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 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.

AI/ML Overview

The provided text does not contain specific acceptance criteria or details of a study that proves the device meets such criteria. It is a 510(k) summary for the CardEP software, focusing on its substantial equivalence to a predicate device.

Therefore, I cannot provide a table of acceptance criteria, reported performance, or details about a study demonstrating the device meets acceptance criteria. The document primarily discusses:

Product Identification: Name, classification, manufacturer, distributor.
Device Description: Post-processing software for CT angiographic images to display and analyze heart structures (MIP, reformat, volume rendering, vessel fly-through, automatic segmentation, diameter measurement, model export).
Indications for Use: Analysis of CT angiographic images for assessment of the heart, including atria, pulmonary veins, and coronary sinus, providing quantitative analysis tools to aid trained physicians.
Comparison with Predicate: CardEP is stated to be substantially equivalent to CT CardiQ Analysis II (K020796).
Adverse Effects on Health: Identified risks are controlled by software development, validation, verification processes, and adherence to standards.
Conclusions: No new potential safety risks, performs as well as devices currently on the market.
FDA Clearance Letter: Official letter granting 510(k) clearance based on substantial equivalence.

Key Absence: The document does not describe performance metrics, clinical study design, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, or adjudication methods. It focuses on the regulatory aspect of substantial equivalence, which often relies on a comparison of features and intended use rather than a detailed performance study against specific acceptance criteria.

Summary

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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: (262) 544-3894, FAX: (262) 544-3863 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:

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Indications for Use:

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	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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:

(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) 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

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
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.(b)
Classification. Class II.