MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 ELECTROCARDIOGRAPHS

K991735 · General Electric Medical Systems Information Techn · LOS · Aug 19, 1999 · CV

Device Facts

• Record ID: K991735
• Device Name: MAC SERIES ELECTROCARDIOGRAPHS INCLUDING MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8 ELECTROCARDIOGRAPHS
• Applicant: General Electric Medical Systems Information Techn
• Product Code: LOS · CV
• Decision Date: Aug 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Attributes: Pediatric

Intended Use

The MAC Series Resting ECG Analysis Systems (Includes the MAC PC, MAC 6, MAC VU, MAC 8, and MAC 5000) are intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations. Basic systems deliver 3, 6, 12, or 15 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. The MAC Series 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.

Device Story

MAC Series (MAC 5000, MAC PC, MAC 6, MAC VU, MAC 8) acquires, analyzes, displays, and records ECG signals via surface electrodes. System comprises processing unit and patient acquisition module; supports 3, 6, 12, or 15 lead ECGs, vector loops, and optional high-resolution signal averaging of QRS/P waves. Used in hospitals/clinics by trained operators under licensed practitioner supervision. Optional connectivity to central cardiovascular information systems for data transmission/reception. Computerized analysis provides interpretive tools; output requires over-reading by qualified physician to inform clinical decision-making. Benefits include standardized ECG interpretation and signal processing to assist in cardiac diagnosis.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and compliance with voluntary standards.

Technological Characteristics

Electrocardiograph system with processing unit and patient acquisition module. Supports 3, 6, 12, or 15 lead configurations. Features include interpretive ECG analysis, vector loops, and high-resolution signal averaging. Connectivity options for central information systems. Battery-operated with optional trolley. Complies with voluntary standards.

Indications for Use

Indicated for adult and pediatric populations requiring acquisition, analysis, display, and recording of ECG signals. Contraindicated for use with high frequency surgical units.

Predicate Devices

• MAC II (K820885)
• Marquette 12SL Analysis Program (K964750)

Submission Summary (Full Text)

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AUG 18 1999 16:27 FR GE MARQUETTE FINANCE 414 362 2420 TO 913014804204

P.07/08
Lbt A K99/725

AUG 19 1999

- 510(k) Summary of Safety and Effectiveness
- May 21, 1999 Date:

GE Marquette Medical Systems, Inc. Submitter: 8200 W. Tower Ave. Milwaukee, WI 53223 USA

David Wahlig Contact Person: Corporate Regulatory Affairs GE Marquette Medical Systems Phone: [phone] Fax: [phone]

### 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 |

Marquette Option II ECG Analysis Computer for MAC I Electrocardiograph Predicate Devices: (MAC II) - K820885

Marquette 12SL Analysis Program - K964750

The Mac Series consists of electrocardiograph models designed to acquire, Device Description: analyze, display, and record ECG signals from surface ECG electrodes. The devices consist 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 ORS 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 Series is intended to be used under the direct supervision of a licensed healthcare practitioner. The MAC Series 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 devices are intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations.

Technology: The technological characteristics of the MAC 5000 and related MAC Series devices have been updated to reflect use of current technology and to incorporate user-requested features. Data in this submission demonstrate that these technological characteristics do not raise new questions of safety or effectiveness.

The MAC Series complies with the voluntary standards as detailed in Section 9 Test Summary:

MAC Series electrocardiographs including MAC 5000, MAC PC, MAC 6, Trade/Proprietary Name: MAC VU, MAC 8

Electrocardiograph Common/Usual Name:

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# Responsibility of the Manufacturer

GE Marquette Medical Systems, Inc. is responsible for the effects of safety, reliability, and performance only if:

- Assembly operations, extensions, readjustments, . modifications, or repairs are carried out by persons authorized by GE Marquette.
- The electrical installation of the relevant room complies with the requirements of the appropriate regulations.
- 트 The equipment is used in accordance with the instructions for use.

# General Information

## Intended Use

The intended use of this device is to record ECG signals from surface ECG electrodes. This device can analyze, record, and store electrocardiographic information from adult and pediatric populations. This data can then be computer analyzed with various algorithms such as interpretive ECG and signal averaging for presentation to the user.

This device is intended for use under the direct supervision of a licensed health care practitioner.

This device is not intended for use with high frequency surgical units. Disconnect the patient from the device before using the high frequency surgical unit.

Caution:

Bold>

This equipment uses a computerized ECG analysis program which can be used as a tool in ECG tracing interpretation. This computerized interpretation is only. significant when used in conjunction with clinical findings. All computer-generated tracings should be overread by a qualified pician

MAC 5000 System -- 418625-010, Revision A

1-7

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 9 1999

Mr. David Wahlig -GE Marquette Medical Systems 8200 W. Tower Avenue - Milwaukee, WI 53223

Re: K991735 MAC 5000 and Related MAC Series Resting ECG Analysis Systems Regulatory Class: III (three) Product Code: 74 LOS, DQK, DPS, and DXH Dated: May 21, 1999 Received: May 21, 1999

Dear Mr. Wahlig:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), 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 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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#### Paqe 2 - Mr. David Wahlig

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro -diagnostic devices), please contact the Office of Compliance at (301) 594–4648. 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological 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 21 May, 1999

May, 1999

・・

MAC Series Resting ECG Analysis System Device Name:

Indications For Use:

The MAC Series Resting ECG Analysis Systems (Includes the MAC PC, MAC 6, MAC VU, MAC 8, and MAC 5000) are intended to acquire, analyze, display, and record electrocardiographic information from adult and pediatric populations. Basic systems deliver 3, 6, 12, or 15 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.

The MAC Series 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.

. .

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
|-------------------------------------------------------------------|---------|----------------------|
| (Division Sign-Off) | | |
| Division of Cardiovascular, Respiratory, and Neurological Devices | | |
| 510(k) Number | K991735 | |
| Prescription Use | OR | Over-The-Counter Use |
| (Per 21 CFR 801.109) | | |
| (Optional Format 1-2-96) | | |

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