CT Perfusion 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 after the injection of contrast and to calculate the various perfusion related parameters (ie: regional cerebral blood flow, regional cerebral blood volume, time to peak). The results are displayed in user-friendly graphic format as parametric images. This software runs on the Advantage Workstation (AW) platform and will aid physicians in the assessment of the extent and type of brain perfusion disturbances.

Device Description

CT Perfusion is an image analysis software package that allows the user to process dynamic image data and to generate information with regard to changes in image intensity over time. It supports the analysis of CT Perfusion images and displays the analysis data in a user friendly graphic format and as parametric (single image that is calculated from a set of time course images at a single location) images.

Application examples include:

° characterization of the amount of blood present in a local region.
° provides the volume of blood that flows through a cerebral circulation region.
° returns the average transit time.
o characterizes image intensity increase during a dynamic process.
o allows selection of any time-series or "dynamic" data set.

AI/ML Overview

The provided text is a 510(k) summary for the GE Medical Systems CT Perfusion option. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not include detailed information about specific acceptance criteria, a study proving device performance against those criteria, or most of the other requested details regarding sample sizes, expert qualifications, or ground truth establishment.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not state specific acceptance criteria in terms of quantitative metrics (e.g., sensitivity, specificity, accuracy, or correlation coefficients) or any reported device performance against such criteria. The "Conclusions" section broadly states: "This product provides images comparable to the predicate device." This is a qualitative statement of equivalence, not a performance metric.

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

This information is not provided in the document. There is no mention of a test set, its size, or the provenance (country, retrospective/prospective) of any data used for validation.

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

This information is not provided in the document. There is no mention of ground truth establishment or expert involvement for a test set.

4. Adjudication Method:

This information is not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This information is not provided. There is no mention of an MRMC study or any effect size related to human reader improvement with AI assistance.

6. Standalone Performance:

The device is described as an "image analysis software package" that "allows the user to process dynamic image data" and "will aid physicians." This implies it's a tool for human review rather than a fully autonomous diagnostic algorithm. While it performs calculations, there's no standalone performance study in the sense of an algorithm making a diagnosis without human intervention mentioned. The document focuses on its functionality as a post-processing tool.

7. Type of Ground Truth Used:

This information is not provided.

8. Sample Size for the Training Set:

This information is not provided. There is no mention of a training set or its size. The document refers to a "Software Development and Validation Process" and "Software Verification Plan," but no details on data used in these processes are given.

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

This information is not provided.

Summary of Available Information from the Provided Text:

The document primarily focuses on establishing substantial equivalence to predicate devices (GEMS Functool, GEMS CT 9800 Regional Cerebral Blood Flow) for its CT Perfusion Option. It describes the device's function (processing dynamic image data to generate perfusion parameters like regional cerebral blood flow, regional cerebral blood volume, time to peak) and its intended use (aiding physicians in assessing brain perfusion disturbances).

The basis for equivalence is stated as:

The algorithms used to calculate perfusion parameters are "similar" to the GEMS CT 9800 Regional Cerebral Blood Flow device.
The product "provides images comparable to the predicate device."

It is crucial to understand that this 510(k) summary does not contain the detailed clinical study data or performance metrics that would typically be described as "acceptance criteria" and "device performance" in a modern regulatory submission for an AI/ML device. The regulatory landscape and expectations for evidence of effectiveness for such software were significantly different in 1999. The focus then was more on functional equivalence and safety based on hazard analysis and software development processes, rather than extensive clinical performance studies using quantitative metrics as is common today.

Summary

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K993791/

Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script. The letters are enclosed within a circular border that has decorative, swirling elements at intervals around its perimeter. The logo is presented in black against a white background, giving it a clear and recognizable appearance.

GE Medical Svstems P.O. Box 414, W-709 Milwaukee, WI 53201 USA

CT PERFUSION 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)

Identification of Submitter:

Larry A. Kroger, Ph.D. Senior Regulatory Program Manager Telephone: (414) 544-3894 Date Prepared: October 21, 1999

Identification of Product:

Name :	CT Perfusion Option
Manufacturer :	General Electric Medical Systems283, rue de la Miniere78533 Buc Cedex, FRANCE
Distributor :	General Electric Medical Systems, Milwaukee, WI

Marketed Devices:

The CT Perfusion is substantially equivalent to the devices listed below:

Model:	Functool
Manufacturer:	General Electric Medical Systems, Milwaukee, WI
510(k) #:	K960265
Model:	CT 9800 Regional Cerebral Blood Flow
Manufacturer:	General Electric Medical Systems, Milwaukee, WI
510(k) #:	83K0739

Device Description:

Application examples include:

° characterization of the amount of blood present in a local region.
° provides the volume of blood that flows through a cerebral circulation region.
° returns the average transit time.

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o characterizes image intensity increase during a dynamic process.
o allows selection of any time-series or "dynamic" data set.

Indications for Use :

CT Perfusion 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 after the injection of contrast and to calculate the various perfusion related parameters (ic: regional cerebral blood flow, regional cerebral blood volume, time to peak). The results are displayed in user-friendly graphic format as parametric images. This software runs on the Advantage Workstation (AW) platform and will aid physicians in the assessment of the extent and type of brain perfusion disturbances.

Comparison with Predicate:

CT Perfusion supports the analysis of perfusion CT images and the display of the data in user-friendly graphs and as parametric images. This package is substantially equivalent to the following devices:

Device Name	FDA Clearance Number
GEMS Functool	K960265
GEMS CT 9800 Regional Cerebral Blood Flow	83K0739

CT Perfusion images as compared with the CT 9800 Regional Cerebral Blood Flow device are obtained by CT scanning after an injection of contrast media. CT Perfusion is a software postprocessing 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 the GEMS CT 9800 Regional Cerebral Blood Flow device.

Conclusions :

The CT Perfusion option provides processing capability for dynamic image data and to the ability to generate information with regard to changes in image intensity over time. The potential hazards are controlled by a risk management plan including:

· a Hazard Analysis/Risk Management Summary
· a Software Development and Validation Process
· a Software Verification Plan

This product provides images comparable to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and body. The eagle is facing to the left.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 4 1999

General Electric Medical Systems c/o Reiner Krumme TUV Rheinland of North America, Inc. 12 Commerce Road Newton, CT 06570

Re:

K993791 CT Perfusion Option Dated: November 4, 1999 Received: November 9, 1999 Regulatory class: II 21 CFR 892.1750/Procode: 90 JAK

Dear Mr. Krumme:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: CT Perfusion

Indications for Use

CT Perfusion 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 after the injection of contrast and to calculate the various perfusion related parameters (ie: regional cerebral blood flow, regional cerebral blood valume, time to peak). The results are displayed in user-friendly graphic format as parametric images. This. software runs on the Advantage Workstation (AW) platform and will aid physicians in the assessment of the extent and type of brain perfusion disturbances.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Per 21 CFR 801-109)

OR Over-The-Counter Use

David A. Segner
(Division Sign-Off)

Division of Reproductive, Abdominal, EN and Radiological Device

510(k) Number K993791

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.