MAC-LAB/CARDIOLAB EP/COMBOLAB

K021366 · General Electric Medical Systems Information Techn · DQK · Jul 3, 2002 · Cardiovascular

Device Facts

• Record ID: K021366
• Device Name: MAC-LAB/CARDIOLAB EP/COMBOLAB
• Applicant: General Electric Medical Systems Information Techn
• Product Code: DQK · Cardiovascular
• Decision Date: Jul 3, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

MAC-LAB System: 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 Medical Systems Information Technologies TRAM modules (k921669), MUSE cardiovascular system and other interfaced information systems. Data includes: ECG waveforms, heart rate, pulse oximetry (SpO2), 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. The system does not transmit alarms or arrhythmias, and does not have arrhythmia detection capabilities. CardioLab EP System: The CardioLab EP System is intended for use under the direct supervision of a licensed healthcare practitioner to acquire, filter, digitize, amplify, display, and record electrical signals obtained during electrophysiological studies and related procedures conducted in an electrophysiological laboratory. Signal types acquired include ECG signals, direct cardiac signals, and pressure recordings. Physiological parameters such as diastolic, systolic, and mean blood pressure, heart rate, and cycle length may be derived from the signal data, displayed and recorded. The system allows the user to monitor the acquisition of data, review the data, store the data, perform elementary caliper-type measurements of the data, and generate reports on the data. Additionally, the system may acquire, amplify, display, and record data received from other medical devices typically used during these procedures, such as imaging devices and RF generators. The system does not transmit alarms or arrhythmias, and does not have arrhythmia detection capabilities. The ComboLab System: The ComboLab is the combination of both CardioLab EP and MAC-LAB allowing the user to run the CardioLab EP and MAC-LAB modes, though only one mode may be used at a time (CardioLab EP for electrophysiology lab cases and MAC-LAB for catheterization lab cases). The system does not transmit alarms or arrhythmias, and does not have arrhythmia detection capabilities.

Device Story

Microprocessor-based data acquisition system for cardiac catheterization and electrophysiology labs; operates under direct supervision of licensed healthcare practitioner. Inputs: surface ECG, invasive/non-invasive blood pressure, SpO2, respiration, temperature, intracardiac signals, and data from external devices (RF generators, fluoro video). System components: TRAM module, amplifier module, computer processors, display monitors, keyboard, mouse, printer. Data transmitted via cable or fiber optic to computer for processing; stored on optical disks. Functions: data acquisition, display, storage, reporting, and transmission via LAN. Provides elementary caliper-type measurements; no arrhythmia detection or alarm transmission. Benefits: enables real-time monitoring and recording of physiological data during procedures to assist clinical decision-making.

Clinical Evidence

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

Technological Characteristics

Microprocessor-based data acquisition system. Components: TRAM module, amplifier module, computer, high-resolution monitors, laser printer. Connectivity: LAN for data transmission, fiber optic cable for EP signal transmission. Software: data acquisition, display, storage, reporting. No energy delivery or life-support functions.

Indications for Use

Indicated for pediatric and adult patients requiring cardiac or circulatory system catheterization in catheterization and related cardiovascular specialty labs.

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 System (K001305)
• CardioLab EP System (K001305)
• CardioTree® Coronary Tree Diagrams (K912829)

Submission Summary (Full Text)

{0}------------------------------------------------

8.021366

Image /page/0/Picture/1 description: The image shows a date written as "JUL 3 2002". The month is "JUL", the day is "3", and the year is "2002". The text is written in a bold, sans-serif font.

1/2

## 510(k) Summary of Safety and Effectiveness

| Date: | June 26, 2002 |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Medical Systems Information Technologies<br>8200 W. Tower Ave.<br>Milwaukee, WI 53223 USA |
| Contact Person: | Lisa Lee Michels<br>Regulatory Affairs Specialist<br>GE Medical Systems Information Technologies<br>Phone: [phone]<br>Fax: [phone] |
| Trade/Proprietary Name: | MAC-LAB/CardioLab EP/ComboLab System |
| Common/Usual Name: | Cardiac Catheterization Laboratory System |

# Classification Names & Citations:

- Programmable Diagnostic Computer (DQK, Class II, 74 CV) 870.1425
Biopotential Amplifier and Signal Conditioner (DRR, Class II, 74 CV) 870.2050

- Electrocardiograph (DPS, Class II, 74 CV) 870.2340
- Blood Pressure Computer (DSK, Class II, 74 CV) 870.1110

Predicate Device:

MAC-LAB System and CardioLab EP System K#001305 and CardioTree®Coronary Tree Diagrams K#912829. The MAC-LAB System:

Device Description:

The MAC-LAB System is a microprocessor based data acquisition system used during cardiac catheterization procedures. The MAC-LAB system, via various models of the GE Medical Systems Information Technologies TRAM module (K921669) and amplifier module, acquires patient data which may include surface ECG, invasive and non-invasive blood pressure, blood oxygen saturation via pulse oximetry, respiration, and The TRAM module is housed in a dedicated front end temperature. chassis called the remote acquisition case (RAC). The MAC-LAB System joins together the TRAM module and amplifier module with computer processors, software, high resolution display monitors, power supply, laser printer, keyboard and mouse. Digital data is transmitted, via cable, from the TRAM module and/or amplifier module to the computer for processing. Major functions of the software include data acquisition and display, data storage, reporting of data, and transmission of data to other information systems via LAN.

#### The CardioLab EP System:

The CardioLab EP System is a microprocessor based data acquisition system used during electrophysiology procedures to acquire ECG, intracardiac signals, and pressure signals via amplifier module. Digital data is also acquired from other devices such as RF generators, fluoro video systems and the GE Medical Systems Information Technologies TRAM module. The ECG, intracardiac and pressure data are acquired by an amplifier that is connected to the patient by third-party devices such as ECG leadwires and catheters. The amplifier filters, amplifies, digitizes and transmits the data to the computer via fiber optic cable. The computer stores the data on optical disks, displays the data on the video monitors, allows the user to perform basic signal measurements, and prints out waveforms on a laser printer or continuous paper recorder. Major functions of the software include data acquisition and display, data storage, reporting of data, and transmission of data to other information systems via LAN.

#### The ComboLab System

The product will be available in three configurations: CardioLab EP application only, MAC-LAB application only, or combination of both CardioLab EP and MAC-LAB applications. The 'CardioLab EP only'

{1}------------------------------------------------

configuration only allows the user to run the CardioLab EP mode. The 'MAC-LAB only' configuration only allows the user to run the MAC-LAB mode. The combination of both CardioLab EP and MAC-LAB allows the user to run the CardioLab EP and MAC-LAB modes, though only one mode may be used at a time (CardioLab EP for electrophysiology lab cases and MAC-LAB for catheterization lab cases).

#### Intended Use:

#### MAC-LAB Svstem:

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 Medical Systems Information Technologies 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). This information can be displayed, trended, stored, printed and/or transmitted to other networked hospital information systems. The system does not transmit alarms or arrhythmias, and does not have arrhythmia detection capabilities.

#### CardioLab EP System:

The CardioLab EP System is intended for use under the direct supervision of a licensed healthcare practitioner to acquire, filter, digitize, amplify, display, and record electrical signals obtained during electrophysiological studies and related procedures conducted in an electrophysiological laboratory. Signal types acquired include ECG signals, direct cardiac signals, and pressure recordings. Physiological parameters such as diastolic, systolic, and mean blood pressure, heart rate, and cycle length may be derived from the signal data, displayed and recorded. The system allows the user to monitor the acquisition of data, review the data, store the data, perform elementary caliper-type measurements of the data, and generate reports on the data. Additionally, the system may acquire. amplify, display, and record data received from other medical devices typically used during these procedures, such as imaging devices and RF generators. The system does not transmit alarms or arrhythmias, and does not have arrhythmia detection capabilities.

#### The ComboLab System

The ComboLab is the combination of both CardioLab EP and MAC-LAB allowing the user to run the CardioLab EP and MAC-LAB modes, though only one mode may be used at a time (CardioLab EP for electrophysiology lab cases and MAC-LAB for catheterization lab cases). The system does not transmit alarms or arrhythmias, and does not have arrhythmia detection capabilities.

The MAC-LAB / CardioLab EP and ComboLab systems do not control the delivery of energy, administer drugs, perform any life-supporting or lifesustaining functions, or analyze physiological data or other data acquired during procedure.

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

Intended for use in catheterization and related cardiovascular specialty labs.

{2}------------------------------------------------

3/3

The proposed MAC-LAB/CardioLab EP/ComboLab System employs the Technology: same functional technology as the predicate device.

# Test Summary:

The MAC-LAB System and CardioLab EP System comply with the voluntary standards as detailed in Section 9 of this submission. The following quality assurance measures are applied to the development of the Systems:

- Requirements specification review .
- Code inspections o
- Software and hardware testing ●
- Safety testing .
- . Environmental testing
- Final validation .

#### Conclusion:

The results of these measurements demonstrate that the MAC-LAB/CardioLab EP/ComboLab System are as safe, as effective, and perform as well as the predicate devices.

{3}------------------------------------------------

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.

# JUL 3 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GE Medical Systems Information Technologies c/o Mr. David Wahlig Senior Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukee. Wisconsin 53223

K021366 Re:

> Device Name: MAC-LAB/CardioLab EP/ComboLab System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: June 5, 2002 Received: June 6, 2002

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.

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

{4}------------------------------------------------

Page 2 - Mr. David Wahlig

systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation >>> 900 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 vour 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,

Rabith

Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

510(k) Number (if known): K021366 MAC-LAB/CardioLab EP/ComboLab System: Device Name:

Indications For Use:

## MAC-LAB System:

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 Medical Systems Information Technologies TRAM modules (k921669). MUSE cardiovascular system and other interfaced information systems. Data includes: ECG waveforms, heart rate, pulse oximetry (SpO2), 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. The system does not transmit alarms or arrhythmias, and does not have arrhythmia detection capabilities.

#### CardioLab EP System:

The CardioLab EP System is intended for use under the direct supervision of a licensed healthcare practitioner to acquire, filter, digitize, amplify, display, and record electrical signals obtained during electrophysiological studies and related procedures conducted in an electrophysiological laboratory. Signal types acquired include ECG signals, direct cardiac signals. and pressure recordings. Physiological parameters such as diastolic, systolic, and mean blood pressure, heart rate, and cycle length may be derived from the signal data, displayed and recorded. The system allows the user to monitor the acquisition of data. review the data, store the data, perform elementary caliper-type measurements of the data, and generate reports on the data. Additionally, the system may acquire, amplify, display, and record data received from other medical devices typically used during these procedures, such as imaging devices and RF generators. The system does not transmit alarms or arrhythmias, and does not have arrhythmia detection capabilities.

(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
and Respiratory Devices
K021366

510(k) Number K021586

Image /page/5/Picture/10 description: The image shows the text "Prescription Use" with a check mark next to it. Below that, the text "(Per 21 CFR 801.109)" is shown. The check mark indicates that the prescription use is confirmed. The text is in a serif font and is black.

OR

Over-The-Counter Use

· Page 1 of 2

{6}------------------------------------------------

# (Optional Format 1-2-96)

| 510(k) Number (if known): | K021366 | Page 2 of 2 |
|---------------------------|--------------------------------------|-------------|
| Device Name: | MAC-LAB/CardioLab EP/ComboLab System | |

# The ComboLab System

The ComboLab is the combination of both CardioLab EP and MAC-LAB allowing the user to run the CardioLab EP and MAC-LAB modes, though only one mode may be used at a time (CardioLab EP for electrophysiology lab cases and MAC-LAB for catheterization lab cases). The system does not transmit alarms or arrhythmias, and does not have arrhythmia detection capabilities.

The MAC-LAB / CardioLab EP and ComboLab systems do not control the delivery of energy. administer drugs, perform any life-supporting or life-sustaining functions, or analyze physiological data or other data acquired during procedure.

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

Intended for use in catheterization and related cardiovascular specialty labs

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use