CARDIQ ANALYSIS III

K041267 · General Electric Medical Systems · JAK · May 27, 2004 · Radiology

Device Facts

• Record ID: K041267
• Device Name: CARDIQ ANALYSIS III
• Applicant: General Electric Medical Systems
• Product Code: JAK · Radiology
• Decision Date: May 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

CardIQ Analysis III is a CT image analysis software package, which allows the visualization of 2D and 3D medical image data of the heart derived from DICOM 3.0 compliant CT scans for the purpose of cardiovascular disease assessment. It provides functionally for 2D/3D rendering, assessment of calcified and non-calcified plaque to determine the densities of the plaque within a coronary artery, ventricular function of the heart, and measurement tools to detect coronary artery stenosis. This product can be used to aid a trained physician for to process, render, review, archive, print and visualizing cardiac anatomy and coronary vessels. CardIQ Analysis III will run on the AW workstation, scanner operator console and PACS system.

Device Story

CardIQ Analysis III is a post-processing software option for GE LightSpeed multi-slice CT scanners. It processes DICOM 3.0 compliant cardiac CT images to generate 2D/3D renderings (MIP, reformat, volume rendering). The software enables physicians to measure vessel diameters, assess plaque density (calcified/non-calcified), and calculate ventricular function parameters using end-systole and end-diastole images. Operated by trained physicians on AW workstations, scanner consoles, or PACS systems, the output aids in clinical decision-making regarding cardiovascular disease. Results are archived, printed, or saved to the workstation. The device benefits patients by providing quantitative data for cardiac anatomy and coronary vessel assessment.

Clinical Evidence

No clinical data provided. Safety and effectiveness are supported by software development, validation, and verification processes, and adherence to industry and international standards.

Technological Characteristics

Software-based post-processing package for CT angiographic images. Operates on GE AW workstations, scanner consoles, and PACS. Compatible with DICOM 3.0 data. Features include 2D/3D rendering, vessel diameter measurement, Hounsfield unit analysis for plaque density, and ventricular function calculation.

Indications for Use

Indicated for trained physicians to visualize and analyze 2D/3D cardiac CT image data for cardiovascular disease assessment, including plaque density assessment, ventricular function analysis, and coronary artery stenosis measurement.

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 II (K020796)
• CardIQ Function (K013422)

Submission Summary (Full Text)

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K041267

MAY 2 7 2004

Image /page/0/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular border. The letters and the border are black, creating a strong contrast against the white background.

GE Medical Systems

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).

Larry A. Kroger, Ph.D. Submitter Senior Regulatory Programs Manager Tel: [phone] Fax: [phone] GE Medical Systems W-400 3000 North Grandview Blvd. Waukesha, WI 53188 USA Date Prepared: February 13, 2004.

## PRODUCT IDENTIFICATION

| Name: | CardIQ Analysis III |
|----------------------|---------------------------------------------------------------------------------------|
| Classification Name: | Accessory to Computed Tomography System |
| Manufacturer : | General Electric Medical Systems<br>283, rue de la Minière<br>78533 Buc Cedex, FRANCE |
| Distributor: | General Electric Medical Systems, Buc, France. |

The CardIQ Analysis III is substantially equivalent to the devices listed below: Marketed Devices

| Model: | CardIQ Analysis II |
|---------------|-------------------------------------------------------------|
| Manufacturer: | General Electric Medical Systems, Buc, France |
| 510(k) #: | K020796 |
| Model: | CardIQ Function |
| Manufacturer: | General Electric 3200 N. Grandview Blvd. Waukesha, WI 53188 |
| 510(k) #: | K013422 |

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#### Device Description:

CardIO Analysis III is a post processing software option that can be used in the analysis of CT angiographic images to display structures of the heart in a MIP, reformat or volume rendering view. When the heart is displayed the software has the ability to measure the diameter of the vessel or hounsfield units within a coronary arteries to determine the size of a vessel or plaque density within a vessel. Functional parameters of the heart can also be determined when images of end systole and end diastole are present. Diarneters, densities, functional parameters and images can all be printed to reports or saved to the AW workstation. It is a software option for the GE family of LightSpeed multi-slice CT scanners.

### Indications for Use:

:

CardIQ Analysis III is a CT image analysis software package, which allows the visualization of 2D and 3D medical image data of the heart derived from DICOM 3.0 compliant CT scans for the purpose of cardiovascular disease assessment. It provides functionally for 2D/3D rendering, assessment of calcified and non-calcified plaque to determine the densities of the plaque within a coronary artery, ventricular function of the heart, and measurement tools to detect coronary artery stenosis. This product can be used to aid a trained physician for to process, render, review, archive, print and visualizing cardiac anatomy and coronary vessels. CardIQ Analysis III will run on the AW workstation, scanner operator console and PACS system.

#### Comparison with Predicate:

The functional features of the CardI() Analysis III software package are substantially equivalent to that of the following device:

| Device Name | FDA Clearance Number |
|--------------------|----------------------|
| CardIQ Analysis II | K020796 |
| CardIQ Function | K013422 |

#### Adverse Effects on Health:

The potential hazards are identified in a risk management summary (hazard analysis) and are controlled by:

- · Software Development, Validation and Verification Process to ensure performance to specifications, Federal Regulations and user requirements.
- · Adherence to industry and international standards.

#### Conclusions:

The CardIQ Analysis III does not result in any new potential safety risks and performs as well as devices currently on the market. GE considers features of the CardIQ Analysis III to be equivalent to those of CardIQ Analysis II (K020796) and CardIQ Function (K013422).

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Image /page/2/Picture/1 description: The image contains the logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes a stylized depiction of an eagle with three lines representing its wings. The seal is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 27 2004

Mr. Tamas Borsai Program Manager 510(k) Review TUV Rheinland of North America, Inc. Medical Division, Newton Office 12 Commerce Road NEWTON CT 06470

Re: K041267

Trade/Device Name: CardIQ Analysis III Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography

x-ray system

Regulatory Class: II Product Code: 90 JAK Dated: May 3, 2004 Received: May 12, 2004

Dear Mr. Borsai:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo never reviewed your 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 for ass surve in the encrease 1976, the enactment date of the Medical Device Amendments, or to conniner of they to rialy 2011 accordance with the provisions of the Federal Food, Drug, de nocs that have boom require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, ate. En orovisions 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 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.

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.

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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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brigdon

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

Enclosure

Page 2

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K041267

Image /page/4/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters and the border are black, contrasting with the white background.

#### General Electric Medical Systems

# STATEMENT OF INTENDED USE

Device name: CardIQ Analysis III

#### Intended Use:

CardIQ Analysis III is a CT image analysis software package, which allows the visualization of 2D and 3D medical image data of the heart derived from DICOM 3.0 compliant CT scans for the purpose of cardiovascular disease assessment. It provides functionally for 2D/3D rendering, assessment of calcified and non-calcified plaque to determine the densities of the plaque within a coronary artery, ventricular function of the heart, and measurement tools to detect coronary artery stenosis. This product can be used to aid a trained physician for to process, render, review, archive, print and visualizing cardiac anatomy and coronary vessels. CardIQ Analysis III will run on the AW workstation, scanner operator console and PACS system.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | <div> -OR- </div> | Over-The-Counter Use |
|---------------------------------------|--------------------------|----------------------|
|---------------------------------------|--------------------------|----------------------|

| (Division Sign-Off) | |
|---------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | 2041267 |

1/1PAGENOMFICHIER