CT PERFUSION 4

K052839 · GE Healthcare · JAK · Mar 10, 2006 · Radiology

Device Facts

• Record ID: K052839
• Device Name: CT PERFUSION 4
• Applicant: GE Healthcare
• Product Code: JAK · Radiology
• Decision Date: Mar 10, 2006
• 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

CT perfusion 4 is an image analysis software package that allows the user to produce dynamic image data and to generate information with regard to changes in image intensity over time. It supports the analysis of CT Perfusion images, obtained by cine imaging (in the head and body) after the intravenous injection of contrast, in calculation of the various perfusion-related parameters (i.e. regional blood flow, regional blood volume, mean transit time and capillary permeability). The results are displayed in a user-friendly graphic format as parametric images. This software will aid in the assessment of the extent and type of perfusion, blood volume and capillary permeability changes, which may be related to stroke or tumor angiogenesis and the treatment thereof.

Device Story

CT Perfusion 4 is an image analysis software package for post-processing dynamic CT data. Input consists of cine CT images acquired after intravenous contrast bolus injection. The software calculates perfusion-related parameters, including regional blood flow, regional blood volume, mean transit time, and capillary permeability, by analyzing changes in image intensity over time. Output is presented as parametric images in a graphic format. Used by clinicians to assess perfusion disturbances, aiding in the evaluation of stroke or tumor angiogenesis and treatment response. The device does not affect CT scanner dosage or imaging performance.

Clinical Evidence

No clinical data provided. Safety and effectiveness are supported by software development, validation, and verification processes, and adherence to industry and international standards.

Technological Characteristics

Software-based image analysis package. Operates on dynamic CT data (cine imaging). Calculates perfusion parameters (regional blood flow, blood volume, mean transit time, capillary permeability) via intensity-over-time analysis. Displays results as parametric images. Standalone software post-processing application.

Indications for Use

Indicated for patients undergoing cine CT imaging of the head or body following intravenous contrast injection to assess perfusion, blood volume, and capillary permeability changes related to stroke or tumor angiogenesis.

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

• CT Perfusion 2 (K010042)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a black and white logo of General Electric (GE). The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized with curved lines, giving the logo a classic and recognizable appearance. The logo is simple and iconic, representing the well-known multinational conglomerate.

MAR 1 0 2006

GE Healthcare

K052839

# 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).

- June 27 2005 Date Prepared
- Submitter Larry A. Kroger, Ph.D. Senior Regulatory Programs Manager Tel: [phone] Fax: [phone] GE Healthcare W-400 3000 North Grandview Blvd. Waukesha, WI 53188 USA

K010042

## PRODUCT IDENTIFICATION

| Name: | CT Perfusion 4 |
|----------------------|-------------------------------------------------------------------------------|
| Classification Name: | Accessory to Computed Tomography System |
| Manufacturer: | GE Medical Systems S.C.S<br>283, rue de la Minière<br>78533 Buc Cedex, FRANCE |
| Distributor: | General Electric Medical Systems S.C.S, Buc, France. |
| Marketed Devices: | The CT Perfusion 4 is substantially equivalent to the devices listed below |
| Model: | CT Perfusion 2 |
| Manufacturer: | GE Medical Systems S.C.S., Buc, France |

### Device Description:

510(k) #:

CT Perfusion 4 is an image analysis software package that allows the evaluation of dynamic CT data following an injection of a compact bolus of contrast material, generating information with regards to changes in image intensity over time. It provides a quick and reliable assessment of the type and

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K052839

extent of perfusion disturbances by providing qualitative information on various perfusion related parameters.

The results are displayed in a user-friendly graphic format as parametric images (single image calculated from a set of time course images at a single location).

#### Indications for Use:

CT perfusion 4 is an image analysis software package that allows the user to produce dynamic image data and to generate information with regard to changes in image intensity over time. It supports the analysis of CT Perfusion images, obtained by cine imaging (in the head and body) after the intravenous injection of contrast, in calculation of the various perfusion-related parameters (i.e. regional blood flow, regional blood volume, mean transit time and capillary permeability). The results are displayed in a user-friendly graphic format as parametric images.

This software will aid in the assessment of the extent and type of perfusion, blood volume and capillary permeability changes, which may be related to stroke or tumor angiogenesis and the treatment thereof.

#### Comparison with Predicate:

CT Perfusion 4 images as compared with the CT Perfusion 2 device are obtained by CT scanning after an injection of contrast media. CT Perfusion 4 is a software post-processing device and as such does not affect the dosage characteristics or the imaging performance of GEMS CT scanners. The algorithms used to calculate the perfusion parameters are similar to CT Perfusion 2 device. The functional features of the CT Perfusion 4 software package are substantially equivalent to that of the following device:

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#### 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:

CT Perfusion 4 does not result in any new potential safety risks and performs as well as devices currently on the market. GE considers features of the CT Perfusion 4 to be equivalent to those of CT Perfusion 2 (K010042).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 0 2006

GE Healthcare c/o Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 017190

Re: K052839

Trade/Device Name: CT Perfusion 4 Regulation Number: 21 CFR §892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: February 14, 2006 Received: February 15, 2006

Dear Mr. Lehtonen:

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.

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 Section 510(k) I mis leter will and it you to organ .
The fication. The FDA Inding of substantial equivalence of your device to a legally premative notification: " The Previous 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 rryou desire sponne davies to ge 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 I hour may obtain other general information on your responsibilities under the Act from the 601:57). I od may octurers, 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. Hogdon

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): K052839 Device Name: CT Perfusion 4 Indications for Use:

CT perfusion 4 is an image analysis software package that allows the user to produce dynamic image data and to generate information with regard to changes in image intensity over time. It supports the analysis of CT Perfusion images, obtained by cine imaging (in the head and body) after the intravenous injection of contrast, in calculation of the various perfusion-related parameters (i.e. regional blood flow, regional blood volume, mean transit time and capillary permeability). The results are displayed in a user-friendly graphic format as parametric images.

This software will aid in the assessment of the extent and type of perfusion, blood volume and capillary permeability changes, which may be related to stroke or tumor angiogenesis and the treatment thereof.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Lee Segerson

510(k) Number

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