MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM

K042177 · Ge Medical Systems Information Technologies · DPS · Aug 27, 2004 · Cardiovascular

Device Facts

• Record ID: K042177
• Device Name: MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM
• Applicant: Ge Medical Systems Information Technologies
• Product Code: DPS · Cardiovascular
• Decision Date: Aug 27, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The MAC 5000 ECG Analysis System is intended to acquire, analyze, display, and record electrocardiographic information for adult and pediatric populations. Basic systems 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. The MAC 5000 is intended to be used under the direct supervision of a licensed medical professional in a hospital or medical professional's facility.

Device Story

MAC 5000 is a mobile electrocardiograph system used in hospitals/clinics under physician supervision. It acquires ECG signals via surface electrodes using the CAM14 modular acquisition device; signal fidelity is improved by placing the module near the patient. The system processes signals to provide 3, 6, 12, or 15 lead ECGs, 12-lead interpretive analysis, vector loops, and optional high-resolution signal averaging of QRS/P wave segments. Output is presented on a full-size VGA display and integrated thermal writer; data can be stored or transmitted to a central cardiovascular information system. The device operates on battery or AC power and can be used as a mobile unit on a trolley or as a desktop unit. It assists clinicians in diagnosing cardiac conditions by providing automated analysis and visual waveform data.

Clinical Evidence

Bench testing only. Evidence includes risk analysis, technical and design reviews, code inspections, module verification, system integration testing, final acceptance validation, performance testing, and safety testing. No clinical data provided.

Technological Characteristics

System consists of a processing unit and CAM14 patient acquisition module. Features include rechargeable battery, thermal writer, VGA display, and alphanumeric keyboard. Connectivity includes optional transmission/reception to central cardiovascular information systems. Software provides interpretive analysis and signal averaging. Complies with voluntary standards for safety and performance.

Indications for Use

Indicated for adult and pediatric populations requiring acquisition, analysis, display, and recording of electrocardiographic information (3, 6, 12, or 15 lead ECGs).

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

• MAC 5000 ECG Analysis System (K033492)

Reference Devices

• CAM14 (K991735)

Submission Summary (Full Text)

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K042177
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## AUG 27 2004

510(k) Summary of Safety and Effectiveness

August 6, 2004 Date:

GE Medical Systems Information Technologies Submitter: 8200 West Tower Avenue Milwaukee, WI 53223 USA

Lisa M. Baumhardt Contact Person: Regulatory Affairs Specialist GE Medical Systems Information Technologies Phone: [phone] Fax: [phone]

MAC 5000 ECG Analysis System Trade Name: Device:

Electrocardiograph Common/Usual Name:

Classification Names:

| 21 CFR 870.1025 Monitor, Physiological Patient (with Arrhythmia Detection or Alarms) | 74MHX |
|--------------------------------------------------------------------------------------|-------|
| 21 CFR 870.1025 Detector and Alarm, Arrhythmia | 74DSI |
| 21 CFR 870.1425 Programmable Diagnostic Computer | 74DQK |
| 21 CFR 870.2340 Electrocardiograph | 74FYW |
| 21 CFR 870.2920 Transmitters and Receivers, Electrocardiograph, Telephone | 74DXH |

K033492 MAC 5000 ECG Analysis System Predicate Device:

The MAC 5000 ECG Analysis System is designed to acquire, analyze, Device Description: display, and record ECG signals from surface ECG electrodes. The display, and two basic components: the processing unit and the 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.

> The MAC 5000 system acquires ECG data using a modular patient data acquisition device called the CAM14 (K991735). By placing the data acquisition device closer to the patient, signal fidelity is improved and noise is reduced. MAC 5000 delivers 12 or 15 lead ECG's on fullsize reports with alphanumeric keyboard for patient demographics and other data entry, a full size VGA graphics and waveform display, integrated thermal writer and removable data storage.

> Additionally, the MAC 5000 utilizes battery power for customer convenience and can transmit and receive ECGs to and from a central ECG cardiovascular information system via optional communication links. The system is intended as a mobile device but the main unit can be separated from the trolley and used as a desktop unit.

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K04277

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- The MAC 5000 ECG Analysis System is intended to acquire, analyze, Intended Use: The MAC 3000 EOO Analysis information adult and pediation ulsplay, and record clock. Sie and all gr 3, 6, 12, or 15 lead ECG's, 12 lead populations. Dasio systems don'ts of can be upgraded to provide merpretive analysis, vootor loops, and resolution signal averaging of Sollware analysis options of the electrocardiogram. Transmission and QRS and I wave portions of and from a central ECG cardiovascular information system is optional.
The MAC 5000 is intended to be used under the direct supervision of a The MAC 5000 is michaou to be be as a loss and a hospital or medical professional's facility.

- The MAC 5000 ECG Analysis System employs the same functional Technology: technology as the predicate devices.
- The MAC 5000 ECG Analysis System complies with the voluntary Test Summary: standards as detailed in Section 9 of this submission. The following Standards as detailed in Soction of the development of the system:
- Risk Analysis .
- Technical Reviews .
- Design Reviews .
- Code Inspections .
- Unit level Testing (module verification) .
- Integration Testing (system verification) .
- Final Acceptance Testing (validation) .
- Performance Testing .
- Safety Testing .
- The results of these measurements demonstrated that the MAC 5000 Conclusion: The Tosalto of thosem is as safe, as effective, and performs as well as the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

JAN 2 2 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GE Medical Systems Information Technologies c/o Ms. Margaret Mucha Regulatory Affairs Leader 9900 Innovation Drive Wauwatosa, WI 53226

Re: K042177

Trade/Device Name: MAC 5500 Resting ECG Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: II (two) Product Code: DPS Dated: August 6, 2004 Received: August 11, 2004

Dear Ms. Mucha:

This letter corrects our substantially equivalent letter of August 27, 2004.

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 (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 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 - Ms. Margaret Mucha

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 continue 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours, .

Blommerfor fr

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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长042177

Page 1 of 1

510(k) Number (if known):

MAC 5000 ECG Analysis System

Device Name:

Indications For Use:

The MAC 5000 ECG Analysis System is intended to acquire, analyze, display, and record
eliver The MAC 5000 ECG Analysis System is intended to acquilot intaly Basic Systems deliver
electrocardiographic information adult and pediations and can be electrocardiographic information addit and peakalise, vector loops, and can be
3, 6, 12, or 15 lead ECG's, 12 lead interpretive analysis, vector loops, and can be 3, 6, 12, or 15 lead ECG3S, 12 lead interprones and resolution signal averaging of upgraded to provide software analysis options such as not reception of reception of Fecelling of ECG
QRS and P wave portions of the electrocardiogram. Transmission of ECG QRS and P wave portions of the electrocardiogram. "Annomes and is optional.

The MAC 5000 is intended to be used under the direct supervision of a licensed The MAC 5000 is intended to be used ander the Group Curcer of Collection of the

Prescription Use_X (Per 21 CFR 801.109 Subpart D) OR

Over-The-Counter Use_ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)
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Division of Cardiovascular Dev

510(k) Number K042177