DIGITAL ELECTROCARDIOGRAPHS

K131262 · Sonoscape Company Limited · DPS · Nov 14, 2013 · Cardiovascular

Device Facts

• Record ID: K131262
• Device Name: DIGITAL ELECTROCARDIOGRAPHS
• Applicant: Sonoscape Company Limited
• Product Code: DPS · Cardiovascular
• Decision Date: Nov 14, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Digital Electrocardiographs, IE3/ IE12/ IE12P/ IE15, 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 IE3, IE6, IE12, IE12P, IE15) acquire, display, and record ECG signals from patient body surfaces via electrodes. The device consists of power supply, amplification, and control modules. It performs simultaneous 12-lead acquisition (bipolar limb, augmented unipolar limb, and unipolar chest leads). Signals are amplified and filtered before being displayed on an LCD and printed via a thermal printer. Data, analysis results, and patient information are stored in device memory. Operated by doctors or trained healthcare professionals in healthcare facilities. The device supports three recording modes: AUTO, MAN, and RHY. Output provides clinicians with ECG waveforms and records to assist in heart disease diagnosis.

Clinical Evidence

Bench testing only. The device demonstrated compliance with IEC 60601-1 (safety), IEC 60601-2-25 (electrocardiograph performance), IEC 60601-1-2 (EMC), and ISO 10993 (biocompatibility). No clinical data was required or provided.

Technological Characteristics

Standard 12-lead ECG acquisition; simultaneous 12-lead processing. Components: power supply, amplification, and control modules. Features LCD display and thermal printer. Connectivity: internal memory storage. Electrical safety: IEC 60601-1; Performance: IEC 60601-2-25; EMC: IEC 60601-1-2. Biocompatibility: ISO 10993. Input impedance >50MΩ; CMRR >60dB; Frequency response 0.05~150Hz.

Indications for Use

Indicated for adult and pediatric patients requiring ECG signal acquisition for the analysis and diagnosis of heart disease. To be used by doctors or trained healthcare professionals in healthcare facilities.

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 (K122712)
• Digital Electrocardiographs (K123816)

Submission Summary (Full Text)

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#### K131262

.

P 1/5

#### 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: K131262

l . Date of Submission: Apr 22, 2013

2. Sponsor Identification

> SonoScape Co., Ltd Yizhe Building, Yuquan Road, Shenzhen, 518051. China

Establishment Registration Number: 3004705634

Contact Person: Toki Wu Position: Regulatory Affairs Manager Tel: [phone] Fax: [phone] Email: [e-mail]

3. Submission Correspondent

> Ms. Diana Hong & Mr. Tarzan Wang Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120, China Tel: [phone] Fax: [phone] Email: [e-mail]

**NOV 1 4 2013**

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#### K 131262 p 2/5

Proposed Device Identification

Proposed Device Trade Name: Digital Electrocardiograph; Proposed Device Common Name: Electrocardiograph; Proposed Device Model: 1E3/ 1E6/ 1E12/ 1E12P/ 1E15

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

Intended Use Statement:

Digital Electrocardiographs, IE3/ 1E12/ IE12P/ IE15, arc 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.

4. Predicate Device Identification

> 510(k) Number: K122712 Product Name: Digital Electrocardiographs Product Model: iE 3S, iE 6S, iE 12 and iE 12P Manufacturer: Shenzhen Biocare Electronics Co., Ltd

> 510(k) Number: K123816 Product Name: Digital Electrocardiographs Product Model: iE 15S Manufacturer: Shenzhen Biocare Electronics Co., Ltd

#### Device Description ર .

Digital Electrocardiographs, IE3/ IE12/ IE12/ IE15, are designed to acquire, analyze, display and record ECG signals from patient body surface by ECG electrodes. After been amplified, filtered and analyzed, the ECG signals waveforms and analysis results are displayed in the LCD and recorded in the paper through thermal printer. ECG data, analysis result and patient information could be stored in the memory of the device.

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| K131262 | Additional Information I | E3 510k Summary |
|---------|--------------------------|-----------------|
| | | |

| | K131262 |
|--|---------|
| | P 3/5 |

The device consists of three modules, which are power supply module, amplification module, and control module.

The device has three recording mode, AUTO mode, MAN mode and RHY mode,

They are standard twelve leads, including bipolar limb leads, augmented unipolar limb leads and unipolar chest leads.

- 6. Non-Clinical Test Conclusion
ព

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.

- 7. Substantially Equivalent (SE) Conclusion
The following table compares the Digital Electrocardiographs to the predicate devices with respect to intended use and technological characteristics, etc.

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## K 131262

#### P 4/5

| ITEM | Proposed Device | Predicate Device<br>K122712 | Predicate Device<br>K123816 |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-----------------------------|
| Model | IE3/IE6/IE12/IE12P/IE15 | iE 3S/iE 6S/iE 12/iE 12P | iE 15S |
| Product Code | DPS | Same | Same |
| Regulation<br>Number | 21CFR 870.2340 | Same | Same |
| Intended Use | Digital Electrocardiographs, IE3/IE6/IE12/IE12P/IE15, 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. | Similar | Similar |
| Main Unit Specification | | | |
| Lead | Standard 12-lead | Same | Same |
| Acquisition mode | Simultaneous 12-lead acquisition | Same | Same |
| Recording format | Automatic / Manual / Rhythm | Same | Same |
| Analysis mode | No | No | No |
| CMRR | >60dB<br>>100 with AC filter | Same | Same |
| Paper Speed | 4 levels as 6.25, 12.5, 25, 50mm/s, OR<br>6 levels as: 5, 6.25, 10, 12.5, 25 and 50mm/s | Same | Same |
| Input CIR current | <0.1μA | Same | Same |
| Input impedance | >50MΩ | Same | Same |
| Patient leak current | <10μA | Same | Same |
| Frequency response | 0.05~150Hz | Same | Same |
| Noise level | <15μVpp | Same | Same |
| Specification of external input and external output | | | |
| 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 | Same |
| Biocompatibility | Comply with ISO 10993 | Same | Same |

,

Table 3-1 Comparison of Technology Characteristics

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.

The proposed devices, Digital Electrocardiographs, 1E3/ 1E12P/ 1E15, are determined to be Substantially Equivalent (SE) to the predicate devices, K122712 and K123816, in respect of safety and effectiveness.

> K131262 P 5/5

:

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Image /page/5/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The logo is black and white and appears to be a scan of a printed document.

November 14, 2013

Sonoscape Company Limited c/o Ms. Diana Hong General Manager P.o. Box 120-119 Shanghai, 237-023 CH

Re: K131262

> Trade/Device Name: Digital Electrocardiographs Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: II (two) Product Code: DPS Dated: September 28, 2013 Received: October 15, 2013

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.

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

Enclosure

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### K131262

#### Indications for Use

510(k) Number: K131262 Device Name: Digital Electrocardiograph

Indications for Use:

Digital Electrocardiographs, IE3/ IE12/ IE12P/ IE15, 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)

OR

OOVER-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) | |
|--------------------------------------------------------|---|
| Digitally signed by Owen P. Faris -S | |
| Date: 2013.11.14 10:26:47 -05'00' | |
| Page | 1 |

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