(90 days)
Visia™ is a medical image processing software application intended for the visualization of images from various sources (e.g., Computed Tomography (CT), Magnetic Resonance (MR), etc). The system provides viewing, quantification, manipulation, communication, and printing of medical images. Visia™ is not meant for primary diagnostic interpretation of mammography.
Visia™ is a medical imaging software platform that allows processing, review, and analysis of multidimensional digital images acquired from a variety of medical imaging modalities. Visia™ offers flexible workflow options to aid clinicians in the evaluation of patient anatomy and pathology. The Visia™ system 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. Images can be displayed based on physician preferences using configurable viewing options or hanging protocols. Visia™ provides the clinician with a broad set of viewing and analysis tools to annotate, measure, and output selected image views or reports.
The provided 510(k) summary for MeVis Medical Solutions AG's Visia™ device primarily focuses on demonstrating substantial equivalence to a predicate device (Vitrea® K071331) and discusses general nonclinical testing.
Based on the provided text, there is no detailed information about specific acceptance criteria, a dedicated study proving performance against these criteria, or the methodology typically found in studies for AI/CADe devices. The device, Visia™, is described as a medical image processing software platform for visualization, quantification, manipulation, and printing, rather than an AI/CADe device that performs diagnostic interpretations or provides automated analysis results for which detailed performance metrics would be assessed. The submission explicitly states: "Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians." and "Visia™ is not meant for primary diagnostic interpretation of mammography."
Therefore, I cannot populate most of the requested fields as the information is not present in the provided document.
Here's an assessment based on the available information:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Not explicitly stated or quantitative for performance) | Reported Device Performance (General statements from submission) |
|---|---|
| Functional Equivalence to Predicate Device | The submission states: "Nonclinical and performance testing results are provided in the 510(k) and demonstrate that the predetermined acceptance criteria are met." It also claims "The design, function, and specifications of Visia™ are similar to the identified legally marketed predicate device." And "The new device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, 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." The validation test plan "was designed to evaluate all input functions, output functions, and actions performed by the software in each operational mode" and "passed all in-house testing criteria including validating design, function, and specifications." |
| Safety and Effectiveness | "The Visia™ 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 testing." And "Nonclinical tests demonstrate that the device is safe, effective, and is substantially equivalent to the predicate device." |
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not specified. The document refers generally to "nonclinical and performance testing" and a "Validation Test Plan" but does not provide details on the number of cases or datasets used.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. The device is a viewing/processing platform, not a diagnostic aid that establishes "ground truth." The submission states "Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians."
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified.
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:
- No, an MRMC study was not described or implied. The device is explicitly stated as "not meant for primary diagnostic interpretation of mammography" and does not perform diagnosis; therefore, a study on human reader improvement with AI assistance would not be relevant to its intended use as described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. The device is a "medical imaging software platform" that provides "viewing, quantification, manipulation, and printing." It is a tool for clinicians, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. As a viewing and processing software, the concept of "ground truth" for its performance isn't in the same vein as for a diagnostic AI. The "ground truth" for showing it works would likely relate to the accuracy of its display, measurements, and functional operations compared to predefined specifications or those of the predicate device, which isn't detailed in terms of a specific "ground truth" type here.
8. The sample size for the training set:
- Not applicable. This device is described as general medical image processing software, not an AI/ML algorithm that requires a training set in the conventional sense.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of Device and Evidence provided:
The Visia™ device is a medical image processing software platform. Its 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device (Vitrea® K071331) and on internal "nonclinical and performance testing" to validate its design, function, and specifications. The criteria for acceptance appear to be primarily functional verification against design requirements and comparison to the predicate device's capabilities, rather than quantitative performance metrics for a diagnostic aid that would analyze medical images or perform AI tasks. The submission emphasizes that the software does not perform diagnosis and is not intended for primary diagnostic interpretation.
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APR 2 3 2012
Image /page/0/Picture/2 description: The image shows a logo with the words "MEDICAL SOLUTIONS" at the bottom. The words are in a bold, sans-serif font and are arranged in a single line. Above the text is a graphic element that appears to be a stylized representation of a medical symbol or emblem. The logo is simple and professional, suggesting a company in the healthcare industry.
510(k) Summary
| Submitted By: | MeVis Medical Solutions AGUniversitaetsallee 2928359 Bremen, Germany |
|---|---|
| Establishment Name: | MeVis Medical Solutions AG |
| Establishment Registration 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: | 1/20/2012 |
| Trade Name: | Visia™ |
| 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 a logo with the words "MEDICAL SOLUTIONS" at the bottom. The logo is in black and white and appears to be a stylized design. The text is in a simple, sans-serif font and is centered below the design. The image is of low resolution and the details are not clear.
Device Description
Visia™ is a medical imaging software platform that allows processing, review, and analysis of multidimensional digital images acquired from a variety of medical imaging modalities. Visia™ offers flexible workflow options to aid clinicians in the evaluation of patient anatomy and pathology. The Visia™ system 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. Images can be displayed based on physician preferences using configurable viewing options or hanging protocols. Visia™ provides the clinician with a broad set of viewing and analysis tools to annotate, measure, and output selected image views or reports.
Intended Use
Visia™ is a medical image processing software application intended for the visualization of images from various sources (e.g., Computed Tomography (CT), Magnetic Resonance (MR), etc). The system provides viewing, quantification, manipulation, and printing of medical images. Visia™ is not meant for primary diagnostic interpretation of mammography.
Predicate Device Information & Comparison
| Product | Predicate Device Name | Predicate 510(k)Submission Reference |
|---|---|---|
| Visia™ | Vitrea® | K071331 |
The design, function, and specifications of Visia™ are similar to the identified legally marketed predicate device. Visia™ and Vital Image's Vitrea® (K071331) both provide viewing, quantification, manipulation, communication, and printing of medical images. Both contain the functionality for processing and analyzing DICOM anatomical data from multiple vendors and modalities. The differences between the Visia™ system and Vitrea@ (K071331) include a limited number of options and features of the predicate device, which are not included in the submitted device. Visia™ does not include web-based accessibility and optional applications such as cardiac EP planning, plaque characterization or vessel probe tools. Additional modifications include minor user interface variations. These differences between Visia™ and the legally marketed predicate device do not impact device safety or effectiveness.
Safety and Effectiveness
The Visia™ 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 testing.
Visia™ 510(k) 510(k) Summary – 1/20/2012 Page 2 of 3
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Image /page/2/Picture/0 description: The image shows a logo for a company called "MEDICAL SOLUTIONS". The logo is black and white and features the company name in bold letters. The word "MEDICAL" is on the top line, and the word "SOLUTIONS" is on the bottom line. The logo is simple and professional.
Nonclinical Testing and Performance Information
Nonclinical and performance testing has been performed by designated individuals as required by MeVis Medical Solution AG's quality procedures. The Validation Test Plan was designed to evaluate all input functions, output functions, and actions performed by the software in each operational mode. The complete system configuration has been assessed and tested at the manufacturer's facility and has passed all in-house testing criteria including validating design, function, and specifications. Nonclinical and performance testing results are provided in the 510(k) and demonstrate that the predetermined acceptance criteria are met.
Technological Characteristics
Visia™ 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.
The new device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, 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™ 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™, 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/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings forming a protective shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
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
APR 2 3 2012
Ms. Rebecca Berghorn Vice President MeVis Medical Solutions AG Universitaetsallee 29 BREMEN 28359 GERMANY
Re: K120207
Trade/Device Name: VisiaTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 20, 2012 Received: January 24, 2012
Dear Ms. Berghorn:
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 or uny 1 vith 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
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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,
Janine M. Morris
Acting 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/5/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" are the words "MEDICAL SOLUTIONS" in smaller letters. The logo is simple and professional, and it is likely used to represent the company on its website and marketing materials.
Indications for Use Statement
510(k) Number (if known): _
Device Name: Visia™
Indications for Use:
Visia™ is a medical image processing software application intended for the visualization of images from various sources (e.g., Computed Tomography (CT), Magnetic Resonance (MR), etc). The system provides viewing, quantification, manipulation, communication, and printing of medical images. Visia™ is not meant for primary diagnostic interpretation of mammography.
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)
H, Office of In Vitro Diagnostic Devices (OIVD) nce of C
Vanne Sharrard
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)
Visia™ 510(k). Indications for Use Statement – 1/20/2012 Page 1 of 1
§ 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).