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.

Device Description

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.

AI/ML Overview

The provided documentation for Visia™ Neuro does not contain specific acceptance criteria or a detailed study that proves the device meets such criteria in terms of quantitative performance metrics for medical diagnosis or image interpretation.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (DC Neuro, K081262) through non-clinical testing and verification/validation activities of the software itself. The document states that the software passed "all in-house testing criteria" and that "the results demonstrated that the predetermined acceptance criteria were met." However, these acceptance criteria are not explicitly defined in terms of clinical performance (e.g., accuracy, sensitivity, specificity for identifying pathologies).

Here's a breakdown of the information that is available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific clinical acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, AUC) are mentioned. The document primarily discusses functional and technical acceptance criteria related to software performance and safety.

Acceptance Criteria Category	Reported Device Performance
Software Functionality	Passed all in-house testing criteria for input functions, output functions, and actions in each operational mode.
Safety and Effectiveness	Risk management procedures identified potential hazards, which were controlled via software development and verification & validation testing.
Technological Characteristics (Substantial Equivalence)	Substantially equivalent to the predicate device (DC Neuro, K081262) in technical characteristics, general function, application, and intended use. Does not raise new safety risks.

2. Sample size used for the test set and the data provenance:

Test Set Description: The document refers to "the complete system configuration" being "assessed and tested at the manufacturer's facility." It also mentions "Validation Test Plan" results.
Sample Size: Not specified. It only refers to "all verification activities."
Data Provenance: Not specified, but given it was "in-house testing," it's likely internal, potentially simulated or based on historical data readily available to the manufacturer. It doesn't specify if it's retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document states: "Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians." and "A physician, providing ample opportunity for competent human interprets images and information being displayed and printed."
However, for the validation testing of the software itself, there's no mention of experts establishing ground truth for evaluating diagnostic performance. The validation appears to be focused on software functionality and technical aspects rather than clinical outcome.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable or not mentioned, as the validation described is for software functionality and not for diagnostic accuracy requiring expert adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. The document describes a software medical device for visualization and analysis, not an AI-assisted diagnostic tool requiring MRMC studies to assess human reader improvement.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device is explicitly described as a tool for visualization and analysis, with diagnoses made by physicians. Therefore, a "standalone algorithm only" performance study in a diagnostic context is not relevant to its intended use as described. The software's performance was evaluated in terms of its functions, not its diagnostic accuracy.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

No ground truth type is specified for evaluating the device's clinical performance because the validation described is centered on software functionality and technical equivalence.

8. The sample size for the training set:

Not applicable. This is a medical image processing software application, not a machine learning or AI algorithm that requires a "training set" in the context of learning to perform a diagnostic task.

9. How the ground truth for the training set was established:

Not applicable, as there is no mention of a training set for an AI/ML algorithm.

Summary

{0}------------------------------------------------

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 AGUniversitaetsallee 2928359 Bremen, Germany
EstablishmentName:	MeVis Medical Solutions AG
EstablishmentRegistration Number:	Applied for and awaiting assignment by FDA
Contact Person:	Thomas E. TynesPresident & CEOMeVis Medical Solutions, Inc.N27 W24075 Paul Court - Suite 100Pewaukee, WI 53072USAPhone: +1-262-691-9530Fax: +1-262-691-9531
Date Prepared:	12/14/2011
Trade Name:	Visia™ Neuro
Common Name:	Medical Image Processing Software
Classification Name:	Image Processing System
ClassificationRegulation Number:	892.2050
Class:	II
Panel:	Radiology
Product Code:	LLZ

{1}------------------------------------------------

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

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

{2}------------------------------------------------

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

{3}------------------------------------------------

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.

K113701

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.

{4}------------------------------------------------

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

{6}------------------------------------------------

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:

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

Regulation Number and Section

§ 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).