MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS

K130626 · Ge Medical Systems Information Technologies, Inc. · DQK · May 1, 2013 · Cardiovascular

Device Facts

• Record ID: K130626
• Device Name: MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS
• Applicant: Ge Medical Systems Information Technologies, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: May 1, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1425
• Device Class: Class 2
• Attributes: Pediatric

Intended 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 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. 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.

Device Story

Hemodynamic and electrophysiology recording systems (Mac-Lab, CardioLab, ComboLab, SpecialsLab) acquire, filter, digitize, and display physiological signals (ECG, SpO2, CO2, pressure, intracardiac signals). Used in interventional labs and ORs by clinicians to monitor patients and generate reports. Inputs include direct patient sensors, interfaced imaging/ablation equipment, and manual data entry. System performs signal processing and parameter calculation (e.g., cardiac output, FFR, cycle length). Outputs displayed on-screen and stored for clinical review. Supports network transmission for distributed viewing. Benefits include real-time visualization and documentation of procedural data to assist clinical decision-making. Version 6.9.5 adds Patient Data Module (PDM) support, CARTO system integration, and enhanced waveform/medication reporting.

Clinical Evidence

No clinical studies were required to support substantial equivalence. Evidence consists of bench testing, including risk analysis, design reviews, module verification, system integration testing, and simulated-use validation.

Technological Characteristics

Hemodynamic/EP recording system; configurable hardware/software. Supports TRAM and PDM data acquisition modules. Connectivity via network (HL7, DICOM) or standalone. Software-based signal processing and parameter calculation. No energy delivery or life-support functions.

Indications for Use

Indicated for adult and pediatric patients undergoing hemodynamic and electrophysiology monitoring in interventional labs, ORs, and clinical settings. Not for unattended patients or diagnostic arrhythmia detection.

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Predicate Devices

• Mac-Lab, CardioLab, ComboLab, and SpecialsLab System (K111200)

Submission Summary (Full Text)

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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<br>(GE Medical Systems Information Technologies, Inc.)<br>8200 West Tower Avenue<br>Milwaukee, WI 53223 |
| Primary Contact Person: | Ms. Carol Alloian<br>Regulatory Leader<br>GE Healthcare<br>(GE Medical Systems Information Technologies, Inc.)<br>Telephone: [phone]<br>Fax: [phone] |
| Secondary Contact<br>Person: | Mr. Philip Malca<br>Regulatory Affairs Director<br>GE Healthcare,<br>(GE Medical Systems Information Technologies, Inc.)<br>Telephone: [phone]<br>Fax: [phone] |
| Device Trade Name: | Mac-Lab, CardioLab, ComboLab, SpecialsLab Recording Systems<br>v6.9.5 |
| 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 Recording<br>Systems are hemodynamic and electrophysiology (EP) recording<br>systems. |
| | The product will be available in the following configurations: Mac-Lab<br>System, CardioLab System, SpecialsLab System, or a combination of<br>both Mac-Lab and CardioLab marketed as the ComboLab System.<br>The product designated as SpecialsLab is the same as the Mac-Lab<br>System with the exception that it will support fewer options. The<br>SpecialsLab System performs the same intended use as the Mac-<br>Lab, executes the same software, and runs on the same hardware. |
| | The Mac-Lab, CardioLab, and ComboLab Recording Systems are<br>each available in several configurations ranging from basic to<br>advanced functionality. |
| Intended Use: | Mac-Lab |
| | The Mac-Lab System is intended for acquiring, filtering, digitizing,<br>amplifying, measuring and calculating, displaying, recording and<br>monitoring of clinical data from adult and pediatric patients. The<br>Mac-Lab System is configurable. Clinical data includes: ECG<br>waveforms, heart rate, pulse oximetry (SpO2), respiration rate, CO2<br>(EtCO2), temperature, hemodynamic measures [e.g. valve gradients<br>and areas, cardiac output, shunts, Fractional Flow Reserve (FFR),<br>invasive and noninvasive blood pressure] Physiological parameters<br>such as diastolic, systolic, and mean pressures, and heart rate are<br>derived from the signal data, displayed and recorded. The data is<br>entered manually or acquired via interfaced devices and/or<br>information systems and may be used for report generation.<br>Procedural information and optional anatomical and physiological<br>imaging and data devices may be interfaced (e.g. X-ray, ultrasound, |
| | patient monitors and information systems). The Mac-Lab System can<br>display, store and annotate images previously acquired and stored by<br>other systems. Data may be provided to other systems via multiple<br>formats (e.g. HL7, DICOM, Analog outputs). Data may be received<br>from other devices via multiple formats (e.g. DICOM, Analog inputs). |
| | Optional accessories for hardware and software include research<br>tools to be used exclusively outside active patient care settings. The<br>purpose of the research tools is to assist researchers or clinicians in<br>developing algorithms. |
| | The Mac-Lab System does not have alarms, does not generate<br>energy delivered to the patient, does not administer drugs and does<br>not perform any life-supporting or life-sustaining functions. The Mac-<br>Lab System is not intended for use on unattended patients, or in<br>situations where diagnostic arrhythmia detection is required. |
| | The Mac-Lab System provides the ability to transmit patient data for<br>storage, analysis and viewing at distributed locations within a clinical |
| | |
| facility via network connectivity. The Mac-Lab System also functions<br>as a stand-alone device. The Mac-Lab System is used in a variety of<br>hospital and clinical settings including interventional laboratories (e.g.<br>cardiac catheterization and radiology), operating room environments,<br>and pre and post areas all under the direct supervision of licensed<br>healthcare practitioners who are responsible for interpreting the data. | |
| CardioLab | |
| The CardioLab System is intended for acquiring, filtering, digitizing,<br>amplifying, measuring and calculating, displaying, recording and<br>monitoring of clinical data from adult and pediatric patients. The<br>CardioLab System is configurable. Clinical data includes: ECG<br>waveforms, intracardiac signals, stimulus data, ablation data, pulse<br>oximetry (SpO2), respiration rate, CO2 (EtCO2), temperature, and<br>invasive and noninvasive blood pressure. Physiological parameters<br>such as diastolic, systolic, mean pressures, heart rate, and cycle<br>length are derived from the signal data, displayed and recorded. The<br>data is entered manually or acquired via interfaced devices and/or<br>information systems and may be used for report generation. | |
| Procedural information and optional anatomical and physiological<br>imaging and data devices may be interfaced [e.g. X-ray, ultrasound,<br>mapping systems, ablation generators (e.g. RF and cryogenic)],<br>stimulators, patient monitors and information systems. The CardioLab<br>System can display, store and annotate images previously acquired<br>and stored by other systems. Data may be provided to other systems<br>via multiple formats (e.g. HL7, DICOM, Analog outputs). Data may be<br>received from other devices via multiple formats (e.g. DICOM, Analog<br>inputs). | |
| Optional accessories for hardware and software include research<br>tools to be used exclusively outside active patient care settings. The<br>purpose of the research tools is to assist researchers or clinicians in<br>developing algorithms. | |
| Optional accessories for hardware and software includes a waveform<br>simulator to be used exclusively outside active patient care settings.<br>The waveform simulator may be used for training, demonstration<br>without a patient attached, and as a troubleshooting tool on the<br>CardioLab System. | |
| The CardioLab System does not have alarms, does not generate<br>energy delivered to the patient, does not administer drugs and does<br>not perform any life-supporting or life-sustaining functions. The<br>CardioLab System is not intended for use on unattended patients, or<br>in situations where diagnostic arrhythmia detection is required. | |
| The CardioLab System provides the ability to transmit patient data for<br>storage, analysis and viewing at distributed locations within a clinical<br>facility via network connectivity. The CardioLab System also functions<br>as a stand-alone device. The CardioLab System is used in a variety<br>of hospital and clinical settings including interventional laboratories | |
| Technology: | (e.g. electrophysiology and cardiac catheterization), operating room<br>environments, and pre and post areas all under the direct supervision<br>of licensed healthcare practitioners who are responsible for<br>interpreting the data.<br><br><b>ComboLab</b><br>The ComboLab System is the combination of both the Mac-Lab and<br>CardioLab Systems. The ComboLab System allows the user to run<br>either the Mac-Lab System or the CardioLab System, although only<br>one system may be used at a time. The ComboLab System executes<br>the same software and runs on the same hardware in the same<br>environments as the Mac-Lab and CardioLab Systems.<br><br><b>SpecialsLab</b><br>The SpecialsLab System executes the same software and runs on<br>the same hardware in the same environments as the Mac-Lab<br>System. Products designated as a SpecialsLab System support fewer<br>options than the Mac-Lab system. |
| | The proposed Mac-Lab, CardioLab, ComboLab, and SpecialsLab<br>Recording Systems employ the same fundamental scientific<br>technology as the predicate devices. |
| | The proposed Mac-Lab, CardioLab, ComboLab, SpecialsLab<br>Recording Systems v 6.9.5 adds an additional data acquisition<br>alternative. In addition to TRAM, the Patient Data Module (PDM) is<br>now supported - inclusive of software, service tools, and hardware<br>(PDM and base station). |
| | Additionally the proposed v 6.9.5 includes software application<br>enhancements to existing features and functions, including the<br>following:<br>Receive and store movies and additional snapshots from<br>CARTO™ system Provide expanded functionality to allow currently available<br>signal data to be requested on-demand Allow association of user defined author names to entries<br>recorded in the procedure log Additional window on Mac-Lab to allow a duplicate display of<br>recorded pressure measurements. Enhanced presentation of the Medication Summary windows Enhanced existing waveform export to include ablation data<br>export and added additional example algorithm Enhanced Service Utilities Support for additional versions of third party software for<br>Antivirus and Backup solutions Hardware and software updates to address normal<br>technological advancement and obsolescence issues |
| Determination of<br>Substantial 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). |

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## 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.

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## 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.

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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 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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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### 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

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### 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'

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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 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.

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'