(89 days)
No
The description focuses on volume rendering and 3D reconstruction from CT/MR data, which are standard image processing techniques, and does not mention AI or ML.
No
The device is a software package for volume visualization of CT/MR images for diagnosis confidence or surgical planning; it does not directly treat or diagnose patients.
Yes
The "Intended Use / Indications for Use" states that the device "reconstructs and displays translucent 3D models to be used for diagnosis confidence or planning surgical treatment." The "Intended User / Care Setting" also mentions "clinical and diagnostic applications in radiology."
Yes
The device is explicitly described as a "software package" that operates on an existing workstation and operating system, utilizing images from external CT or MR systems. It does not include any hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "volume visualization of three dimensional structures imaged with computed tomography (CT), or magnetic resonance (MR)." This is a medical imaging visualization tool, not a test performed on biological samples (in vitro).
- Device Description: The device is a software package that processes medical images (CT and MR) to create 3D reconstructions. It does not interact with or analyze biological specimens.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnosis based on laboratory test results
The device is clearly a medical imaging software used for visualization and planning based on images acquired from the patient's body (in vivo).
N/A
Intended Use / Indications for Use
The Advantage Windows Volume Rendering Option is intended to provide volume visualization of three dimensional structures imaged with computed tomography (CT), or magnetic resonance (MR). It reconstructs and displays translucent 3D models to be used for diagnosis confidence or planning surgical treatment. The images are reconstructed and displayed on the CT/MR Advantage Windows Diagnostic Workstation (K913770).
Product codes (comma separated list FDA assigned to the subject device)
90 JAK, 90 LNH
Device Description
The device is a soltware package to be used on the same software as used for Advantage Windows 3D (VoxTool) and will operate on the Advantage Windows Operating System. The workstation hardware required for operation will be the Sun Spar 20, Mod 40, or higher. The images used to provide these 3D reconstructions can be captured by any CT or MR system and transferred to Advantage Windows workstation by DICOM or Ethernet.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
computed tomography (CT), magnetic resonance (MR)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiology, surgery, and treatment planning. It runs on Advantage Windows independent workstations
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
9723999
SEP 2 3 1997
GE Medical Systems
Summary of Safety & Effectiveness
This 510(k) summary of safety and effectiveness is submitted in accordance with the requirements of 21 CFR Part 807.87(h).
Identification of Submitter.
Larry A. Kroger, Ph.D. (414) 544-3894 Summary prepared 24 June 1997
Product Identification:
Name: Advantage Windows Volume Rendering Option General Electric Medical Systems Manufacturer. 16800 W. Ryerson Road New Berlin, WI 53151
Marketed Devices: The Advantage Windows Valume Rendering Option is substantially equivalent to the currently marketed Advantage Windows 3D (K923077), Advantage Windows 3D with Navigator Option (K954355), and Advantage CT (9800 Quick) 3D (K871859)
Indications for Use Advantage Windows Volume Rendering Option is intended to provide fast, easy volume visualization of three dimensional structures imaged with a computed tomography (CT) or magnetic resoriance (MR) system. It is dedicated to clinical and disgnostic applications in radiology, surgery, and treatment planning. It runs on Advantage Windows independent workstations
Device Description: Design: The device is a soltware package to be used on the same software as used for Advantage Windows 3D (VoxTool) and will operate on the Advantage Windows Operating System. The workstation hardware required for operation will be the Sun Spar 20, Mod 40, or higher. The images used to provide these 3D reconstructions can be captured by any CT or MR system and transferred to Advantage Windows workstation by DICOM or Ethernet.
Energy Source and Exposure Levels: There is no energy source associated with this package in and of itself. However, the energy source used to make the image being analyzed is the same used to take standard CT or MR diagnostic images.
Principals of Operation: The same as Advantage Windows 3D. Features: To provide translucent 3D models of areas of interest selected by the operator. Accessories: None
Adverse fifteds on Health: The package itself will not have any adverse affects on health. This woll reconstructs and displays a translucent 3D model of a region of interest selected by the operator. The selection of the region of interest is up to the operator who can choose to accept or reject the region selected.
Conclusions: The Advantage Windows Volume Rendering Option enbances the current Advantage Windows 3D package by providing showing depth and position of overlapping structures. It is substantially equivalent to the Advantage Windows 3D package in design, construction, principle of operation, and features.
1
Image /page/1/Picture/2 description: The image shows a logo for the Department of Health. The logo features the words "DEPARTMENT OF HEALTH &" in a vertical orientation on the left side of the image. To the right of the text is a symbol consisting of three stylized, curved lines that resemble a human figure or abstract design. The logo is printed in black ink on a white background.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 3 1997
Larry A. Kroger, Ph.D. Regulatory Program Manager GE Medical Systems P.O. Box 414 Milwaukee, WI 53201
Re: K972399
Advantage Windows Volume Rendering Option (CT/MR Accessory) Dated: June 24, 1997 Received: June 26, 1997 Regulatory Class: II 21 CFR 892.1750/Procode: 90 JAK 21 CFR 892.1000/Procode: 90 LNH
Dear Dr. Kroger:
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 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 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 requirement, 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 regulatory 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 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 prediction 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) 594-4613. Additionally, for question 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/dsmamain.html".
Sincerely yours,
h.7.liau Yu
Lillian Yiu, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known):
Advantage Windows Volume Rendering Option Device Name:
Indications For Use:
The Advantage Windows Volume Rendering Option is intended to provide volume visualization of three dimensional structures imaged with computed tomography (CT), or magnetic resonance (MR). It reconstructs and displays translucent 3D models to be used for diagnosis confidence or planning surgical treatment. The images are reconstructed and displayed on the CT/MR Advantage Windows Diagnostic Workstation (K913770).
(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 | |
|---|---|
| ---------------------- | --------------- |
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
| 510(k) Number | K972399 |
|---|---|
| --------------- | --------- |