Mac-Lab: The Mac-Lab System is intended for acquiring, filtering, digitizing, amplifying, measuring and calculating, displaying, recording and monitoring of clinical data from adult and pediatric patients. The Mac-Lab System is configurable. Clinical data includes: ECG waveforms, heart rate, pulse oximetry (SpO2), respiration rate, CO2 (EtCO2), temperature, hemodynamic measures [e.g. valve gradients and areas, cardiac output, shunts, Fractional Flow Reserve (FFR), invasive and noninvasive blood pressure] Physiological parameters such as diastolic. systolic, mean pressures, and heart rate are derived from the signal data, displayed and recorded. The data is entered manually or acquired via interfaced devices and/or information systems and may be used for report generation. Procedural information and optional anatomical and physiological imaging and data devices may be interfaced (e.g. X-ray, ultrasound, patient monitors and information systems). The Mac-Lab System can display, store and annotate images previously acquired and stored by other systems. Data may be provided to other systems via multiple formats (e.g. HL7, DICOM. Analog outputs). Data may be received from other devices via multiple formats (e.g. DICOM, Analog inputs). Optional accessories for hardware and software include research tools to be used exclusively outside active patient care settings. The purpose of the research tools is to assist researchers or clinicians in developing algorithms. The Mac-Lab System does not have alarms, does not generate energy delivered to the patient, does not administer drugs and does not perform any life-supporting or life-sustaining functions. The Mac-Lab System is not intended for use on unattended patients, or in situations where diagnostic arrhythmia detection is required. The Mac-Lab System provides the ability to transmit patient data for storage, analysis and viewing at distributed locations within a clinical facility via network connectivity. The Mac-Lab System also functions as a stand-alone device. The Mac-Lab System is used in a variety of hospital and clinical settings interventional laboratories (e.g. cardiac catheterization and radiology), operating room environments, and post areas all under the direct supervision of licensed healthcare practitioners who are responsible for interpreting the data.

CardioLab: The CardioLab System is intended for acquiring, filtering, digitizing, amplifying, measuring and calculating, displaying, recording and monitoring of clinical data from adult and pediatric patients. The CardioLab System is configurable. Clinical data includes: ECG waveforms, intracardiac signals, stimulus data, ablation data, pulse oximetry (SpO2), respiration rate, CO2 (EtCO2), temperature, and invasive and noninvasive blood pressure. Physiological parameters such as diastolic, systolic, mean pressures, heart rate, and cycle length are derived from the signal data, displayed and recorded. The data is entered manually or acquired via interfaced devices and/or information systems and may be used for report generation. Procedural information and optional and physiological imaging and data devices may be interfaced [e.g. X-ray, ultrasound, mapping systems, ablation generators (e.g. RF and cryogenic)], stimulators, patient monitors and information systems. The CardioLab System can display, store and annotate images previously acquired and stored by other systems. Data may be provided to other systems via multiple formats (e.g. HL7, DICOM, Analog outputs). Data may be received from other devices via multiple formats (e.g. DICOM, Analog inputs). Optional accessories for hardware and software include research tools to be used exclusively outside active patient care settings. The purpose of the research tools is to assist researchers or clinicians in developing algorithms. Optional accessories for hardware and software include a waveform simulator to be used exclusively outside active patient care settings. The waveform simulator may be used for training, demonstration without a patient attached, and as a troubleshooting tool on the CardioLab System. The CardioLab System does not have alarms, does not generate energy delivered to the patient, does not administer drugs and does not perform any life-sustaining functions. The CardioLab System is not intended for use on unattended patients, or in situations where diagnostic arrhythmia detection is required. The CardioLab System provides the ability to transmit patient data for storage, analysis and viewing at distributed locations within a clinical facility via network connectivity. The CardioLab System also functions as a stand-alone device. The CardioLab System is used in a variety of hospital and clinical settings including interventional laboratories (e.g. electrophysiology and cardiac catheterization), operating room environments, and pre and post areas all under the direct supervision of licensed healthcare practitioners who are responsible for interpreting the data.

SpecialsLab: The SpecialsLab System executes the same software and runs on the same hardware in the same environments as the Mac-Lab System. Products designated as a SpecialsLab System support fewer options than the Mac-Lab system.

ComboLab: The ComboLab System is the combination of both the Mac-Lab and CardioLab Systems. The ComboLab System allows the user to run either the Mac-Lab System or the CardioLab System, although only one system may be used at a time. The ComboLab System executes the same software and runs on the same hardware in the same environments as the Mac-Lab and CardioLab Systems.

Device Description

Mac-Lab, CardioLab, ComboLab, and SpecialsLab Recording Systems are hemodynamic and electrophysiology (EP) recording systems. The product will be available in the following configurations: Mac-Lab System, CardioLab System, SpecialsLab System, or a combination of both Mac-Lab and CardioLab marketed as the ComboLab System. The product designated as SpecialsLab is the same as the Mac-Lab System with the exception that it will support fewer options. The SpecialsLab System performs the same intended use as the Mac-Lab, executes the same software, and runs on the same hardware. The Mac-Lab, CardioLab, and ComboLab Recording Systems are each available in several configurations ranging from basic to advanced functionality.

AI/ML Overview

The document provided is a 510(k) summary for GE Healthcare's Mac-Lab, CardioLab, ComboLab, and SpecialsLab Recording Systems v6.9.5. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria through a clinical study.

Here's an analysis based on your requested information:

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

This information is not provided in the document. The 510(k) summary for this type of device (a hemodynamic and electrophysiology recording system update) typically focuses on demonstrating that the new version is as safe and effective as the predicate device. It highlights new features or changes and asserts that these changes do not raise new questions of safety or effectiveness. Specific performance acceptance criteria and reported numerical performance values against those criteria are generally not part of a 510(k) summary for software updates in this context, especially when no clinical studies were deemed necessary.

The document states: "The Mac-Lab, CardioLab, ComboLab, and SpecialsLab Recording Systems and their applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission." However, the specific acceptance criteria from these voluntary standards and the device's measured performance against them are not included in this summary.

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

This information is not applicable as the document explicitly states: "The subject of this premarket submission, Mac-Lab, CardioLab, ComboLab, and SpecialsLab Recording Systems and their applications did not require clinical studies to support substantial equivalence." Therefore, there was no "test set" of patient data in the context of a clinical performance study. The testing mentioned (unit, integration, performance, safety, simulated use) would have been internal engineering and validation testing, not a clinical trial with a patient data test set.

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)

This information is not applicable as no clinical studies were performed, and thus no ground truth was established by human experts for a clinical test set.

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

This information is not applicable as no clinical studies requiring adjudication of a test set were conducted.

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

An MRMC study was not performed, nor is it applicable. This device is a recording system, not an AI-assisted diagnostic tool for interpretation by human readers. It collects and displays physiological data. The update involves "an additional data acquisition alternative" (PDM support) and "software application enhancements to existing features and functions." These changes do not relate to AI assistance for human interpretation.

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

A standalone performance study of an algorithm is not applicable to this device. This is a system for acquiring, displaying, and recording physiological data, not an algorithm providing a diagnostic output that would typically undergo standalone evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for the test set.

This information is not applicable as no clinical studies requiring a ground truth were performed.

8. The sample size for the training set

This information is not applicable. The device described is a hemodynamic and electrophysiology recording system, updated with new data acquisition and software enhancements. It does not appear to utilize machine learning or AI that would require a "training set" in the conventional sense for algorithm development. The "research tools" mentioned are for clinicians to develop algorithms, implying the device itself is not an algorithm-driven diagnostic tool relying on a training set.

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

This information is not applicable as there is no indication of a training set or ground truth in the context of machine learning.

Summary of the Study:

The "study" presented here is a non-clinical assessment for substantial equivalence. The document confirms that "The subject of this premarket submission... did not require clinical studies to support substantial equivalence."

Instead, substantial equivalence was demonstrated through:

Comparison to a predicate device: K111200 Mac-Lab, CardioLab, ComboLab, and SpecialsLab System.
Assessment of technological characteristics: The proposed systems "employ the same fundamental scientific technology as the predicate devices." The update includes additional data acquisition alternatives (PDM support) and software application enhancements to existing features.
Compliance with voluntary standards: Stated without providing details in this summary.
Quality assurance measures applied to development: Including Risk Analysis, Requirements Reviews, Design Reviews, Unit Testing, Integration Testing, Performance Testing, Safety Testing, and Simulated Use Testing. These are internal validation activities, not clinical trials.

In essence, this 510(k) summary asserts that the changes in v6.9.5 are minor and do not alter the safety or effectiveness of the device compared to the previously cleared predicate, thus no new clinical data or performance acceptance criteria against patient data sets were required by the FDA for this particular submission.

Summary

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

K130626 pg 1 of 5

Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circle. The letters and the circle are in black, and the background is white.

MAY 1 2013

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date:	March 7, 2013
Submitter:	GE Healthcare(GE Medical Systems Information Technologies, Inc.)8200 West Tower AvenueMilwaukee, WI 53223
Primary Contact Person:	Ms. Carol AlloianRegulatory LeaderGE Healthcare(GE Medical Systems Information Technologies, Inc.)Telephone: 224 280-1008Fax: 847 589 8524
Secondary ContactPerson:	Mr. Philip MalcaRegulatory Affairs DirectorGE Healthcare,(GE Medical Systems Information Technologies, Inc.)Telephone: 33(0) 1 3070 4207Fax: 33(0) 1 3070 4399
Device Trade Name:	Mac-Lab, CardioLab, ComboLab, SpecialsLab Recording Systemsv6.9.5
Common/Usual Name:	Hemodynamic and Electrophysiology (EP) Recording Systems
Classification Names:	21 CFR 870.1425 Computer, Diagnostic Programmable
Product Code:	DQK
Predicate Device(s):	K111200 Mac-Lab, CardioLab, ComboLab, and SpecialsLab System
Device Description:	Mac-Lab, CardioLab, ComboLab, and SpecialsLab RecordingSystems are hemodynamic and electrophysiology (EP) recordingsystems.
	The product will be available in the following configurations: Mac-LabSystem, CardioLab System, SpecialsLab System, or a combination ofboth Mac-Lab and CardioLab marketed as the ComboLab System.The product designated as SpecialsLab is the same as the Mac-LabSystem with the exception that it will support fewer options. TheSpecialsLab System performs the same intended use as the Mac-Lab, executes the same software, and runs on the same hardware.
	The Mac-Lab, CardioLab, and ComboLab Recording Systems areeach available in several configurations ranging from basic toadvanced functionality.
Intended Use:	Mac-Lab
	The Mac-Lab System is intended for acquiring, filtering, digitizing,amplifying, measuring and calculating, displaying, recording andmonitoring of clinical data from adult and pediatric patients. TheMac-Lab System is configurable. Clinical data includes: ECGwaveforms, heart rate, pulse oximetry (SpO2), respiration rate, CO2(EtCO2), temperature, hemodynamic measures [e.g. valve gradientsand areas, cardiac output, shunts, Fractional Flow Reserve (FFR),invasive and noninvasive blood pressure] Physiological parameterssuch as diastolic, systolic, and mean pressures, and heart rate arederived from the signal data, displayed and recorded. The data isentered manually or acquired via interfaced devices and/orinformation systems and may be used for report generation.Procedural information and optional anatomical and physiologicalimaging and data devices may be interfaced (e.g. X-ray, ultrasound,
	patient monitors and information systems). The Mac-Lab System candisplay, store and annotate images previously acquired and stored byother systems. Data may be provided to other systems via multipleformats (e.g. HL7, DICOM, Analog outputs). Data may be receivedfrom other devices via multiple formats (e.g. DICOM, Analog inputs).
	Optional accessories for hardware and software include researchtools to be used exclusively outside active patient care settings. Thepurpose of the research tools is to assist researchers or clinicians indeveloping algorithms.
	The Mac-Lab System does not have alarms, does not generateenergy delivered to the patient, does not administer drugs and doesnot perform any life-supporting or life-sustaining functions. The Mac-Lab System is not intended for use on unattended patients, or insituations where diagnostic arrhythmia detection is required.
	The Mac-Lab System provides the ability to transmit patient data forstorage, analysis and viewing at distributed locations within a clinical

facility via network connectivity. The Mac-Lab System also functionsas a stand-alone device. The Mac-Lab System is used in a variety ofhospital and clinical settings including interventional laboratories (e.g.cardiac catheterization and radiology), operating room environments,and pre and post areas all under the direct supervision of licensedhealthcare practitioners who are responsible for interpreting the data.
CardioLab
The CardioLab System is intended for acquiring, filtering, digitizing,amplifying, measuring and calculating, displaying, recording andmonitoring of clinical data from adult and pediatric patients. TheCardioLab System is configurable. Clinical data includes: ECGwaveforms, intracardiac signals, stimulus data, ablation data, pulseoximetry (SpO2), respiration rate, CO2 (EtCO2), temperature, andinvasive and noninvasive blood pressure. Physiological parameterssuch as diastolic, systolic, mean pressures, heart rate, and cyclelength are derived from the signal data, displayed and recorded. Thedata is entered manually or acquired via interfaced devices and/orinformation systems and may be used for report generation.
Procedural information and optional anatomical and physiologicalimaging and data devices may be interfaced [e.g. X-ray, ultrasound,mapping systems, ablation generators (e.g. RF and cryogenic)],stimulators, patient monitors and information systems. The CardioLabSystem can display, store and annotate images previously acquiredand stored by other systems. Data may be provided to other systemsvia multiple formats (e.g. HL7, DICOM, Analog outputs). Data may bereceived from other devices via multiple formats (e.g. DICOM, Analoginputs).
Optional accessories for hardware and software include researchtools to be used exclusively outside active patient care settings. Thepurpose of the research tools is to assist researchers or clinicians indeveloping algorithms.
Optional accessories for hardware and software includes a waveformsimulator to be used exclusively outside active patient care settings.The waveform simulator may be used for training, demonstrationwithout a patient attached, and as a troubleshooting tool on theCardioLab System.
The CardioLab System does not have alarms, does not generateenergy delivered to the patient, does not administer drugs and doesnot perform any life-supporting or life-sustaining functions. TheCardioLab System is not intended for use on unattended patients, orin situations where diagnostic arrhythmia detection is required.
The CardioLab System provides the ability to transmit patient data forstorage, analysis and viewing at distributed locations within a clinicalfacility via network connectivity. The CardioLab System also functionsas a stand-alone device. The CardioLab System is used in a varietyof hospital and clinical settings including interventional laboratories
Technology:	(e.g. electrophysiology and cardiac catheterization), operating roomenvironments, and pre and post areas all under the direct supervisionof licensed healthcare practitioners who are responsible forinterpreting the data.ComboLabThe ComboLab System is the combination of both the Mac-Lab andCardioLab Systems. The ComboLab System allows the user to runeither the Mac-Lab System or the CardioLab System, although onlyone system may be used at a time. The ComboLab System executesthe same software and runs on the same hardware in the sameenvironments as the Mac-Lab and CardioLab Systems.SpecialsLabThe SpecialsLab System executes the same software and runs onthe same hardware in the same environments as the Mac-LabSystem. Products designated as a SpecialsLab System support feweroptions than the Mac-Lab system.
	The proposed Mac-Lab, CardioLab, ComboLab, and SpecialsLabRecording Systems employ the same fundamental scientifictechnology as the predicate devices.
	The proposed Mac-Lab, CardioLab, ComboLab, SpecialsLabRecording Systems v 6.9.5 adds an additional data acquisitionalternative. In addition to TRAM, the Patient Data Module (PDM) isnow supported - inclusive of software, service tools, and hardware(PDM and base station).
	Additionally the proposed v 6.9.5 includes software applicationenhancements to existing features and functions, including thefollowing:Receive and store movies and additional snapshots fromCARTO™ system Provide expanded functionality to allow currently availablesignal data to be requested on-demand Allow association of user defined author names to entriesrecorded in the procedure log Additional window on Mac-Lab to allow a duplicate display ofrecorded pressure measurements. Enhanced presentation of the Medication Summary windows Enhanced existing waveform export to include ablation dataexport and added additional example algorithm Enhanced Service Utilities Support for additional versions of third party software forAntivirus and Backup solutions Hardware and software updates to address normaltechnological advancement and obsolescence issues
Determination ofSubstantial Equivalence:	Summary of Non-Clinical Tests:
	The Mac-Lab, CardioLab, ComboLab, and SpecialsLab Recording Systems and their applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:
	Risk Analysis Requirements Reviews Design Reviews Testing on unit level (Module verification) Integration testing (System verification) Performance testing (Verification) Safety testing (Verification) Simulated use testing (Validation)
	Summary of Clinical Tests:
	The subject of this premarket submission, Mac-Lab, CardioLab, ComboLab, and SpecialsLab Recording Systems and their applications did not require clinical studies to support substantial equivalence.
Conclusion:	GE Healthcare considers the Mac-Lab, CardioLab, ComboLab, and SpecialsLab Recording Systems and their applications to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).

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

K130626 pg 2ofs

Image /page/1/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized and appear to be hand-drawn or calligraphic, giving the logo a classic and recognizable look.

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

K130626 Pg 30f5

GE Healthcare 510(k) Premarket Notification Submission Mac-Lab, CardioLab, ComboLab, SpecialsLab v 6.9.5

Image /page/2/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular frame. There are three small, rounded shapes evenly spaced around the outside of the circle, giving the logo a distinctive and recognizable appearance. The logo is black and white.

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

GE Healthcare 510(k) Premarket Notification Submission Mac-Lab, CardioLab, ComboLab, SpecialsLab v 6.9.5

Image /page/3/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters and the border are in black, contrasting with the white background.

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

K130626 pg 5 of 5

Image /page/4/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. There are small, stylized flourishes or dots placed around the circle, enhancing the logo's design.

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

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

May 1. 2013

GE Healthcare C/O Philip Malca Regulatory Affairs Director 8200 West Tower Avenue Milwaukee, Wisconsin 53223

Re: K130626

Trade/Device Name: Mac-Lab, Cardio-Lab, ComboLab, and SpecialsLab Recording Systems

Regulation Number: 21 CFR 870.1425

Regulation Name: Programmable Diagnostic Computer

Regulatory Class: Class II Product Code: DQK

Dated: March 29, 2013

Received: April 2, 2013
Dear Mr. Malca:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading,

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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

Page 2 - Philip Malca

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

OwenPEaris -S

for Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

GE Healthcare 510(k) Premarket Notification Submission Mac-Lab, CardioLab, ComboLab, SpecialsLab v 6.9.5

510(k) Number (if known): To be Assianed

Device Name: Mac-Lab, CardioLab, ComboLab, SpecialsLab Recording System(s)

Indications for Use: Mac-Lab

The Mac-Lab System is intended for acquiring, filtering, digitizing, amplifying, measuring and calculating, displaying, recording and monitoring of clinical data from adult and pediatric patients. The Mac-Lab System is configurable. Clinical data includes: ECG waveforms, heart rate, pulse oximetry (SpO2), respiration rate, CO2 (EtCO2), temperature, hemodynamic measures [e.g. valve gradients and areas, cardiac output, shunts, Fractional Flow Reserve (FFR), invasive and noninvasive blood pressure] Physiological parameters such as diastolic. systolic, mean pressures, and heart rate are derived from the signal data, displayed and recorded. The data is entered manually or acquired via interfaced devices and/or information systems and may be used for report generation.

Procedural information and optional anatomical and physiological imaging and data devices may be interfaced (e.g. X-ray, ultrasound, patient monitors and information systems). The Mac-Lab System can display, store and annotate images previously acquired and stored by other systems. Data may be provided to other systems via multiple formats (e.g. HL7, DICOM. Analog outputs). Data may be received from other devices via multiple formats (e.g. DICOM, Analog inputs).

Optional accessories for hardware and software include research tools to be used exclusively outside active patient care settings. The purpose of the research tools is to assist researchers or clinicians in developing algorithms.

The Mac-Lab System does not have alarms, does not generate energy delivered to the patient, does not administer drugs and does not perform any life-supporting or life-sustaining functions. The Mac-Lab System is not intended for use on unattended patients, or in situations where diagnostic arrhythmia detection is required.

The Mac-Lab System provides the ability to transmit patient data for storage, analysis and viewing at distributed locations within a clinical facility via network connectivity. The Mac-Lab System also functions as a stand-alone device. The Mac-Lab System is used in a variety of hospital and clinical settings interventional laboratories (e.g. cardiac catheterization and radiology), operating room environments, and post areas all under the direct supervision of licensed healthcare practitioners who are responsible for interpreting the data.

Prescription Use x AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use_ (Part 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)

Owen P. Faris -S
2013.05.01 15:45:04
-04'00'

FM000031

{8}------------------------------------------------

GE Healthcare

Image /page/8/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circle. There are decorative swirls around the outside of the circle. The logo is black and white.

510(k) Premarket Notification Submission Mac-Lab, CardioLab, ComboLab, SpecialsLab v 6.9.5

510(k) Number (if known): To Be Assigned

Device Name: Mac-Lab, CardioLab, ComboLab, and SpecialsLab Recording Systems Indications for Use:

SpecialsLab

The SpecialsLab System executes the same software and runs on the same hardware in the same environments as the Mac-Lab System. Products designated as a SpecialsLab System support fewer options than the Mac-Lab system.

ComboLab

The ComboLab System is the combination of both the Mac-Lab and CardioLab Systems. The ComboLab System allows the user to run either the Mac-Lab System or the CardioLab System, although only one system may be used at a time. The ComboLab System executes the same software and runs on the same hardware in the same environments as the Mac-Lab and CardioLab Systems.

Prescription Use X

AND/OR

(Part 21 CFR 801 Subpart D)

Over-The-Counter Use (Part 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)

Owen P. Faris -S
2013.05.01 15:45:41
-04'00'

{9}------------------------------------------------

Image /page/9/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is black and white, with the letters and border in black and the background in white.

510(k) Number (if known): To Be Assigned

Device Name: Mac-Lab, CardioLab, ComboLab, and SpecialsLab Recording System(s)

Indications for Use: CardioLab

The CardioLab System is intended for acquiring, filtering, digitizing, amplifying, measuring and calculating, displaying, recording and monitoring of clinical data from adult and pediatric patients. The CardioLab System is configurable. Clinical data includes: ECG waveforms, intracardiac signals, stimulus data, ablation data, pulse oximetry (SpO2), respiration rate, CO2 (EtCO2), temperature, and invasive and noninvasive blood pressure. Physiological parameters such as diastolic, systolic, mean pressures, heart rate, and cycle length are derived from the signal data, displayed and recorded. The data is entered manually or acquired via interfaced devices and/or information systems and may be used for report generation.

Procedural information and optional and physiological imaging and data devices may be interfaced [e.g. X-ray, ultrasound, mapping systems, ablation generators (e.g. RF and cryogenic)], stimulators, patient monitors and information systems. The CardioLab System can display, store and annotate images previously acquired and stored by other systems. Data may be provided to other systems via multiple formats (e.g. HL7, DICOM, Analog outputs). Data may be received from other devices via multiple formats (e.g. DICOM, Analog inputs).

Optional accessories for hardware and software include a waveform simulator to be used exclusively outside active patient care settings. The waveform simulator may be used for training, demonstration without a patient attached, and as a troubleshooting tool on the CardioLab System.

The CardioLab System does not have alarms, does not generate energy delivered to the patient, does not administer drugs and does not perform any life-sustaining functions. The CardioLab System is not intended for use on unattended patients, or in situations where diagnostic arrhythmia detection is required.

The CardioLab System provides the ability to transmit patient data for storage, analysis and viewing at distributed locations within a clinical facility via network connectivity. The CardioLab System also functions as a stand-alone device. The CardioLab System is used in a variety of hospital and clinical settings including interventional laboratories (e.g. electrophysiology and cardiac catheterization), operating room environments, and pre and post areas all under the direct supervision of licensed healthcare practitioners who are responsible for interpreting the data.

Prescription Use x AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (Part 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)

Owen P. Faris -S
2013.05.01
15:45:25 -04'00'

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).