CardIQ Fusion is intended to provide an optimized non-invasive application to analyze vascular anatomy and pathology, aid in the assessment of functional data e.g. PET perfusion, and aid in tailoring treatment plans based on the fused anatomical and functional information. Anatomical data could be from a set of Computed Tomography (CT) Angiographic images while functional data could be from PET, SPECT, or processed CT data.

Device Description

CardIQ Fusion is a post processing analysis software package designed to assist Radiologists, Nuclear Medicine Doctors, Cardiologists, and other clinicians in the evaluation and assessment of heart including its coronary vasculature and perfusion conditions.

CardIQ Fusion is a software post-processing package for the Advantage Workstation (AW) platform, PET/CT and CT scanners and PACS reading stations. It is an additional tool for the analysis of 3D CT angiographic cardiac images/data providing a number of display, measurements and batch filming/archive features to study user-selected vessels. Also included is the capability to visualize reformatted CT/PET/SPECT perfusion and viability data. Finally, it provides different ways of visualizing CT anatomy fused with PET/SPECT functional information.

AI/ML Overview

The provided 510(k) summary for GE Healthcare's CardIQ Fusion device does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria.

The document primarily focuses on:

Device Description: Explaining what CardIQ Fusion is and its functionalities.
Indications for Use: Defining the intended clinical applications.
Comparison with Predicate Devices: Demonstrating substantial equivalence to existing cleared devices.
Adverse Effects on Health: Stating that potential hazards are controlled through software development processes and adherence to standards.
Conclusions: Reaffirming substantial equivalence and lack of new safety risks.
FDA Clearance Letter: Official communication from the FDA confirming 510(k) clearance.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or MRMC studies, as these are not present in the provided text.

Based on the nature of the 510(k) submission, particularly the reliance on substantial equivalence to predicate devices, it is common for such submissions to emphasize the similarity in performance and safety to already cleared devices rather than providing detailed, de novo performance studies with explicit acceptance criteria. The "study" mentioned in this context is likely the comparative analysis showing equivalence to the predicate devices.

Summary

{0}------------------------------------------------

MAY 3 0 2006

K061370
Phylof

GE Healthcare

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 Programs Manager Tel: (262) 544-3894 Fax: (262) 544-3202 GE Healthcare W-440 3000 North Grandview Blvd. Waukesha, WI 53188 USA Date Prepared: April 19, 2006

PRODUCT IDENTIFICATION

Name:Manufacturer:	CardIQ FusionClassification Name: Accessory to Computed Tomography System per 21 CFR 892-1750GE Medical Systems SCS283, rue de la Minière78533 Buc Cedex, FRANCE
Distributor:	GE Healthcare, P.O. Box 414, Milwaukee, WI 53210
Marketed Devices	CardIQ Fusion is substantially equivalent to the devices listed below:
Model:Manufacturer:Model:Manufacturer:Model:�Manufacturer:	CardIQ Pro, 510(k) #K041267GE Medical Systems SCS, Buc, FranceCT/PET Fusion, 510(k) # K010336GE Medical Systems SCS, Buc, FranceCardIO Function, 510(k) # K013422GE Healthcare, 3200 North Grandview Blvd, Waukesha, WI 53188 USA
Model:Manufacturer:Model:●1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -	ECToolbox with HeartFusion, 510(k) # K040141Syntermed, INC, USAAdvanced Vessel Analysis II, 510(k) # K060779CD Madinal Cristoma CCC Duo Eronoo

GE Medical Systems SCS, Buc, France Manufacturer: .

Device Description:

CardIQ Fusion is a software post-processing package for the Advantage Workstation (AW) platform, PET/CT and CT scanners and PACS reading stations. It is an additional tool for the

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows handwritten text. The text at the top appears to be a code or identifier, possibly "K061370". Below this, the text "page 2 of 3" is visible, indicating this is page 2 of a 3-page document. The handwriting is somewhat stylized and the ink is dark, providing clear contrast against the background.

analysis of 3D CT angiographic cardiac images/data providing a number of display, measurements and batch filming/archive features to study user-selected vessels. Also included is the capability to visualize reformatted CT/PET/SPECT perfusion and viability data. Finally, it provides different ways of visualizing CT anatomy fused with PET/SPECT functional information.

Indications for Use:

With CardIQ Fusion, clinicians have the opportunity to overlay functional information over the (CT) anatomy of a patient's heart, and thus, they can potentially tailor their decision for that particular patient. CardIQ Fusion provides the visualization of the vessels in several different formats including 3D rendering, curved reformats. Once vessels are visualized, tools are available for sizing the vessel, analyzing calcified and non-calcified plaque to determine the densities of plaque within a vessel, measure areas of abnormalities within a vessel (like stenosis, plaque).

Functional data could come from PET, SPECT, or processed CT data for perfusion information. The functional and anatomical data could come from the same scanner as in the case of PET/CT scanner; or they could come from separate scanners like stand alone NUC camera and stand alone CT scanner.

Comparison with Predicate:

CardIO Fusion is substantially equivalent to the predicate devices listed below:

Device Name	FDA Clearance Number
CardIQ Pro	K041267
CT PET Fusion	K010336
CardIQ Function	K013422
AVA II	K060779
ECToolbox with HeartFusion	K040141

Adverse Effects on Health:

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows handwritten text that appears to be a combination of numbers and letters. The text includes "K061370" on the top line, followed by what looks like "page 303" on the second line. The handwriting is somewhat stylized, making it slightly difficult to read some of the characters.

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:

CardIQ Fusion 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 Fusion to be equivalent to those of CardIQ Pro, CT PET Fusion, ECToolbox with HeartFusion, CardIQ Function, and Advanced Vessel Analysis II.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

MAY 3 0 2006

GE Healthcare % Mr. Neil E. Devine, Jr. Responsible Third Party Official Intertek Testing Services NA, Inc. 2307 East Aurora Rd, Unit B7 TWINSBURG OH 44087

Re: K061370

Trade/Device Name: CardIQ Fusion Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: May 16, 2006 Received: May 17, 2006

Dear Mr. Devine:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 910(x) prematice is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate winest the use stated in the encrosuly manation date of the Medical Device Amendments, or to devices that proof to May 26, 1770, the chaomistic date the no visions of the Federal Food, Drug, and Cosmetic liave bech recassified in accordines not a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, matter the device, babyer ex- ex- general registration, listing of devices, good Controls provisions of the necessariat misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket IT your device is classified (soc accres) additional controls. Existing major regulations affecting your Apploval), it they be subject to out Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/3/Picture/10 description: The image is a black and white circular logo. The logo commemorates the centennial anniversary from 1906 to 2006. The letters "FDA" are prominently displayed in the center of the logo. The word "Centennial" is written below the letters.

oting Public Healt

{4}------------------------------------------------

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); Habeling (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.

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 this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): _ K 0 4 137 0

Device Name: CardIQ Fusion

Indications for Use:

ರ

Prescription Use Over-The-Counter Use ANDIOR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Dorman

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number_ K061370

Page_1_of__1_

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.