(51 days)
No
The description focuses on standard image viewing, manipulation, and analysis tools without mentioning AI or ML algorithms.
No
The device is a software application for viewing and manipulating images from MRI and CT scanners for diagnostic purposes, not for providing therapy.
Yes
The device is described as a "Multi Modality Viewer" that allows the "examination and manipulation of a series of medical images" to "help qualified physicians provide efficient and effective patient care." While it doesn't automatically diagnose, it provides tools for clinicians to review and analyze medical images (MRI and CT scans) that are used for diagnosis. "Examination" of medical images for "patient care" is integral to the diagnostic process by a clinician.
Yes
The device is explicitly described as a "software application" that functions on a cleared platform. The description focuses solely on software features and functionalities for viewing and manipulating medical images. There is no mention of accompanying hardware components or hardware-specific testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for the examination and manipulation of medical images obtained from MRI and CT scanners. This is for diagnostic purposes, but it's based on in vivo imaging data (images of the inside of the body), not in vitro samples (like blood, urine, or tissue).
- Device Description: The description reinforces that it's a software application for viewing and manipulating medical images from MRI and CT.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
The device is clearly intended for the interpretation and analysis of medical images acquired from imaging modalities, which falls under the category of medical image processing and viewing software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Multi Modality Viewer is a software application within Vitrea® that allows the examination and manipulation of a series of medical images obtained from MRI and CT scanners.
The option also enables clinicians to compare multiple series for the same patient, side-by-side, and switch to other integrated applications to further examine the data.
Product codes
LLZ
Device Description
Multi Modality Viewer is a software application which functions on the Vitrea Platform, cleared by K150258. This application allows intuitive navigation, and manipulation of medical images obtained from MRI and CT scanners. This application enables clinicians to compare multiple series of the same patient, side-by-side, and switch to other integrated applications to further examine the data.
lt provides clinical tools to review images to help qualified physicians provide efficient and effective patient care.
Key features:
General Viewing:
- · Linked 2D, MPR and 4D viewers for single and multi-study comparison
- · Creation of retrievable evidence and snapshots
- · User defined flexible display protocols
Access to Advanced Applications and Workflows:
- In application access to MR Stitching application
- · Evidence creation and sharing across workflows
General Image Display, Manipulation, and Analysis Tools:
- · Maximum and Minimum Intensity Projection (MIP/MinIP)
- · Identification and Display of Regions of Interest (ROIs)
- · CINE image display
- · Multi-frame display
- · Color image display
- . Simultaneous multiple studies review
- · Cross-reference lines support
- Display of selected images, series, or entire study .
- · Comparison of multiple series or studies
- · Scroll
- Pan
- Zoom
- · Focus
- · Flip (Vertically, horizontally)
- Invert
- · Rotate (Clockwise, counter-clockwise)
- · Arrow
- · Adjust Registration
- · Auto window level/width setting
- · Text/Arrow annotation (Label)
- · Measurement of distance (Ruler), Angle, Cobb Angle, Ellipse ROI, and Freehand ROI
Specialized Tools:
- · Image subtraction of two series/datasets
- · Access to semi-automated image stitching
- Study and series linking .
- · Register two different series or groups that do not share a frame of reference to link them spatially
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI and CT scanners
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Radiologists, Clinicians or Technologists
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 Multi Modality Viewer software was designed, and tested according to written procedures that included risk management. Software testing was completed to ensure the new features operate according to defined requirements.
The following design control measures were applied to the development of the Multi Modality Viewer software:
- Risk Management
- Requirements Reviews
- Code Designs
- Code Development Testing
- Code Reviews
- Design Reviews
- Verification of the software that included performance and safety testing
- Validation of the software that included simulated usability testing by experienced professionals.
Risk Management: Each risk pertaining to these features have been individually assessed to determine if the benefits outweigh the risk. Every risk has been reduced as low as possible and has been evaluated to have a probability of occurrence of harm of at least "Improbable." All risks for this feature were collectively reviewed to determine if the benefits outweigh the risk. Because of the risk control measures included in this feature, it is believed that the risk for the feature as a whole is extremely low. Taking into account all risks against the benefits of this feature, it has been assessed that the benefits do outweigh the risks for this feature.
During the design review, the following conclusions were reached:
- All Occurrence Factors for Hazards were mitigated as low as possible
- Of the unresolved defects remaining in the released application, each has been carefully . evaluated and it has been determined that the software can be used safely and effectively.
- . The medical benefits of the device outweigh the residual risk for each individual risk and all risks together.
Verification: The software verification team's primary goal was to assure that the software fully satisfies all expected system requirements and features. Test cases were executed against the system features and requirements. As a part of creating the test cases, the verification team reviewed and monitored the Requirements Traceability Matrix ("RTM") to ensure coverage of the items within the RTM.
Validation: The software validation team's primary goal was assuring the software conforms to user needs and intended use. The validation team conducted workflow testing that provided evidence that the system requirements and features were implemented, reviewed and met.
External Validation: During external validation of the Multi Modality Viewer software, experienced medical professionals evaluated the application. All validators confirmed that the Multi Modality Viewer software fulfills its intended use.
Clinical Tests: The subject of this 510(k) notification, Multi Modality Viewer software, did not require clinical studies to support safety and effectiveness of the software.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The graphic is positioned inside a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the border.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 13, 2016
Vital Images, Inc. % Ms. Katie Ryan Regulatory Affairs Specialist 5850 Opus Parkway, Suite 300 MINNETONKA MN 55343-4414
Re: K161419
Trade/Device Name: Multi Modalitv Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 20, 2016 Received: May 23, 2016
Dear Ms. Ryan:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041
1
Page 2-Ms. Katie Ryan
or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D. Hara
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
For
Enclosure
2
Indications for Use
510(k) Number (if known) K161419
Device Name Multi Modality Viewer
Indications for Use (Describe)
Multi Modality Viewer is a software application within Vitrea® that allows the examination and manipulation of a series of medical images obtained from MRI and CT scanners.
The option also enables clinicians to compare multiple series for the same patient, side-by-side, and switch to other integrated applications to further examine the data.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | × |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510K Summary
This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part 807.92(c).
| Basis for the
Submission: | Vital Images, Inc. hereby submits this traditional 510(k) to obtain
510(k) clearance for the Multi Modality Viewer software which is
substantially equivalent to the FDA cleared MR Core Software
(K151115). |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Vital Images, Inc.
5850 Opus Parkway, Suite 300
Minnetonka, MN, 55343-4414 |
| Establishment
Registration: | 2134213 |
| Contact Person: | Katie Ryan, M.S.
Regulatory Affairs Specialist
Phone : 952-487-9793
Fax: 952-487-9510
E-mail: kryan@vitalimages.com |
| 510(k) Type: | Traditional |
| Summary Date: | May 20, 2016 |
| Device Trade Name: | Multi Modality Viewer |
| Device Common
Name/ Regulatory
Description: | Radiological Image Processing Software, Picture Archiving and
Communications System |
| Device Classification
Name: | System, Image Processing, Radiological |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | LLZ |
| Regulatory
Classification: | Class II |
| Device Panel: | Radiology |
Predicate Device(s):
| Predicate Device | Manufacturer | FDA 510(k) Number |
|---|---|---|
| MR Core Software | Vital Images, Inc. | K151115 |
4
Image /page/4/Picture/0 description: The image shows the word "VITAL" in black letters. The "i" in "VITAL" has a red dot above it. The letters are bold and sans-serif. The background is white.
Reference Device(s):
| Reference Device | Manufacturer | FDA 510(k) Number |
|---|---|---|
| Softread Software | ||
| (Vitrea® 2, Version 3.5 | ||
| Medical Image Processing | ||
| Software) | Vital Images, Inc. | K040305 |
Device Description:
Multi Modality Viewer is a software application which functions on the Vitrea Platform, cleared by K150258. This application allows intuitive navigation, and manipulation of medical images obtained from MRI and CT scanners. This application enables clinicians to compare multiple series of the same patient, side-by-side, and switch to other integrated applications to further examine the data.
lt provides clinical tools to review images to help qualified physicians provide efficient and effective patient care.
Key features:
General Viewing:
- · Linked 2D, MPR and 4D viewers for single and multi-study comparison
- · Creation of retrievable evidence and snapshots
- · User defined flexible display protocols
Access to Advanced Applications and Workflows:
- In application access to MR Stitching application
- · Evidence creation and sharing across workflows
General Image Display, Manipulation, and Analysis Tools:
- · Maximum and Minimum Intensity Projection (MIP/MinIP)
- · Identification and Display of Regions of Interest (ROIs)
- · CINE image display
- · Multi-frame display
- · Color image display
- . Simultaneous multiple studies review
- · Cross-reference lines support
- Display of selected images, series, or entire study .
- · Comparison of multiple series or studies
- · Scroll
- Pan
- Zoom
- · Focus
- · Flip (Vertically, horizontally)
- Invert
- · Rotate (Clockwise, counter-clockwise)
- · Arrow
5
- · Adjust Registration
- · Auto window level/width setting
- · Text/Arrow annotation (Label)
- · Measurement of distance (Ruler), Angle, Cobb Angle, Ellipse ROI, and Freehand ROI
Specialized Tools:
- · Image subtraction of two series/datasets
- · Access to semi-automated image stitching
- Study and series linking .
- · Register two different series or groups that do not share a frame of reference to link them spatially
Intended Use / Indications for Use:
Multi Modality Viewer is a software application within Vitrea that allows the examination and manipulation of a series of medical images obtained from MRI and CT scanners.
The option also enables clinicians to compare multiple series for the same patient, side-by-side, and switch to other integrated applications to further examine the data.
Intended for Disease / Condition / Patient Population:
Multi Modality Viewer is medical image viewer software. Therefore, particular information of intended for disease, condition, and patient population is not applicable.
Substantial Equivalence Comparison:
Regulatory Comparison:
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Characteristic | Multi Modality | ||
| Viewer | MR Core | ||
| Software | |||
| (K151115) | Comparison | ||
| Classification Name | System, Image | ||
| Processing, | |||
| Radiological | System, Image | ||
| Processing, | |||
| Radiological | Same | ||
| Regulatory Number | 892.2050 | 892.2050 | Same |
| Product Code | LLZ | LLZ | Same |
| Classification | Class II | Class II | Same |
| Review Panel | Radiology | Radiology | Same |
| Decision Date | Under Review | June 3, 2015 | Predicate device |
| is cleared | |||
| Subject Device | Predicate Device | Comparison | |
| Criteria | Multi Modality Viewer | MR Core Software | |
| (K151115) | Comparison | ||
| Indications for | |||
| Use | Multi Modality Viewer is | ||
| a software application | |||
| within Vitrea® that | |||
| allows the examination | |||
| and manipulation of a | |||
| series of medical | |||
| images obtained from | |||
| MRI and CT scanners. | |||
| The option also | |||
| enables clinicians to | |||
| compare multiple series | |||
| for the same patient, | |||
| side-by-side, and | |||
| switch to other | |||
| integrated applications | |||
| to further examine the | |||
| data. | MR Core is an option | ||
| within Vitrea® that allows | |||
| the examination and | |||
| manipulation of a series | |||
| of medical images | |||
| obtained from MRI | |||
| scanners. | |||
| The option also enables | |||
| clinicians to compare | |||
| multiple series for the | |||
| same patient, side-by- | |||
| side, and switch to other | |||
| integrated applications to | |||
| further exam the data. | Similar | ||
| Added support for the | |||
| ability to examine and | |||
| manipulate medical | |||
| images obtained from | |||
| CT scanners was not | |||
| part of the predicate | |||
| device's indications for | |||
| use. | |||
| Intended Users | Radiologists, Clinicians | ||
| or Technologists | Radiologists, Clinicians or | ||
| Technologists | Same | ||
| Patient | |||
| Population | Multi Modality Viewer is | ||
| medical image viewer | |||
| software. Therefore, | |||
| particular information of | |||
| intended for disease, | |||
| condition, and patient | |||
| population is not | |||
| applicable. | MR Core Software is | ||
| medical image viewer | |||
| software. Therefore, | |||
| particular information of | |||
| intended for disease, | |||
| condition, and patient | |||
| population is not | |||
| applicable. | Same | ||
| Modality | |||
| Support | CT and MRI | MRI | Similar |
| Added support for the | |||
| ability to examine and | |||
| manipulate medical | |||
| images obtained from | |||
| CT scanners was not | |||
| part of the predicate | |||
| device's indications for | |||
| use. | |||
| Subject Device | Predicate Device | ||
| Criteria | Multi Modality Viewer | MR Core Software | |
| (K151115) | Comparison | ||
| Data Loading | |||
| Image | |||
| Communication | |||
| Standard: DICOM | Yes | Yes | Same |
| Data Viewing Support | |||
| 2D Image Review | Yes | Yes | Same |
| 2D Comparative | |||
| Review | Yes | Yes | Same |
| Features and Capabilities | |||
| Multi-Planner | |||
| Reformatting | Yes | Yes | Same |
| Maximum and | |||
| Minimum Intensity | |||
| Projection | |||
| (MIP/MinIP) | Yes | Yes | Same |
| Image Editing, | |||
| Setting, Saving | Yes | Yes | Same |
| Annotation & | |||
| Tagging Tools | |||
| (Label) | Yes | Yes | Same |
| Display Options | |||
| (e.g. thickness) | Yes | Yes | Same |
| Quantitative | |||
| Measurements | Yes | Yes | Same |
| Snapshot | Yes | Yes | Same |
| Cine Image Display | Yes | Yes | Same |
| Multi-frame Display | Yes | Yes | Same |
| Color Image Display | Yes | Yes | Same |
| Criteria | Subject Device | Predicate Device | |
| Multi Modality Viewer | MR Core Software | ||
| (K151115) | Comparison | ||
| Simultaneous | |||
| Multiple Studies | |||
| Review | Yes | Yes | Same |
| Cross-reference | |||
| Lines Support | Yes | Yes | Same |
| Display of Selected | |||
| Images, Series, or | |||
| Entire Study | Yes | Yes | Same |
| Comparison of | |||
| Multiple Series or | |||
| Studies | Yes | Yes | Same |
| Scroll Image | Yes | Yes | Same |
| Zoom Image | Yes | Yes | Same |
| Pan Image | Yes | Yes | Same |
| Focus Image | Yes | Yes | Same |
| Rotate Image | Yes | Yes | Same |
| Flip Image - Vertical | Yes | Yes | Same |
| Flip Image - | |||
| Horizontal | Yes | Yes | Same |
| Rotate Image - | |||
| Clockwise | Yes | Yes | Same |
| Rotate Image - | |||
| Counter-clockwise | Yes | Yes | Same |
| Invert Image | Yes | Yes | Same |
| Arrow | Yes | Yes | Same |
| Auto Window | |||
| Level/Width Setting | Yes | Yes | Same |
| Measurement of | |||
| Distance | Yes | Yes | Same |
| Measurement of | |||
| Angle | Yes | Yes | Same |
| Criteria | Subject Device | ||
| Multi Modality Viewer | Predicate Device | ||
| MR Core Software | |||
| (K151115) | Comparison | ||
| Measurement of | |||
| Cobb Angle | Yes | Yes | Same |
| Identification and | |||
| Display of Ellipse | |||
| Regions of Interest | |||
| (ROIs) | Yes | Yes | Same |
| Identification and | |||
| Display of Freehand | |||
| Regions of Interest | |||
| (ROIs) | Yes | Yes | Same |
| Manual Registration | Yes | Yes | Same |
| Image subtraction of | |||
| two series/datasets | Yes | Yes | Same |
| Study and Series | |||
| Linking | Yes | Yes | Same |
| Semi-automated | |||
| image stitching | Yes | Yes | Same |
| Time Intensity | |||
| Analysis | Yes | Yes | Same |
| Batch Save of | |||
| MPR reformats | Yes | Yes | Same |
6
Image /page/6/Picture/1 description: The image shows the word "VITAL" in black letters. The "i" in "VITAL" has a red dot above it. The letters are bold and sans-serif. The background is white.
Indications for Use Comparison with Predicate Device:
7
Image /page/7/Picture/0 description: The image shows the word "VITAL" in a sans-serif font. The letters are black, except for the dot above the "i", which is red. The letters are evenly spaced and the word is centered.
Similarities in Technology with Predicate Device:
8
Image /page/8/Picture/1 description: The image shows the word "VITAL" in black letters. The "i" in "VITAL" has a red dot above it. The letters are all capitalized and evenly spaced.
Page: 010-6 (of 13)
9
Image /page/9/Picture/1 description: The image shows the word "VITAL" in black font. The "i" in "VITAL" has a red dot above it. The font is sans-serif and the letters are evenly spaced. The background is white.
10
Image /page/10/Picture/1 description: The image shows the word "VITAL" in black font. The "i" in "VITAL" has a red dot above it. The font is sans-serif and the letters are evenly spaced. The image is simple and clean, with a focus on the word itself.
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Criteria | Multi Modality Viewer | MR Core Software | |
| (K151115) | Comparison | ||
| Feature: Support for | |||
| CT Modality Data | Yes | No | Multi Modality Viewer |
| allows the | |||
| examination and | |||
| manipulation of | |||
| medical images | |||
| obtained from CT | |||
| scanners in addition | |||
| to MRI scanners. |
Note: The added CT
Modality feature is
similar to the feature
available on Vital
Image's Softread
software ("Reference
Device"), which was
cleared by the FDA
under K040305
(Vitrea 2, Version 3.5
Medical Image
Processing
Software). Therefore,
this added feature
does not raise
different questions of
safety and
effectiveness. |
Differences in Technology with the Predicate Device:
Similarities in Technology with the Reference Device:
| Criteria | Subject Device | Predicate Device | |
|---|---|---|---|
| Multi Modality Viewer | Softread (K040305) | Comparison | |
| Modality | |||
| Support for CT and | |||
| MRI Modality Data | Yes | Yes | Same |
| Data Loading | |||
| Image | |||
| Communication | |||
| Standard: DICOM | Yes | Yes | Same |
| Data Viewing Support | |||
| Subject Device | Predicate Device | ||
| Criteria | Multi Modality Viewer | Softread (K040305) | Comparison |
| 2D Image Review | Yes | Yes | Same |
| 2D Comparative | |||
| Review | Yes | Yes | Same |
| Features and Capabilities | |||
| Multi-Planner | |||
| Reformatting | Yes | Yes | Same |
| Maximum and | |||
| Minimum Intensity | |||
| Projection | Yes | Yes | Same |
| Image Editing, | |||
| Setting, Saving | Yes | Yes | Same |
| Annotation & Tagging | |||
| Tools (Label) | Yes | Yes | Same |
| Display Options (e.g. | |||
| thickness) | Yes | Yes | Same |
| Quantitative | |||
| Measurements | Yes | Yes | Same |
| Snapshot | Yes | Yes | Same |
| Cine Image Display | Yes | Yes | Same |
| Multi-frame Display | Yes | Yes | Same |
| Color Image Display | Yes | Yes | Same |
| Simultaneous | |||
| Multiple Studies | |||
| Review | Yes | Yes | Same |
| Cross-reference | |||
| Lines Support | Yes | Yes | Same |
| Display of Selected | |||
| Images, Series, or | |||
| Entire Study | Yes | Yes | Same |
| Comparison of | |||
| Multiple Series or | |||
| Studies | Yes | Yes | Same |
| Scroll Image | Yes | Yes | Same |
| Zoom Image | Yes | Yes | Same |
11
Image /page/11/Picture/0 description: This image contains text related to medical device regulatory processes. The text "Multi Modality Viewer" appears at the top, followed by "Traditional 510(k) Pre-market Notification" on the next line. This suggests the image is related to the FDA's 510(k) pre-market notification process for medical devices, specifically in the context of multi-modality viewers.
Image /page/11/Picture/5 description: The image shows the word "VITAL" in a bold, sans-serif font. The letters are black, except for the dot above the "i", which is red. The letters are evenly spaced and the word is centered.
12
Image /page/12/Picture/0 description: The image contains text that appears to be part of a document or presentation. The text includes "Multi Modality Viewer" on the first line, followed by "Traditional 510(k) Pre-market Notification" on the second line. The text is left-aligned and appears to be a title or heading for the document.
| Criteria | Subject Device | Predicate Device | |
|---|---|---|---|
| Multi Modality Viewer | Softread (K040305) | Comparison | |
| Pan Image | Yes | Yes | Same |
| Focus Image | Yes | Yes | Same |
| Rotate Image | Yes | Yes | Same |
| Flip Image - Vertical | Yes | Yes | Same |
| Flip Image - | |||
| Horizontal | Yes | Yes | Same |
| Rotate Image - | |||
| Clockwise | Yes | Yes | Same |
| Rotate Image - | |||
| Counter-clockwise | Yes | Yes | Same |
| Invert Image | Yes | Yes | Same |
| Arrow | Yes | Yes | Same |
| Auto Window | |||
| Level/Width Setting | Yes | Yes | Same |
| Measurement of | |||
| Distance | Yes | Yes | Same |
| Measurement of | |||
| Angle | Yes | Yes | Same |
| Measurement of | |||
| Cobb Angle | Yes | Yes | Same |
| Identification and | |||
| Display of Ellipse | |||
| Regions of Interest | |||
| (ROIs) | Yes | Yes | Same |
| Identification and | |||
| Display of Freehand | |||
| Regions of Interest | |||
| (ROIs) | Yes | Yes | Same |
| Manual Registration | Yes | Yes | Same |
| Image subtraction of | |||
| two series/datasets | Yes | Yes | Same |
| Study and Series | |||
| Linking | Yes | Yes | Same |
Page: 010-10 (of 13)
13
Image /page/13/Picture/0 description: The image shows the word "VITAL" in black letters. The "i" in "VITAL" has a red dot above it. The font is sans-serif and the letters are evenly spaced.
Summary of Non-Clinical Tests:
The Multi Modality Viewer software was designed, and tested according to written procedures that included risk management. Software testing was completed to ensure the new features operate according to defined requirements.
The following design control measures were applied to the development of the Multi Modality Viewer software:
- Risk Management ●
- Requirements Reviews ●
- Code Designs ●
- Code Development Testing
- Code Reviews ●
- Design Reviews ●
- Verification of the software that included performance and safety testing ●
- Validation of the software that included simulated usability testing by experienced ● professionals.
Risk Management:
Each risk pertaining to these features have been individually assessed to determine if the benefits outweigh the risk. Every risk has been reduced as low as possible and has been evaluated to have a probability of occurrence of harm of at least "Improbable." All risks for this feature were collectively reviewed to determine if the benefits outweigh the risk. Because of the risk control measures included in this feature, it is believed that the risk for the feature as a whole is extremely low. Taking into account all risks against the benefits of this feature, it has been assessed that the benefits do outweigh the risks for this feature.
During the design review, the following conclusions were reached:
- All Occurrence Factors for Hazards were mitigated as low as possible ●
- Of the unresolved defects remaining in the released application, each has been carefully . evaluated and it has been determined that the software can be used safely and effectively.
- . The medical benefits of the device outweigh the residual risk for each individual risk and all risks together.
Verification:
The software verification team's primary goal was to assure that the software fully satisfies all expected system requirements and features. Test cases were executed against the system features and requirements. As a part of creating the test cases, the verification team reviewed and monitored the Requirements Traceability Matrix ("RTM") to ensure coverage of the items within the RTM.
Validation:
The software validation team's primary goal was assuring the software conforms to user needs and intended use. The validation team conducted workflow testing that provided evidence that the system requirements and features were implemented, reviewed and met.
External Validation:
During external validation of the Multi Modality Viewer software, experienced medical professionals evaluated the application. All validators confirmed that the Multi Modality Viewer software fulfills its intended use.
010 510(k) Summary
14
Image /page/14/Picture/0 description: The image shows the word "VITAL" in black letters. The "i" in "VITAL" has a red dot above it. The letters are bold and sans-serif. The background is white.
Summary of Clinical Tests:
The subject of this 510(k) notification, Multi Modality Viewer software, did not require clinical studies to support safety and effectiveness of the software.
Cyber and Information Security:
Confidentiality
The Vitrea platform (K150258) relies on built in Windows Login security to limit access to the system. The Vitrea platform can only be installed and configured by an administrator of the Windows machine.
Integrity
The Vitrea platform complies with the DICOM standard for transfer and storage of this data and does not modify the contents of DICOM instances. New DICOM produced by Vitrea is identified as such with the appropriate manufacturer tags per the DICOM standard.
Availability
The Vitrea platform is always available to the logged on user as long as the Windows machine itself is properly maintained.
Accountability
The Vitrea platform includes an audit capability that enables accountability by tracking authenticated and authorized user operations along with information accessed. Vitrea audit logs are time stamped, enabling correlation with Windows system logging to track information accessed by a user.
Performance Standards:
The FDA has not established mandatory performance standards and no special controls exist for this device. General software verification and validation tests were conducted to confirm proper function of the device's features.
| Standard No. | Standards Organization | Standard Title | Version | Date |
|---|---|---|---|---|
| PS 3.1- 3.20 (2011) (Recognition Number 12-238) | NEMA | Digital Imaging and Communications in Medicine (DICOM) Set (Radiology) | 3 | 03/16/2012 |
| ISO 14971:2007 (Recognition Number 5-70) | AAMI / ANSI / ISO | Medical Devices - Applications of Risk Management to Medical Devices | 2007 | 03/16/2012 |
| IEC 62304:2006 (Recognition Number 13-32) | AAMI / ANSI / IEC | Medical Device Software - Software Life Cycle Processes (Software / Informatics) | 2006 | 08/20/2012 |
The Vitrea software complies with the following voluntary recognized consensus standards:
Page: 010-12 (of 13)
15
Image /page/15/Picture/0 description: The image shows the word "VITAL" in a sans-serif font. The letters are black, except for the dot on the "i", which is red. The word is horizontally oriented and centered.
Substantial Equivalence Analysis Conclusion:
Multi Modality Viewer is a software application within Vitrea that allows for the examination and manipulation of a series of medical images obtained from MRI and CT scanners. Vital Images believes the Multi Modality Viewer software application has a similar intended use, indications for use, principle of operation, and technological characteristics as the legally marketed, predicate device MR Core Software (K151115). In addition, the CT Modality feature is similar to the feature in the reference device, Softread, which was cleared by the FDA under K040305 (Vitrea 2, Version 3.5 Medical Image Processing Software).
Furthermore, the verification and validation testing performed demonstrate the subject device is as safe and effective as the predicate and reference devices and does not raise any different questions of safety and effectiveness. Therefore, Vital believes the addition of the CT Modality feature in the Multi Modality Viewer software does not alter the fundamental scientific technology, safety or intended use of the device.
Any noted minor differences have been explained and do not raise any different questions of safety or effectiveness when used as labeled. The implemented design controls, risk management activities, labeling, and performed verification tests demonstrate the safety and efficacy of the subject device. Based on the comparison information provided above, Vital Images believes the subject device should be found substantially equivalent to the predicate device.