MAC-LAB SYSTEM

K992948 · General Electric Medical Systems Information Techn · DQK · Nov 29, 1999 · Cardiovascular

Device Facts

• Record ID: K992948
• Device Name: MAC-LAB SYSTEM
• Applicant: General Electric Medical Systems Information Techn
• Product Code: DQK · Cardiovascular
• Decision Date: Nov 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The MAC-LAB System is intended for use under the direct supervision of a licensed healthcare practitioner to monitor and/or calculate and/or record cardiovascular data from patients as they undergo cardiac catheterization. Cardiovascular data may be manually entered or acquired via an interfaced GE Marquette TRAM modules (k921669), MUSE cardiovascular system and other interfaced information systems. Data includes: ECG waveforms, heart rate, pulse oximetry (SpO-), respiration rate, valve gradients and areas, cardiac output, hemodynamic measurements, invasive and noninvasive blood pressure, procedural information, and optional intracardiac electrocardiogram (IECG). Applicable to pediatric/adult patients requiring cardiac/circulatory system catheterization Intended for use in catheterization and related cardiovascular specialty labs

Device Story

MAC-LAB System is a programmable diagnostic computer for cardiac catheterization labs; operates under physician supervision. Inputs include ECG waveforms, heart rate, pulse oximetry, respiration rate, hemodynamic measurements, and intracardiac electrocardiogram (IECG) signals via TRAM modules in a Remote Acquisition Unit (RAU). System processes, displays, trends, stores, and prints cardiovascular data; supports transmission to networked hospital information systems. Provides real-time monitoring and calculations (e.g., valve gradients, cardiac output) to assist clinicians in procedural decision-making during catheterization. Benefits include integrated data management and visualization of physiological parameters during cardiac interventions.

Clinical Evidence

Bench testing only. No clinical data provided. Safety and effectiveness were established through requirements specification review, code inspections, software and hardware testing, safety testing, environmental testing, and final validation.

Technological Characteristics

System includes Remote Acquisition Unit (RAU) with TRAM modules, computer processors, high-resolution display monitors, power supply, thermal printer, and keyboard. Uses electronic amplifiers for signal processing. Connectivity includes networking to hospital information systems. Software-based diagnostic computer.

Indications for Use

Indicated for pediatric and adult patients undergoing cardiac or circulatory system catheterization in a cardiovascular specialty lab.

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-LAB Cardiac System (K895801)
• MAC-LAB Electrophysiology (IECG) Option (K935394)

Reference Devices

• GE Marquette TRAM modules (K921669)

Submission Summary (Full Text)

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Devic

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GE Marquette Medical Systems, Inc.

## Section 2: 510(k) Summary of Safety and Effectiveness

| | Date: August 28, 1999 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Marquette Medical Systems<br>100 Marquette Drive<br>Jupiter, FL USA |
| Contact Person: | Maria Vitug Fouts<br>Sr. Regulatory Compliance Specialist<br>GE Marquette Medical Systems<br>Phone: [phone]<br>Fax: (410) 897 - 6294 |
| Trade Name: | MAC-LAB System |
| Common/Usual Name: | MAC-LAB, MAC-LAB System EX |
| Classification Names: | 21 CFR 870.1425 Programmable Diagnostic Computer |
| Predicate Devices: | MAC-LAB Cardiac System,<br>k895801, SE date: 04 April 1990 |

MAC-LAB Electrophysiology (IECG)Option, K935394, SE date: 20 October 1994

- Device Description: The MAC-LAB Systems ioin together the TRAM module which is housed in a Remote Acquisition Unit (RAU) with computer processors, software, high resolution display monitors, power supply, thermal printer and a keyboard. Data acquisition modules, depending upon application, are inserted into the RAU and then digital data is transmitted, via cable, to the computers for An optional IECG module (K935394) processing. enables electrophysiological investigations of the heart to be performed. The IECG module consists of electronic amplifiers and other signal processing devices. An IECG cable connects an intracardiac catheter (not covered by this submission) to the IECG system.
- The MAC-LAB Systems are intended for use under the direct supervision of Intended Use: a licensed healthcare practitioner. The device is intended to monitor and/or calculate and/or record cardiovascular data from patients as they undergo catheterization of the heart and circulatory system. Data includes: ECG waveforms, heart rate, pulse oximetry, respiration rate, valve gradients and areas, cardiac output, hemodynamic measurements, invasive and noninvasive blood pressure, procedural information, and optional intracardiac electrocardiogram (IECG). This information can be displayed, trended, stored, printed and/or transmitted to other networked hospital information systems.

Applicable to pediatric/adult patients requiring cardiac/circulatory system catheterization

Intended for use in catheterization and related cardiovascular specialty labs.

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GE Marquette Medical Systems, Inc.

## Section 2: 510(k) Summary of Safety and Effectiveness, continued

The proposed MAC-LAB Cardiac Catheterization Laboratory System Technology: employs the same functional technology as the predicate devices.

- Test Summary: The MAC-LAB 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-LAB System:
- . Requirements specification review
- Code inspections .
- . Software and hardware testing
- . Safety testing
- Environmental testing .
- Final validation .
- Conclusion: The results of these measurements demonstrated that the MAC-LAB system is as safe, as effective, and performs as well as the predicate devices.

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

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 9 1999

Ms. Maria Vitug Fouts Senior Requlatory Compliance Specialist GE Marquette Medical Systems A GE Medical Systems Company 200 Harry S. Truman Parkway, Suite 220 Annapolis, Maryland 21401

Re: K992948 Trade Name: MAC-LAB System Version 18A Requlatory Class: 2 Product Code: 74-DQK Dated: August 28, 1999 Received: August 31, 1999

Dear Ms. Fouts:

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 reqistration, 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance 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

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Page 2 - Ms. Maria Vitug Fouts

for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 requlation (21 CFR Part 801 and additionally 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 Also, please note the regulation entitled, [phone]. "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,

Dank Miller

lia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K992948

510(k) Number (if known):

MAC-LAB System Device Name:

Indications For Use:

The MAC-LAB System is intended for use under the direct supervision of a licensed healthcare practitioner to monitor and/or calculate and/or record cardiovascular data from patients as they undergo cardiac catheterization. Cardiovascular data may be manually entered or acquired via an interfaced GE Marquette TRAM modules (k921669), MUSE cardiovascular system and other interfaced information systems. Data includes: ECG waveforms, heart rate, pulse oximetry (SpO-), respiration rate, valve gradients and areas, cardiac output, hemodynamic measurements, invasive and noninvasive blood pressure, procedural information, and optional intracardiac electrocardiogram (IECG).

Applicable to pediatric/adult patients requiring cardiac/circulatory system catheterization

Intended for use in catheterization and related cardiovascular specialty labs

Note: Catheterization devices are not provided or offered for use with the MAC-LAB system.

*To be assigned by FDA upon receipt of 510(k) submission

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division 3)
Division of Cardiovascular, Respiratory,
and Neurological Devices,
510(k) Number K992948

Prescription Use
(Per 21 CFR 801.109)
OR Over-The-Counter Use

(Optional Format 1-2-96)