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, and 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 including interventional laboratories (e.g. cardiac catheterization and radiology), operating room environments, and pre 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 anatomical 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 includes 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-supporting or 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 application, CardioLab application, SpecialsLab application, or a combination of both CardioLab and Mac-Lab applications marketed as ComboLab. 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 full advanced functionality.

AI/ML Overview

The provided document is a 510(k) Premarket Notification Submission for GE Healthcare's Mac-Lab, CardioLab, ComboLab, and SpecialsLab Recording Systems. This type of submission is for medical devices that are substantially equivalent to legally marketed predicate devices.

Medical device submissions for substantial equivalence do not typically include acceptance criteria, performance tables, or clinical studies of the type described in the prompt (e.g., sample sizes, expert ground truth, MRMC studies, standalone performance). Instead, the focus is on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or that any differences do not raise new questions of safety and effectiveness.

Here's a breakdown based on the provided text, addressing the prompt's points where applicable, and explaining why other points cannot be addressed:

Response to Prompt:

Based on the provided 510(k) Summary, the device did not require a clinical study to demonstrate that it meets acceptance criteria because it is being submitted for substantial equivalence to a predicate device. The document explicitly states:

"The subject of this premarket submission, Mac-Lab, CardioLab, ComboLab, and SpecialsLab Recording Systems, did not require clinical studies to support substantial equivalence." (Page 4, "Summary of Clinical Tests")

Therefore, most of the requested information regarding acceptance criteria and a study proving their fulfillment is not available or applicable in this submission. The submission relies on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of fundamental scientific technology.

However, I can provide information based on the "Summary of Non-Clinical Tests" mentioned:

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

Not applicable / Not provided. The submission focuses on substantial equivalence to a predicate device, not on meeting specific, de novo acceptance criteria with reported performance values from a clinical study. The non-clinical tests mentioned are quality assurance measures, not performance metrics against specific acceptance thresholds.

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

Not applicable / Not provided. No clinical test set or data provenance is detailed, as clinical studies were not required. The non-clinical tests (e.g., unit testing, integration testing) would not typically involve patient data or sample sizes in the context of clinical performance evaluation.

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)

Not applicable / Not provided. No clinical ground truth establishment is described, as clinical studies were not required.

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

Not applicable / Not provided. No clinical 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

Not applicable / Not provided. No MRMC study was conducted or is documented, nor is there any mention of AI assistance in the context of human reader performance. This device is an EP/hemodynamic recording system, not an AI diagnostic tool.

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

Not applicable / Not provided. The device is a recording system, not an algorithm performing a diagnostic task independently. Its function is to acquire, process, display, and record physiological data for interpretation by licensed healthcare practitioners.

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

Not applicable / Not provided. No clinical ground truth is detailed, as clinical studies were not required. The non-clinical tests likely used engineering specifications and reference standards as a "ground truth" for verification.

8. The sample size for the training set

Not applicable / Not provided. This device is not described as utilizing a machine learning algorithm that would require a "training set" in the conventional sense for AI/ML performance evaluation. Its software development followed traditional quality assurance measures.

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

Not applicable / Not provided. (See point 8).

Information from the Document Regarding Device Performance and Verification:

While specific acceptance criteria and clinical performance data are not provided, the document does list the quality assurance measures applied during the development of the system to ensure its functionality and safety, implying these serve as the verification methods against internal requirements:

Summary of Non-Clinical Tests (Page 4):
The Mac-Lab, CardioLab, ComboLab, and SpecialsLab Recording Systems and their applications comply with voluntary standards (as detailed in Sections 9, 11, and 17 of the submission, which are not provided here). The following quality assurance measures were applied:

Risk Analysis
Requirements Reviews
Design Reviews
Testing on unit level (Module verification)
Integration testing (System verification)
Performance testing (Verification)
Safety testing (Verification)
Simulated use and Usability testing (Validation)

These measures confirm that the device was developed following a robust quality system and that its functions were verified and validated against design requirements and intended use within a non-clinical context. The basis for its market clearance is "substantial equivalence" to existing predicate devices (K061741 Mac-Lab, CardioLab, ComboLab, and SpecialsLab System), rather than de novo clinical proof of specific performance metrics against pre-defined acceptance criteria.

Summary

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111200

Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular border. The letters are stylized with curved lines, and the border has a textured appearance.

OCT 1 2 2011

GE Healthcare 510(k) Premarket Notification Submission

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510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided: Date: April 27, 2011 Submitter: GE Healthcare,

(GE Medical Systems Information Technologies, Inc.) 8200 West Tower Avenue Milwaukee, WI 53223

Primary Contact Person: Ms. Carol Alloian Regulatory Leader

GE Healthcare, (GE Medical Systems Information Technologies, Inc.) Telephone: 224 280-1008 Fax: 847 589 8524

Secondary Contact Person: Mr. Philip Malca Regulatory Affairs Director

GE Healthcare, (GE Medical Systems Information Technologies, Inc.) Telephone: 33(0) 1 3070 4207 Fax: 33(0) 1 3070 4399

Device: Trade Name: Mac-Lab, CardioLab, ComboLab, and SpecialsLab Recording Systems
Common/Usual Name: Hemodynamic and Electrophysiology (EP) Recording Systems
Classification Names: 21 CFR 870.1425 Computer, Diagnostic Programmable Product Code: DOK
- Predicate Device(s): K061741 Mac-Lab, CardioLab, ComboLab, and SpecialsLab System

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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 application, CardioLab application, SpecialsLab application, or a combination of both CardioLab and Mac-Lab applications marketed as ComboLab. 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 full advanced functionality.

Intended Use/ Mac-Lab

Indications for Use:

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, and 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

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Intended Use/ Indications for Use: 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 including interventional laboratories (e.g. cardiac catheterization and radiology), operating room environments, and pre 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 anatomical 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.

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Intended Use/ Indications for Use:

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 includes 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-supporting or 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,

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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.

The proposed Mac-Lab, CardioLab, ComboLab, and SpecialsLab Technology: Recording Systems employ the same fundamental scientific technology as their predicate devices.

Determination of Summary of Non-Clinical Tests:

Substantial Equivalence: 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 and Usability testing (Validation) .

Summary of Clinical Tests:

The subject of this premarket submission, Mac-Lab, CardioLab, ComboLab, and SpecialsLab Recording Systems, did not require clinical studies to support substantial equivalence.

Conclusion: GE Healthcare considers the Mac-Lab, CardioLab, ComboLab, and SpecialsLab Recording Systems to be as safe and effective as, and to have performance substantially equivalent to, the predicate devices.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or other bird in flight. The symbol is composed of three curved lines that converge at the bottom.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20995-0002

OCT 1 2 2011

GE Healthcare c/o Ms. Carol Alloian. RAC Regulatory Leader, Interventional Systems 9900 W Innovation Drive Wauwatosa, WI 53266-4856

Re: K111200

Trade/Device Names: Mac-Lab, CardioLab, ComboLab and SpecialsLab Recording Systems, Version 6.9 Regulatory Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (Two) Product Code: DOK Dated: September 19, 2011 Received: September 21, 2011

Dear Ms. Alloian:

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 additional controls. Existing major regulations affecting your devil (1111) 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. Carol Alloian. RAC

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D. -0-Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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111200

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GE Healthcare 510(k) Premarket Notification Submission

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

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

Indications for Use: Mac-Lab

The Mac-Lab System is intended for acquiring, filtering, 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 oximerry (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, 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 mav be used for report generation.

Procedural information and optional analomical and physiological imaging and data devices may be interfaced (e.g. X -rav, 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).

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

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 In Vitro Diagnostic Devices (OIVD)

(Division Sign-Off)
---------------------	--

Division of Cardiovascular Devices

510(k) Number	K117200
---------------	---------

R-C 000

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KII200 510(k) Number (if known): To Be Assigned

Device Name: Mac-Lab, CardioLab, ComboL.ab, and SpecialsL.ab Recording Systems

Indications for Use: CardioLab

The CardioLab System is intended for acquiring, filtering, amplitying, 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 (EiCO2), 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.

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 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 post areas all under the direct supervision of licensed healthcare practitioners who are responsible for interpreting the data.

Prescription Use x (Part 21 CFR 801 Subpart D)

510(k) Numb

AND/OR

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 In Vitro Diagnostic Devices (OIVD)

(Division Sign-Off)
Division of Cardiovascular Devices

R-C 000003

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

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

Indications for Use:

SpecialsLab

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 Combol.ab 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
(Part 21 CFR 801 Subpart D)

AND/OR

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 In Vitro Diagnostic Devices (OIVD)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number	(111200

4
R-C 000004

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).