(30 days)
Vitrea is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea is not meant for primary image Interpretation in mammography.
Vitrea is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices.
The Vitrea system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including:
- Retrieve image data over the network via DICOM
- Display images that are automatically adapted to exam type via dedicated protocols
- Select images for closer examination from a gallery of up to six 2D or 3D views
- Interactively manipulate an image in real-time to visualize anatomy and pathology
- Annotate, tag, measure, and record selected views
- Output selected views to standard film or paper printers, or post a report to an intranet web server or export views to another DICOM device
- Retrieve reports that are archived on a Web server
The provided text states that Vitrea, Version 7.0 Medical Image Processing Software, underwent a special 510(k) submission for proposed software changes. The information focuses on demonstrating substantial equivalence to its predicate device (Vitrea, Medical Image Processing Software, Version 4.0, K071331) rather than presenting a performance study with specific acceptance criteria and detailed results for a new medical claim.
Therefore, the document does not contain details about acceptance criteria, a specific study proving the device meets these criteria, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC comparative effectiveness studies, standalone performance studies, or ground truth types and training set information.
Instead, the document details:
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Scope of Changes: The document primarily describes changes in the software's components and deployment, such as:
- Replacing/updating product infrastructure components (e.g., "Study Directory" replaced by "Vitrea Client" and "Study List") for better user experience and web-based application support.
- Redesigning the Vitrea Services Platform (VSP) for improved manageability and application integration, with enhanced features like Application Management, User Management, Data Access, System Management, and Workflow.
- Adding a new CPU-based rendering engine to support deployments without GPU hardware, particularly for virtual deployments. The rationale is that this new engine was designed to mirror the behavior of the GPU rendering in both image quality and performance.
- Replacing the DICOM Cache component ("External Communications Framework (ECF)") with "Vitrea Information Management System (VIMS)" and "MINT" for better user experience and improved functionality.
- Adding a new "Multiple User Workstation Deployment" to allow multiple concurrent users access to the workstation without degrading performance.
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Rationale for Changes: Each change is accompanied by a brief rationale, generally related to improving user experience, functionality, manageability, platform support, or deployment capabilities.
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Comparison to Predicate Device: The document extensively compares the modified subject device (Vitrea, Version 7.0) to its predicate device (Vitrea, Version 4.0) across various criteria including device type, common name, regulation, product code, classification, review panel, indications for use, general description, key features, and software functionality. For all these aspects, the comparison column consistently states "Same."
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Absence of Clinical Studies: The "Summary of Clinical Tests" section explicitly states: "The subject of special 510(k) notification, Vitrea software, did not require clinical studies to support safety and effectiveness of the software."
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Non-Clinical Tests: The "Summary of Non-Clinical Tests" mentions that changes were designed and tested according to written procedures including risk management, requirements reviews, code designs, code development testing, code reviews, design reviews, and verification of the software. It states that "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." However, specific quantitative acceptance criteria and the performance metrics against those criteria are not provided.
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Cyber and Information Security: Details on confidentiality, integrity, availability, and accountability are provided, indicating compliance with internal security measures and DICOM standards.
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Performance Standards: The device complies with voluntary recognized consensus standards such as NEMA PS 3.1-3.20 (DICOM), ISO 14971:2007 (Risk Management), and IEC 62304:2006 (Medical Device Software - Software Life Cycle Processes).
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Substantial Equivalence Conclusion: The conclusion is that the minor software enhancements do not affect the intended use or alter the fundamental scientific technology, and the modified software has the same indications for use, principle of operation, and performs the same technological functions as the predicate device. The differences are considered "not consequential from the standpoint of device operation, safety, effectiveness or intended use."
In summary, this document is a 510(k) Special submission for software changes, focusing on demonstrating that the modifications do not introduce new questions of safety or effectiveness, and therefore, does not present a performance study with specific acceptance criteria as it would for a novel device or a device with new clinical claims.
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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 encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 5, 2015
Vital Images, Inc. % Parthiv Shah Sr. Regulatory Affairs Specialist 5850 Opus Parkway, Suite 300 MINNETONKA MN 55343
Re: K150258
Trade/Device Name: Vitrea®, Version 7.0 Medical Image Processing Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 4, 2015 Received: February 5, 2015
Dear Parthiv Shah:
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.
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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 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,
Robert A Ochs
Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Vitrea®, Version 7.0 Medical Image Processing Software
Indications for Use (Describe)
Vitrea is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea is not meant for primary image Interpretation in mammography.
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) |
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Image /page/3/Picture/0 description: The image shows the word "VITAL" in large, bold, black letters. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. The text is centered below the word "VITAL".
510(k) Summary
This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part 807.92(c)
| Purpose ofSubmission: | Vital Images, Inc. hereby submits this special 510(k) to provide anotification submission for proposed software changes in the already510(k) cleared Vitrea software (K071331). |
|---|---|
| Submitter: | Vital Images, Inc.5850 Opus ParkwaySuite 300Minnetonka, MN, 55343-4414 |
| EstablishmentRegistration: | 2134213 |
| Contact Person: | Parthiv ShahSr. Regulatory Affairs SpecialistPhone : 952-487-9574Fax: 952-487-9510E-mail: pshah@vitalimages.com |
| 510(k) Type: | Special |
| Summary Date: | February 3, 2015 |
| Device Trade Name: | Vitrea, Medical Image Processing Software |
| Other Device TradeNames: | Vitrea Enterprise Suite, VitreaCore, VitreaAdvanced, VitreaAdvanced fX,VitreaWorkstation, VitreaWorkstation fX, VitreaExtend |
| Device CommonName: | Radiological Image Processing Software |
| DeviceClassificationName: | System, Image Processing, Radiological |
| RegulatoryDescription: | Picture Archiving and Communications System |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | LLZ |
| RegulatoryClassification: | Class II |
| Device Panel: | Radiology |
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Image /page/4/Picture/0 description: The image shows the word "VITAL" in large, bold, black letters. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The word "VITAL" is the main focus of the image, with the company affiliation provided as additional context.
Predicate Device:
| Predicate Device | Manufacturer | FDA 510(k) number |
|---|---|---|
| Vitrea, Medical ImageProcessing Software,Version 4.0(Legally Marketed Device) | Vital Images, Inc. | K071331 |
Device Description:
Vitrea is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices.
The Vitrea system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including:
- Retrieve image data over the network via DICOM ●
- Display images that are automatically adapted to exam type via dedicated protocols ●
- Select images for closer examination from a gallery of up to six 2D or 3D views
- Interactively manipulate an image in real-time to visualize anatomy and pathology ●
- Annotate, tag, measure, and record selected views
- Output selected views to standard film or paper printers, or post a report to an intranet web server or export views to another DICOM device
- . Retrieve reports that are archived on a Web server
Intended Use / Indications for Use:
Vitrea is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea is not meant for primary image interpretation in mammography.
Scope of Changes:
Vital Images is replacing / updating some components of Vitrea platform to utilize enhancements in software technology for better performance of the Vitrea software.
| # | Replaced Software Component(Version 7.0) | Rationale forChanges |
|---|---|---|
| 1 | Product InfrastructureIt is a collection of non-clinical applications that work on top ofthe platform to provide common functions and assist withoverall workflow. | Redesigned for betteruser experience andsupport for web-basedapplications. |
| # | Replaced Software Component(Version 7.0) | Rationale forChanges |
| New Components: | ||
| Vitrea Client (AppShell):Launches other applications and embeds the applicationswithin a common window. | ||
| Hosts product applications that allow the users to view theStudy List and launch various applications with DICOM data. | ||
| Study List:Displays the list of patient data received from DICOMmodalities, associated evidence for patient studies, andavailable applications to load data into. | ||
| 2 | ||
| Enhanced features: | application integration. | |
| Application Management:Application Management is a key feature of the platform,which is designed to let applications be installed, registered,and licensed independently of the platform. | ||
| The AppManager component is also responsible for lifecyclemanagement (startup and shutting down idle/abandonedsessions) for launched applications. | ||
| User Management:User Management provides authentication and authorization,auditing, user preferences, roles & groupmanagement. These can be configured directly within theplatform, or integrated to external user management systemssuch as Active Directory. | ||
| Data Access:Data Access features include DICOM search, evidencemanagement, temporary data management, UID generation,and session save/restore. | ||
| Systems Management: Systems Management consists ofsystem settings, configuring DICOM endpoints, installinglicenses, and configuring network security settings. | ||
| # | Replaced Software Component(Version 7.0) | Rationale forChanges |
| Workflow:Workflow is an anticipatory processing feature which allowsapplications to register for and perform batch processing whennew data arrives; for example extracting data from structurereports, generating alternate representations (e.g. MPRprojections, bone removal), image analysis. | ||
| 3 | CPU-Based Rendering EngineA CPU-based rendering engine performs rendering using CPUonly. It does not require a GPU card to be present on thesystem. In order to support deployments those do not haveGPU hardware or do not have access to GPU hardware, suchas virtual deployments, it is important to have a CPU-basedrendering engine.New Component:We have introduced an additional CPU-based renderingengine. It is a software-based rendering engine used forrendering patient data in clinical applications. | Newly addedrendering engine forCPU renderingsupport use for virtualdeployments. |
| 4 | DICOM CacheThis component keeps a local copy of DICOM imagesreceived from PACS and/or modalities in order to provide fastaccess for user applications to enable a good userexperience.New Components:Vitrea Information Management System (VIMS):The VIMS is the communicator to the world outside the Vitreastation. It connects to other systems via the DICOM standard.VIMS is a separate process running on the Vitrea station thatis independent of the Vitrea application.Communication to and from VIMS is done via Web Services.The key features are DICOM receive (multi-byte data setsupport), DICOM Export, Volume building, and DICOM print.MINT:The Medical Imaging Network Transport (MINT) protocol is aserver component for accessing DICOM data through webservices. | Replaced the old ECFcomponent for betteruser experience andimproved functionality. |
Software Platform Components:
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Image /page/5/Picture/0 description: The image shows the word "VITAL" in bold, black letters. Below the word is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The logo is simple and clean, with a focus on the company name and affiliation.
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Image /page/6/Picture/0 description: The image shows the word "VITAL" in large, bold, black letters. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. The text is centered below the word "VITAL".
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Image /page/7/Picture/0 description: The image shows the word "VITAL" in large, bold, black letters. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. The logo appears to be a company logo.
Software Deployment:
| # | New Deployment(version 7.0) | Reason for Changes |
|---|---|---|
| 5 | Multiple User Workstation DeploymentNew Deployment:Multi-user multi-modality departmental deployment of theworkstation, which allows multiple concurrent user access tothe workstation at the same time without degrading theperformance. | To extend thecapabilities of theworkstation to multiple(currently up to 3)concurrent users. |
Intended for Disease / Condition / Patient Population:
Vitrea system is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Therefore intended disease, conditions, or patient population information is not applicable.
Substantial Equivalence Comparison:
| Criteria | Legally Marketed DeviceVitrea, Medical ImageProcessing Software,version 4.0(K071331)(Predicate Device) | Modified Subject DeviceVitrea, Medical ImageProcessing Software,version 7.0 | Comparison |
|---|---|---|---|
| Device Type /ClassificationName | System, Image Processing,Radiological | System, Image Processing,Radiological | Same |
| CommonName | Radiological ImageProcessing Software | Radiological ImageProcessing Software | Same |
| Regulation /ClassificationNumber | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
| Product Code | LLZ | LLZ | Same |
| Classification | Class II | Class II | Same |
| Review Panel | Radiology | Radiology | Same |
● Regulatory Comparison
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Image /page/8/Picture/0 description: The image shows the word "VITAL" in large, bold, black letters. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. The word "VITAL" is the main focus of the image, with the company affiliation provided as additional context.
| Criteria | Legally Marketed DeviceVitrea, Medical ImageProcessing Software,version 4.0(K071331)(Predicate Device) | Modified Subject DeviceVitrea, Medical ImageProcessing Software,version 7.0 | Comparison |
|---|---|---|---|
| Indications forUse | Vitrea is a medical diagnosticsystem that allows theprocessing, review, analysis,communication and mediainterchange of multi-dimensional digital imagesacquired from a variety ofimaging devices. Vitrea is notmeant for primary imageinterpretation inmammography. | Vitrea is a medical diagnosticsystem that allows theprocessing, review, analysis,communication and mediainterchange of multi-dimensional digital imagesacquired from a variety ofimaging devices. Vitrea is notmeant for primary imageinterpretation inmammography. | Same |
Intended Use Comparison ●
Device Description Comparison ●
| Device Description | Legally MarketedDeviceVitrea, MedicalImageProcessingSoftware,version 4.0(K071331)(Predicate Device) | ModifiedSubject DeviceVitrea, MedicalImageProcessingSoftware,version 7.0 | Comparison |
|---|---|---|---|
| General Description: | |||
| The Vitrea system is a medicaldiagnostic device that allows theprocessing, review, analysis,communication, and media interchangeof multi-dimensional digital imagesacquired from a variety of imagingdevices. | Same | Same | Same |
| Device Description | Legally MarketedDeviceVitrea, MedicalImageProcessingSoftware,version 4.0(K071331)(Predicate Device) | ModifiedSubject DeviceVitrea, MedicalImageProcessingSoftware,version 7.0 | Comparison |
| The Vitrea system provides multi-dimensional visualization of digitalimages to aid clinicians in their analysisof anatomy and pathology. | Same | Same | Same |
| The Vitrea system user interface followstypical clinical workflow patterns toprocess, review, and analyze digitalimages. | Same | Same | Same |
| Key Features: | |||
| Retrieve image data over the networkvia DICOM. | Same | Same | Same |
| Display images that are automaticallyadapted to exam type via dedicatedprotocols. | Same | Same | Same |
| Select images for closer examinationfrom a gallery of up to six 2D or 3Dviews. | Same | Same | Same |
| Interactively manipulate an image inreal-time to visualize anatomy andpathology. | Same | Same | Same |
| Annotate, tag, measure, and recordselected views. | Same | Same | Same |
| Output selected views to standard filmor paper printers, or post a report to anintranet Web server or export views toanother DICOM device | Same | Same | Same |
| Retrieve reports that are archived on aWeb server. | Same | Same | Same |
| Software Functionality | Legally MarketedDeviceVitrea, MedicalImageProcessingSoftware,version 4.0(K071331)(Predicate Device) | ModifiedSubject DeviceVitrea, MedicalImageProcessingSoftware,version 7.0 | Comparison |
| General Features: | |||
| Selection and loading a patient studyComponent: "Study Directory" (oldname) / "AppShell / Vitrea Client andStudy List" (new name) | Same | Same | Same |
| Selection of protocol and preset forpatient studyComponent: Gallery Window | Same | Same | Same |
| Visualization and analysis of patientstudyComponent: Viewer Window | Same | Same | Same |
| Allows access to the visual, analysis,and batch pagesComponent: Viewer Window | Same | Same | Same |
| Segment, trim, sculpt, performmeasurements, and change displaysettingsComponent: Viewer Window | Same | Same | Same |
| Record images, batches of images, andmovies for physician reportingComponent: Viewer Window | Same | Same | Same |
| Creation of a report for the patientstudy) data publishing and archivingComponent: Report Window | Same | Same | Same |
| Software Functionality | Legally MarketedDeviceVitrea, MedicalImageProcessingSoftware,version 4.0(K071331)(Predicate Device) | ModifiedSubject DeviceVitrea, MedicalImageProcessingSoftware,version 7.0 | Comparison |
| Review of report for any patient studyComponent: Report Window | Same | Same | Same |
| Help on Vitrea softwareComponent: Help Window | Same | Same | Same |
| DICOM Compliance and DataManagement | Same | Same | Same |
| Data Security and HIPAA Compliance | Same | Same | Same |
| Picture Achieving and CommunicationSystem (PACS) Information Sharing | Same | Same | Same |
| Multi-vendor scanner compatibility | Same | Same | Same |
| Integrated 2D and 3D visualizationmeasurements | Same | Same | Same |
| Interactive navigation in 3D | Same | Same | Same |
| Large data set capability, including theability to render multi-detectorcomputed tomography (MDCT) data | Same | Same | Same |
| Multi-modality Support | Same | Same | Same |
| Vitrea Basic Clinical Toolset: | |||
| Retrieve image data over the network | Same | Same | Same |
| Display images that are automaticallyadapted to exam type via dedicatedprotocols | Same | Same | Same |
| Software Functionality | Legally MarketedDeviceVitrea, MedicalImageProcessingSoftware,version 4.0(K071331)(Predicate Device) | ModifiedSubject DeviceVitrea, MedicalImageProcessingSoftware,version 7.0 | Comparison |
| Select images for closer examinationfrom a gallery of up to six 2D or 3Dviews | Same | Same | Same |
| Interactively manipulate an image inreal-time to visualize anatomy andpathology | Same | Same | Same |
| Annotate, tag, measure, and recordselected views | Same | Same | Same |
| Output selected views to standard filmor paper printers, or post a report to anIntranet | Same | Same | Same |
| Study List (old name- Study Directory Window): | |||
| Automatic reading and display ofdemographic and scanner informationincluding Patient, ID, Date, Time,Series, Modality, Exam Type,Thickness/Spacing, and the number ofimages in the series | Same | Same | Same |
| Each patient entry can include multipleseries of image data | Same | Same | Same |
| Fully sortable listing of all studiespresent on the system to optimize datasearching and selection for users, alongwith user-specific filters | Same | Same | Same |
| Preview of an image of the selectedseries to ensure its applicability | Same | Same | Same |
| Customization of the layout of study listto each user's personal preference | Same | Same | Same |
| Software Functionality | Legally MarketedDeviceVitrea, MedicalImageProcessingSoftware,version 4.0(K071331)(Predicate Device) | ModifiedSubject DeviceVitrea, MedicalImageProcessingSoftware,version 7.0 | Comparison |
| Series thumbnail display indicatingavailable series | Same | Same | Same |
| Display of selected images, series, orentire study and loading of multipleseries or studies for simultaneousanalysis and review | Same | Same | Same |
| Direct launch into 2D or 3D workflow fora study or series | Same | Same | Same |
| Display image findings and reports inthe Evidence Manager | Same | Same | Same |
| Retrieve reports that are archived on aWeb server | Same | Same | Same |
| Gallery Window: | |||
| Unique clinical protocols based onanatomy, workflow, and image type | Same | Same | Same |
| Automatic pre-selection of clinicalprotocol of images to exam type, asindicated in the DICOM header fields | Same | Same | Same |
| Easy selection of up to six independent2D and 3D views of selected imagedata for review, optimized and renderedbased on the clinical protocol | Same | Same | Same |
| Ability to return to the Gallery window atany time to select other views, or toselect alternative protocols | Same | Same | Same |
| Software Functionality | Legally Marketed DeviceVitrea, Medical Image Processing Software, version 4.0(K071331)(Predicate Device) | Modified Subject DeviceVitrea, Medical Image Processing Software, version 7.0 | Comparison |
| Customized presets that can be created in the Viewer window for display and selection in the Gallery window (one custom preset for each view available for any of the protocols) | Same | Same | Same |
| Viewer Window: | |||
| A choice of four 2D review and four 3D display formats, as well as a 2D "All Exams" comparative viewer that allows the user to display up to nine series on the screen at once | Same | Same | Same |
| Pick tabs in both 2D comparative and 2D montage formats, allowing the user to change the orientation of the image views and the order of the series displayed in comparative viewing | Same | Same | Same |
| Simultaneous view of 3D volume-rendered projections and correlated multi-planar reformatted projections (MPRs) | Same | Same | Same |
| Orthogonal, Oblique, Double Oblique, and Curved MPRs | Same | Same | Same |
| Cross-reference lines (Crosshairs) to identify and correlate point of interest in all 2D and 3D views | Same | Same | Same |
| Ability to navigate, scroll, pan, cine, zoom, rotate, flip, invert interactively that lets the user select, edit, measure, annotate, and record the optimum 2D and 3D views for diagnosis and reporting | Same | Same | Same |
| Software Functionality | Legally MarketedDeviceVitrea, MedicalImageProcessingSoftware,version 4.0(K071331)(Predicate Device) | ModifiedSubject DeviceVitrea, MedicalImageProcessingSoftware,version 7.0 | Comparison |
| Navigation through or around the 3Dview selected (Fly-around, Fly-through,Point-of-interest) | Same | Same | Same |
| Adjustment of window/level on screeninteractively | Same | Same | Same |
| Adjustment of a broad range of imagingcontrols and displays such as rendering(Normal, Min/Max Intensity Projections),brightness, contrast, shading,transparency, and color | Same | Same | Same |
| Image segmentation using any ofseveral segmentation methods(trimming, freehand/box sculpting, semi-automated vessel inclusion/boneremoval based on threshold andconnectivity) | Same | Same | Same |
| Variable size slab reformat andrendering | Same | Same | Same |
| Annotation of the images withembedded 3D arrows and text | Same | Same | Same |
| Distance measurements using ruler andarea and volume measurements usingellipse or freehand ROI | Same | Same | Same |
| Keyboard shortcuts for many functions | Same | Same | Same |
| Creation of custom visualization presetsto appear in the Gallery Tab | Same | Same | Same |
| Software Functionality | Legally MarketedDeviceVitrea, MedicalImageProcessingSoftware,version 4.0(K071331)(Predicate Device) | ModifiedSubject DeviceVitrea, MedicalImageProcessingSoftware,version 7.0 | Comparison |
| Recording of selected views(snapshots) for report generation and toallow return to the same view at a latertime to continue the work donepreviously; ability to record a multi-volume snapshot for cases whenmultiple series or volumes have beenloaded simultaneously | Same | Same | Same |
| Batch creation functionality that allows2D, 3D, or 3D fly through batchedimages or movies to print or be sent tothe report page | Same | Same | Same |
| Report Application: | |||
| Report configuration in 1-on-1,4-on-1,9-on-1, 12-on-1, 16-on-1, 20-on-1 and24-on-1 image formats | Same | Same | Same |
| Report header that includes userconfigurable information such asInstitution Name, Patient ID, PatientName, Referring Physician, ReadingPhysician, Exam Type, Modality, ScanDate, and Scan Time | Same | Same | Same |
| Inclusion or deletion of patient andhospital information for filming purposes | Same | Same | Same |
| Slide Tray containing snapshots,batches, and movies saved in theViewer window | Same | Same | Same |
| Snapshot restoration | Same | Same | Same |
| Movie preview | Same | Same | Same |
| Software Functionality | Legally MarketedDeviceVitrea, MedicalImageProcessingSoftware,version 4.0(K071331)(Predicate Device) | ModifiedSubject DeviceVitrea, MedicalImageProcessingSoftware,version 7.0 | Comparison |
| Electronic posting of reports to a Webserver | Same | Same | Same |
| Printing of the report on DICOM orPostscript® format printers, exporting toa DICOM image archive, posting onVitrea software's web server, recordingon a CD or a DVD, or exporting to a MSWord document with a defined template | Same | Same | Same |
| Evidence Manager (old name- Review Window): | |||
| Allows the user to view published Image/ batch finding reports and related digitalmovies | Same | Same | Same |
| Help Window: | |||
| Provides on-line help manual, quickreference and index in HTML format oras PDF documents | Same | Same | Same |
| DICOM Data Management: | |||
| DICOM conformance | Same | Same | Same |
| DICOM Storage as SCU & SCP(receive and push) | Same | Same | Same |
| DICOM query/retrieve SCU (pullingimages from other DICOM devices) | Same | Same | Same |
| DICOM query/retrieve SCP (can serveimages to other vendor workstations) | Same | Same | Same |
| DICOM Connection Management | Same | Same | Same |
| Software Functionality | Legally MarketedDeviceVitrea, MedicalImageProcessingSoftware,version 4.0(K071331)(Predicate Device) | ModifiedSubject DeviceVitrea, MedicalImageProcessingSoftware,version 7.0 | Comparison |
| Save & Send images in DICOM | Same | Same | Same |
| PACS Interface: | |||
| Provides an API targeting PACSvendors for usage, and a new level ofintegration in which Vitrea data can beautomatically (or more easily) storedback to the PACS station | Same | Same | Same |
| Data Security and HIPAA Compliance: | |||
| Software can de-identify patient data,removing patient name and informationfrom the image | Same | Same | Same |
| Software controls workstation accessand reporting security | Same | Same | Same |
| Authentication and access controlsrequire users to enter a confidentialpassword to view both patient studiesand reports | Same | Same | Same |
| An audit log automatically records useraccess, privilege, and operations | Same | Same | Same |
| Secured access (NT or domain -Login) | Same | Same | Same |
| User group preference and accesscontrol | Same | Same | Same |
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● Similarities in Technology
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Differences ●
| Difference | Legally MarketedDeviceVitrea, MedicalImageProcessingSoftware,version 4.0(K071331)(Predicate Device) | Modified SubjectDeviceVitrea, MedicalImageProcessing Software,version 7.0 | Rationale forChanges | Comparison |
|---|---|---|---|---|
| ------------ | ------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------- | -------------------------- | ------------ |
Product Infrastructure
It is a collection of non-clinical applications that work on top of the platform to provide common functions and assist with overall workflow.
Functionality: Retrieve and load image data over the network or from datasets previously uploaded to the workstation.
| Difference:Replacement ofsoftwarecomponent.Note: Onlycomponent isreplaced, nochange in basicfunctionality. | Study Directory:The Study Directorywindow lets the userretrieve and loadimage data over thenetwork or fromdatasets previouslyuploaded to theworkstation. | Vitrea Client:It launches otherapplications andembeds theapplications within acommon window.It hosts application forthe product that allowsthe user to view theStudy List and launchvarious applicationswith DICOM data.Study List:It displays the list ofpatient data receivedfrom DICOMmodalities, associatedevidence for patientstudies, and availableapplications to loaddata into. | Replaced theold "StudyDirectory"component forbetter userexperience andsupport forweb-basedapplications. | Thereplacementdoes notaffect theintended useorfundamentalscientifictechnology ofalreadyclearedVitreasoftware(K071331). |
|---|---|---|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| Difference | Legally MarketedDeviceVitrea, MedicalImageProcessingSoftware,version 4.0(K071331)(Predicate Device) | Modified SubjectDeviceVitrea, MedicalImageProcessing Software,version 7.0 | Rationale forChanges | Comparison |
|---|---|---|---|---|
| Vitrea Services Platform (VSP)It is a basic service platform for managing patient data, applications, licensing, and configuration.Functionality: Managing patient data, applications, licensing, and configuration. | ||||
| Difference:Redesign ofsoftwarecomponent.Note: Nochange in basicfunctionality. | Vitrea ServicesPlatform:It is a basic serviceplatform formanaging patientdata, applications,licensing, andconfiguration. | Modified VitreaServices Platform:It is a basic serviceplatform for managingpatient data,applications, licensing,and configuration.Enhanced features:• ApplicationManagement• User Management• Data Access• SystemManagement• Workflow | Redesigned toimprovemanageabilityand simplifyapplicationintegration. | Thereplacementdoes notaffect theintended useorfundamentalscientifictechnology ofalreadyclearedVitreasoftware(K071331). |
| CPU-Based Rendering EngineFunctionality: A CPU-based rendering engine performs rendering using CPU only. It does not | ||||
| require a GPU card to be present on the system. In order to support deployments that do not haveGPU hardware or do not have access to GPU hardware, such as virtual deployments, it isimportant to have a CPU-based rendering engine. | ||||
| Difference:Addition of newCPU-basedrenderingengine. | No CPU renderingsupport.Note: Vitrea 4.0 hadonly GPU renderingsupport. | New Component:We have introducedan additional CPU-based renderingengine. It is asoftware-basedrendering engine usedfor rendering patientdata in clinicalapplications. | Newly addedrenderingengine for CPUrenderingsupport use forvirtualdeployments. | The CPUrenderingengine wasdesigned tomirror thebehavior ofthe GPUrendering inboth imagequality andperformance. |
| Difference | Legally MarketedDeviceVitrea, MedicalImageProcessingSoftware,version 4.0(K071331)(Predicate Device) | Modified SubjectDeviceVitrea, MedicalImageProcessing Software,version 7.0 | Rationale forChanges | Comparison |
| Although theyare notidentical, thedifferencesare mostlycosmetic anddo not affectthe intendeduse orfundamentalscientifictechnology ofalreadyclearedVitreasoftware(K071331). | ||||
| DICOM Cache |
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Functionality: This component keeps a local copy of DICOM images received from PACS and/or modalities, in order to provide fast access for user applications to enable a good user experience.
| Difference:Replacement ofsoftwarecomponent.Note: Onlycomponent isreplaced, nochange in basicfunctionality. | ExternalCommunicationsFramework (ECF):The ECF is thecommunicator to theworld outside theVitrea Workstation.It connects to othersystems via theDICOM standard.ECF is a separateprocess running onthe VitreaWorkstation that isindependent of the | Vitrea InformationManagement System(VIMS):The VIMS is thecommunicator to theworld outside theVitrea Workstation. Itconnects to othersystems via theDICOM standard.VIMS is a separateprocess running onthe Vitrea Workstationthat is independent ofthe Vitrea application. | Replaced theold ECFcomponent forbetter userexperience andimprovedfunctionality. | Thereplacementdoes notaffect theintended useorfundamentalscientifictechnology ofalreadyclearedVitreasoftware(K071331). |
|---|---|---|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| Difference | Legally MarketedDeviceVitrea, MedicalImageProcessingSoftware,version 4.0(K071331)(Predicate Device) | Modified SubjectDeviceVitrea, MedicalImageProcessing Software,version 7.0 | Rationale forChanges | Comparison | |||
|---|---|---|---|---|---|---|---|
| Vitrea application.Communication toand from ECF isdone via inter-process messages(through a CORBA-based interface) andnot direct calls tobinary code. | Communication to andfrom VIMS is done viaWeb Services.The key features areDICOM receive (multi-byte data set support),DICOM Export,Volume building, andDICOM print.MINT:The Medical ImagingNetwork Transport(MINT) protocol is aserver component foraccessing DICOMdata through webservices. | ||||||
| Multiple User Workstation Deployment | |||||||
| Difference:Addition of typeof softwaredeployment. | No Multiple Userworkstation support | Multiple UserWorkstationDeploymentNew Deployment.Multi-user multi-modality departmentaldeployment of theworkstation, whichallows multipleconcurrent useraccess to theworkstation at thesame time withoutdegrading theperformance. | To extend thecapabilities ofthe workstationto multipleusers. | The additionof newdeploymentdoes notaffect theintended useorfundamentalscientifictechnology ofalreadyclearedVitreasoftware(K071331). |
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Summary of Non-Clinical Tests:
The changes to the Vitrea software were designed, and tested according to written procedures that included applying risk management. Software testing was completed to ensure the new feature operates according to its requirements.
The following design control measures were applied to the development of the Vitrea Software:
- . Risk Management
- Requirements Reviews ●
- o Code Designs
- Code Development Testing o
- Code Reviews
- Design Reviews
- Verification of the Software ●
Risk Management:
Each risk pertaining to these modifications has been individually assessed to determine if the benefits outweigh the risk. Every risk has been reduced as low as possible. Based on Post Market information and because of the risk control measures included in these modifications, it is believed that the risk for these modifications as a whole is extremely low.
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.
Summary of Clinical Tests:
The subject of special 510(k) notification, Vitrea software, did not require clinical studies to support safety and effectiveness of the software.
Cyber and Information Security:
- Confidentiality .
The Vitrea platform 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 o
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.
- o 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.
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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. | StandardsOrganization | Standard Title | Version | Date |
|---|---|---|---|---|
| PS 3.1-3.20(2011)(RecognitionNumber 12-238) | NEMA | Digital Imaging andCommunications inMedicine (DICOM) Set(Radiology) | 3 | 03/16/2012 |
| ISO 14971:2007(RecognitionNumber 5-70) | AAMI / ANSI/ ISO | Medical Devices -Applications of RiskManagement to MedicalDevices | 2007 | 03/16/2012 |
| IEC 62304:2006(RecognitionNumber 13-32) | AAMI / ANSI/ IEC | Medical Device Software -Software Life CycleProcesses (Software /Informatics) | 2006 | 08/20/2012 |
The Vitrea software complies with the following voluntary recognized consensus standards:
Substantial Equivalence Analysis Conclusion:
The minor software enhancements do not affect the intended use or alter the fundamental scientific technology of legally marketed Vitrea software (K071331). The modified Vitrea software has the same indications for use, principle of operation, and performs the same technological functions as already cleared Vitrea software - K071331 (Predicate Device). The modifications are not consequential from the standpoint of device operation, safety, effectiveness or intended use.
Any minor differences noted have been explained and do not raise any new questions of safety or effectiveness when used as labeled. The implemented design mitigations, labeling, and the performed verification and validation tests demonstrate the safety and efficacy of the device is equivalent to the predicate device. Based on the comparison data and test data. Vital Images believes the subject device should be found substantially equivalent to the predicate device.
§ 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).