(17 days)
VitreaView is a medical image viewing and information distribution application that provides access, through the internet and within the enterprise to multi-modality softcopy medical images, reports, and other patient-related information. This data is hosted within disparate archives and repositories for diagnosis, review, communication, and reporting of DICOM and non-DICOM data.
Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance.
Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations.
When accessing VitreaView from a mobile device, images viewed are for informational purposes only and not intended for diagnostic use.
VitreaView is a cross-browser, cross-platform, zero-footprint universal medical image viewer solution capable of displaying both DICOM and non-DICOM medical images for diagnosis, review, communication, and reporting.
VitreaView enables clinicians and other medical professionals to access patients' medical images with integrations into a variety of medical record systems, such as Electronic Health Record (EHR), Electronic Medical Record (EMR), Health Information Exchange (HIE), Personal Health Record (PHR), and image exchange systems. It supports the physician in medical image viewing and treatment planning.
VitreaView offers medical professionals a universal viewer for accessing multi-dimensional imaging data in context with reports from enterprise patient health information databases, fosters collaboration, and provides workflows and interfaces appropriate for referring physicians and clinicians. IT departments will not have to install client systems, due to the zero footprint/zero download nature of VitreaView. VitreaView offers scalability to add new users as demand grows, may be deployed in a virtualized environment, and is designed to be integrated with enterprise patient health information databases.
When accessing VitreaView from a mobile device, images viewed are for informational purposes only and not intended for diagnostic use.
The Acceptance Criteria and Study for the VitreaView software are as follows:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic / Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Software Functionality | New features operate according to defined requirements. | Test cases were executed against system features and requirements, and the Requirements Traceability Matrix (RTM) was reviewed to ensure coverage. |
| Diagnostic Quality (External Validation) | Resulting image display is of diagnostic quality (brightness, sharpness, artifacts, overall diagnostic quality). | During external validation, experienced radiologists found the display to be of diagnostic quality in all cases. |
| Risk Management | All risks were reduced as low as possible, and the medical benefits outweigh the residual risk (individual and collective). | Each risk was assessed, determined to have a probability of occurrence of harm of "Improbable," and benefits were found to outweigh risks. The overall residual risk was deemed acceptable. |
| Software Verification | Software fully satisfies all expected system requirements and features. | Test cases were executed against the system features and requirements, ensuring RTM coverage. |
| Software Validation | Software conforms to user needs and intended use, and system requirements/features are implemented and met. | Workflow testing was conducted, providing evidence that system requirements and features were implemented, reviewed, and met. |
| Cyber and Information Security | Follows security best practices (OWASP, HIPAA) to limit unauthorized access (User Identification, Automatic logoff, Audit, Data integrity, Authentication, Transport Layer Security, Authentication & Authorization, Access Control, Audit subsystem). | VitreaView implements all listed HIPAA security standards and described security measures (TLS, Active Directory integration, internal database for user passwords, third-party system integration, role-based authorization, site-configurable access control, audit subsystem). |
| Voluntary Recognized Consensus Standards Compliance | Complies with NEMA PS 3.1-3.20 (DICOM), ISO 14971 (Risk Management), and IEC 62304 (Software Life Cycle). | VitreaView software complies with all three listed standards. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a numerical sample size for the test set used in the validation by radiologists. It generically refers to "datasets."
- Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: "Experienced radiologists" were used. The exact number is not specified.
- Qualifications of Experts: They were "experienced radiologists." Further specific qualifications (e.g., years of experience, subspecialty) are not provided.
4. Adjudication method for the test set:
- The document does not describe a formal adjudication method (e.g., 2+1, 3+1). It states that "In all cases the radiologists found the display to be of diagnostic quality," implying a consensus or individual judgment without a specific adjudication process described.
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 MRMC comparative effectiveness study involving AI assistance for human readers was mentioned or performed. The device is a medical image viewing and information distribution application, not an AI-powered diagnostic aid that enhances human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device described is a medical image viewer intended for human use and interpretation. There is no mention of a standalone algorithm-only performance assessment. The "external validation" involved human radiologists evaluating the display.
7. The type of ground truth used:
- The ground truth for assessing diagnostic quality was expert consensus/judgment from experienced radiologists. They evaluated "brightness, sharpness, artifacts, and overall diagnostic quality" of the displayed images.
8. The sample size for the training set:
- The document does not describe a training set or a machine learning model that would require one. The VitreaView software is a viewing and information distribution application, and its validation focused on software functionality, risk management, and the diagnostic quality of its image display as perceived by human readers, rather than training an algorithm.
9. How the ground truth for the training set was established:
- Not applicable, as no training set for a machine learning model is mentioned in the document.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines, creating a sense of unity and movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 6, 2015
Vital Images, Inc. % Mr Parthiv Shah Sr. Regulatory Affairs Specialist 5850 Opus Parkway, Suite 300 MINNETONKA MN 55343-4414
Re: K150738 Trade/Device Name: VitreaView Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 18, 2015 Received: March 20, 2015
Dear Mr. 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.
{1}------------------------------------------------
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K150738
Device Name VitreaView
Indications for Use (Describe)
VitreaView is a medical image viewing and information distribution application that provides access, through the internet and within the enterprise to multi-modality softcopy medical images, reports, and other pation. This data is hosted within disparate archives and repositories for diagnosis, review, communication, and reporting of DICOM and non-DICOM data.
Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance.
Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations.
When accessing VitreaView from a mobile device, images viewed are for informational purposes only and not intended for diagnostic use.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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 Druq 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}------------------------------------------------
Image /page/3/Picture/0 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 a slightly lighter shade. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font.
510(k) 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: | Modifications to a legally marketed device which are not qualified for aSpecial 510(k) notification |
|---|---|
| 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: | Traditional |
| Summary Date: | March 30, 2015 |
| Device Trade Name: | VitreaView Software |
| Device CommonName / RegulatoryDescription: | Picture Archiving and Communications System |
| DeviceClassificationName: | System, Image Processing, Radiological |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | LLZ |
| RegulatoryClassification: | Class II |
| Device Panel: | Radiology |
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the word "VITAL" in black font. Underneath the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in red font. The font of the word "VITAL" is sans-serif. The dot above the "i" in "VITAL" is a circle.
Predicate Devices:
| Predicate Device(s) | Manufacturer | FDA 510(k) number |
|---|---|---|
| VitreaView | Vital Images, Inc. | K122136 |
| ViTALConnect | Vital Images, Inc. | K071362 |
Device Description:
VitreaView is a cross-browser, cross-platform, zero-footprint universal medical image viewer solution capable of displaying both DICOM and non-DICOM medical images for diagnosis, review, communication, and reporting.
VitreaView enables clinicians and other medical professionals to access patients' medical images with integrations into a variety of medical record systems, such as Electronic Health Record (EHR), Electronic Medical Record (EMR), Health Information Exchange (HIE), Personal Health Record (PHR), and image exchange systems. It supports the physician in medical image viewing and treatment planning.
VitreaView offers medical professionals a universal viewer for accessing multi-dimensional imaging data in context with reports from enterprise patient health information databases, fosters collaboration, and provides workflows and interfaces appropriate for referring physicians and clinicians. IT departments will not have to install client systems, due to the zero footprint/zero download nature of VitreaView. VitreaView offers scalability to add new users as demand grows, may be deployed in a virtualized environment, and is designed to be integrated with enterprise patient health information databases.
When accessing VitreaView from a mobile device, images viewed are for informational purposes only and not intended for diagnostic use.
Intended Use / Indications for Use:
VitreaView is a medical image viewing and information distribution application that provides access, through the internet and within the enterprise to multi-modality softcopy medical images, reports, and other patient-related information. This data is hosted within disparate archives and repositories for diagnosis, review, communication, and reporting of DICOM and non-DICOM data.
Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance.
Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations.
When accessing VitreaView from a mobile device, imaqes viewed are for informational purposes only and not intended for diagnostic use.
Intended for Disease / Condition / Patient Population:
VitreaView is medical image viewer software. Therefore, particular information of intended for disease, condition, and patient population is not applicable.
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the word "VITAL" in black, with a red tagline underneath that says "A Toshiba Medical Systems Group Company". The word "VITAL" is written in a bold, sans-serif font, with a dot above the "i". The tagline is written in a smaller, serif font.
Software Changes (from the last 510(k) clearance K122136):
Key changes:
- Query on demand searches archives in real-time directly from the source without the need for an index
- Color and Greyscale Softcopy Presentation State (CSPS and GSPS) ●
- Easy study navigation and study sharing via email, including bookmarking ●
- View DICOM key image objects that have been saved with a study
- . Comparative review allows users to view multiple studies and to track and quantify changes
- . Markup tools allow you to create measurements and add annotations, with indication if off-screen
- . Window/Level sets specific window-level, grayscale-inverted, a user preset or stored-DICOM
- Volume rendering presets allow you to change the appearance of the 3D view
- Enhanced notifications for study changes and study processing .
- Linking is available across modalities and can be applied to duplicated series. A default ● set of linking options are remembered by modality and applied to linked series, including: navigation, window/level and zoom per modality.
- . Auto-Cine enables users of cine to quickly see the dynamic view of studies most often viewed in cine mode
- Provides diagnostic quality image review to medical professionals .
Other minor enhancements:
- Annotation Indicator ●
- Markup Scrollbar Indicator for easy access to key slices .
- Bookmarks automatically save when users log out ●
- Query retrieve progress indicator
- Text annotation is available with the Arrow tool ●
- Arrow tool is available from the Ruler toolbar ●
- Ability to review the report and move through the VitreaView studies ●
- Calibration handling for projection modalities ●
- . Windows 8.1 support
- Internet Explorer 11 support ●
- Windows 8 support ●
- Internet Explorer 10 support ●
- Administrators can remove changed or deleted studies from the VitreaView Study List by ● authorized permissions
- . The updated URL encryption method provides additional security for patient health information (PHI)
- Support for automatic LDAP group mapping ●
- . Structured reports can be created from metadata during the initial study load
- The patient demographics display within the viewport has been refined to show more ● information when the browser is resized
- . Custom actions are available to define specific search behavior
- Improved selection of the viewport layout
- MINT storage can be optimized to minimize overhead
- Improved access to related images and documents ●
- . The status of Pending has been added to Administration Change Sets
- Ability to redirect the user to another URL .
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the word "VITAL" in 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.
- Ability to use a custom logout hook ●
- . Carousel swipe navigation
- . Ability to disable pixel measurements
- . Ability to disable logout
Substantial Equivalence Comparison:
. Regulatory Comparison
| Characteristic | Modified VitreaViewSoftware(Submission Subject) | 510(k) ClearedVitreaView Software(K122136)(Predicate Device-1) | ViTALConnect(K071362)(Predicate Device-2) | NotedDifferences |
|---|---|---|---|---|
| ClassificationName | Picture Archiving andCommunicationsSystem | Picture Archiving andCommunicationsSystem | Picture ArchivingandCommunicationsSystem | None |
| RegulatoryNumber | 892.2050 | 892.2050 | 892.2050 | None |
| Product Code | LLZ | LLZ | LLZ | None |
| Classification | Class II | Class II | Class II | None |
| Review Panel | Radiology | Radiology | Radiology | None |
| Decision Date | Under Review | September 7, 2012 | May 30, 2007 | Both predicatesare cleared |
Intended Use / Indications for Use Comparison with the Predicate Device-1 .
| Characteristic | Modified VitreaViewSoftware(Submission Subject) | 510(k) ClearedVitreaView Software(K122136)(Predicate Device-1) | Noted Differences |
|---|---|---|---|
| Intended Use /Indications forUse | VitreaView is amedical image viewingand informationdistribution applicationthat provides access,through the internetand within theenterprise to multi-modality softcopy | VitreaView is a medicalimage viewing andinformation distributionapplication thatprovides access,through the Internetand within theenterprise, to multi-modality softcopy | The only changes in theIntended Use statementsare as below:• The following line fromthe Intended Usestatement of alreadycleared VitreaView |
| Characteristic | Modified VitreaViewSoftware(Submission Subject) | 510(k) ClearedVitreaView Software(K122136)(Predicate Device-1) | Noted Differences |
| medical images,reports, and otherpatient-relatedinformation. This datais hosted withindisparate archives andrepositories fordiagnosis, review,communication, andreporting of DICOMand non-DICOM data.Display monitors usedfor reading medicalimages for diagnosticpurposes must complywith the applicableregulatory approvalsand quality controlrequirements for theiruse and maintenance.Lossy compressedmammographyimages and digitizedfilm screen imagesmust not be reviewedfor primary imageinterpretations.When accessingVitreaView from amobile device, imagesviewed are forinformational purposesonly and not intendedfor diagnostic use. | medical images, reportsand other patient-related information, thatmay be hosted withindisparate archives andrepositories for review,communication andreporting of DICOM andnon-DICOM data.VitreaView is notintended for primarydiagnosis. Whenaccessed from a mobiletablet, VitreaView is forinformational purposesonly and not intendedfor diagnostic use.Display monitors usedfor reading medicalimages for diagnosticpurposes must complywith applicableregulatory approvalsand with quality controlrequirements for theiruse and maintenance.Lossy compressedmammographic imagesand digitized filmscreen images must notbe reviewed for primaryimage interpretations.Mammographic imagesmay only be interpretedusing an FDA approvedmonitor that offers atleast 5 MP resolutionand meets othertechnical specificationsreviewed and acceptedby FDA. | 510(k) — K122136 hasbeen removed:"VitreaView is notintended for primarydiagnosis"The following word hasbeen added the in theupdated Intended Usestatement:"for diagnosis" | |
| ModalitySupport | Multi-modality | Multi-modality | None |
| Characteristic | Modified VitreaViewSoftware(Submission Subject) | VITALConnect(K071362)(Predicate Device-2) | Noted Differences |
| Intended Use /Indications forUse | VitreaView is amedical image viewingand informationdistribution applicationthat provides access,through the internetand within theenterprise to multi-modality softcopymedical images,reports, and otherpatient-relatedinformation. This datais hosted withindisparate archives andrepositories fordiagnosis, review,communication, andreporting of DICOMand non-DICOM data.Display monitors usedfor reading medicalimages for diagnosticpurposes must complywith the applicableregulatory approvalsand quality controlrequirements for theiruse and maintenance.Lossy compressedmammographyimages and digitizedfilm screen imagesmust not be reviewedfor primary imageinterpretations.When accessingVitreaView from amobile device, imagesviewed are forinformational purposesonly and not intendedfor diagnostic use. | VITALConnect, Version4.1 is a medicaldiagnostic softwaresystem intended toprocess, analyze,review, and distributemulti-dimensionaldigital images acquiredfrom a variety ofimaging devicesincluding: CT, MR,CR/DR/DX, SC, US,NM, PET, XA, and RF,etc.VITALConnect is notmeant for primaryImage Interpretation Inmammography. | NoneBoth software productsprovide diagnostic qualitymedical image review formulti-dimensional digitalimages acquired from avariety of imaging devices. |
| Characteristic | Modified VitreaViewSoftware(Submission Subject) | ViTALConnect(K071362)(Predicate Device-2) | Noted Differences |
| ModalitySupport | Multi-modality | Multi-modality | None |
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the word "VITAL" in bold, black letters. Below the word is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. The dot on the "i" in "VITAL" is a circle.
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the word "VITAL" in bold, black letters. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The dot above the "i" in "VITAL" is a perfect circle.
Intended Use / Indications for Use Comparison with the Predicate Device-2 ●
{9}------------------------------------------------
Image /page/9/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 dot on the "i" in "VITAL" is a perfect circle.
Device Description Comparison with the Predicate Device-1 •
| Characteristic | Modified VitreaViewSoftware(Submission Subject) | 510(k) ClearedVitreaView Software(K122136)(Predicate Device-1) | Noted Differences |
|---|---|---|---|
| DeviceDescription | VitreaView is a cross-browser, cross-platform, zero-footprintuniversal medicalimage viewer solutioncapable of displayingboth DICOM and non-DICOM medicalimages for diagnosis,review,communication, andreporting.VitreaView enablesclinicians and othermedical professionalsto access patients'medical images withintegrations into avariety of medicalrecord systems, suchas Electronic HealthRecord (EHR),Electronic MedicalRecord (EMR), HealthInformation Exchange(HIE), Personal HealthRecord (PHR), andimage exchangesystems. It supportsthe physician inmedical image viewing | VitreaView is a cross-browser, cross-platform, zero-footprintuniversal medicalimage viewer solutioncapable of displayingboth DICOM and non-DICOM medicalimages.VitreaView enablesclinicians and othermedical professionalsto access patients'medical images withintegrations into avariety of medicalrecord systems, suchas Electronic HealthRecord (EHR),Electronic MedicalRecord (EMR), HealthInformation Exchange(HIE), Personal HealthRecord (PHR), andimage exchangesystems. It supports thephysician in medicalimage viewing andtreatment planning. | The only change in theDevice Descriptionstatements is as below:●The support fordiagnostic qualitymedical imagereview has beenadded into thesubject device. |
| Characteristic | Modified VitreaViewSoftware(Submission Subject) | 510(k) ClearedVitreaView Software(K122136)(Predicate Device-1) | Noted Differences |
| and treatmentplanning.VitreaView offersmedical professionalsa universal viewer foraccessing multi-dimensional imagingdata in context withreports from enterprisepatient healthinformation databases,fosters collaboration,and providesworkflows andinterfaces appropriatefor referring physiciansand clinicians. ITdepartments will nothave to incur time toinstall client systems,due to the zerofootprint/zero-download nature ofVitreaView. VitreaViewoffers scalability toadd new users asdemand grows, maybe deployed in avirtualizedenvironment, and isdesigned to beintegrated withenterprise patienthealth informationdatabases.When accessingVitreaView from amobile device, imagesviewed are forinformational purposesonly and not intendedfor diagnostic use. | VitreaView offersmedical professionals auniversal viewer foraccessing imaging datain context with reportsfrom enterprise patienthealth informationdatabases, fosterscollaboration, andprovides workflows andinterfaces appropriatefor referring physiciansand clinicians. ITdepartments will nothave to incur time toinstall client systems,due to the zerofootprint, zero-download nature ofVitreaView. VitreaViewoffers scalability to addnew users as demandgrows, may bedeployed in avirtualized environment,and is designed to beintegrated withenterprise patienthealth informationdatabases.When accessed theVitreaView softwarefrom a mobile device,the image viewed onthe VitreaView softwareis for informationalpurposes only and notintended for diagnosticuse. |
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the word "VITAL" in black font. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in red font. The letters in the word "VITAL" are all capitalized except for the "i", which is lowercase and has a dot above it.
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the word "VITAL" in a bold, sans-serif font. The "i" in "VITAL" has a circular dot above it. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font.
| Characteristic | Modified VitreaViewSoftware(Submission Subject) | VITALConnect(K071362)(Predicate Device-2) | Noted Differences |
|---|---|---|---|
| DeviceDescription | VitreaView is a cross-browser, cross-platform, zero-footprint universal medical image viewer solution capable of displaying both DICOM and non-DICOM medical images for diagnosis, review, communication, and reporting.VitreaView enables clinicians and other medical professionals to access patients' medical images with integrations into a variety of medical record systems, such as Electronic Health Record (EHR), Electronic Medical Record (EMR), Health Information Exchange (HIE), Personal Health Record (PHR), and image exchange systems. It supports the physician in medical image viewing and treatment planning.VitreaView offers medical professionals a universal viewer for accessing multi-dimensional imaging data in context with reports from enterprise patient health information databases, fosters collaboration | The VITALConnect system is a medical diagnostic device that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices.The VITALConnect system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The VITALConnect system user interface follows typical clinical workflow patterns to process, review, and analyze digital images. | NoneBoth software products provide diagnostic quality medical image review for multi-dimensional digital images acquired from a variety of imaging devices. |
| Characteristic | Modified VitreaViewSoftware(Submission Subject) | VITALConnect(K071362)(Predicate Device-2) | Noted Differences |
| and providesworkflows andinterfaces appropriatefor referring physiciansand clinicians. ITdepartments will nothave to incur time toinstall client systems,due to the zerofootprint/ zero-download nature ofVitreaView. VitreaViewoffers scalability toadd new users asdemand grows, maybe deployed in avirtualizedenvironment, and isdesigned to beintegrated withenterprise patienthealth informationdatabases. | |||
| When accessingVitreaView from amobile device, imagesviewed are forinformational purposesonly and not intendedfor diagnostic use. |
. Device Description Comparison with the Predicate Device-2
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the word "VITAL" in a bold, sans-serif font. The "i" in "VITAL" has a circular dot above it. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font.
{13}------------------------------------------------
Image /page/13/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.
Technological Characteristics Similarity with the Predicate Device-1 ●
| Modified VitreaViewSoftware(SubmissionSubject)TechnologicalCharacteristic | Description | 510(k) ClearedVitreaView Software(K122136)(Predicate Device-1) | Explanation ofDifferences |
|---|---|---|---|
| Annotation andMeasurement Tools | Line Angle Ruler Arrow | Same | Same |
| User InstallationRequirements | Runs within browser using HTML and JavaScript only No installation is required on user's machine | Same | Same |
| Data Type Supported | DICOM Non-DICOM | Same | Same |
| Image View/Manipulation | Image Zoom Pan Window Level Auto Window Level Reset Scout Lines Image Rotate Image Flip Magnify Image Invert Image Cine | Same | Same |
| Data Encryption | HTTPS SSL | Same | Same |
| Patient DemographicDisplay | Capable of displaying patient demographic information | Same | Same |
| Linking | Co-planar linking:Autolink Manual | Same | Same |
| Modified VitreaViewSoftware(SubmissionSubject)TechnologicalCharacteristic | Description | 510(k) ClearedVitreaView Software(K122136)(Predicate Device-1) | Explanation ofDifferences |
| User and PasswordControl | Users can bemanaged via aninternal database,active directory, orparent application | Same | Same |
| Data Security | Stored on server | Same | Same |
| Audit Trail | Audit trail logged | Same | Same |
| User Management | Database structureallows mapping usersto groups internally ormapping externalgroups (AD, parentapplication) to internalgroups and role | Same | Same |
| Transmission Modes | Via the web withInternet browsers | Same | Same |
| File Type Used | • JPEG forLossy data• PNG forLossless data | Same | Same |
| MPR Viewing | This viewing featureenables the display ofreformatted CT andMR images into axial,coronal and sagittalorientations. | Same | Same |
| 3D Volume RenderedViewing | This viewing featureenables the display of3D perspective viewsof CT and MR imagesets that have beentransformed intovolumes. It alsoprovides presets toenable users to alterthe visualization | Same | Same |
| Modified VitreaViewSoftware(SubmissionSubject)TechnologicalCharacteristic | Description | 510(k) ClearedVitreaView Software(K122136)(Predicate Device-1) | Explanation ofDifferences |
| parameters of the 3Dviews to highlightfeatures. | |||
| Active Target Tool | This viewing featureprovides a facility toview a single targetlocation withinmultiple images. | Same | Same |
| Crosshair Navigationand Synchronization: | This viewing featureprovides a facility tosynchronize andscroll throughmultiple views at thesame time. | Same | Same |
| Ability to cloneimages side by side | Ability to cloneimages side by side. | Same | Same |
| Ability to close animage by clicking an"X" in the upper-leftportion of theviewport | Ability to close animage by clicking an"X" in the upper-leftportion of theviewport. | Same | Same |
| Ability to select localeand languagesettings on the loginscreen | Ability to select localeand language settingson the login screen. | Same | Same |
| Ability to customizethe columns in thestudy directory byselecting thedropdown arrow onthe right side of eachcolumn. | Ability to customizethe columns in thestudy directory byselecting thedropdown arrow onthe right side of eachcolumn. | Same | Same |
| Help Tips | Proactive help tipsappear for 10-15seconds to educateusers on certainfunctionality that may | Same | Same |
{14}------------------------------------------------
Image /page/14/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 text appears to be a company logo.
{15}------------------------------------------------
Image /page/15/Picture/0 description: The image shows the word "VITAL" in a bold, sans-serif font. The "i" in "VITAL" has a circular dot above it. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font.
{16}------------------------------------------------
Image /page/16/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.
| Modified VitreaViewSoftware(SubmissionSubject)TechnologicalCharacteristic | Description | 510(k) ClearedVitreaView Software(K122136)(Predicate Device-1) | Explanation ofDifferences |
|---|---|---|---|
| not be obvious to anew user. | |||
| Support for TIF Files | VitreaView candisplay TIF files. | Same | Same |
| Tablet support forinformation purposeonly(Not for diagnosticuse) | This viewing featureprovides access ofVitreaView softwareon various iOS andAndroid tabletdevices through thedefault internetbrowser. Keyfeatures are:Two-fingerpinch to zoomand pan Touch anddrag to scroll Double-tap toaccessGesturemenu Tap Carouselthumbnail,then tapImage Paneto swapimages AmbientLightingCheck | Same | Same |
{17}------------------------------------------------
Image /page/17/Picture/0 description: The image shows the word "VITAL" in black font. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in red font. The font of the word "VITAL" is sans-serif.
Technological Characteristics Similarity with the Predicate Device-2 ●
| Modified VitreaViewSoftware(SubmissionSubject)TechnologicalCharacteristic | Description | ViTALConnect(K071362)(Predicate Device-2) | Explanation ofDifferences |
|---|---|---|---|
| Diagnostic qualitymedical image review | Ability to providediagnostic qualitymedical imagereview for multi-dimensional digitalimages acquiredfrom a variety ofimaging devices | Same | Same |
Technological Characteristics Differences with the Predicate Device-1 .
| Modified VitreaViewSoftware(SubmissionSubject)TechnologicalCharacteristic | Description | 510(k) ClearedVitreaView Software(K122136)(Predicate Device-1) | Explanation ofDifferences | |
|---|---|---|---|---|
| GeneralEnhancements | Color Softcopy Presentation State (CSPS) Greyscale Softcopy Presentation State (GSPS) Query on Demand provides real-time access to an archive, without indexing Annotation Indicator Ability to provide a bookmark | These enhancements do not affect the intended use or alter the fundamental scientific technology of already cleared VitreaView. | ||
| Modified VitreaViewSoftware(SubmissionSubject)TechnologicalCharacteristic | Description | 510(k) ClearedVitreaView Software(K122136)(Predicate Device-1) | Explanation ofDifferences | |
| when sharing astudy Markup Scrollbar Indicator for easy access to key slices Share studies via email Bookmarks automatically save when users log out Query retrieve progress indicator Text annotation is available with the Arrow tool Arrow tool is available from the Ruler toolbar Ability to review the report and move through the VitreaView studies Simple Auto-Cine automatically plays the cine at the expected rate | ||||
| Modified VitreaViewSoftware(SubmissionSubject)TechnologicalCharacteristic | Description | 510(k) ClearedVitreaView Software(K122136)(Predicate Device-1) | Explanation ofDifferences | |
| Calibration handling for projection modalities Windows 8.1 support Internet Explorer 11 support Windows 8 support Internet Explorer 10 support Administrators can remove changed or deleted studies from the VitreaView Study List by authorized permissions The updated URL encryption method provides additional security for patient health information (PHI) Support for automatic LDAP group mapping | ||||
| Modified VitreaViewSoftware(SubmissionSubject)TechnologicalCharacteristic | Description | 510(k) ClearedVitreaView Software(K122136)(Predicate Device-1) | Explanation ofDifferences | |
| Structured reports can becreated from metadataduring the initial studyload The patient demographicsdisplay within the viewporthas been refined to showmore information when thebrowser is resized Custom actions are available todefine specific searchbehavior Improved selection of theviewport layout MINT storage can beoptimized to minimizeoverhead Improved access torelated images and documents | ||||
| Modified VitreaViewSoftware(SubmissionSubject)TechnologicalCharacteristic | Description | 510(k) ClearedVitreaView Software(K122136)(Predicate Device-1) | Explanation ofDifferences | |
| The status of●Pending hasbeen added toAdministrationChange SetsAbility to●redirect theuser to anotherURLAbility to use a●custom logouthookCarousel swipe●navigation●Ability todisable pixelmeasurementsAbility to●disable logout | ||||
| Diagnostic qualitymedical imagereview | Ability to providediagnostic qualitymedical image reviewfor multi-dimensionaldigital images acquiredfrom a variety ofimaging devices | This feature issubstantiallyequivalent to thePredicate Device-2. |
{18}------------------------------------------------
Image /page/18/Picture/0 description: The image shows the word "VITAL" in a bold, sans-serif font. The "i" in "VITAL" has a circular dot above it. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font.
{19}------------------------------------------------
Image /page/19/Picture/0 description: The image shows the word "VITAL" in a bold, sans-serif font. The letters are black, and the "i" has a circular dot above it. 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".
{20}------------------------------------------------
Image /page/20/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.
{21}------------------------------------------------
Image /page/21/Picture/0 description: The image shows the word "VITAL" in a bold, sans-serif font. The letters are black, and the dot on the "i" is a perfect circle. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font.
{22}------------------------------------------------
Image /page/22/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 dot on the "i" in "VITAL" is a solid black circle.
. Technological Characteristics Differences with the Predicate Device-2
None, as both software provide diagnostic quality medical image review for multi-dimensional digital images acquired from a variety of imaging devices.
Summary of Non-Clinical Tests:
The changes to the VitreaView software were 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 enhancements of the VitreaView 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 enhancements 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 "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 risks were reduced as low as possible .
- The medical benefits of the device outweigh the residual risk for each individual risk and ● all risks together
- . The overall residual risk for the project is deemed acceptable
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 VitreaView software, experienced radiologists evaluated that the resulting image was of diagnostic quality. The radiologists evaluated acceptability of datasets on
{23}------------------------------------------------
Image /page/23/Picture/0 description: The image shows the word "VITAL" in black, block letters. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in red letters. The letters are all capitalized except for the "i" in "VITAL", which is lowercase and has a black dot above it.
brightness, sharpness, artifacts, and overall diagnostic quality. In all cases the radiologists found the display to be of diagnostic quality.
Summary of Clinical Tests:
The subject of this 510(k) notification. VitreaView software, did not require clinical studies to support safety and effectiveness of the software.
Cyber and Information Security:
VitreaView follows security best practices, including those outlined by OWASP and HIPAA, to limit the risk of unauthorized access to the system or data. In summary, the following HIPAA security standards have been implemented:
- HIPAA §164.312 User Identification ●
- . HIPAA §164.312 Automatic logoff
- HIPAA §164.312 Audit ●
- . HIPAA §164.312 Data integrity
- . HIPAA §164.312 Authentication
Security is enforced at multiple layers within the system:
Transport Layer Security ●
The most common form of security found in web applications is TLS, or SSL (secure sockets layer). All communication over SSL is encrypted. VitreaView has been designed to allow and encourage operation with SSL turned on "full time" for all components.
. Authentication & Authorization
VitreaView provides Active Directory integration via Kerberos for Single Sign On, an internal database for user passwords, and an integration laver to authenticate users against a 3rd party system, such as a PACS.
Once a user is authenticated, the system determines actions the user is authorized to perform. Access to a given action may be guarded by one or more permissions. Roles are defined to aggregate a set of permissions, and roles are assigned to one or more groups.
. Access Control
Access Control is concerned with governing what data a user may perform their permitted operations upon. Access Control is site-configurable through installation of a custom script that is executed each time a study is launched.
- . Audit
VitreaView includes an audit subsystem that tracks user operations along with source IP address, time of day, specific operation performed, etc.
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.
{24}------------------------------------------------
Image /page/24/Picture/0 description: The image shows the logo for VITAL, a Toshiba Medical Systems Group Company. The word "VITAL" is written in large, bold, black letters. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font.
| 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 VitreaView software complies with the following voluntary recognized consensus standards:
Substantial Equivalence Analysis Conclusion:
Vital Images believes that VitreaView software has a substantially equivalent intended use, indications for use, and technological characteristics as the predicate devices. Any minor differences noted have been explained and do not raise any new questions of safety or effectiveness as the predicate devices. The implemented design controls, risk management, and performed testing demonstrate the VitreaView software device is as safe and effective as both predicate devices. Based on the comparison data and test data Vital Images believes the subject device should be found substantially equivalent to the predicate devices.
§ 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).