CV3000 HOLTER ANALYSIS SYSTEM

K131897 · Vales & Hills Biomedical Tech. , Ltd. · MLO · Nov 26, 2013 · Cardiovascular

Device Facts

• Record ID: K131897
• Device Name: CV3000 HOLTER ANALYSIS SYSTEM
• Applicant: Vales & Hills Biomedical Tech. , Ltd.
• Product Code: MLO · Cardiovascular
• Decision Date: Nov 26, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2

Intended Use

The proposed device is intended to continuously acquire ambulatory ECG data for up to twelve leads or five leads. It can record the ECG data for twenty four hours. The ECG data obtained will be stored in the recorder first and then download to PC for analysis, reviewing and printing by a trained physician in health facilities.

Device Story

CV3000 Holter Analysis System consists of ambulatory ECG recorder and PC-based analysis software. Recorder captures 5 or 12-lead ECG data over 24-hour period; stores data on internal memory. Data transferred to PC for review, analysis, and printing by trained physician in clinical setting. System facilitates cardiac rhythm and ST-segment measurement. Physician uses output to assess cardiac health and inform clinical decision-making. Benefits include continuous monitoring of ambulatory patients to detect cardiac abnormalities.

Clinical Evidence

Bench testing only. Compliance verified against IEC 60601-1, IEC 60601-1-2, ANSI/AAMI EC38, and ANSI/AAMI EC57 standards for safety, electromagnetic compatibility, and cardiac rhythm/ST-segment measurement algorithm performance.

Technological Characteristics

Ambulatory ECG system; 5 or 12-lead configuration; 24-hour recording capacity. PC-based analysis software. Connectivity via SD card reader. Standards: IEC 60601-1, IEC 60601-1-2, ANSI/AAMI EC38, ANSI/AAMI EC57. Time constant ≥3.2s; patient leak current <10μA; frequency response 0.05~40 Hz; CMRR >80dB.

Indications for Use

Indicated for patients requiring continuous ambulatory ECG monitoring for up to 24 hours using 5 or 12 leads. Intended for use in health facilities by trained physicians.

Regulatory Classification

Identification

A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.

Predicate Devices

• Dynamic ECG Systems, TLC5000 (K101273)

Submission Summary (Full Text)

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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: K131897

- 1. Date of Submission: Jun 19, 2013
- in Sponsor Identification

Vales & Hills Biomedical Tech. Ltd Bldg 46-1 BDA International Business Park, 100176, Beijing, P.R. China

Establishment Registration Number: Not yet registered

Contact Person: Jianfang Liu Position: Quality 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]

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#### 4. Proposed Device Identification

Proposed Device Name: CV3000 Holter Analysis System Proposed Device Common Name: Dynamic ECG System

Regulatory Information: Classification Name: Electrocardiograph, Ambulatory, With Analysis Algorithm Classification: II; Product Code: MLO Regulation Number: 21CFR 870.2800 Review Panel: Cardiovascular;

#### Intended Use Statement:

The proposed device is intended to continuously acquire ambulatory ECG data for up to twelve leads or five leads. It can record the ECG data for twenty four hours. The ECG data obtained will be stored in the recorder first and then download to PC for analysis, reviewing and printing by a trained physician in health facilities.

- 5. Predicate Device Identification
510(k) Number: K101273 Product Name: Dynamic ECG Systems, TLC5000 Manufacturer: CONTEC Medical System Co., Ltd

- Device Description 6.
The CV3000 Holter Analysis System is intended to continuously acquire ambulatory ECG data for up to twelve leads or five leads. It can record the ECG data for twenty four hours. The ECG data obtained will be stored in the recorder first and then download to PC for analysis, reviewing and printing by a trained physician in health facilities.

The CV3000 Holter Analysis System is consisting of Holter recorder and the PC-based CV3000 Analysis Software.

The Holter recorder is an ambulatory electrocardiograph designed to be used with the PC-based CV3000 Analysis Software. It is intended to acquire, record and store up to 24 hours of ECG data from the patient. It performs no cardiac analysis by itself and is intended to be used with the CV3000 analysis software. ECG data prerecorded by the Holter recorder is analyzed by the CV3000 analysis software.

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The main accessories contain disposable electrodes, cables, SD card reader and battery. The disposable electrodes and battery is not provided during marketing, the users need purchase disposable electrode/battery by themselves.

The collateral devices contain personal computer (PC) and printer.

7. 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 60601-1:1988+A1:1993+A2:1995, 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 teats.

ANSI/AAMI EC38:2007, Ambulatory electrocardiographs

ANSI/AAMI EC 57:1998(R) 2003, Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms

- 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.

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| ITEM | Proposed Device | Predicate Device |
|----------------------|----------------------------------------|---------------------------|
| Product Code | MLO | Same |
| Regulation Number | 21 CFR 870.2800 | Same |
| Operation mode | Automatic | Same |
| Time constant | ≥3.2s | Same |
| Patient leak current | <10μA | Same |
| Frequency response | 0.05~40 Hz | Similar |
| Noise level | <50μV | Similar |
| CMRR | >80dB | Similar |
| Scan speed | 5 mm/mV,10 mm/mV, 20 mm/mV, error ±10% | Unknown |
| Measurement Function | Have measurement function | Have measurement function |

Table 3-1 Comparison of Technology Characteristics

The proposed device, CV3000 Holter Analysis System, is determined to be Substantially Equivalent (SE) to the predicate device, Dynamic ECG Systems, TLC5000 (K101273), 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or supporting another, represented by flowing, abstract lines.

#### Public Health Service

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

November 26, 2013

Vales & Hills Biomedical Tech. Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, CH 200120

Re: K131897

> Trade/Device Name: Cv3000 Holter Analysis System Regulation Number: 21 CFR 870.2800 Regulation Name: Dynamic Ecg System Regulatory Class: Class II Product Code: MLO Dated: October 15, 2013 Received: October 24, 2013

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, 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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## Page 2 - 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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Owen=P.Earis -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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## Section 2 Indications for Use

510(k) Number: K131897 Device Name: CV3000 Holter Analysis System

Indications for Use:

The proposed device is intended to continuously acquire ambulatory ECG data for up to twelve leads or five leads. It can record the ECG data for twenty four hours. The ECG data obtained will be stored in the recorder first and then download to PC for analysis, reviewing and printing by a trained physician in health facilities.

�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)

Digitally signed by
Owen P. Faris -S
Date: 2013.11.26
15:51:01-05'00'

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