CARD EP

K031261 · GE Medical Systems · JAK · May 6, 2003 · Radiology

Device Facts

• Record ID: K031261
• Device Name: CARD EP
• Applicant: GE Medical Systems
• Product Code: JAK · Radiology
• Decision Date: May 6, 2003
• 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

CardEP is a post processing software option for the Advantage Workstation (AW) Platform. This product can be used for the analysis of CT angiographic images for the assessment of the heart to include the atria, pulmonary veins, and coronary sinus. It provides quantitative analysis tools which include a number of display, measurement and model export capabilities. This product can be used to aid trained physicians in the visualization and assessment of cardiac anatomy.

Device Story

CardEP is a post-processing software option for GE Advantage Workstation (AW) platform; used by trained physicians in clinical settings. Input: CT angiographic images. Processing: software performs automatic segmentation of heart cavities, vessel diameter measurement, and image reformatting. Output: visualization tools including MIP (Maximum Intensity Projection), reformat, volume rendering, vessel fly-through views, and exported heart models. Clinical utility: aids physicians in assessing cardiac anatomy; supports clinical decision-making through quantitative analysis and visualization of cardiac structures.

Clinical Evidence

Bench testing only. Performance verified through software development, validation, and verification processes to ensure compliance with specifications and user requirements.

Technological Characteristics

Post-processing software for Advantage Workstation (AW) platform. Features include automatic segmentation, diameter measurement, and model export. Visualization modes: MIP, reformat, volume rendering, and vessel fly-through. Operates on CT angiographic image data.

Indications for Use

Indicated for trained physicians to aid in the visualization and assessment of cardiac anatomy, including atria, pulmonary veins, and coronary sinus, using CT angiographic images.

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

• CT CardiQ Analysis II (K020796)

Submission Summary (Full Text)

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MAY 0 6 2003

Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, intertwined font, enclosed within a circular frame. The letters and the frame are solid black, creating a strong contrast against the white background. The logo is simple, recognizable, and represents the brand identity of General Electric.

K031261

P1012

GE Medical Systems 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).

Larry A. Kroger, Ph.D. Submitter Senior Regulatory Program Manager Telephone: [phone], FAX: [phone] Date Prepared: March 13, 2003

## PRODUCT IDENTIFICATION

Name: CardEP Classification Name: Accessory to Computed Tomography System Classification 892 - Radiology Panel: Classification Number: 892.1750 Manufacturer : General Electric Medical Systems 283, rue de la Miniere 78533 Buc Cedex, FRANCE General Electric Medical Systems, Milwaukee, WI Distributor: Marketed Devices CardEP is substantially equivalent to the device listed below: Model: CardIQ Analysis II General Electric Medical Systems, Milwaukee, W1 Manufacturer: K020796 510(k) #:

## Device Description:

The CardEP option is a post processing software option for the Advantage Workstation (AW) Platform. This product can be used in the analysis of CT angiographic images to display structures of the heart in a MIP, reformat, volume rendering and vessel fly through view. The software has an ability to automatically segment out cavities of the heart, measure the diameter of the vessels and export models of the heart for further review.

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#### Indications for Use:

CardEP is a post processing software option for the Advantage Workstation (AW) Platform. This product can be used for the analysis of CT angiographic images for the assessment of the heart to include the atria, pulmonary veins, and coronary sinus. It provides quantitative analysis tools which include a number of display, measurement and model export capabilities. This product can be used to aid trained physicians in the visualization and assessment of cardiac anatomy.

#### Comparison with Predicate:

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

| Device Name | FDA Clearance Number |
|-----------------------|----------------------|
| CT CardiQ Analysis II | K020796 |

#### 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:

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

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines forming the body and head, and two curved lines forming the legs and feet.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 0 6 2003

GE Medical Systems, Inc. c/o Mr. Heinz Joerg Steneberg TÜV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470

Re: K031261

Trade/Device Name: Card EP, Version 1.0 Regulation Number: 21 CFR §892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: April 17, 2003 Received: April 21, 2003

Dear Mr. Steneberg:

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): K031261

Device Name: CardEP

# Indications For Use:

CardEP is a post processing software option for the Advantage Workstation (AW) Platform. This product can be used for the analysis of CT angiographic images for the assessment of the heart to include the atria, pulmonary veins, and coronary sinus. It provides quantitative analysis tools which include a number of display, measurement and model export capabilities. This product can be used to aid trained physicians in the visualization and assessment of cardiac anatomy.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) and the markdown is: `Prescription Use` `(Per 21 CFR 801.109)` `-OR-` `Over-The-Counter Use

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K031261