CARD IQ ANALYSIS II

K020796 · GE Medical Systems · JAK · Mar 26, 2002 · Radiology

Device Facts

• Record ID: K020796
• Device Name: CARD IQ ANALYSIS II
• Applicant: GE Medical Systems
• Product Code: JAK · Radiology
• Decision Date: Mar 26, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Indications for Use

CardIQ Analysis II is a post processing software option for Advantage Windows Workstation (AW) Platform. This product can be used for the analysis of CT angiography images and for the assessment of plaque densities with the coronary arteries. It provides a number of display, measurement and batch filming features. The product can be used to aid trained physicians for visualizing and assessing cardiac anatomy, and coronary vessels.

Device Story

CardIQ Analysis II is a post-processing software option for the Advantage Windows (AW) Workstation. It processes CT angiography images to generate visualizations of cardiac structures, including MIP (Maximum Intensity Projection), reformatted, and volume-rendered views. The software enables clinicians to perform measurements of vessel diameter, Hounsfield Units within coronary arteries, and plaque density. Outputs include processed images, measurements, and reports, which can be saved to the workstation or printed. Used in clinical settings by trained physicians to aid in the visualization and assessment of cardiac anatomy and coronary vessels, supporting clinical decision-making regarding cardiac health.

Clinical Evidence

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

Technological Characteristics

Post-processing software for CT angiography; operates on Advantage Windows (AW) Workstation platform. Features include image display (MIP, volume rendering), vessel diameter measurement, and plaque density assessment. Software-based; no specific hardware materials or energy sources described. Verification follows industry and international standards.

Indications for Use

Indicated for trained physicians to visualize and assess cardiac anatomy and coronary vessels using CT angiography images, including assessment of plaque densities within coronary arteries.

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 Option 1.0 (K003408)

Submission Summary (Full Text)

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K020796

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GE Medical Sv General Electric Company P O Box 414 Milwaukee, WI 53201

# 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).

Submitter Larry A. Kroger, Ph.D. Senior Regulatory Program Manager Telephone: [phone], FAX: [phone] Date Prepared: February 8, 2002

# PRODUCT IDENTIFICATION

| Name: | CardIQ Analysis II |
|------------------------|---------------------------------------------------------------------------------------|
| Classification Name: | Accessory to Computed Tomography System |
| Classification Panel: | 892 - Radiology |
| Classification Number: | 892.1750 |
| Manufacturer : | General Electric Medical Systems<br>283, rue de la Miniere<br>78533 Buc Cedex, FRANCE |
| Distributor: | General Electric Medical Systems, Milwaukee, WI |
| Marketed Devices | CardIQ Analysis II is substantially equivalent to the device listed below: |
| Model: | CardIQ Option 1.0 |
| Manufacturer: | General Electric Medical Systems, Milwaukee, WI |
| 510(k) #: | K003408 |

### Device Description:

CardIQ Analysis II is a post processing software option that can be used in the analysis of CT angiography images to display structures of the heart in a MIP, reformat or volume rendering view. The software has the ability to measure the diameter of the vessel, Hounsfield Units within connay arteries, or plaque density within a vessel. Measurements, densities and images can all be priced to reports or saved to the AW workstation.

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#### Indications for Use:

CardIQ Analysis II is a post processing software option for Advantage Windows Workstation (AW) Platform. This product can be used for the analysis of CT angiography images and for the assessment of plaque densities with the coronary arteries. It provides a number of display, measurement and batch filming features. The product can be used to aid trained physicians for visualizing and assessing cardiac anatomy, and coronary vessels.

#### Comparison with Predicate:

CardIQ Analysis II is a software option for CT Scanners. Features of this software package are substantially equivalent to the following device:

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#### 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.
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- · Adherence to industry and international standards.
#### Conclusions:

CardIQ Analysis II does not result in any new potential safety risks and performs as well as devices currently on the market. GE considers features of the CardIO Analysis II to be equivalent to those of CT CardIQ Option 1.0 (K003408).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 6 2002

General Electric Medical Systems % Mr. Wolfram Gmelin Technical Manager TÜV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470

Re: K020796

Trade/Device Name: Card IQ Analysis II CT Scanner Post-Processing Software Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: February 1, 2002 Received: March 12, 2002

Dear Mr. Gmelin:

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 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 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 this 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" (21 CFR Part 807.97). 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. 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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## STATEMENT OF INTENDED USE

510(k) Number (if known): _ Ko 2 079 6 _______________________________________________________________________________________________________________________________________

Device Name: CardIQ Analysis II

### Indications For Use:

CardIQ Analysis II is a post processing software option for Advantage Windows Workstation (AW) Platform. This product can be used for the analysis of CT angiography images and for the assessment of plaque densities with the coronary arteries. It provides a number of display, measurement and batch filming features. The product can be used to aid trained physicians for visualizing and assessing cardiac anatomy, and coronary vessels.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Nancy C. Brogdon

| (Division Sign-Off) | |
|---------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K020796 |