CARDIQ FUSION

K061370 · GE Healthcare · JAK · May 30, 2006 · Radiology

Device Facts

• Record ID: K061370
• Device Name: CARDIQ FUSION
• Applicant: GE Healthcare
• Product Code: JAK · Radiology
• Decision Date: May 30, 2006
• 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 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. 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. 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.

Device Story

CardIQ Fusion is a post-processing software package for Advantage Workstation (AW), PET/CT, CT scanners, and PACS. It inputs 3D CT angiographic cardiac images and functional data (PET, SPECT, or processed CT). The device transforms these inputs by overlaying functional perfusion/viability data onto anatomical CT heart structures. It provides 3D rendering, curved reformats, vessel sizing, and plaque density/stenosis analysis. Used by radiologists, cardiologists, and nuclear medicine physicians in clinical settings to visualize fused data; the output assists clinicians in tailoring patient-specific treatment plans. The device benefits patients by providing non-invasive, integrated anatomical and functional assessment of coronary vasculature.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing, software verification, and validation processes.

Technological Characteristics

Software post-processing package for Advantage Workstation (AW), PET/CT, CT scanners, and PACS. Features include 3D rendering, curved reformats, vessel sizing, and plaque analysis. Operates on standard clinical imaging hardware. Software-based analysis.

Indications for Use

Indicated for clinicians (radiologists, nuclear medicine doctors, cardiologists) to analyze cardiac vascular anatomy and pathology, assess functional data (PET/SPECT/CT perfusion/viability), and aid treatment planning via fused anatomical/functional visualization in patients undergoing cardiac imaging.

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 Pro (K041267)
• CT PET Fusion (K010336)
• CardIQ Function (K013422)
• AVA II (K060779)
• ECToolbox with HeartFusion (K040141)

Submission Summary (Full Text)

{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: [phone] Fax: [phone] GE Healthcare W-440 3000 North Grandview Blvd. Waukesha, WI 53188 USA Date Prepared: April 19, 2006
## PRODUCT IDENTIFICATION

| Name:<br>Manufacturer: | CardIQ Fusion<br>Classification Name: Accessory to Computed Tomography System per 21 CFR 892-1750<br>GE Medical Systems SCS<br>283, rue de la Minière<br>78533 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:<br>Manufacturer:<br>Model:<br>Manufacturer:<br>Model:<br>�<br>Manufacturer: | CardIQ Pro, 510(k) #K041267<br>GE Medical Systems SCS, Buc, France<br>CT/PET Fusion, 510(k) # K010336<br>GE Medical Systems SCS, Buc, France<br>CardIO Function, 510(k) # K013422<br>GE Healthcare, 3200 North Grandview Blvd, Waukesha, WI 53188 USA |
| Model:<br>Manufacturer:<br>Model:<br>●<br>1 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - | ECToolbox with HeartFusion, 510(k) # K040141<br>Syntermed, INC, USA<br>Advanced Vessel Analysis II, 510(k) # K060779<br>CD Madinal Cristoma CCC Duo Eronoo |

- GE Medical Systems SCS, Buc, France Manufacturer: .
## 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

{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:

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.

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.

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 [phone] or [phone] 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

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.

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.

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.

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_