CARDIQ EXPRESS VERSION 2.0

K073138 · GE Medical Systems · JAK · Feb 26, 2008 · Radiology

Device Facts

• Record ID: K073138
• Device Name: CARDIQ EXPRESS VERSION 2.0
• Applicant: GE Medical Systems
• Product Code: JAK · Radiology
• Decision Date: Feb 26, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

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, non-invasive, 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/hyper-dense 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 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 is post-processing software for Advantage Workstation, CT scanners, PACS, or Centricity systems. It processes 2D/3D DICOM CT angiographic images to analyze cardiovascular anatomy and pathology. Key features include automatic tracking to pre-process data into multiple viewing ports for expedited workflow; myocardial tissue color-coding for density visualization; and IVUS-like views created by applying volume rendering on cross-sections perpendicular to detected centerlines. The software provides graphic and text reports with predefined templates. Clinicians use the output to visualize coronary vessels, assess atherosclerosis (calcified vs. non-calcified plaque), evaluate heart structures, and determine treatment paths. It benefits patients by providing non-invasive diagnostic insights into coronary artery disease and post-procedural follow-up.

Clinical Evidence

Bench testing only. Validation included testing on phantoms and evaluation of previously acquired diagnostic images to confirm software performance and design requirements.

Technological Characteristics

Software-based post-processing application for DICOM 3.0 CT data. Operates on Advantage Workstation, CT scanners, PACS, or Centricity stations. Features include automatic centerline tracking, volume rendering for IVUS-like cross-sectional views, and Hounsfield Unit (HU) based color-coding. Designed to meet AAMI/ANSI SW68 (software life cycle) and NEMA PS 3.1-3.18 (DICOM) standards.

Indications for Use

Indicated for patients requiring non-invasive cardiovascular analysis, including diagnosis of coronary artery disease, assessment of heart structures and functional parameters, and follow-up for stent placement, bypasses, and plaque imaging using CT angiography data.

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 Analysis III

Submission Summary (Full Text)

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K073138

#### 510(K) Summary As Required by 21 CFR 807.92

### 510(k) Number: __

#### 1. Submitter Information

FEB 26 2002

| Submitter Name: | GE Medical Systems SCS<br>283, rue de la Minière<br>78533 Buc Cedex, FRANCE |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Reg: | 9611343 |
| Contact Person: | Stephen Slavens<br>Global RA Premarket Director<br>3000 N Grandview Blvd.<br>Waukesha, WI 53188<br>Tel: [phone]<br>Fax: [phone]<br>[e-mail] |

February 21, 2008 Date Prepared:

### 2. Device information

| Trade Name: | CardIQ Xpress 2.0 |
|----------------------|-------------------------------------|
| Common Name: | Computed Tomography X-Ray System |
| Classification Name: | System, x-ray, tomography, computed |
| Procode: | JAK |
| Class: | Class II per 21 CFR 892.1750 |

### 3. Predicate Devices

CardIQ Xpress 2.0 is substantially equivalent to the predicate device listed below:

| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>Company of the collection of the control control and the program and any and<br>A 1 on 1999<br>01/1<br>valne | --------------------------------------------------------------------------------<br>Annual Production Arms Antiques of Article<br>ance |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| | |
| REE I R & LEBERT LAND MENSELVER | --------------------------------------------------------------------------------------- |
| AND ANNOR --- LA LE L & AN | |

### 4. Device Description

The GE Medical Systems CardIQ Xpress 2.0 software is a post processing software option for the Advantage Workstation (AW) Platform, CT scanner, PACS or Centricity systems. This product can be used in the analysis of CT angiographic images to view the coronary vessels to determine if the patient has normal coronary arteries, arteriolosclerosis or severe stenosis, which needs to go on for treatment. This software also can look at the heart structures to include valve imaging, heart motion and ejection fraction. CardIQ Xpress 2.0 contains both graphic and text report capabilities with predefined templates for ease of use.

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### 5. Indication for 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, non-invasive, 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/hyper-dense 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 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.

## 6. Summary of non-clinical and/or clinical tests and results

| Standard | Standards<br>Organization | Standard Title |
|---------------|---------------------------|------------------------------------------------------------|
| PS 3.1 - 3.18 | NEMA | Digital Imaging and Communications<br>in Medicine (DICOM) |
| SW68 | AAMI/ANSI | Medical Device Software - Software<br>life cycle processes |

The software was designed to meet the following standards:

Software and medical device design validation have been completed. Medical device design included testing on phantoms and evaluation of previously acquired diagnostic images.

The results concluded the device was acceptable for use.

#### 7. Statement of Equivalence

The General Electric CardIQ Xpress 2.0 workstation software is equivalent to the predicate General Electric CardIQ Analysis III device and is safe and effective for use.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

FEB 26 2008

GE Medical Systems % Mr. Jay Y. Kogoma Sr. Staff Engineer - Medical Devices Intertek Testing Services NA, Inc. 2307 E. Aurora Road, Unit B7 TWINSBURG OH 44087

Re: K073138

Trade/Device Name: CardIQ Epress 2.0 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: February 8, 2008 Received: February 11, 2008

Dear Mr. Kogoma:

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 (Premarket Approval), it may be subject to such 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.

Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. The letters "FDA" are in the center of the logo in a bold, stylized font. Below the letters, the word "Centennial" is written in cursive. The logo is surrounded by a dotted circle and some text that is difficult to read.

Protecting and Promoting Public Health

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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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known):

K073138

Device Name: CardIQ Xpress 2.0

Indications For 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, non-invasive, image analysis software package, which aids in diagnosing of cardiovascular disease to include, coronary artery disease, functional and mothers 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/hyper-dense 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.

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

Over-The-Counter Use (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)

Hozilton Whan

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