CardlQ Xpress 2.0 is intended to provide an optimized non-invasive application to andyze cardiovascular anatomy and pathology and aid in determining treatment paths from a set of Computed Tomography (CT) Angiographic images. CardlQ Xpress 2.0 is a CT, noninvasive, 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 hyperdense 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 alian 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 informotion 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 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. CardIO Xpress 2.0 contains both graphic and text report capabilities with predefined templates for ease of use.

CardIO Xpress 2.0 with SnapShot* Freeze is additionally designed to reduce the coronary artery motion blurring in a CT image.

AI/ML Overview

The provided text describes a 510(k) premarket notification submission for the GE Healthcare CardIQ Xpress 2.0 with SnapShot* Freeze Option. However, the document does not explicitly state acceptance criteria or the study details that prove the device meets specific performance criteria. It focuses on demonstrating substantial equivalence to a predicate device (CardIQ Xpress 2.0).

Based on the available information, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state specific acceptance criteria in measurable terms (e.g., accuracy, sensitivity, specificity, or quantitative reduction in motion blurring) or reported device performance against such criteria. The submission aims to establish substantial equivalence to a predicate device, CardIQ Xpress 2.0. The "Summary of Non-Clinical Tests" and "Summary of Clinical Tests" sections mention verification and validation activities, but they don't provide the results in a quantifiable way related to acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: Not explicitly stated.
Data Provenance: The images used were "CT acquired clinical images... obtained from a non-significant risk reader study of care patient images." The country of origin is not specified, and it is a "reader study," implying retrospective use of existing patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Number of Experts: Not explicitly stated.
Qualifications of Experts: Not explicitly stated.

4. Adjudication Method for the Test Set:

Adjudication Method: Not explicitly stated.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

The text mentions a "non-significant risk reader study," which implies human readers were involved. However, it does not explicitly state that it was an MRMC comparative effectiveness study comparing human readers with AI assistance vs. without AI assistance.
Effect Size: No effect size or quantitative improvement of human readers with AI assistance is provided.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The document implies that the device "aids in diagnosing" and "aids in determining treatment paths," suggesting it's an assistance tool for a human. It's not clear if a standalone performance study of the algorithm without human interaction was conducted and reported with specific metrics.

7. The Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcome data). Given it's a reader study, expert consensus is a likely, but unconfirmed, possibility.

8. The Sample Size for the Training Set:

Training Set Sample Size: Not mentioned. The document describes verification and validation using "CT acquired clinical images" but does not distinguish between training and test sets or their respective sizes.

9. How the Ground Truth for the Training Set Was Established:

Ground Truth Establishment for Training Set: Not mentioned.

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence based on fundamental scientific technology and adherence to quality assurance measures. It lacks detailed quantitative performance metrics, specific acceptance criteria, and comprehensive information about the clinical study design, including sample sizes, expert qualifications, and ground truth establishment methods, which are typically found in more detailed study reports.

Summary

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GE Healthcare 510(k) Premarket Notification Submission

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date:	March 21, 2012
Submitter:	GE Medical Systems, SCS (d.b.a. GE Healthcare)
	283, rue de la Miniere BP34
	78530 Buc Cedex - France
	FDA Registration Number: 9611343
Primary ContactPerson:	Stephen Slavens, RACRegulatory Affairs Director, MICTGE HealthcarePhone: (262) 548-4992FAX: 262-548-3844Stephen.Slavens@ge.com
Secondary ContactPerson:	Helen Peng, RACRegulatory Affairs LeaderGE HealthcarePhone: (262) 548-5091FAX: 262-548-3844Hong.Peng@ge.com
Device:Trade Name:	CardIQ Xpress 2.0 with SnapShot* Freeze Option
Common/UsualName:	Accessory to: System, x-ray, tomography, computed
Classification Names:	21CFR 892.1750
Product Code:	JAK
Predicate Device(s):	Predicate Device Name: CardIQ Xpress Version 2.0Predicate 510k Number: K073138Predicate Manufacturer: GE Medical Systems
Device Description:	The GE Medical Systems CardIQ Xpress 2.0 software is apost processing software option for the AdvantageWorkstation (AW) Platform, CT scanner, PACS or Centricitysystems. This product can be used in the analysis of CTangiographic images to view the coronary vessels todetermine if the patient has normal coronary arteries,arteriolosclerosis or severe stenosis, which needs to go on

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Image /page/1/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 solid black, creating a strong contrast against the white background.

GE Healthcare 510(k) Premarket Notification Submission

for treatment. This software also can look at the heart structures to include valve imaging, heart motion and ejection fraction. CardIO Xpress 2.0 contains both graphic and text report capabilities with predefined templates for ease of use.

CardIO Xpress 2.0 with SnapShot* Freeze is additionally designed to reduce the coronary artery motion blurring in a CT image.

Indications for Use:

CardIO Xpress 2.0 is intended to provide an optimized noninvasive 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, noninvasive, image analysis software package, which aids in diagnosina 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/hyperdense 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 lavouts to alian the heart. The IVUS like view is created by applying GE's Volume Rendering on a crosssection 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

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Image /page/2/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The letters are stylized with curved lines, and the circle has decorative elements around its perimeter.

GE Healthcare 510(k) Premarket Notification Submission

images/data derived from DICOM 3.0 CT scans.

Technology: The proposed medical device, CardIQ Xpress 2.0 with Snapshot Freeze Option, employs the same fundamental scientific technology as its predicate device CardIQ Xpress 2.0.

Determination of Substantial

Equivalence:

Summary of Non-Clinical Tests:

CardIQ Xpress 2.0 with SnapShot Freeze Option complies with voluntary standards as discussed in Section 9, and 11 of this premarket submission. The following quality assurance measures were applied to the development of the system:

. Risk Analysis
. Requirements Reviews
Design Reviews .
. Testing on unit level (Module verification)
Integration testing (System verification) .
Performance testing (Verification) .
. Safety testing (Verification)
. Simulated use testing (Validation)

Summary of Clinical Tests:

As referenced in Section 20, the CT acquired clinical images used for the completion of verification and validation testing for CardIQ Xpress 2.0 with Snapshot Freeze Option were obtained from a non-significant risk reader study of care patient images.

GE Healthcare considers the CardIQ Xpress 2.0 with Conclusion: Snapshot Freeze Option application to be as safe, as effective, and performance is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN 1 8 2012

GE Healthcare c/o Mr. Stephen Slavens Regulatory Affairs Director, MICT 3000 N Grandview Blvd W 1140 Waukesha, WI 53188

Re: K120910

Trade Name: CardIO Xpress 2.0 with Snapshot Freeze Option Regulation Number: 21.CFR892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II (two) Product Codes: JAK Dated: June 17, 2012 Received: June 22, 2012

Dear Mr. Slavens:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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Page 2 –Mr. Slavens

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part -807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram DA Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular frame. The letters and the frame are in black, set against a white background. The design is simple and recognizable, representing the brand identity of General Electric.

K120910 S001

GE Healthcare 510(k) Premarket Notification Submission

510(k) Number (if known):

Device Name: CardIO Xpress 2.0 with SnapShot* Freeze Option

Indications for Use:

*ShapShot is a trademark of General Electric Company

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

Over-The-Counter Use (Part 21 CFR 801 Subport C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510k)

Page 1 of 1

Signature

11:37 32:005

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.