The Mac-Lab System is intended for use in a catheterization and related cardiovascular specialty laboratories under the direct supervision of a licensed healthcare practitioner. It is intended to monitor, calculate and/or record cardiovascular data from adult and pediatric patients undergoing cardiac catheterization procedures. The data may be manually entered or acquired via interfaced devices. Data includes: ECG, heart rate, pulse oximetry (SpO2), respiration rate, EtCO2, temperature, valve gradients and areas, cardiac output, hemodynamic measurements, invasive and noninvasive blood pressure and procedural information and optional intracardiac electrocardiogram (IECG). 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, and generate reports on the data. Additionally, the system may acquire, amplify, display and record data received from other interfaced medical devices typically used during these procedures, such as imaging devices. The Mac-Lab System does not control the delivery of energy, administer drugs, perform any life-supporting or life-sustaining functions, or analyze data acquired during procedure. The Mac-Lab System does not transmit alarms or arrhythmias and does not have arrhythmia detection capabilities.

The CardioLab EP System is intended for use in an electrophysiological laboratory and related specialty laboratories under the direct supervision of a licensed healthcare practitioner. It is intended to monitor, calculate and/or record electrophysiological data from adult and pediatric patients under going electrophysiological studies. Data includes: ECG, pressure, and intracardiac electrocardiogram (IECG) waveforms, heart rate, pulse oximetry (SpO2), respiration rate, EtCO2, temperature, invasive and noninvasive blood pressure, and procedural information. 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, and generate reports on the data. Additionally, the system may acquire, amplify, display and record data received from other interfaced medical devices typically used during these procedures, such as imaging devices and RF generators. The CardioLab EP System does not control the delivery of energy, administer drugs, perform any life-supporting or life-sustaining functions, or analyze data acquired during the procedure. The CardioLab EP System does not transmit alarms or arrhythmias and does not have arrhythmia detection capabilities.

The ComboLab System is the combination of the both the Mac-Lab and CardioLab EP systems. The ComboLab System is intended for use in either a catheterization laboratory or electrophysiological laboratory and related speciality laboratories under the direct supervision of a licensed healthcare practitioner. The ComboLab System allows the user to run either the Mac-Lab System or the CardioLab EP System, although only one may be used at a time.

Device Description

The Mac-Lab System is a microprocessor based data acquisition system used during cath procedures to monitor, calculate and record physiological data from pediatric or adult patients. Data may be entered manually or acquired via an interfaced GE Medical Systems Information Technologies acquisition device, such as: TRAM module (K011000), EtCO2 module (K904789), CardioLab Amplifier Module (K910307), DASH 3000/4000 Monitor (K001359), Solar 8000M Monitor (K993757), MUSE cardiovascular system (K992637) or other peripheral interface. Data includes: ECG, pressure, respiration intracardiac electrocardiograms (IECG), and SpO2 waveforms, heart rate, pulse oximetry (SpO2), respiration rate, valve gradients and areas, cardiac output, EtCO2, hemodynamic measurements, invasive and noninvasive blood pressure, temperature, and procedural information. The Mac-Lab joins together the acquisition devices with computer processors, software, highresolution display monitors, power supply, printers, keyboard and mouse. Digital data is transmitted, via cable, from the acquisition devices 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 the CardioLink INW server and other networked hospital information systems.

The CardioLab EP System is a microprocessor based data acquisition system used during electrophysiology procedures to monitor, calculate and record physiological data from pediatric or adult patients. Data may be entered manually or acquired via an interfaced GE Medical Systems Information Technologies acquisition device, such as: CardioLab Amplifier Module (K910307), TRAM module (K011000), EtCO2 module (K904789), DASH 3000/4000 Monitor (K001359), Solar 8000M Monitor (K993757), MUSE cardiovascular system (K992637) or other peripheral interface, such as RF generators and fluoro video Data includes: ECG. intracardiac pressure waveforms, heart rate, pulse electrocardiograms (IECG), and oximetry (SpO2), respiration rate, EtCO2, invasive and noninvasive blood pressure, temperature, and procedural information. 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 CardioLab joins together the acquisition devices with computer processors, software, high-resolution display monitors, power supply, printers, Digital data is transmitted, via cable, from the keyboard and mouse. acquisition devices 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 the CardioLink INW server and other networked hospital information systems.

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's 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 ComboLab configuration is 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

Here's a breakdown of the acceptance criteria and study information for the Mac-Lab/CardioLab EP/ComboLab System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Safety and Effectiveness	"The Mac-Lab/CardioLab EP/ComboLab System is as safe, as effective, and performs as well as the predicate device." (K032577)
Compliance with Voluntary Standards	"The Mac-Lab/CardioLab EP/ComboLab System complies with the voluntary standards as detailed in Section 9 of this submission."
Quality Assurance Measures	Applied: Risk Analysis, Requirements Reviews, Design Reviews, Unit-level Testing (Module verification), Clinical Use Validation, Integration Testing (System verification), Final acceptance testing (Validation), Performance testing, Safety testing, Environmental Testing. Outcomes: Demonstrated equivalence in safety, effectiveness, and performance to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not explicitly state a specific sample size for a test set in the context of validating algorithm performance or diagnostic accuracy. The testing mentioned (Unit-level, Integration, Final Acceptance, Performance, Safety, Environmental) seems to focus on the system's functional and safety aspects, rather than a clinical accuracy study with a defined test set.

Sample Size: Not specified for performance validation of algorithms or diagnostic accuracy.
Data Provenance: Not specified. The mention of "Clinical Use Validation" suggests some form of clinical data was involved, but details like country of origin or retrospective/prospective nature are absent.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the given text. The submission references "Clinical Use Validation" but does not detail how ground truth was established or if experts were involved in a diagnostic accuracy assessment for a test set.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was it done? No, there is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The submission focuses on demonstrating equivalence to a predicate device via functional and safety testing.
Effect Size: Not applicable, as no MRMC study was reported.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The device described is a data acquisition and display system for physiological data, not an AI or algorithm-driven diagnostic tool that would typically have a "standalone" performance assessment in the absence of a human. Its function is to "monitor, calculate and/or record" data. Therefore, a standalone algorithm performance study, as typically understood for AI devices, was not conducted or reported. The validation focused on the system's ability to accurately acquire, process, and display physiological data, which inherently involves human interpretation.

7. Type of Ground Truth Used

The text does not specify a "ground truth" in the context of diagnostic accuracy. Given the nature of the device (data acquisition, monitoring, calculation, and recording of physiological parameters), the "ground truth" would likely be the accurate and verifiable physiological signals and measurements themselves, rather than a diagnostic outcome (like pathology or a physician's final diagnosis). The system derives physiological parameters (diastolic/systolic BP, heart rate, cycle length) from signal data but doesn't perform diagnostic analysis or have arrhythmia detection capabilities.

8. Sample Size for the Training Set

The text does not mention a training set size. This type of device, which is primarily a data acquisition and display system based on well-established physiological monitoring principles, would not typically involve "training" in the machine learning sense. Its functionality is based on predefined algorithms for processing signals, not learning from a dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set is mentioned or implied for this type of device.

Summary

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MAY 1 3 2005

Section 2 Summary

K050093

510(k) Summary of Safety and Effectiveness

Date:	January 7, 2005
Submitter:	GE Medical Systems Information Technologies8200 West Tower AvenueMilwaukee, WI 53223 USA
Contact Person:	Ronald N. BlaskiRegulatory Affairs SpecialistGE Medical Systems Information TechnologiesPhone: (414) 362-2348Fax: (262) 293-2585
Device:
Trade Name:	Mac-Lab/CardioLab EP/ComboLab System
Common/Usual Name:	Cardiac Catheterization Laboratory System
Classification Names:	21 CFR 870.1425 Programmable Diagnostic Computer
Predicate Device:	Mac-Lab/CardioLab EP/ComboLab System Version 6.0 (K032577)

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050093 2/4

The Mac-Lab System:

The CardioLab EP System:

The ComboLab System:

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Intended Use:

050093 3/4

Mac-Lab System:

The Mac-Lab System is intended for use in a catheterization and related cardiovascular specialty laboratories under the direct supervision of a licensed healthcare practitioner. It is intended to monitor, calculate and/or record cardiovascular data from adult and pediatric patients undergoing cardiac catheterization procedures. The data may be manually entered or acquired via interfaced devices. Data includes: ECG, heart rate, pulse oximetry (SpO2), respiration rate, EtCO2, temperature, valve gradients and areas, cardiac output, hemondynamic measurements, invasive and noninvasive blood pressure and procedural information and optional intracardiac electrocardiogram (IECG). 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, and generate reports on the data. Additionally, the system may acquire, amplify, display and record data received from other interfaced medical devices typically used during these procedures, such as imaging devices. The Mac-Lab System does not control the delivery of energy, administer drugs, perform any life-supporting or life-sustaining functions, or analyze data acquired during procedure. The Mac-Lab System does not transmit alarms or arrhythmias and does not have arrhythmia detection capabilities.

CardioLab EP System

ComboLab System

The proposed Mac-Lab/CardioLab EP/ComboLab System employs the same Technology: functional scientific technology as the predicate device Mac-Lab/CardioLab EP/ComboLab System (K032577).

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K050093 4
tem /

The Mac-Lab/CardioLab EP/ComboLab System Test Summary:

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 device:

Risk Analysis .
. Requirements Reviews
Design Reviews .
Testing on unit level (Module verification) .
. Clinical Use Validation
Integration Testing (System verification) .
Final acceptance testing (Validation) .
. Performance testing
. Safety testing
Environmental Testing .
The results of these measurements demonstrated that the Mac-Lab/CardioLab Conclusion: EP/ComboLab System is as safe, as effective, and performs as well as the predicate device.

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Image /page/4/Picture/2 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the top half of the circle. In the center of the seal is a stylized image of what appears to be an eagle or other bird-like figure, represented by three curved lines that suggest wings or feathers.

MAY 1 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GE Medical Systems Information Technologies c/o Mr. Ronald N. Blaski Regulatory Affairs Specialist 8200 West Tower Avenue Milwaukee WI 53223

Re: K050093

K050095
Trade Name: Mac-Lab / CardioLab EP / ComboLab Systems
Trade Name: Mac-Lab / CardioLab 1945 Regulation Number: 21 CFR 870.1245 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: April 11, 2005 Received: April 12, 2005

Dear Mr. Blaski:

We have reviewed your Section 510(k) premarket notification of intent to market the device to We have reviewed your Section 3 IQ(x) premantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and have deemined the ucvices ated in interstate
for use stated in the enclosure) to legally marketed prediced Device Amendments, for use stated in the enclosure) to the enactment date of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food, Drug, commerce prior to May 28, 1976, the enactment and of the Federal Food, Drug, devices that have been reclassified in accordance who meetires and onlines of PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that do not require approval or approval on the Act. The Act. The
You may, therefore, market the device, subject to the general on the Act. The You may, therefore, market the device, subject to the general cregistration, listing of
general controls provisions of the Act 1 heline and recisibitions anainst misbranding general controls provisions of the Act Include requirements to the many of the many adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it
em and the can and the caller and a Fristing major regulations affecti If your device is classified (see above) mio entrely in the states of the major can
may be subject to such additional controls. Existing major regulations affective your dev may be subject to such additional controis: Existing major regal to 898. In addion, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. be found in the Code of Federal Kegulations, Priro 24, 2017
publish further announcements concerning your device in the Federal Register.

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Page 2 – Mr. Ronald N. Blaski

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that I Driv issualles over device complies with other requirements of the Act that I Dri has made a aved regulations administered by other Federal agencies. You must or any I edolar bathates the requirements, including, but not limited to: registration and listing comply with an the Hec b requirement, at 801); good manufacturing practice requirements as set (21 CFR Part 807), acoming (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro resin marketing your device as described in your Section 510(k) I mis icher witi anow you to ogin maing of substantial equivalence of your device to a legally premarket notification: "The PDF Intellegsification 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 If you desire specific acrieves y at (240) 276-0120.. Also, please note the regulation entitled, Colliati the Office of Compulline in (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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,

Bummer for

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): Кобосорз

Device Name:

Mac-Lab/CardioLab EP/ComboLab System

Indications For Use:

Mac-Lab System:

The Mac-Lab System is intended for use in a catheterization and related cardiovascular specialty laboratories under the direct supervision of a licensed healtheare practitioner. It is intended to monitor, calculate and/or record cardiovascular data from adult super raiser or a neens on and ac catheterization procedures. The data may be manually entered or acquired via interfaced devices. Data includes: ECG, heart rate, pulse oximetry (SpO2), respiration rate, ExCO2, temperature, valve gradients million on the output, herrondynamic measurements, invasive and noninvasive blood pressure and procedural information and optional intracardiac electrocardiogram (IECG). 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, and generate reports on the data. Additionally, the system may acquire, amplify, display and received from other interfaced medical devices typically used during these procedures, such as imaging devices. The Mac-Lab System does not control the delivery of energy, administer drugs, perform any life-supporting or lifesustaining functions, or analyze data acquired during procedure. The Mac-Lab System does not transmit alarms or arritythmias and does not have arrhythmia detection capabilities.

CardioLab EP System:

The CardioLab EP System is intended for use in an electrophysiological laboratory and related specially laboratories under the I in Caroletao en Cystom is mended to monitor, it is intended to monitor, calculate and/or record electrophysiological data from adult and petiative patients under going electrophysiological studies. ECG, pressure, and intracadiac tual tron and pecificile patients and gate, pulse oximetry (SpO2), respiration rate, ElCO2, temperature, invasive and enouraliations and procedural information. Physiological parameters such as diastolic, systolic, and mean blood pressure, heartere, and cycle length may be derived from the signal data, displayed and recorded. The system allows the user to pressure, its acquisition of data, review the data. Additionally, the system may acquire, amplify, display and record data received from other interfaced medical devices typically used during these procedures, such as imaging devices and RF generators. The CardioLab EP System does not control the delivery of energy, administer drugs, perform any life-supporting or life-sustaining functions, or analyze data acquired during the procedure. The CardioLab EP System does not transmit alarms or arrhythmias and does not have arrhythmia detection capabilities.

ComboLab System:

The Combol ab System is the combination of the both the Mac-Lab and CardioLab EP systems. The ComboLab System is intended for use in either a catherization laboratory or clectrophysiological laboratory and related speciality laboratories under the direct supervision of a licensed health are practitioner. The ComboLab System allows the user to run either the Mac-Lab System or the CardioLab EP System, although only one may be used at a time.

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Per 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)

Bhummar
Divisi

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).