(62 days)
Not Found
No
The summary describes standard medical image processing and visualization tools without mentioning AI or ML algorithms.
No.
This device is a medical image processing software application intended for visualization, quantification, manipulation, and printing of medical images, focusing on analysis and viewing capabilities for anatomical and physiological/functional imaging datasets. It does not directly provide therapy or treatment.
Yes
Explanation: The device is described as "a medical image processing software application intended for the visualization of images from various sources such as Magnetic Resonance Imaging systems or from image archives." It provides "viewing, quantification, manipulation, and printing of medical images" and "provides both analysis and viewing capabilities for anatomical and physiologic/functional imaging datasets." This analysis and visualization of medical images, especially for identifying small susceptibility changes from neuronal activity, analyzing diffusion of water molecules, tracking white matter structures, and visualizing vascular structures, directly contributes to informing a medical diagnosis by providing insights into the patient's condition.
Yes
The device is described as a "medical image processing software application" that can be loaded on a standard off-the-shelf personal computer. The description focuses entirely on the software's functionality for viewing, processing, and analyzing medical images, without mentioning any proprietary or specific hardware components included with the device.
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 description of Visia™ Neuro clearly states it processes images from sources like Magnetic Resonance Imaging (MRI) systems or image archives. It analyzes the images of the brain, not biological samples like blood, urine, or tissue.
- The intended use is image processing and visualization. The core function is to view, quantify, manipulate, and print medical images, and to provide analysis capabilities for anatomical and physiological imaging datasets. This is distinct from analyzing biological samples for diagnostic information.
The device is a medical image processing software application, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Visia ™ Neuro is a medical image processing software application intended for the visualization of images from various sources such as Magnetic Resonance Imaging systems or from image archives. The system provides viewing, quantification, manipulation, and printing of medical images. Visia™ Neuro provides both analysis and viewing capabilities for anatomical and physiologic/functional imaging datasets, including blood oxygen dependent (BOLD) fMRI, diffusion, fiber tracking, dynamic review, and vessel visualization. Data can be visualized in both 2D and 3D views.
BOLD fMRI Review
The BOLD fMRI feature is useful in identifying small susceptibility changes arising from neuronal activity during performance of a specific task.
Diffusion Review
The diffusion review feature is intended for visualization and analysis of the diffusion of water molecules through brain tissue.
Fiber Tracking Review
The fiber tracking feature uses the directional portion of the diffusion vector to track and visualize white matter structures within the brain.
Dynamic Review
Dynamic review feature is intended for visualization and analysis of MRI dynamic studies, showing changes in contrast over time, where such techniques are useful or necessary.
Vessel Visualization
The vessel feature is used to identify and visualize the vascular structures of the brain.
3D Visualization
The 3D visualization feature allows image data to be reconstructed as 3D objects that are visualized and manipulated on a 2D screen.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Visia™ Neuro is a medical image processing software application intended for the visualization of images from various sources such as Magnetic Resonance Imaging systems or from image archives. The system provides viewing, quantification, manipulation, and printing of medical images.
Visia™ Neuro integrates within typical clinical workflow patterns through receiving and transferring medical images over a computer network. The software can be loaded on a standard off-the-shelf personal computer (PC) and can operate as a stand-alone workstation or in a distributed server-client configuration across a computer network.
The software provides functionality for processing and analyzing both anatomical and physiologic/functional imaging datasets. Specifically, the software includes user defined processing modules for image registration, blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI), diffusion imaging, fiber tracking, dynamic imaging, and vessel imaging. Processed images are stored as separate files from the original data such that the original data is preserved.
Images may be displayed based on physician preferences using configurable layouts, or hangings. Visia™ Neuro provides the clinician with a broad set of viewing and analysis tools in both 2D and 3D. The software includes tools to annotate, measure, and output selected image views or user defined reports.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging systems
Anatomical Site
brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiologists, Clinicians and referring 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)
The complete system configuration has been assessed and tested at the manufacturer's facility and has passed all in-house testing criteria. The Validation Test Plan was designed to evaluate all input functions, output functions, and actions performed by the software in each operational mode and followed the process documented in the Validation Test Plan.
Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification activities and that the results demonstrated that the predetermined acceptance criteria were met.
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.
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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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Image /page/0/Picture/0 description: The image shows the logo for MeVis MEDICAL SOLUTIONS. The logo is in black and white, with the word "MeVis" in large, bold letters. Below the word "MeVis" is the phrase "MEDICAL SOLUTIONS" in smaller letters. The logo is simple and professional, and it is likely used to represent a medical company.
FEB 1 6 2012
KII3701 P/4
510(k) Summary
| Submitted By: | MeVis Medical Solutions AG
Universitaetsallee 29
28359 Bremen, Germany |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Name: | MeVis Medical Solutions AG |
| Establishment
Registration Number: | Applied for and awaiting assignment by FDA |
| Contact Person: | Thomas E. Tynes
President & CEO
MeVis Medical Solutions, Inc.
N27 W24075 Paul Court - Suite 100
Pewaukee, WI 53072
USA
Phone: +1-262-691-9530
Fax: +1-262-691-9531 |
| Date Prepared: | 12/14/2011 |
| Trade Name: | Visia™ Neuro |
| Common Name: | Medical Image Processing Software |
| Classification Name: | Image Processing System |
| Classification
Regulation Number: | 892.2050 |
| Class: | II |
| Panel: | Radiology |
| Product Code: | LLZ |
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Image /page/1/Picture/0 description: The image shows the logo for MeVis MEDICAL SOLUTIONS. The logo is in black and white, with the word "MeVis" in large, bold letters. Below the word "MeVis" is the phrase "MEDICAL SOLUTIONS" in smaller letters. The logo is simple and professional, and it is likely used to represent a medical company.
Device Description
Visia™ Neuro is a medical image processing software application intended for the visualization of images from various sources such as Magnetic Resonance Imaging systems or from image archives. The system provides viewing, quantification, manipulation, and printing of medical images.
Visia™ Neuro integrates within typical clinical workflow patterns through receiving and transferring medical images over a computer network. The software can be loaded on a standard off-the-shelf personal computer (PC) and can operate as a stand-alone workstation or in a distributed server-client configuration across a computer network.
The software provides functionality for processing and analyzing both anatomical and physiologic/functional imaging datasets. Specifically, the software includes user defined processing modules for image registration, blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI), diffusion imaging, fiber tracking, dynamic imaging, and vessel imaging. Processed images are stored as separate files from the original data such that the original data is preserved.
Images may be displayed based on physician preferences using configurable layouts, or hangings. Visia™ Neuro provides the clinician with a broad set of viewing and analysis tools in both 2D and 3D. The software includes tools to annotate, measure, and output selected image views or user defined reports.
Intended Use
Visia ™ Neuro is a medical image processing software application intended for the visualization of images from various sources such as Magnetic Resonance Imaging systems or from image archives. The system provides viewing, quantification, manipulation, and printing of medical images. Visia™ Neuro provides both analysis and viewing capabilities for anatomical and physiologic/functional imaging datasets, including blood oxygen dependent (BOLD) fMRI, diffusion, fiber tracking, dynamic review, and vessel visualization. Data can be visualized in both 2D and 3D views.
BOLD fMRI Review
The BOLD fMRI feature is useful in identifying small susceptibility changes arising from neuronal activity during performance of a specific task.
Diffusion Review
The diffusion review feature is intended for visualization and analysis of the diffusion of water molecules through brain tissue.
Fiber Tracking Review
The fiber tracking feature uses the directional portion of the diffusion vector to track and visualize white matter structures within the brain.
Visia™ Neuro 510(k) 510(k) Summary - 12/14/2011 Page 2 of 4
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Image /page/2/Picture/0 description: The image shows the logo for MeVis Medical Solutions. The logo consists of the word "MeVis" in large, bold, sans-serif font, with the letters slightly overlapping. Below the word "MeVis" is the phrase "MEDICAL SOLUTIONS" in a smaller, sans-serif font.
Dynamic Review
Dynamic review feature is intended for visualization and analysis of MRI dynamic studies, showing changes in contrast over time, where such techniques are useful or necessary.
Vessel Visualization
The vessel feature is used to identify and visualize the vascular structures of the brain.
3D Visualization
The 3D visualization feature allows image data to be reconstructed as 3D objects that are visualized and manipulated on a 2D screen.
Predicate Device Information
| Product | Predicate Device Name | Predicate 510(k)
Submission Reference |
|--------------|-----------------------|------------------------------------------|
| Visia™ Neuro | DC Neuro | K081262 |
Safety and Effectiveness
The Visia™ Neuro labeling contains instructions for use and necessary cautions, warnings and notes to provide for safe and effective use of the device. Risk Management is ensured via MeVis Medical Solution AG's Risk Management procedure, which is used to identify potential hazards. These potential hazards are controlled via software development and verification & validation testing.
Nonclinical Testing and Performance Information
The complete system configuration has been assessed and tested at the manufacturer's facility and has passed all in-house testing criteria. The Validation Test Plan was designed to evaluate all input functions, output functions, and actions performed by the software in each operational mode and followed the process documented in the Validation Test Plan.
Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification activities and that the results demonstrated that the predetermined acceptance criteria were met.
Technological Characteristics
Visia™ Neuro is a software device that does not contact the patient, nor does it control any life sustaining devices. Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians.
A physician, providing ample opportunity for competent human interprets images and information being displayed and printed.
Visia™ Neuro 510(k) 510(k) Summary - 12/14/2011 Page 3 of 4
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Image /page/3/Picture/0 description: The image shows the logo for MeVis MEDICAL SOLUTIONS. The logo is in black and white. The word "MeVis" is in large, bold letters, and the words "MEDICAL SOLUTIONS" are in smaller letters below it.
P 4/4
The new device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and intended use. The new device does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed devices.
Conclusion
The 510(k) Pre-Market Notification for Visia™ Neuro contains adequate information, data, and nonclinical test results to enable FDA – CDRH to determine substantial equivalence to the predicate device. MeVis Medical Solutions has determined that its device, Visia™ Neuro, is substantially equivalent to the identified predicate device listed above. A comparison with the legally marketed predicate device indicates that it is substantially equivalent to this device, and that it does not raise any new safety or efficacy concerns. Nonclinical tests demonstrate that the device is safe, effective, and is substantially equivalent to the predicate device.
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Image /page/4/Picture/0 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" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, composed of three curved, overlapping shapes.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
MeVis Medical Solutions AG % Mr. Thomas E. Tynes President and CEO MeVis Medical Solutions, Inc. N27 W24075 Paul Court, Suite 100 PEWAUKEE WI 28359
FEB 1 6 2012
Re: K113701
Trade/Device Name: Visia™ Neuro Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 14, 2011 Received: December 16, 2011
Dear Mr. Tynes:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
5
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Mary Pastel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Image /page/6/Picture/1 description: The image shows the logo for MeVis Medical Solutions. The logo is in black and consists of the word "MeVis" in large, bold letters. Below the word "MeVis" are the words "MEDICAL SOLUTIONS" in smaller, less bold letters.
Indications for Use Statement
510(k) Number (if known): K113701
Device Name: Visia™ Neuro
Indications for Use:
Visia™ Neuro is a medical image processing software application intended for the visualization of images from various sources such as Magnetic Resonance Imaging systems or from image archives. The system provides viewing, quantification, manipulation, and printing of medical images. Visia™ Neuro provides both analysis and viewing capabilities for anatomical and physiologic/functional imaging datasets, including blood oxygen dependent (BOLD) fMRI, diffusion, fiber tracking, dynamic review, and vessel visualization. Data can be visualized in both 2D and 3D views.
BOLD fMRi Review
The BOLD MRI feature is useful in identifying small susceptibility changes arising from neuronal activity during performance of a specific task.
Diffusion Review
The diffusion review feature is intended for visualization and analysis of the diffusion of water molecules through brain tissue.
Fiber Tracking Review
The fiber tracking feature uses the directional portion of the diffusion vector to track and visualize white matter structures within the brain.
Dynamic Review
Dynamic review feature is intended for visualization and analysis of MRI dynamic studies, showing changes in contrast over time, where such techniques are useful or necessary.
Vessel Visualization
The vessel feature is used to identify and visualize the vascular structures of the brain.
3D Visualization
The 3D visualization feature allows image data to be reconstructed as 3D objects that are visualized and manipulated on a 2D screen.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary Spoth
Division Sign Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)
Visia™ Neuro 510(k) Indications for Use Statement - 12/14/2011 Page 1 of 1