(15 days)
K960265, 83K0739
Not Found
No
The description focuses on standard image processing techniques and parameter calculation from dynamic CT data, with no mention of AI, ML, or related concepts like training or testing data sets.
No.
The device is described as image analysis software that aids physicians in assessment, not as a device that delivers therapy or directly treats a condition.
Yes
The device is an image analysis software package that aids physicians in the assessment of brain perfusion disturbances by calculating various perfusion-related parameters. This assessment directly contributes to a diagnosis.
Yes
The device is explicitly described as an "image analysis software package" and its function is to process and display data from existing CT Perfusion images. It runs on a separate hardware platform (Advantage Workstation) but the device itself is the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is an "image analysis software package" that processes "CT Perfusion images." It analyzes imaging data obtained from a patient's brain after the injection of contrast.
- No Biological Samples: There is no mention of the device analyzing any biological samples taken from the patient. Its input is imaging data, not biological material.
Therefore, since the device operates on medical images and not biological samples, it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
90 JAK
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT Perfusion images obtained by cine imaging after the injection of contrast
Anatomical Site
brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K960265, 83K0739
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 Systems |
| 283, rue de la Miniere | |
| 78533 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:
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.
1
- 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.
2
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
3
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