DIGITAL ELECTROCARDIOGRAPHS

K123816 · Shenzhen Biocare Electronics Co., Ltd. · DPS · Feb 27, 2013 · Cardiovascular

Device Facts

• Record ID: K123816
• Device Name: DIGITAL ELECTROCARDIOGRAPHS
• Applicant: Shenzhen Biocare Electronics Co., Ltd.
• Product Code: DPS · Cardiovascular
• Decision Date: Feb 27, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Digital Electrocardiographs, iE 12A / iE 15S. 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 12A, iE 15, iE 15S) acquire, display, and record ECG signals from patient body surfaces using ECG electrodes. Input signals undergo amplification and filtering; processed waveforms are displayed on an integrated LCD and printed via a thermal printer. ECG data and patient information are stored in device memory. Used in healthcare facilities by physicians or trained healthcare professionals to assist in heart disease diagnosis. Device provides visual ECG data to support clinical decision-making.

Clinical Evidence

Bench testing only. Compliance with EN 60601-1, EN 60601-2-25, EN 60601-1-2, and IEC 60601-2-51 standards verified design specifications and substantial equivalence.

Technological Characteristics

Standard 12-lead (iE 12A) or 12/15-lead (iE 15/15S) acquisition. Frequency response 0.05-250 Hz. CMRR >60dB (>100dB with AC filter). Input impedance >50MΩ. Thermal printer output. LCD display. Connectivity includes external input/output ports. Powered by medical electrical equipment standards (EN 60601 series).

Indications for Use

Indicated for adult and pediatric patients to acquire ECG signals via body surface electrodes for the analysis and diagnosis of heart disease. For use 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 Electrocardiograph / iE 12 (K122712)

Submission Summary (Full Text)

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K123816 1/4

Premarket Notification 510(k) Submission

Project #:M0152012B Section III 510(k) Summary

# FEB 2 7 2013

## Section V 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 21 CFR 807.92.

The assigned 510(k) Number:

1. Date of prepared: Dec. 7, 2012

2. Sponsor

> Shenzhen Biocare Electronics Co., Ltd 5/F, Taohuayuan High-Tech Innovation Park, Baoan Shenzhen, Guangdong, 518102, China

Establishment Registration Number: 3008457078

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

- Submission Correspondent 3. Ms. Diana Hong & Mr. Tarzan Wang Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: [phone] Fax: [phone] Email: [e-mail]
- 4. Proposed Device Identification

Proposed Device Trade Name: Digital Electrocardiographs Proposed Device Common Name: Electrocardiographs Proposed Device Model: iE 12A / iE 15 / iE 15S Classification: Class II Product Code: DPS Regulation Number: 21 CFR 870.2340 Review Panel: Cardiovascular

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Intended Use Statement:

Digital Electrocardiographs, iE 12A / iE 15S. 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.

- ડ. Predicate Device Identification
510(k) Number: K122712 Product Name: Digital Electrocardiograph / iE 12 Manufacturer: Shenzhen Biocare Electronics Co., Ltd

- Device Description 6.
Digital Electrocardiographs, iE 12A / iE 15 / iE 15S, are designed to acquire, display and record ECG signals from patient body surface by ECG electrodes. After been amplified and filtered, the ECG signals waveforms are displayed in the LCD and recorded in the paper through thermal printer. ECG data result and patient information could be stored in the memory of the device.

All the models. iE 12A / iE 15 / iE 15S, of the proposed device. Digital Electrocardiographs, follow · the same design principle and similar technical specifications.

#### Non-Clinical Test Conclusion 7.

Bench 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:

EN 60601-1:1990+A1:1993+A11:1993+A12:1993+A2:1995+A13:1996, Medical electrical equipment - Part } : General requirements for safety.

EN 60601-2-25:1999, Medical electrical equipment - Part 2: Particular requirements for the safety of electrocardiographs.

EN 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for safety -Collateral standard: Electromagnetic compatibility - Requirements and teats.

IEC60601-2-51:2003. Medical electrical equipment - Part 2: Particular requirements for the safety, including essential performance, of recording and analysing single channel and multi-channel electrocardiographs.

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### Section III 510(k) Summary

Project #:M0152012B

| | | Proposed Device | | | Predicate Device |
|------|-----------------------|-----------------------------------------------------------------------|-------------------------------------------------------------------------|------------------------------------------------------------------------|---------------------------------------------------------------------------|
| ITEM | Model | iE 12A | iE 15 | iE 15S | iE 12 |
| | Lead | Standard 12-lead | Standard<br>12-lead/15-lead | Standard<br>12-lead/15-lead | Standard 12-lead |
| | Acquisition<br>mode | Simultaneous 12-lead<br>acquisition | Simultaneous<br>12-lead/15-lead<br>acquisition | Simultaneous<br>12-lead/15-lead<br>acquisition | Simultaneous<br>12-lead acquisition |
| | Recording<br>format | Automatic / Manual /<br>Rhythm | Automatic / Manual /<br>Rhythm | Automatic / Manual /<br>Rhythm | Automatic /<br>Manual / Rhythm |
| | Frequency<br>response | 0.05 Hz~150 Hz | 0.05 Hz~250 Hz | 0.05 Hz~250 Hz | 0.05~150Hz |
| | Noise level | <15μVp-p | <15μVp-p | <15μVp-p | <15μVp-p |
| | CMRR | >60dB<br>>100dB with AC<br>filter | >60dB<br>>100dB with AC filter | >60dB<br>>100dB with AC<br>filter | >60dB<br>>100dB with AC<br>filter |
| | Recording<br>Speed | Six levels as 5, 6.25,<br>10, 12.5, 25, 50mm/s | Six levels as 5, 6.25,<br>10, 12.5, 25, 50mm/s | Six levels as 5, 6.25,<br>10, 12.5, 25, 50mm/s | Six levels as 5,<br>6.25, 10, 12.5,<br>25, 50mm/s |
| | Input CIR<br>current | ≤0.1μΑ | ≤0.1μΑ | ≤0.1μΑ | ≤0.1μΑ |
| | Input<br>impedance | >50ΜΩ | >50ΜΩ | >50ΜΩ | >50ΜΩ |
| | External<br>Input | Input impedance: ≥<br>100k Ω<br>Sensitivity:<br>10mm/V±5% | Input impedance: ≥<br>100k Ω<br>Sensitivity:<br>10mm/V±5% | Input impedance: ≥<br>100k Ω<br>Sensitivity:<br>10mm/V±5% | Input impedance:<br>≥100k Ω<br>Sensitivity:<br>10mm/V±5% |
| | External<br>Output | Output impedance:<br>≤100 Ω<br>Sensitivity: 1V/mV±<br>5% (at 10mm/mV) | Output impedance: ≤<br>100 Ω<br>Sensitivity: 1V/mV ±<br>5% (at 10mm/mV) | Output impedance:<br>≤ 100 Ω<br>Sensitivity: 1 V/mV<br>±5%(at 10mm/mV) | Output impedance:<br>≤100 Ω<br>Sensitivity: 1V/mV<br>±5% (at<br>10mm/mV ) |

#### Technological Characteristics Comparison 8.

#### Substantially Equivalent Conclusion 9.

We compared the proposed device with predicate device in product code, regulation number, class, intended use, performance, safety and EMC, the differences are frequency response and lead, for such differences we conducted relative standard to demonstrate such performance meet the

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Project #:M0152012B

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requirements, the test result shown so.

The proposed device, Digital Electrocardiograph, is determined to be Substantially Equivalent (SE) to the predicate device, Digital Electrocardiograph (K122712), in respect of safety and effectiveness.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

### Public Health Service

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

February 27, 2013

Shenzhen Biocare Electronics Co., Ltd c/o Ms. Diana Hong Submission Correspondent P.O. Box 237-023 Shanghai, 200237, China

Re: K123816

Trade Name: Digital Electrocardiographs Models iE 12A, iE 15 and iE 15S Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiographs Regulatory Class: Class II Product Code: DPS Dated: February 1, 2013 Received: February 5, 2013

Dear Ms. 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. Iisting 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 mav publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Diana Hong

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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/Resourcesfor You/Industrv/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

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Premarket Notification 510(k) Submission

Section II Indications for Use

Project #:M0152012B

## Section II Indications for Use

510(k) Number: Device Name:Digital Electrocardiographs

Indications for Use:

Digital Electrocardiographs, iE 12A / iE 15S, 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.

�PRESCRIPTION USE (Part 21 CFR 801 Subpart D) O OVER-THE-COUNTER USÉ (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)

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