<br>trained<br>healthcare | doctors and trained healthcare | them to a common format.<br>normalizes |
| | professionals. The cardiogram | professionals. The cardiogram | ECGs are<br>then measured,<br>interpreted, |
| | recorded<br>by<br>the | recorded<br>by<br>the | previous<br>compared<br>to<br>ECGs<br>("serial |
| | electrocardiograph<br>can<br>help | electrocardiograph can<br>help | comparison"), optionally printed and stored |
| | users to analyze and diagnose | users to analyze and diagnose | with a preliminary diagnosis. A graphical user |
| | heart disease. However the ECG | heart disease. However<br>the | interface allows a physician to review these |
| | with<br>measurements<br>and | ECG with measurements and | computer-generated reports, modify them or |
| | interpretive statements is offered | interpretive<br>statements<br>is | add comments as appropriate, electronically |
| | to clinician on an advisory basis | offered to clinician on<br>an | his or her signature and trigger the<br>apply |
| | only. | advisory basis only. | automatic distribution of final, confirmed |
| | | | diagnostic reports to other care providers. |
| Lead | Standard 12-lead or 15 lead | Standard 12-lead | N.A. |
| Acquisition | Simultaneous 12-lead acquisition | Simultaneous<br>12-lead | N.A. |
| mode | or 15 lead acquisition | acquisition | |
| Recording | Automatic / Manual / Rhythm | Same | Unknown |
| format | | | |
| Analysis mode | Yes | Yes | Yes |
| CMRR | >60dB | Similar | Unknown |
| | >100 with AC filter | | |
| Paper Speed | 4 levels as 6.25, 12.5, 25,<br>50mm/s, OR<br>6 levels as: 5, 6.25, 10, 12.5, 25<br>and 50mm/s | Similar | Unknown |
| | | | |
| Input CIR<br>current | ≤0.1μΑ | Similar | Unknown |
| | | | |
| Input impedance | >50ΜΩ | Same | Unknown |
| Patient leak<br>current | <10μΑ | Same | Unknown |
| | | | |
| Frequency<br>response | 0.05~150Hz | Same | Unknown |
| | | | |
| Noise level | <15μVp-p | Similar | Unknown |
| Electrical Safety | Comply with IEC 60601-1 | Same | Same |
| EMC | Comply with IEC 60601-1-2 | Same | Same |
| Particular<br>requirements | Comply with IEC 60601-2-25 | Same | Unknown |
| | | | |
| Biocompatibility | Comply with ISO 10993 | Same | N.A. |

Table 3-1 Comparison of Technology Characteristics

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The proposed device, Digital Electrocardiograph, is determined to be Substantially Equivalent (SE) to the predicate device, Smart ECG (SE) Series Electrocardiograph, SE-12 (K091513) and Ascentia HeartStation™ ECG Management System (K050858) in respect of safety and effectiveness.