Digital Electrocardiograph

K160092 · Shenzhen Biocare Bio-Medical Equipment Co., Ltd. · DPS · Feb 12, 2016 · Cardiovascular

Device Facts

• Record ID: K160092
• Device Name: Digital Electrocardiograph
• Applicant: Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
• Product Code: DPS · Cardiovascular
• Decision Date: Feb 12, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

Indications for 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. The proposed device has analysis feature, however the ECC with measurements and interpretive statements is offered to clinician on an advisory basis only.

Device Story

Digital electrocardiographs (iE101, iE300) acquire 12-lead ECG signals via body surface electrodes. Signals are amplified, filtered, and processed by internal control modules. Output includes real-time waveform display on an LCD screen and hard-copy printouts via an integrated thermal printer. Used in hospitals and clinics by physicians and trained healthcare professionals. Device provides automated analysis, measurements, and interpretive statements on an advisory basis to assist clinicians in diagnosing heart disease; clinical decision-making remains the responsibility of the provider. Benefits include rapid acquisition and visualization of cardiac electrical activity.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

12-lead ECG acquisition; thermal printer; LCD display. Modules: power supply, signal collection, amplification, control. Complies with IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and IEC 60601-2-25 (electrocardiograph requirements). Biocompatibility per ISO 10993. Software-based analysis and interpretation.

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

• Digital Electrocardiograph, iE 3 (K141946)

Submission Summary (Full Text)

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

Public Health Service

Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized caduceus symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the symbol.

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

February 12, 2016

Shenzhen Biocare Bio-medical Equipment Co., Ltd. Ms. Diana Hong General Manager P.O. Box 120-119 Shanghai, 200120 CN

Re: K160092

Trade/Device Name: Digital Electrocardiograph, iE101 and iE300 Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: December 29, 2015 Received: January 15, 2016

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 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

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

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 (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,

Mitchell Stein

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

Enclosure

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

## Indications for Use

510(k) Number (if known) K160092

Device Name Digital Electrocardiograph, iE101 and iE300

#### 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. The proposed device has analysis feature, however the ECC with measurements and interpretive statements is offered to clinician on an advisory basis only.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"> <span> <span style="font-size:16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div style="display:flex; align-items:center;"> <span> <span style="font-size:16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

## K160092

# Page 1 of 4

## 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: K160092

- 1. Date of Preparation: 01/21/2016
- 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. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)

#### Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

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

K160092

Page 2 of 4

#### Identification of Proposed Device 4.

Trade Name: Digital Electrocardiograph; Common Name: Electrocardiograph Models: iE 101 and iE300

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. The proposed device has analysis feature, however the ECG with measurements and interpretive statements is offered to clinician on an advisorv basis only.

#### Device Description

The proposed digital electrocardiograph, iE 101 and iE 300, are designed based on the cleared digital electrocardiographs K141946 (iE 3). The proposed device has same intended use, functional modules design, working modes, analysis function and accessories. the proposed devices are different than the predicate device in that they has new printing channel for iE 101); new layout of user-machine interface; three different physical specification, such as screen size, device dimension, device weight; three different specification, such as battery capacity, noise level and CMRR; and a modified software which is modified to applicable to the proposed devices.

The proposed electrocardiographs, iE 101 and iE 300, 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

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

K160092 Page 3 of 4

module, and control module.

They can acquire ECG signal via twelve leads simultaneously, display or print waveform of ECG signal via one channel (iE 101) or three channel (iE 300).

- న్. Identification of Predicate Device
510(k) Number: K141946 Product Name: Digital Electrocardiograph Model: iE 3

- 6. 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 + A 1: 2012, Medical electrical equipment, Part 1: General requirements for safety.
- > 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 tests.
- A IEC 60601-2-25:2011, Medical electrical equipment, Part 2-25: Particular requirements for the safety of electrocardiographs.
- 7. Clinical Test Conclusion

No clinical study is included in this submission.

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

## K160092 Page 4 of 4

#### 8. Substantially Equivalent (SE) Comparison

| Item | Proposed Devices | Predicate Device<br>K141946 |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Model | iE 101/ iE 300 | iE 3 |
| Product Code | DPS | DPS |
| Regulation Number | 870.2340 | 870.2340 |
| 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. The proposed device has analysis feature, however the ECG with measurements and interpretive statements is offered to clinician on an advisory basis only. | SAME |
| Intended Population | Adult and pediatric patients | SAME |
| Intended Environment | Hospital, clinics | SAME |
| Configuration | ECG main unit<br>Chest electrodes and Limb electrode | SAME |
| Lead | Standard 12-lead | SAME |
| Acquisition mode | Simultaneous 12-lead acquisition | SAME |
| Recording format | Automatic / Manual / Rhythm | SAME |
| Analysis mode | Yes | SAME |
| Screen size | 5.0" (iE 101)<br>5.0" (iE 300) | 6.0" |
| Channel | 1 channel (iE 101)<br>3 channel (iE 101) | 3 channel |
| Biocompatibility | Comply with ISO 10993 | SAME |
| Electrical Safety | Comply with IEC 60601-1 | SAME |
| EMC | Comply with IEC 60601-1-2 | SAME |
| Particular requirements | Comply with IEC 60601-2-25 | SAME |

## Table 1 Comparison of Technology Characteristics

- 9. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.