(17 days)
Not Found
No
The document describes a medical image viewer and information distribution application. While it handles multi-modality images and integrates with various medical record systems, there is no mention of AI, ML, deep learning, or any related terms in the provided text. The focus is on image viewing, access, and integration, not on algorithmic analysis or interpretation using AI/ML.
No.
The device is described as a medical image viewing and information distribution application for diagnosis, review, communication, and reporting, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the application provides access to medical images and information "for diagnosis, review, communication, and reporting of DICOM and non-DICOM data." It also mentions "Display monitors used for reading medical images for diagnostic purposes." Furthermore, the "Device Description" states it is "capable of displaying both DICOM and non-DICOM medical images for diagnosis, review, communication, and reporting." While there are disclaimers for mobile device use, the core functionality includes diagnostic use.
Yes
The device description explicitly states "VitreaView is a cross-browser, cross-platform, zero-footprint universal medical image viewer solution". This indicates it is a software application that runs on existing hardware (browsers, platforms) and does not include dedicated hardware components. The mention of display monitors needing to comply with regulations refers to the hardware used to view the images, not the VitreaView device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that VitreaView is for accessing and viewing medical images, reports, and patient information for diagnosis, review, communication, and reporting. This involves interpreting images and data already generated from the patient, not performing tests on biological samples in vitro.
- Device Description: The description focuses on the software's ability to display and integrate medical images and data from various sources. It's a viewing and information distribution tool.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health status. VitreaView's function is to display and manage existing medical data, not to generate new diagnostic information through in vitro testing.
N/A
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 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Multi-modality
Anatomical Site
Not Found
Indicated Patient Age Range
Not applicable
Intended User / Care Setting
Clinicians and other medical professionals. Care setting is within the enterprise (healthcare facilities).
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo 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."
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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 a
Special 510(k) notification |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Vital Images, Inc.
5850 Opus Parkway
Suite 300
Minnetonka, MN, 55343-4414 |
| Establishment
Registration: | 2134213 |
| Contact Person: | Parthiv Shah
Sr. Regulatory Affairs Specialist
Phone : 952-487-9574
Fax: 952-487-9510
E-mail: pshah@vitalimages.com |
| 510(k) Type: | Traditional |
| Summary Date: | March 30, 2015 |
| Device Trade Name: | VitreaView Software |
| Device Common
Name / Regulatory
Description: | Picture Archiving and Communications System |
| Device
Classification
Name: | System, Image Processing, Radiological |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | LLZ |
| Regulatory
Classification: | Class II |
| Device Panel: | Radiology |
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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.
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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 .
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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 VitreaView
Software
(Submission Subject) | 510(k) Cleared
VitreaView Software
(K122136)
(Predicate Device-1) | ViTALConnect
(K071362)
(Predicate Device-2) | Noted
Differences |
|------------------------|---------------------------------------------------------|----------------------------------------------------------------------------|------------------------------------------------------|--------------------------------|
| Classification
Name | Picture Archiving and
Communications
System | Picture Archiving and
Communications
System | Picture Archiving
and
Communications
System | None |
| Regulatory
Number | 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 predicates
are cleared |
Intended Use / Indications for Use Comparison with the Predicate Device-1 .
| Characteristic | Modified VitreaView
Software
(Submission Subject) | 510(k) Cleared
VitreaView Software
(K122136)
(Predicate Device-1) | Noted Differences |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | VitreaView is a medical
image viewing and
information distribution
application that
provides access,
through the Internet
and within the
enterprise, to multi-
modality softcopy | The only changes in the
Intended Use statements
are as below:
• The following line from
the Intended Use
statement of already
cleared VitreaView |
| Characteristic | Modified VitreaView
Software
(Submission Subject) | 510(k) Cleared
VitreaView Software
(K122136)
(Predicate Device-1) | Noted Differences |
| 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. | medical images, reports
and other patient-
related information, that
may be hosted within
disparate archives and
repositories for review,
communication and
reporting of DICOM and
non-DICOM data.
VitreaView is not
intended for primary
diagnosis. When
accessed from a mobile
tablet, VitreaView is for
informational purposes
only and not intended
for diagnostic use.
Display monitors used
for reading medical
images for diagnostic
purposes must comply
with applicable
regulatory approvals
and with quality control
requirements for their
use and maintenance.
Lossy compressed
mammographic images
and digitized film
screen images must not
be reviewed for primary
image interpretations.
Mammographic images
may only be interpreted
using an FDA approved
monitor that offers at
least 5 MP resolution
and meets other
technical specifications
reviewed and accepted
by FDA. | 510(k) — K122136 has
been removed:
"VitreaView is not
intended for primary
diagnosis"
The following word has
been added the in the
updated Intended Use
statement:
"for diagnosis" | |
| Modality
Support | Multi-modality | Multi-modality | None |
| Characteristic | Modified VitreaView
Software
(Submission Subject) | VITALConnect
(K071362)
(Predicate Device-2) | Noted Differences |
| 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, images
viewed are for
informational purposes
only and not intended
for diagnostic use. | VITALConnect, Version
4.1 is a medical
diagnostic software
system intended to
process, analyze,
review, and distribute
multi-dimensional
digital images acquired
from a variety of
imaging devices
including: CT, MR,
CR/DR/DX, SC, US,
NM, PET, XA, and RF,
etc.
VITALConnect is not
meant for primary
Image Interpretation In
mammography. | None
Both software products
provide diagnostic quality
medical image review for
multi-dimensional digital
images acquired from a
variety of imaging devices. |
| Characteristic | Modified VitreaView
Software
(Submission Subject) | ViTALConnect
(K071362)
(Predicate Device-2) | Noted Differences |
| Modality
Support | Multi-modality | Multi-modality | None |
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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.
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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 ●
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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 VitreaView
Software
(Submission Subject) | 510(k) Cleared
VitreaView Software
(K122136)
(Predicate Device-1) | Noted Differences |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | VitreaView is a cross-
browser, cross-
platform, zero-footprint
universal medical
image viewer solution
capable of displaying
both DICOM and non-
DICOM medical
images.
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. | The only change in the
Device Description
statements is as below:
●
The support for
diagnostic quality
medical image
review has been
added into the
subject device. |
| Characteristic | Modified VitreaView
Software
(Submission Subject) | 510(k) Cleared
VitreaView Software
(K122136)
(Predicate Device-1) | Noted Differences |
| | 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 incur time 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. | VitreaView offers
medical professionals a
universal viewer for
accessing 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 incur time 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 accessed the
VitreaView software
from a mobile device,
the image viewed on
the VitreaView software
is for informational
purposes only and not
intended for diagnostic
use. | |
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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.
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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 VitreaView
Software
(Submission Subject) | VITALConnect
(K071362)
(Predicate Device-2) | Noted Differences |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | 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. | None
Both software products provide diagnostic quality medical image review for multi-dimensional digital images acquired from a variety of imaging devices. |
| Characteristic | Modified VitreaView
Software
(Submission Subject) | VITALConnect
(K071362)
(Predicate Device-2) | Noted Differences |
| | and provides
workflows and
interfaces appropriate
for referring physicians
and clinicians. IT
departments will not
have to incur time 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. | | |
. 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 VitreaView
Software
(Submission
Subject)
Technological
Characteristic | Description | 510(k) Cleared
VitreaView Software
(K122136)
(Predicate Device-1) | Explanation of
Differences |
|---------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|-------------------------------|
| Annotation and
Measurement Tools | Line Angle Ruler Arrow | Same | Same |
| User Installation
Requirements | 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 Demographic
Display | Capable of displaying patient demographic information | Same | Same |
| Linking | Co-planar linking:
Autolink Manual | Same | Same |
| Modified VitreaView
Software
(Submission
Subject)
Technological
Characteristic | Description | 510(k) Cleared
VitreaView Software
(K122136)
(Predicate Device-1) | Explanation of
Differences |
| User and Password
Control | Users can be
managed via an
internal database,
active directory, or
parent application | Same | Same |
| Data Security | Stored on server | Same | Same |
| Audit Trail | Audit trail logged | Same | Same |
| User Management | Database structure
allows mapping users
to groups internally or
mapping external
groups (AD, parent
application) to internal
groups and role | Same | Same |
| Transmission Modes | Via the web with
Internet browsers | Same | Same |
| File Type Used | • JPEG for
Lossy data
• PNG for
Lossless data | Same | Same |
| MPR Viewing | This viewing feature
enables the display of
reformatted CT and
MR images into axial,
coronal and sagittal
orientations. | Same | Same |
| 3D Volume Rendered
Viewing | This viewing feature
enables the display of
3D perspective views
of CT and MR image
sets that have been
transformed into
volumes. It also
provides presets to
enable users to alter
the visualization | Same | Same |
| Modified VitreaView
Software
(Submission
Subject)
Technological
Characteristic | Description | 510(k) Cleared
VitreaView Software
(K122136)
(Predicate Device-1) | Explanation of
Differences |
| | parameters of the 3D
views to highlight
features. | | |
| Active Target Tool | This viewing feature
provides a facility to
view a single target
location within
multiple images. | Same | Same |
| Crosshair Navigation
and Synchronization: | This viewing feature
provides a facility to
synchronize and
scroll through
multiple views at the
same time. | Same | Same |
| Ability to clone
images side by side | Ability to clone
images side by side. | Same | Same |
| Ability to close an
image by clicking an
"X" in the upper-left
portion of the
viewport | Ability to close an
image by clicking an
"X" in the upper-left
portion of the
viewport. | Same | Same |
| Ability to select locale
and language
settings on the login
screen | Ability to select locale
and language settings
on the login screen. | Same | Same |
| Ability to customize
the columns in the
study directory by
selecting the
dropdown arrow on
the right side of each
column. | Ability to customize
the columns in the
study directory by
selecting the
dropdown arrow on
the right side of each
column. | Same | Same |
| Help Tips | Proactive help tips
appear for 10-15
seconds to educate
users on certain
functionality 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 VitreaView
Software
(Submission
Subject)
Technological
Characteristic | Description | 510(k) Cleared
VitreaView Software
(K122136)
(Predicate Device-1) | Explanation of
Differences |
|-----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|-------------------------------|
| | not be obvious to a
new user. | | |
| Support for TIF Files | VitreaView can
display TIF files. | Same | Same |
| Tablet support for
information purpose
only
(Not for diagnostic
use) | This viewing feature
provides access of
VitreaView software
on various iOS and
Android tablet
devices through the
default internet
browser. Key
features are:
Two-finger
pinch to zoom
and pan Touch and
drag to scroll Double-tap to
access
Gesture
menu Tap Carousel
thumbnail,
then tap
Image Pane
to swap
images Ambient
Lighting
Check | Same | Same |
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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 VitreaView
Software
(Submission
Subject)
Technological
Characteristic | Description | ViTALConnect
(K071362)
(Predicate Device-2) | Explanation of
Differences |
|-----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|-------------------------------|
| Diagnostic quality
medical image review | Ability to provide
diagnostic quality
medical image
review for multi-
dimensional digital
images acquired
from a variety of
imaging devices | Same | Same |
Technological Characteristics Differences with the Predicate Device-1 .
| Modified VitreaView
Software
(Submission
Subject)
Technological
Characteristic | Description | 510(k) Cleared
VitreaView Software
(K122136)
(Predicate Device-1) | Explanation of
Differences | |
|-----------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|--|
| General
Enhancements | 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 VitreaView
Software
(Submission
Subject)
Technological
Characteristic | Description | 510(k) Cleared
VitreaView Software
(K122136)
(Predicate Device-1) | Explanation of
Differences | |
| | when sharing a
study 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 VitreaView
Software
(Submission
Subject)
Technological
Characteristic | Description | 510(k) Cleared
VitreaView Software
(K122136)
(Predicate Device-1) | Explanation of
Differences | |
| | 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 VitreaView
Software
(Submission
Subject)
Technological
Characteristic | Description | 510(k) Cleared
VitreaView Software
(K122136)
(Predicate Device-1) | Explanation of
Differences | |
| | 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 | | | |
| Modified VitreaView
Software
(Submission
Subject)
Technological
Characteristic | Description | 510(k) Cleared
VitreaView Software
(K122136)
(Predicate Device-1) | Explanation of
Differences | |
| | The status of
●
Pending has
been added to
Administration
Change Sets
Ability to
●
redirect the
user to another
URL
Ability to use a
●
custom logout
hook
Carousel swipe
●
navigation
●
Ability to
disable pixel
measurements
Ability to
●
disable logout | | | |
| Diagnostic quality
medical image
review | Ability to provide
diagnostic quality
medical image review
for multi-dimensional
digital images acquired
from a variety of
imaging devices | | This feature is
substantially
equivalent to the
Predicate Device-2. | |
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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.
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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. | Standards
Organization | Standard Title | Version | Date |
|----------------------------------------------------------|---------------------------|-------------------------------------------------------------------------------------------|---------|------------|
| PS 3.1- 3.20
(2011)
(Recognition
Number 12-238) | NEMA | Digital Imaging and
Communications in
Medicine (DICOM) Set
(Radiology) | 3 | 03/16/2012 |
| ISO 14971:2007
(Recognition
Number 5-70) | AAMI / ANSI
/ ISO | Medical Devices -
Applications of Risk
Management to Medical
Devices | 2007 | 03/16/2012 |
| IEC 62304:2006
(Recognition
Number 13-32) | AAMI / ANSI
/ IEC | Medical Device Software -
Software Life Cycle
Processes (Software /
Informatics) | 2006 | 08/20/2012 |
The 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.