CARDIQ XPRESS 2.0 WITH SNAPSHOT FREEZE OPTION CARDIQ XPRESS 2.0 REVEAL

K120910 · GE Medical Systems SCS · JAK · Jun 18, 2012 · Radiology

Device Facts

• Record ID: K120910
• Device Name: CARDIQ XPRESS 2.0 WITH SNAPSHOT FREEZE OPTION CARDIQ XPRESS 2.0 REVEAL
• Applicant: GE Medical Systems SCS
• Product Code: JAK · Radiology
• Decision Date: Jun 18, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

CardIQ Xpress 2.0 is intended to provide an optimized non-invasive application to analyze cardiovascular anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images. CardIQ Xpress 2.0 is a CT, noninvasive, image analysis software package, which aids in diagnosing of cardiovascular disease to include, coronary artery disease, functional parameters of the heart, heart structures and follow-up for stent placement, bypasses and plaque imaging. CardIQ Xpress 2.0 offers unique tools such as automatic tracking, which will pre-process the CT data into multiple viewing ports to allow for an expedited read time improving workflow. With CardIQ Xpress 2.0, the user can color code the myocardial tissue to show hypo/hyperdense areas in the myocardial tissue of the heart. With the IVUS-like view the user can color code the HU units of the plaque to better visualize the difference between calcified and non-calcified plaque in the wall of the vessel and the lumen to determine the amount of atherosclerosis. The user can see the different valve planes along with a variety of new layouts to align the heart. The IVUS like view is created by applying GE's Volume Rendering on a cross-section perpendicular to the detected centerline. This view merely displays a cross section as in IVUS imaging and color codes like IVUS images. No new or additional diagnostic information is added. CardIQ Xpress 2.0 is for use on the Advantage Workstation (AW) platform, CT scanner, PAC or Centricity stations, which can be used in the analysis of 2D or 3D CT angiography images/data derived from DICOM 3.0 CT scans.

Device Story

CardIQ Xpress 2.0 with SnapShot Freeze is post-processing software for CT angiography images. It processes DICOM 3.0 CT data to visualize coronary vessels, heart structures, and myocardial tissue. Key features include automatic tracking for multi-view port display, myocardial tissue color-coding (hypo/hyperdense areas), and an IVUS-like view created via volume rendering on cross-sections perpendicular to detected centerlines. The software is used on GE Advantage Workstations, CT scanners, or PACS/Centricity stations by clinicians to assess atherosclerosis, plaque composition (calcified vs. non-calcified), and heart function (e.g., ejection fraction). SnapShot Freeze reduces coronary artery motion blurring. Output includes 2D/3D visualizations and text/graphic reports with templates. It aids clinical decision-making by streamlining workflow and providing anatomical/pathological insights for treatment planning.

Clinical Evidence

No clinical trials were conducted. Verification and validation testing utilized clinical images from a non-significant risk reader study of patient images to confirm performance.

Technological Characteristics

Software-based image analysis application. Operates on DICOM 3.0 CT data. Features include automatic tracking, volume rendering for IVUS-like views, and color-coding of Hounsfield Units (HU) for plaque and myocardial tissue analysis. Designed for integration with GE Advantage Workstation, CT scanners, and PACS/Centricity systems.

Indications for Use

Indicated for analysis of cardiovascular anatomy and pathology in patients undergoing CT angiography. Aids in diagnosis of coronary artery disease, assessment of heart structures, functional parameters, and follow-up for stent placement, bypasses, and plaque imaging.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• CardIQ Xpress Version 2.0 (K073138)

Submission Summary (Full Text)

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GE Healthcare 510(k) Premarket Notification Submission

## 510(k) Summary

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

| Date: | March 21, 2012 |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Medical Systems, SCS (d.b.a. GE Healthcare) |
| | 283, rue de la Miniere BP34 |
| | 78530 Buc Cedex - France |
| | FDA Registration Number: 9611343 |
| Primary Contact<br>Person: | Stephen Slavens, RAC<br>Regulatory Affairs Director, MICT<br>GE Healthcare<br>Phone: [phone]<br>FAX: [phone]<br>[e-mail] |
| Secondary Contact<br>Person: | Helen Peng, RAC<br>Regulatory Affairs Leader<br>GE Healthcare<br>Phone: [phone]<br>FAX: [phone]<br>[e-mail] |
| Device:<br>Trade Name: | CardIQ Xpress 2.0 with SnapShot* Freeze Option |
| Common/Usual<br>Name: | Accessory to: System, x-ray, tomography, computed |
| Classification Names: | 21CFR 892.1750 |
| Product Code: | JAK |
| Predicate Device(s): | Predicate Device Name: CardIQ Xpress Version 2.0<br>Predicate 510k Number: K073138<br>Predicate Manufacturer: GE Medical Systems |
| Device Description: | The GE Medical Systems CardIQ Xpress 2.0 software is a<br>post processing software option for the Advantage<br>Workstation (AW) Platform, CT scanner, PACS or Centricity<br>systems. This product can be used in the analysis of CT<br>angiographic images to view the coronary vessels to<br>determine if the patient has normal coronary arteries,<br>arteriolosclerosis or severe stenosis, which needs to go on |

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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 and the border are solid black, creating a strong contrast against the white background.

## GE Healthcare 510(k) Premarket Notification Submission

for treatment. This software also can look at the heart structures to include valve imaging, heart motion and ejection fraction. CardIO Xpress 2.0 contains both graphic and text report capabilities with predefined templates for ease of use.

CardIO Xpress 2.0 with SnapShot* Freeze is additionally designed to reduce the coronary artery motion blurring in a CT image.

Indications for Use:

CardIO Xpress 2.0 is intended to provide an optimized noninvasive application to analyze cardiovascular anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images. CardIQ Xpress 2.0 is a CT, noninvasive, image analysis software package, which aids in diagnosina of cardiovascular disease to include, coronary artery disease, functional parameters of the heart, heart structures and follow-up for stent placement, bypasses and plaque imaging.

CardIQ Xpress 2.0 offers unique tools such as automatic tracking, which will pre-process the CT data into multiple viewing ports to allow for an expedited read time improving workflow. With CardIQ Xpress 2.0, the user can color code the myocardial tissue to show hypo/hyperdense areas in the myocardial tissue of the heart. With the IVUS-like view the user can color code the HU units of the plaque to better visualize the difference between calcified and non-calcified plaque in the wall of the vessel and the lumen to determine the amount of atherosclerosis. The user can see the different valve planes along with a variety of new lavouts to alian the heart. The IVUS like view is created by applying GE's Volume Rendering on a crosssection perpendicular to the detected centerline. This view merely displays a cross section as in IVUS imaging and color codes like IVUS images. No new or additional diagnostic information is added.

CardIQ Xpress 2.0 is for use on the Advantage Workstation (AW) platform, CT scanner, PAC or Centricity stations, which can be used in the analysis of 2D or 3D CT angiography

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Image /page/2/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The letters are stylized with curved lines, and the circle has decorative elements around its perimeter.

# GE Healthcare 510(k) Premarket Notification Submission

# images/data derived from DICOM 3.0 CT scans.

Technology: The proposed medical device, CardIQ Xpress 2.0 with Snapshot Freeze Option, employs the same fundamental scientific technology as its predicate device CardIQ Xpress 2.0.

Determination of Substantial

Equivalence:

### Summary of Non-Clinical Tests:

CardIQ Xpress 2.0 with SnapShot Freeze Option complies with voluntary standards as discussed in Section 9, and 11 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:

As referenced in Section 20, the CT acquired clinical images used for the completion of verification and validation testing for CardIQ Xpress 2.0 with Snapshot Freeze Option were obtained from a non-significant risk reader study of care patient images.

- GE Healthcare considers the CardIQ Xpress 2.0 with Conclusion: Snapshot Freeze Option application to be as safe, as effective, and performance is substantially equivalent to the predicate device.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping bodies, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN 1 8 2012

GE Healthcare c/o Mr. Stephen Slavens Regulatory Affairs Director, MICT 3000 N Grandview Blvd W 1140 Waukesha, WI 53188

#### Re: K120910

Trade Name: CardIO Xpress 2.0 with Snapshot Freeze Option Regulation Number: 21.CFR892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II (two) Product Codes: JAK Dated: June 17, 2012 Received: June 22, 2012

#### Dear Mr. Slavens:

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.

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### Page 2 –Mr. Slavens

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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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

Enclosure

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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular frame. The letters and the frame are in black, set against a white background. The design is simple and recognizable, representing the brand identity of General Electric.

### k120910 S001

# GE Healthcare 510(k) Premarket Notification Submission

#### 510(k) Number (if known):

Device Name: CardIO Xpress 2.0 with SnapShot* Freeze Option

#### Indications for Use:

CardlQ Xpress 2.0 is intended to provide an optimized non-invasive application to andyze cardiovascular anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images. CardlQ Xpress 2.0 is a CT, noninvasive, image analysis software package, which aids in diagnosing of cardiovascular disease to include, coronary artery disease, functional parameters of the heart, heart structures and follow-up for stent placement, bypasses and plaque imaging.

CardIQ Xpress 2.0 offers unique tools such as automatic tracking, which will pre-process the CT data into multiple viewing ports to allow for an expedited read time improving workflow. With CardIQ Xpress 2.0, the user can color code the myocardial tissue to show hyperdense areas in the myocardial tissue of the heart. With the IVUS-like view the user can color code the HU units of the plaque to better visualize the difference between calcified and noncalcified plaque in the wall of the vessel and the lumen to determine the amount of atherosclerosis. The user can see the different valve planes along with a variety of new layouts to alian the heart. The IVUS like view is created by applying GE's Volume Rendering on a cross-section perpendicular to the detected centerline. This view merely displays a cross section as in IVUS imaging and color codes like IVUS images. No new or additional diagnostic informotion is added.

CardIQ Xpress 2.0 is for use on the Advantage Workstation (AW) platform, CT scanner, PAC or Centricity stations, which can be used in the analysis of 2D or 3D CT angiography images/data derived from DICOM 3.0 CT scans.

*ShapShot is a trademark of General Electric Company

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

Over-The-Counter Use (Part 21 CFR 801 Subport 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 Office of In Vitro Diagnostic Device Evaluation and Safety

510k)

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Signature

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