(146 days)
No
The document describes standard image processing techniques like registration, fusion, and quantitative analysis based on comparison to normal databases, without mentioning AI or ML.
No
The device is image analysis software that aids physicians in the evaluation of patient pathologies by assessing and quantifying PET brain scans. It is an adjunct to other diagnostic evaluations but does not directly provide therapy or treatment.
Yes.
Explanation: The "Intended Use / Indications for Use" section states that the software "has been developed to aid physicians in the evaluation of patient pathologies" and "may aid physicians in the image interpretation process of PET studies conducted on patients being evaluated for cognitive impairment, or other causes of cognitive decline, and is an adjunct to other diagnostic evaluations." This clearly indicates its role in the diagnostic process.
Yes
The device description explicitly states "CortexID, image analysis software" and details its functions as software-based image processing and analysis. While it mentions being available on a workstation, the core device being described and cleared is the software itself.
Based on the provided information, CortexID software is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The intended use and device description clearly state that CortexID analyzes images of the brain obtained from PET, CT, and MR scans. These are imaging modalities, not laboratory tests performed on biological samples like blood, urine, or tissue.
- The analysis is based on image processing and quantification. The software quantifies tracer uptake and compares it to normal databases, but this is done on the image data itself, not on a biological sample.
- The output is image-based and statistical. The results are presented as volumes of interest, voxel-based maps, and statistical comparisons, all derived from the image data.
While the software aids in the evaluation of patient pathologies and is used in conjunction with other diagnostic evaluations, its function is centered around the analysis of medical images, not the analysis of biological samples in vitro.
N/A
Intended Use / Indications for Use
CortexID software has been developed to aid physicians in the evaluation of patient pathologies via assessment and quantification of PET brain scans.
The software aids in the assessment of human brain PET scans enabling automated analysis through quantification of tracer uptake and comparison with the corresponding tracer uptake in normal subjects. The resulting quantification is presented using volumes of interest, voxel-based or 3D stereotactic surface projection maps of the brain. The package allows the user to generate information regarding relative changes in PET-FDG glucose metabolism.
CortexID Suite additionally allows the user to generate information in PET brain amyloid load between a subject's images and a normal database, which may be the result of brain neurodegeneration.
PET co-registration and fusion display capabilities with CT and MR allow PET findings to be related to brain anatomy and offers visualization of structural abnormalities, which may result from brain injury, trauma, disease or dysfunction, such as subdural hematoma, tumor, stroke, or cerebrovascular disease, etc.
CortexID Suite may aid physicians in the image interpretation process of PET studies conducted on patients being evaluated for cognitive impairment, or other causes of cognitive decline, and is an adjunct to other diagnostic evaluations.
Product codes
KPS
Device Description
CortexID, image analysis software, has been developed to aid clinicians in the assessment and quantification of pathologies derived from PET scans. The software enables the display, co-registration, and fusion of PET images with those from other modalities. It enables automated quantitative and statistical analysis of tracer uptake by registration to a standard template space and comparing intensity values. Additionally, CortexID assists with comparison of the activity in defined brain regions of individual scans relative to normal activity values as found in normal subjects. Quantification is presented using volumes of interest, voxel-based or 3D stereotactic surface projection maps of the brain.
Key features of the CortexID Suite include:
a. Integrated platform for FDG and Beta Amyloid analysis
b. PET-MR and PET-CT registration and fusion
c. Automatic reorientation and standardization
d. 3D SSP, Voxel based images and VOI statistics
e. Comparison with normals databases
f. Longitudinal Analysis
g. Q.Check
h. Summing input dynamic PET scan
i. Exam Summary (integrated report)
j. Easy Export
k. Multiple Reference Regions
l. Reoreintation
m. Region Overlay
n. Fully Customizable Interface
o. Preset Presentations
p. MR Template Image
The CortexID Suite is also made available as a standalone post processing application on the AW VolumeShare 5 workstation (K110834) that hosts advanced image processing applications.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
PET, CT, MR
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)
Summary of Non-Clinical Tests:
The CortexID Suite software complies with NEMA PS 3.1 - 3.20 (2011) Digital Imaging and Communications in Medicine (DICOM) Set (Radiology) standard.
CortexID Suite employs the same fundamental scientific technology as its predicate device, CortexID. CortexID Suite uses the equivalent DICOM image data input requirements. It has equivalent display, formatting, archiving and visualization technologies compared to the predicate device. CortexID Suite utilizes essentially the same methodology to quantify and assess uptake of FDG and beta amyloid tracers. The information is presented using volumes of interest, voxel-based or 3D stereotactic surface projection maps of the brain. CortexID Suite utilizes existing PET & CT co-registration and fusion technologies and provides for PET & MR co-registration and fusion capabilities. Thorough testing of these capabilities has not raised any safety or effectiveness issues.
The following quality assurance measures were applied to the development of the system:
■ Risk Analysis
■ Requirements Reviews
■ Design Reviews
■ Integration testing (System verification)
■ Performance testing (Bench testing, verification)
■ Safety testing (Verification)
Summary of Clinical tests:
The subject of this premarket submission, CortexID Suite software did not require clinical studies to support substantial equivalence since it introduces analysis of new PET image contrast agents only. The clinical utility for the analysis of the new image processing has not been studied since modification does not significantly affect the clinical safety and performance. The substantial equivalence determination is based on the software documentation for a MODERATE level of concern device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 19, 2014
GE Medical Systems, LLC % Mr. David Duersteler Regulatory Affairs Leader 3000 North Grandview Blvd. WAUKESHA WI 53188
Re: K141074 Trade/Device Name: CortexID Suite Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: September 12, 2014 Received: September 15, 2014
Dear Mr. Duersteler:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. O'Hara
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K141074
Device Name CortexID Suite
Indications for Use (Describe)
CortexID software has been developed to aid physicians in the evaluation of patient pathologies via assessment and quantification of PET brain scans.
The software aids in the assessment of human brain PET scans enabling automated analysis through guantification of tracer uptake and comparison with the corresponding tracer uptake in normal subjects. The resulting quantification is presented using volumes of interest, voxel-based or 3D stereotactic surface projection maps of the brain. The package allows the user to generate information regarding relative changes in PET-FDG glucose metabolism.
CortexID Suite additionally allows the user to generate information in PET brain amyloid load between a subject's images and a normal database, which may be the result of brain neurodegeneration.
PET co-registration and fusion display capabilities with CT and MR allow PET findings to be related to brain anatomy and offers visualization of structural abnormalities, which may result from brain injury, trauma, disease or dysfunction, such as subdural hematoma, tumor, stroke, or cerebrovascular disease, etc.
CortexID Suite may aid physicians in the image interpretation process of PET studies conducted on patients being evaluated for cognitive impairment, or other causes of cognitive decline, and is an adjunct to other diagnostic evaluations. Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
3
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Image /page/4/Picture/1 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in white inside. The circle is surrounded by a white border with a stylized design that looks like water droplets. The logo is simple and recognizable, and it is often used to represent the company's products and services.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | April 23, 2014 |
|---|---|
| Submitter: | GE Medical Systems, LLC |
| 3000 North Grandview Blvd. | |
| Waukesha, WI 53188, USA | |
| Primary Contact Person: | Peter Uhlir |
| Regulatory Affairs Leader | |
| Tel: 00 36 23 410121 | |
| Fax: 1-847-277-4506 | |
| Secondary Contact | |
| Person: | Jeme Wallace |
| Regulatory Affairs Director | |
| GE Healthcare | |
| Tel: 1-847-277-4468 | |
| Fax: 1-847-277-4506 | |
| Device Trade Name: | CortexID Suite |
| Common/Usual Name: | CortexID Suite |
| Classification Names: | 21CFR 892.1200, Radiology |
| Product Code: | KPS |
| Predicate Device(s): | K062393 - CortexID (originally called GE Vantage PET Neuro) |
| Device Description: | CortexID, image analysis software, has been developed to aid |
| clinicians in the assessment and quantification of pathologies | |
| derived from PET scans. The software enables the display, co- | |
| registration, and fusion of PET images with those from other | |
| modalities. It enables automated quantitative and statistical | |
| analysis of tracer uptake by registration to a standard template | |
| space and comparing intensity values. Additionally, CortexID | |
| assists with comparison of the activity in defined brain regions | |
| of individual scans relative to normal activity values as found in | |
| normal subjects. Quantification is presented using volumes of | |
| interest, voxel-based or 3D stereotactic surface projection maps | |
| of the brain. | |
| Key features of the CortexID Suite include: | |
| a. Integrated platform for FDG and Beta Amyloid analysis | |
| b. PET-MR and PET-CT registration and fusion | |
| c. Automatic reorientation and standardization | |
| d. 3D SSP, Voxel based images and VOI statistics | |
| e. Comparison with normals databases | |
| f. Longitudinal Analysis | |
| g. Q.Check | |
| h. Summing input dynamic PET scan | |
| i. Exam Summary (integrated report) | |
| j. Easy Export | |
| k. Multiple Reference Regions | |
| l. Reoreintation | |
| m. Region Overlay | |
| n. Fully Customizable Interface | |
| o. Preset Presentations | |
| p. MR Template Image | |
| The CortexID Suite is also made available as a standalone post processing application on the AW VolumeShare 5 workstation (K110834) that hosts advanced image processing applications. | |
| Indications for Use / | |
| Intended Use: | CortexID software has been developed to aid physicians in the evaluation of patient pathologies via assessment and quantification of PET brain scans. |
| The software aids in the assessment of human brain PET scans enabling automated analysis through quantification of tracer uptake and comparison with the corresponding tracer uptake in normal subjects. The resulting quantification is presented using volumes of interest, voxel-based or 3D stereotactic surface projection maps of the brain. The package allows the user to generate information regarding relative changes in PET-FDG glucose metabolism. | |
| CortexID Suite additionally allows the user to generate information in PET brain amyloid load between a subject's images and a normal database, which may be the result of brain neurodegeneration. | |
| PET co-registration and fusion display capabilities with CT and | |
| MR allow PET findings to be related to brain anatomy and offers | |
| visualization of structural abnormalities, which may result from | |
| brain injury, trauma, disorder, disease or dysfunction, such as | |
| subdural hematoma, tumor, stroke, or cerebrovascular disease, | |
| etc. |
CortexID Suite may aid physicians in the image interpretation
process of PET studies conducted on patients being evaluated
for cognitive impairment, or other causes of cognitive decline,
and is an adjunct to other diagnostic evaluations. |
| Technology: | The CortexID Suite software employs the same fundamental
scientific technology as its predicate device. |
| Determination of
Substantial Equivalence: | Summary of Non-Clinical Tests:
The CortexID Suite software complies with NEMA PS 3.1 - 3.20
(2011) Digital Imaging and Communications in Medicine (DICOM)
Set (Radiology) standard.
CortexID Suite employs the same fundamental scientific
technology as its predicate device, CortexID. CortexID Suite uses
the equivalent DICOM image data input requirements. It has
equivalent display, formatting, archiving and visualization
technologies compared to the predicate device. CortexID Suite
utilizes essentially the same methodology to quantify and
assess uptake of FDG and beta amyloid tracers. The information
is presented using volumes of interest, voxel-based or 3D
stereotactic surface projection maps of the brain. CortexID Suite
utilizes existing PET & CT co-registration and fusion
technologies and provides for PET & MR co-registration and
fusion capabilities. Thorough testing of these capabilities has
not raised any safety or effectiveness issues.
The following quality assurance measures were applied to the
development of the system:
■ Risk Analysis
■ Requirements Reviews
■ Design Reviews
■ Integration testing (System verification)
■ Performance testing (Bench testing, verification)
■ Safety testing (Verification) |
| | Summary of Clinical tests:
The subject of this premarket submission, CortexID Suite
software did not require clinical studies to support substantial
equivalence since it introduces analysis of new PET image
contrast agents only. The clinical utility for the analysis of the
new image processing has not been studied since modification |
| | does not significantly affect the clinical safety and performance.
The substantial equivalence determination is based on the
software documentation for a MODERATE level of concern
device. |
| Conclusion: | GE Healthcare considers the CortexID Suite software
application to be as safe, as effective, and performance is
substantially equivalent to the predicate device. |
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Image /page/6/Picture/1 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circle. There are small, white, teardrop-shaped elements surrounding the circle, giving it a dynamic and recognizable appearance. The logo is simple, yet distinctive, and is widely recognized as the symbol of the General Electric company.
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Image /page/7/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. The circle has a series of white, curved lines around it, resembling water droplets or stylized waves, which gives the logo a dynamic and modern appearance.