(15 days)
No
The summary describes image analysis and visualization software with features like 3D rendering and navigation, but it does not mention AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms.
No
The device is an image analysis software package used for visualization and detection of colonic lesions and other anatomical structures, complementing diagnosis and treatment planning rather than directly providing therapy.
Yes
Explanation: The device is described as "image analysis software package" that "allows the user to study the inside, wall and outside of the colon," facilitates "detection of colonic lesions," helps "investigate structures (such as polyps, tumors, stones, calcification etc.) within anatomy, airways and organs," and provides "supplemental information, complementing endoscopy/colonoscopy, to support interpretation and treatment planning." These functions clearly indicate the device is used to diagnose medical conditions by analyzing images and identifying abnormalities.
Yes
The device is explicitly described as an "image analysis software package" and its function is to process and visualize medical images. While it relies on input from imaging modalities (CT, X-ray, CT/MR), the device itself is the software that performs the analysis and visualization. The description focuses solely on the software's capabilities and does not mention any accompanying hardware components that are part of the device itself.
Based on the provided information, this device 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 this software analyzes images acquired from CT, X-ray, and CT/MR modalities. These are imaging techniques that visualize structures within the body, not analyze biological samples taken from the body (like blood, urine, tissue, etc.).
- The purpose is image analysis and visualization. The software is designed to help users study and visualize anatomical structures, particularly the colon, to facilitate the detection of lesions. This is a function of medical imaging analysis, not in vitro testing.
Therefore, while this is a medical device used for diagnostic purposes, it falls under the category of medical imaging software rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CT Colonography/Navigator2 is an image analysis software package that contains CT Colonogarphy and Navigator2.
CT Colonography allows the user to study the inside, wall and outside of the colon. It provides the user with an ability to view datasets from both, prone and supine positions, facilitating detection of colonic lesions. In comparison to colonoscopy, this tool has an advantage of non-invasive depth penetration due to its 3D presentation capability.
Navigator2 provides endoluminal views of anatomical structures. Navigator2 is designed to enhance and modify current image quality, tools, speed and user interface of Navigator for improved productivity. Navigator2 provides a visualization tool to investigate structures (such as polyps, tumors, stones, calcification etc.) within anatomy, airways and organs. Thus, its viewing capability of the inner and outer surfaces of organs as well as within their walls provides additional supplemental information, complementing endoscopy/colonoscopy, to support interpretation and treatment planning. Navigation2 is applicable to X-ray as well as CT/MR.
Product codes (comma separated list FDA assigned to the subject device)
90 JAK
Device Description
CT Colonography/Navigator2 (CTC/Nav2) is an image analysis software package that allows the user to study the inside, wall, and outside of the colon using CT-acquired helical images. The tool is laid out to facilitate the detection of colonic lesions. CT Colonography requires Navigator2 for its operation however, Navigator2 can also be utilized as a stand-alone option. Navigator2 is an advanced visualization software option that provides endoluminal views of anatomical structures. The flexibility of this software allows the user to move interactively from air paths to inner vessels visualization and thus, it is not limited to inner navigation of structures as lungs and sinuses. Volume Analysis (includes both, CT/MR Windows Workstation, K913770 and 3D & Dentascan for Windows K923077) provides the base for CTC/Nav2 and Nav2 alone, which allows an increase in the ease of use and productivity. CTC/Nav2 and Nav2 alone, also use some options of Volume Rendering (AW Volume Render Option K972399), which allows the user to quickly isolate structure of interest and render volumetric data in three dimensions.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, X-ray, CT/MR
Anatomical Site
Colon, anatomical structures, airways and organs (such as lungs and sinuses)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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.
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.
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/0 description: The image shows a date, "AUG - 7 2001". The month is August, the day is the 7th, and the year is 2001. The text is in a bold, sans-serif font.
GE Medical Systems General Electric Company P O Box 414 Milwaukee, WI 53201
Koi23/3
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).
Larry A. Kroger, Ph.D. Submitter Senior Regulatory Program Manager Telephone: (262) 544-3894, FAX: (262) 544-3863 Date Prepared: June 12, 2001
PRODUCT IDENTIFICATION
Name: CT Colonography/Navigator2
Classification Name: Accessory to Computed Tomography System
Manufacturer : General Electric Medical Systems 283, rue de la Miniere 78533 Buc Cedex, FRANCE
General Electric Medical Systems, Milwaukee, WI Distributor:
Marketed Devices The CT Colonography/Navigator2 is substantially equivalent to the device listed below:
Model: Navigator Manufacturer: General Electric Medical Systems, Milwaukee, WI 510(k) #: K954355
Device Description:
CT Colonography/Navigator2 (CTC/Nav2) is an image analysis software package that allows the user to study the inside, wall, and outside of the colon using CT-acquired helical images. The tool is laid out to facilitate the detection of colonic lesions. CT Colonography requires Navigator2 for its operation however, Navigator2 can also be utilized as a stand-alone option. Navigator2 is an advanced visualization software option that provides endoluminal views of anatomical structures. The flexibility of this software allows the user to move interactively from air paths to inner vessels visualization and thus, it is not limited to inner navigation of structures as lungs and sinuses. Volume Analysis (includes both, CT/MR Windows Workstation, K913770 and 3D & Dentascan for Windows K923077) provides the base for CTC/Nav2 and Nav2 alone, which allows an increase in the ease of use and productivity. CTC/Nav2 and Nav2 alone, also use some options of Volume Rendering (AW Volume Render Option
Image /page/0/Picture/15 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular border. The letters are stylized and connected, and the border has decorative flourishes around the edges. The logo is black and white.
1
K972399), which allows the user to quickly isolate structure of interest and render volumetric data in three dimensions.
Indications for Use :
CT Colonography Navigator2 is an image analysis software package that contains CT Colonogarphy and Navigator2.
CT Colonography allows the user to study the inside, wall and outside of the colon. It provides the user with an ability to view datasets from both, prone and supine positions, facilitating detection of colonic lesions. In comparison to colonoscopy, this tool has an advantage of non-invasive depth penetration due to its 3D presentation capability.
Navigator2 provides endoluminal views of anatomical structures. Navigator2 is designed to enhance and modify current image quality, tools, speed and user interface of Navigator for improved productivity. Navigator2 provides a visualization tool to investigate structures (such as polyps, tumors, stones, calcification etc.) within anatomy, airways and organs. Thus, its viewing capability of the inner and outer surfaces of organs as well as within their walls provides additional supplemental information, complementing endoscopy/colonoscopy, to support interpretation and treatment planning. Navigation2 is applicable to X-ray as well as CT/MR.
Comparison with Predicate:
CT Colonography/Navigator2 is an image analysis software built on Navigator 2 features that allows the user to study the inside, wall, and outside of the colon using CT acquired helical images. The tool is laid out to facilitate the detection of colonic lesions. Navigator 2 is a new version of the current GE Navigator, it has improved performance and usability. The functional features of this package are substantially equivalent to that of the following device:
| Device Name | FDA Clearance Number |
|---|---|
| Advantage Windows 3D with Navigator Option* | K 954355 |
- referred as Navigator in this application
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:
The CT Colonography/Navigator2 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 Colonography/Navigator2 to be equivalent to those of Navigator (K954355).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling three stylized lines that form the shape of a bird or a stylized human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 7 2001
General Electric Medical Systems % Mr. Reiner Krumme Manager, Medical Division TUV Rheinland of North America 12 Commerce Road NEWTON CT 06470
Re: K012313
CT Colonography/Navigator 2 (CT Navigation software package) Dated: July 18, 2001 Received: July 23, 2001 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 W C hard reviewed your became of 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, that nave boom reculasined in abbert 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 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 substantiality equivalent determination assumes compliance with the Current Good Manufacturing THE 21, I arts oor to 093. I Forestimation (QS) for Medical Devices: General regulation (21 CFR Part I rache requirements, a sol tour in the econner, the Food and Drug Administration (FDA) will verify such assumptions. Failure one may with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements to comply with 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 r has letter will and if 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 yitto diagnostic devices), please contact the Office of Compliance at (301) 594-4639. 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" (21CFR 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 vours.
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 (s)
3
510(k) Number (if known):
Device Name: CT Colonography
Indications for Use
CT Colonography/Navigator2 is an image analysis software package that contains CT Colonogarphy and Navigator2.
CT Colonography allows the user to study the inside, wall and outside of the colon. It provides the user with an ability to view datasets from both, prone and supine positions, facilitating detection of colonic lesions. In comparison to colonoscopy, this tool has an advantage of non-invasive depth penetration due to its 3D presentation capability.
Navigator2 provides endoluminal views of anatomical structures. Navigator2 is designed to enhance and modify current image quality, tools, speed and user interface of Navigator for improved productivity. Navigator2 provides a visualization tool to investigate structures (such as polyps, tumors, stones, calcification etc.) within anatomy, airways and organs. Thus. its viewing capability of the inner and outer surfaces of organs as well as within their walls provides additional supplemental information, complementing endoscopy/colonoscopy, to support interpretation and treatment planning. Navigation2 is applicable to X-ray as well as CTMR.
(PLEASE 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
Nancy C. Hardon
(Division Sign-Off)
d Radiological Devices