MAC-LAB System: The MAC-LAB System is intended for use under the direct supervision of a licensed healthcare 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 (K01 1000), 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, 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 archythmia detection capabilities.

The ComboLab System: The ComboLab is the combination of both CardioLab EP and MAC-LAB allowing the user to run the CardioLabEP 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 anthythmias, and does not have arrhythmia detection capabilities.

The MAC-LAB/CardioLab EP/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.

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 (K011000) 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 temperature, The TRAM module is housed in a dedicated front end 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 L.A.N.

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 product will be available in three configurations: CardioLab EP application only, MAC-LAB application only, or a combination of both CardioLab EP and MAC-LAB applications. The 'CardioLab EP only' configuration only allows the user to run the CardioLab EP modes. The 'MAC-LAB only' configuration only allows the user to run the MAC-LAB mode. The combination of both CardioLab EP and MAC-LAB modes, though only one mode may be used at a time (CardioLab EP for electrophysiological lab cases and MAC-LAB for catheterization lab cases).

AI/ML Overview

This document is a 510(k) summary for the MAC-LAB/CardioLab EP/ComboLab System Version 6.0. It describes the device's intended use and states that it employs the same functional technology as a predicate device (K021366). However, the provided text does not contain information about acceptance criteria or a study proving the device meets those criteria.

Therefore, most of the requested information cannot be extracted from the given input.

Here's a breakdown of what can be stated based on the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document does not define specific acceptance criteria (e.g., minimum accuracy, sensitivity, specificity values) for any aspect of the device's performance. It also does not report performance metrics against such criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. The document states that the new device employs the "same functional technology as the predicate device" but does not describe any specific testing or clinical study for this 510(k) submission that would involve a test set, sample size, or data provenance. 510(k) submissions often rely on substantial equivalence to a predicate device rather than new clinical trials, especially for Class II devices like this.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot be provided. No test set or ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be provided. No test set or adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Cannot be provided. This document describes a cardiac catheterization and electrophysiology system for data acquisition and display, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study or AI assistance effect size is not applicable to the device as described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Cannot be provided. The device is a data acquisition system for use "under the direct supervision of a licensed healthcare practitioner." It explicitly states it "does 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." This strongly indicates it's not a standalone diagnostic algorithm but rather a tool for practitioners.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Cannot be provided. No ground truth is described.

8. The sample size for the training set

Cannot be provided. The document describes a medical device system, not an AI or machine learning algorithm that would typically involve a training set.

9. How the ground truth for the training set was established

Cannot be provided. No training set or ground truth establishment is described.

Summary based on the document:

The 510(k) submission for the MAC-LAB/CardioLab EP/ComboLab System Version 6.0 relies on demonstrating substantial equivalence to a predicate device (K021366), rather than presenting new performance data against specific acceptance criteria. The document states:

Technology: "The proposed MAC-LAB/CardioLab EP/ComboLab System Version 6.0 employs the same functional technology as the predicate device."

This implies that the device is considered to meet implicitly acceptable performance levels because its technology and intended use are the same as a device already cleared by the FDA. Such submissions typically do not include detailed performance studies with acceptance criteria, ground truth, or sample sizes unless there are significant technological differences or new intended uses that raise new questions of safety or effectiveness.

Summary

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Classifi

K032577
p. 1 of 2

510(k) Summary of Safety and Effectiveness

Date:	August 20, 2003
Submitter:	GE Medical Systems Information Technologies8200 W. Tower Ave.Milwaukee, WI 53223 USA
Contact Person:	Lisa Lee MichelsRegulatory Affairs SpecialistGE Medical Systems Information TechnologiesPhone: (262) 293-1609Fax: (414) 918-8203
Trade/Proprietary Name:	MAC-LAB/CardioLab EP/ComboLab System
Common/Usual Name:	Cardiac Catheterization Laboratory System
Classification Names & Citations:
870.1425	Programmable Diagnostic Computer (DQK, Class II, 74 CV)

670.1423 Programmable Diagnostic Computer (DDC), Class II, 74 C.V.)
950.3050 Differential Amplifier and Signal Conditioner (DDC, Class II)

870.2050 Biopotential Amplifier and Signal Conditioner (DRR, Class II, 74 CV)

Electrocardiograph (DPS, Class II, 74 CV) 870.2340

870.1110 Blood Pressure Computer (DSK, Class II, 74 CV)

MAC-LAB/CardioLab EP/ComboLab System (K021366), Predicate Device:

The MAC-LAB System: Device Description:

The CardioLab EP System:

The ComboLab System:

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K$\phi$32577
p. 2 of 2

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

Intended 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 (KOI 1000), 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 CardioLabEP 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.

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

Intended for use in catheterization and related cardiovascular specialty labs.

Technology:

The proposed MAC-LAB/CardioLab EP/ComboLab System Version 6.0 employs the same functional technology as the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 0 2003

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

Re: K032577

Trade Name: MAC-LAB/CardioLab EP/ComboLab System Version 6.0 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: August 20, 2003 Received: August 21, 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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

CAdelmer

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):

K032577

Device Name:

MAC-LAB/CardioLab EP/ComboLab System Version 6.0

Indications For Use:

MAC-LAB System:

The MAC-LAB System is intended for use under the direct supervision of a licensed healthcare 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 (K01 1000), 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, 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 archythmia detection capabilities.

The ComboLab System:

The ComboLab is the combination of both CardioLab EP and MAC-LAB allowing the user to run the CardioLabEP 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 anthythmias, and does not have arrhythmia detection capabilities.

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 (OD

Merin Mey for BDZ

Prescription Use X (Per 21 CFR 801.109) (Optional Format 1-2-96)

(Division Sign-Off)
Division of Cardiovascular Devices
For Center Use

510(k) number K032571

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
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.(b)
Classification. Class II (performance standards).