CARDIQ FUNCTION XPRESS

K073153 · GE Medical Systems SCS · JAK · Feb 26, 2008 · Radiology

Device Facts

• Record ID: K073153
• Device Name: CARDIQ FUNCTION XPRESS
• Applicant: GE Medical Systems SCS
• Product Code: JAK · Radiology
• Decision Date: Feb 26, 2008
• 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

CardIQ Function Xpress 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 Function Xpress in conjunction with CT cardiac images to automatically calculate and display various left ventricular and right ventricular functional parameters as ejection fraction, end systolic and end diastolic volumes, stroke volumes, wall motion, wall thickening, cardiac output, myocardial mass, systemic and pulmonary vascular resistance. Volume measurement of each chamber of the heart is also available. With CardIQ Function Xpress atrium volumes may be used to determine volume assessment of atrial disease to include but not limited to atrial fibrillation. CardIQ Function Xpress is a CT, non-invasive image analysis software package, which aids in the assessment of cardiac function and in determination of cardiovascular disease diagnosis and management. CardIQ Function Xpress 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 Story

CardIQ Function Xpress is post-processing software for Advantage Workstation, CT scanners, PACS, or Centricity systems. It processes 2D/3D DICOM CT angiographic images to analyze cardiovascular anatomy and pathology. The software enables selection of heart chambers and cardiac phases (systolic/diastolic) to automatically calculate functional parameters: ejection fraction, ventricular volumes, stroke volumes, wall motion, wall thickening, cardiac output, myocardial mass, and vascular resistance. It provides graphic and text reports via predefined templates. Used by clinicians to aid in cardiovascular disease diagnosis, management, and treatment planning. Benefits include non-invasive assessment of cardiac function and atrial disease.

Clinical Evidence

Bench testing only. Software and medical device design validation completed, including testing and evaluation of previously acquired diagnostic images. No clinical trials or human subject data reported.

Technological Characteristics

Post-processing software for CT angiography images. Operates on Advantage Workstation, CT scanners, PACS, or Centricity platforms. Complies with NEMA PS 3.1-3.18 (DICOM) and AAMI/ANSI SW68 (software life cycle processes).

Indications for Use

Indicated for patients undergoing CT angiography requiring analysis of cardiovascular anatomy and pathology. Used to calculate cardiac functional parameters including ejection fraction, ventricular volumes, stroke volumes, wall motion/thickening, cardiac output, myocardial mass, and vascular resistance. Aids in assessment of cardiac function and diagnosis/management of cardiovascular disease, including atrial disease/fibrillation.

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

• GE CardIQ Analysis III (K041267)
• GE CardIQ Function (K013422)

Submission Summary (Full Text)

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K073153

### 510(K) Summary As Required by 21 CFR 807.92

510(k) Number: ___________________

## 1. Submitter Information

FEB 26 20CB

- GE Medical Systems SCS Submitter Name: 283, rue de la Minière 78533 Buc Cedex, FRANCE
9611343 Establishment Reg:

Contact Person: Stephen Slavens Global RA Premarket Director 3000 N Grandview Blvd. Waukesha, WI 53188 Tel: [phone] Fax: [phone] [e-mail]

August 22nd, 2007 Date Prepared:

#### 2. Device information

| Trade Name: | CardIQ Function Xpress |
|----------------------|--------------------------------------------|
| Common Name: | Picture Archiving and Communication Device |
| Classification Name: | System, Image Processing, Radiological |
| Procode: | JAK |
| Class: | Class II per 21 CFR 892.1750 |

# 3. Predicate Devices

CardIQ Function Xpress is substantially equivalent to the predicate devices listed below:

| Device Name | FDA Clearance |
|------------------------|---------------|
| GE CardIQ Analysis III | K041267 |
| GE CardIQ Function | K013422 |

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#### 4. Device Description

The GE Medical Systems CardIQ Function Xpress 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 calculate and display ventricular analysis of several functional cardiac parameters. The software has the ability to select the chambers of the heart and diastolic and/or systolic phases to determine the hearts function. CardIO Function Xpress contains both graphic and text report capabilities with predefined templates for ease of use.

### 5. Indication for Use

CardIQ Function Xpress 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 Function Xpress in conjunction with CT cardiac images to automatically calculate and display various left ventricular and right ventricular functional parameters as ejection fraction, end systolic and end diastolic volumes, stroke volumes, wall motion, wall thickening, cardiac output, myocardial mass, systemic and pulmonary vascular resistance. Volume measurement of each chamber of the heart is also available. With CardIQ Function Xpress atrium volumes may be used to determine volume assessment of atrial disease to include but not limited to atrial fibrillation. CardIQ Function Xpress is a CT, non-invasive image analysis software package, which aids in the assessment of cardiac function and in determination of cardiovascular disease diagnosis and management.

CardIQ Function Xpress 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.

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# 6. Summary of non-clinical and/or clinical tests and results

The software was designed to meet the following standards:

| Standard | Standards<br>Organization | Standard Title |
|---------------|---------------------------|------------------------------------------------------------|
| PS 3.1 - 3.18 | NEMA | Digital Imaging and Communications<br>in Medicine (DICOM) |
| SW68 | AAMI/ANSI | Medical Device Software - Software<br>life cycle processes |

Software and medical device design validation have been completed. Medical device design included testing and evaluation of previously acquired diagnostic images.

The results concluded the device was acceptable for use.

# 7. Statement of Equivalence

The General Electric CardIQ Function Xpress workstation software is equivalent to a combination of the predicate General Electric CardIQ Analysis III and CardIQ Function devices and is safe and effective for use.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines forming the body and wings. The logo is black and white.

FEB 26 2008

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

GE Medical Systems SCS % Mr. Jay Y. Kogoma Senior Staff Engineer - Medical Devices Intertek Testing Services 2307 E. Aurora Road, Unit B7 TWINSBURG OH 44087

Re: K073153

Trade/Device Name: CardIQ Function Xpress Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK, LLZ Dated: February 8, 2008 Received: February 11, 2008

Dear Mr. Kogoma:

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 (Premarket Approval), it may be subject to such 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.

Image /page/3/Picture/10 description: The image is a circular logo or emblem. The text "1906-2006" is at the top of the circle. The letters "FDA" are in the center of the circle. The word "Centennial" is at the bottom of the circle. There are stars below the word "Centennial".

Protecting and Promoting Public Health.

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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 Actor 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.

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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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

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# Indications for Use

510(k) Number (if known): 073153

Device Name: CordIO Function Xpress

Indications For Use: CardIQ Function Xpress 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.

Cardia Function Xpress in conjunction with CT cardiac images to automatically calculate and display various left ventricular and right ventricular functional parameters as ejection fraction, end systolic and end diastolic volumes, stroke volumes, wall motion, wall thickening, cardiac output, myocardlal mass, systemic and pulmonary vascular resistance. Volume measurement of each chamber of the heart is also available. With CardiQ Function Xpress atrium volumes may be used to determine volume assessment of atrial disease to include but not limited to atrial fibrillation. CardIQ Function Xpress is a CT, non-Invasive image analysis software package, which alds in the assessment of cardiac function and in determination of cardlovascular disease diagnosis and management.

CardIQ Function Xpress 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 anglography images/data derived from DICOM 3.0 CT scans.

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

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Homi Khan
(Division Sign-Off)

Division of Reproductive, Abdomina and Radiological Device 510(k) Number

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