MAC 5000 ECG ANALYSIS SYSTEM

K014108 · General Electric Medical Systems Information Techn · DQK · Jan 10, 2002 · Cardiovascular

Device Facts

• Record ID: K014108
• Device Name: MAC 5000 ECG ANALYSIS SYSTEM
• Applicant: General Electric Medical Systems Information Techn
• Product Code: DQK · Cardiovascular
• Decision Date: Jan 10, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The MAC 5000 ECG Analysis System is intended to be used under the direct supervision of a licensed healthcare practitioner. The MAC 5000 is intended to be used by trained operators in a hospital or medical professional's facility environment to record ECG signals from surface electrodes. The device is intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations.

Device Story

MAC 5000 ECG Analysis System acquires, analyzes, displays, and records ECG signals via surface electrodes; utilizes processing unit and patient acquisition module. Provides 3, 6, 12, or 15-lead ECGs, interpretive analysis, and vector loops; optional high-resolution signal averaging for QRS and P-wave segments. Used in hospitals/clinics by trained operators under physician supervision. Optional transmission/reception of data to central cardiovascular information systems. Output assists clinicians in cardiac diagnosis and patient monitoring.

Clinical Evidence

No clinical data provided. Compliance with voluntary standards and quality assurance measures (requirements reviews, code inspections, software/hardware testing, safety/environmental testing, and final system validation) used to demonstrate safety and effectiveness.

Technological Characteristics

System includes processing unit and patient acquisition module; supports rechargeable battery and trolley. Connectivity includes optional transmission to central information systems. Software includes interpretive analysis, vector loops, and signal averaging. Complies with voluntary standards for ECG analysis systems.

Indications for Use

Indicated for acquisition, analysis, display, and recording of electrocardiographic information in adult and pediatric populations. Used under direct supervision of licensed healthcare practitioner by trained operators in hospital or clinical settings.

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Predicate Devices

• Mac 5000 Rest ECG Analysis System (K991735)
• GE Marquette ECG Analysis Program (K002209)
• ACI TIPI Algorithm (K974199)
• MAX 1 System (K890323)

Submission Summary (Full Text)

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K014108
p.1/2

JAN 1 0 2002

### Section 2 Summary & Certification

### 510(k) Summary of Safety and Effectiveness

- December 13, 2001 Date:
GE Medical Systems - Information Technologies Submitter: 8200 W. Tower Ave. Milwaukee, WI 53223 USA

- Contact Person: David Wahlig GE Medical Systems - Information Technologies Phone: [phone] Fax: [phone]
Karen Webb Contact Person: GE Medical Systems - Information Technologies Phone: [phone] Fax: [phone]

#### MAC 5000 ECG Analysis System Trade/Proprietary Name:

Common/Usual Name: Electrocardiograph

#### Classification Names & Citations:

| 21 CFR 870.1425 Programmable diagnostic computer | 74DQK |
|---------------------------------------------------------------------------|-------|
| 21 CFR 870.2920 Transmitters and Receivers, Electrocardiograph, Telephone | 74DXH |
| 21 CFR 870.2340 Electrocardiograph | 74DPS |
| 21 CFR 870.2340 System, ECG Analysis | 74LOS |
| 21 CFR 870.1025 Detector and Alarm, Arrhythmia | 74DSI |

Mac 5000 Rest ECG Analysis System K#991735 Predicate Devices: GE Marquette ECG Analysis Program K#002209 ACI TIPI Algorithm K#974199 MAX 1 System K#890323

Device Description: The Mac 5000 ECG Analysis System is designed to acquire, analyze, display, and record ECG signals from surface ECG electrodes. The device consists of two basic components: the processing unit and patient acquisition module. Models provide rechargeable battery operation and/or optional trolley for transporting the equipment.

> The MAC 5000 can deliver 3, 6, 12, or 15 lead ECG's, 12 lead interpretive analysis, vector loops, and can be upgraded to provide software analysis options such as high resolution signal averaging of QRS and P wave portions of the electrocardiogram. Transmission and reception of ECG data to and from a central ECG cardiovascular information system is optional.

Intended Use: The MAC 5000 ECG Analysis System is intended to be used under the direct supervision of a licensed healthcare practitioner. The MAC 5000 is intended to be used by trained operators in a hospital or medical

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professional's facility environment to record ECG signals from surface electrodes. The device is intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations.

- The technological characteristics of the MAC 5000 device have been Technology: updated to reflect use of current technology and to incorporate userrequested features. Data in this submission demonstrate that these technological characteristics do not raise new questions of safety or effectiveness.
The MAC 5000 complies with the voluntary standards as detailed in Test Summary: Section 9 of this submission.

> The following quality assurance measures were applied to the development of the MAC 5000.

- Requirements specification reviews ●
- Code inspections .
- Software and hardware testing .
- Safety testing �
- Environmental testing .
- Final system validation �

#### Conclusion:

The MAC 5000 is a modification to GEMS-IT's existing MAC 5000 device incorporating features that have been previously cleared under different 510(k)'s. This premarket notification submission demonstrates that the MAC 5000 ECG Analysis System is substantially equivalent to the cleared MAC 5000 ECG Analysis System because this device has the same basic intended use and the differences in technological characteristics do not raise new questions of safety or effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 1 0 2002

Mr. David Wahlig Senior Regulatory Affairs Specialist GE Medical Systems Information Technologies 8200 West Tower Avenue Milwaukee, WI 53223

Re: K014108

Trade Name: MAC 5000 ECG Analysis Systems Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: DSI Dated: December 13, 2001 Received: December 13, 2001

Dear Mr. Wahlig:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Mr. David Wahlig

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Walh Tlh
Dr. Brian D. Zuckerman, M.D.

m D. Zuckerman, M.L. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Unknown;

510(k) filed on 13 December, 2001

MAC 5000 ECG Analysis System Device Name: _________________________________________________________________________________________________________________________________________________________________

K014108

Indications For Use:

The MAC 5000 ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations. Basic systems electrocatulographic information from lead. and potitution playsis, vector loops, and can be upgraded to provide software analysis options such as high resolution signal averaging of upgraded to provide somnary of the electrocardiogram. Transmission and reception of ECG QRO and from a central ECG cardiovascular information system is optional.

The MAC 5000 is intended to be used under the direct supervision of a licensed healthcare practitioner, by trained operators in a hospital or medical professional's facility.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K014108

Prescription Use V (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)