MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM

K033492 · Ge Medical Systems Information Technologies · MHX · Nov 24, 2003 · Cardiovascular

Device Facts

• Record ID: K033492
• Device Name: MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM
• Applicant: Ge Medical Systems Information Technologies
• Product Code: MHX · Cardiovascular
• Decision Date: Nov 24, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1025
• 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

Mobile ECG analysis system; acquires, analyzes, displays, and records surface ECG signals. Components: processing unit, patient acquisition module (CAM14), optional trolley. Inputs: surface ECG electrodes. Processing: 12-lead interpretive analysis, vector loops, high-resolution signal averaging of QRS/P waves. Outputs: full-size reports, VGA waveform display, thermal printouts, removable storage. Connectivity: optional transmission/reception to central cardiovascular information systems. Used in hospitals/clinics by trained operators; supports clinical decision-making via automated interpretation. Benefits: improved signal fidelity/noise reduction via modular acquisition; mobile/desktop flexibility.

Clinical Evidence

Bench testing only. Quality assurance measures included requirements specification reviews, code inspections, software/hardware testing, safety testing, environmental testing, and final system validation. No clinical data presented.

Technological Characteristics

Mobile/desktop ECG system; modular patient acquisition (CAM14). Features: 3/6/12/15-lead ECG, interpretive analysis, vector loops, high-resolution signal averaging. Connectivity: optional network transmission. Power: rechargeable battery/AC. Software: includes 12SL and Phi Res algorithms. Complies with voluntary standards.

Indications for Use

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

Regulatory Classification

Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Predicate Devices

• Mac 5000 Rest ECG Analysis System with ST Option (K014108)

Reference Devices

• ECG Analysis Program 12SL (K002209)
• Phi Res Algorithm (K972199)
• CAM14 (K991735)

Submission Summary (Full Text)

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K033492
-page 1 of 2

## NOV 2 4 2003

| | 510(k) Summary of Safety and Effectiveness |
|--|--------------------------------------------|
|--|--------------------------------------------|

October 30, 2003 Date:

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

Contact Person: Lisa Lee Michels GE Medical Systems - Information Technologies Phone: [phone] Fax: [phone]

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

Trade/Proprietary Name: MAC 5000 ECG Analysis System

Common/Usual Name: Electrocardiograph

## Classification Names & Citations:

| 21 CFR 870.1425 Programmable diagnostic computer | 74DQH |
|---------------------------------------------------------------------------|-------|
| 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 |

Predicate Devices: Mac 5000 Rest ECG Analysis System with ST Option (K014108).

> All algorithms have been previously cleared and include: ECG Analysis Program 12SL (K002209) Phi Res Algorithm (K972199)

The Mac 5000 ECG Analysis System is designed to acquire, analyze, Device Description: 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.

> The MAC 5000 system acquires ECG data using a modular patient

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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 full-size reports with alphanumeric keyboard for patient demographic 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.

- The MAC 5000 ECG Analysis System is intended to be used under Intended Use: 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.
- Technology: The technological characteristics of the MAC 5000 device have been 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.
- Test Summary: The MAC 5000 complies with the voluntary standards as detailed in 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 results of these measurements demonstrate that the MAC 5000 is as safe, effective, and performs as well as the predicate device.

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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 features a stylized eagle with three wavy lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 4 2003

GE Medical Systems Information Technologies c/o Ms. Lisa Lee Michels Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukee, WI 53223

Re: K033492

Trade Name: MAC 5000 ECG Analysis System Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (arrhythmia detector and alarm) Regulatory Class: Class III (three) Product Code: MHX Dated: October 30, 2003 Received: November 4, 2003

Dear Ms. Michels:

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 -- Ms. Lisa Lee Michels

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 (OS) 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), 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,

стаделтар

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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510(k) Number (if known):

Unknown;

510(k) filed on 13 December, 2001

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## MAC 5000 ECG Analysis System Device Name:

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 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 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)

(Divis
Division:
ular Devices
510(k) Num
k033492
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)