DIGITAL ELECTROCARDIOGRAPH

K132758 · Shenzhen Biocare Bio-Medical Equipment Co., Ltd. · DPS · Jan 30, 2014 · Cardiovascular

Device Facts

• Record ID: K132758
• Device Name: DIGITAL ELECTROCARDIOGRAPH
• Applicant: Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
• Product Code: DPS · Cardiovascular
• Decision Date: Jan 30, 2014
• Decision: SESE
• Submission Type: Special
• 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 Electrocardiographs (models iE 3, iE 6) acquire, display, and record ECG signals from adult and pediatric patients via body surface electrodes. Device stores ECG data and patient information in internal memory. Used in healthcare facilities by physicians or trained healthcare professionals to assist in heart disease diagnosis. Output consists of ECG records for clinical review. Benefits include facilitating diagnostic assessment of cardiac conditions.

Clinical Evidence

Bench testing only. No clinical data provided. Compliance with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC) standards verified to demonstrate substantial equivalence.

Technological Characteristics

Electrocardiograph; ABS/Tin Alloy patient contact materials; AC/DC power source; limb and chest electrodes; non-sterile; reusable. Connectivity and specific software architecture details not provided.

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

• Digital Electrocardiographs, iE12 (K122712)

Submission Summary (Full Text)

{0}------------------------------------------------

# JAN 30 2014

# Section 10 510(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: K132758

10.1 Date of Submission: 08/30/2013

10.2 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, Bao'an, Shenzhen, Guangdong, 518102, China

Establishment Registration Number: 3008457078

Contact Person: Mr. HongboZhong Position: R&D Director Tel: [phone]-8856 Fax: [phone] Email: [e-mail]

10.3 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]

{1}------------------------------------------------

#### Premarket Notification 510(k) Submission

10.4Proposed Device Identification

Proposed Device Name: Digital Electrocardiograph Models: iE 3.iE 6 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.

10.5 Predicate Device Identification

510(k) Number:K 122712

Predicate Device Name: Digital Electrocardiographs, iE12

Manufacturer: Shenzhen Biocare Electronics Co., Ltd

10.6Device Description

Digital Electrocardiographs, iE 3, iE 6, are intended to acquire, display and record ECG signals from adult and pediatric patients through body surface by ECG electrodes. ECG data result and patient information could be stored in the memory of the device. The obtained ECG records can help users to analyze and diagnose heart disease.

#### 10.7 Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as vas Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed 10-2

{2}------------------------------------------------

device complies with the following standards:

- A 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, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests.

10.8 Substantially Equivalent (SE) Conclusion

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

| Item | Proposed Device(s) | Predicate Device |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model | iE 3 | iE 12 |
| 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 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 in<br>healthcare facilities by doctors<br>and/or trained healthcare<br>professionals. |
| Patient Contact Material | ABS / Tin Alloy | ABS / Tin Alloy |
| 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 |
| Accessories | Limb Electrode<br>Chest Electrode<br>Battery | Limb Electrode<br>Chest Electrode<br>Battery |

Table 3-1 Comparison of Technology Characteristics between iE 3 and iE 12

10-3

{3}------------------------------------------------

#### Premarket Notification 510(k) Submission

| Item | Proposed Device(s) | Predicate Device |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | K122712 |
| Model | iE 6 | iE 12 |
| 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 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 in<br>healthcare facilities by doctors<br>and/or trained healthcare<br>professionals. |
| Patient Contact Material | ABS / Tin Alloy | ABS / Tin Alloy |
| 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 |
| Accessories | Limb Electrode<br>Chest Electrode<br>Battery | Limb Electrode<br>Chest Electrode<br>Battery |

## Table 3-2 Comparison of Technology Characteristics between iE 6 and iE 12

## 10.9 SE Conclusion

.

The proposed devices, Digital Electrocardiographs, iE 3 and iE 6, are determined to be Substantially Equivalent (SE) to the predicate devices, Digital Electrocardiographs, iE 12.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Public Health Service

ood and Drug Administration 903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 30, 2014

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

Re: K132758

> Trade/Device Name: Digital electrocardiograph models iE 3 and iE 6 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: December 21, 2013 Received: January 3, 2014

Dear Ms. 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 11 (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 (2) CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-

{5}------------------------------------------------

## Page 2 - Ms. Diana Hong

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/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 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,

# Owen P. Faris -S

for

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

Enclosure

{6}------------------------------------------------

Premarket Notification 510(k) Submission Section 2 Indications for Use Project #: M0602013

# Section 2 Indications for Use

and/or trained healthcare professionals.

.

| 510(k) Number: | |
|-----------------------------------------|--|
| Device Name: Digital Electrocardiograph | |
| Indications for Use: iE 3, iE 6 | |

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

Page I of I

| PRESCRIPTION USE | | | | | |
|--------------------------------------------------------------------------|--|--|--|--|--|
| (Part 21 CFR 801 Subpart D) | | | | | |
| OR | | | | | |
| 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) | | | | | |

Digi
Owe
Date
15-2

Digitally signed by Owen P. Faris -5 Date: 2014.01.30 1 5:21:59 -05/00/

2- I