Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard image processing and visualization features common in medical imaging software, with no mention of AI, ML, or related concepts.

Therapeutic

No
The device is described as a "medical diagnostic system" for processing and analyzing digital images to aid in the analysis of "anatomy and pathology," which are diagnostic rather than therapeutic functions.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states, "Vitrea is a medical diagnostic system." The "Device Description" also reiterates that it is a "medical diagnostic system" that aids clinicians in their analysis of anatomy and pathology.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states "Vitrea is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices." and details software functionalities like retrieving, displaying, manipulating, and outputting images. There is no mention of accompanying hardware components being part of the device itself, only that it acquires images from imaging devices. The testing described is also focused on software verification.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use/Indications for Use: The description clearly states that Vitrea is a "medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices." It focuses on the manipulation and visualization of images from imaging devices, not on analyzing biological samples or specimens.
Device Description: The description details how the system processes, displays, and allows interaction with digital images. This aligns with image processing and visualization, not with in vitro testing.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.

IVD devices are specifically designed to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. Vitrea's function is centered around the interpretation and manipulation of medical images, which are generated by imaging modalities like MRI, CT, etc., not from biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Vitrea is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea is not meant for primary image Interpretation in mammography.

Product codes (comma separated list FDA assigned to the subject device)

LLZ

Device Description

Vitrea is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices.

The Vitrea system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including:

Retrieve image data over the network via DICOM ●
Display images that are automatically adapted to exam type via dedicated protocols ●
Select images for closer examination from a gallery of up to six 2D or 3D views
Interactively manipulate an image in real-time to visualize anatomy and pathology ●
Annotate, tag, measure, and record selected views
Output selected views to standard film or paper printers, or post a report to an intranet web server or export views to another DICOM device
. Retrieve reports that are archived on a Web server

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

multi-dimensional digital images acquired from a variety of imaging devices.

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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 Vitrea software were designed, and tested according to written procedures that included applying risk management. Software testing was completed to ensure the new feature operates according to its requirements.

The following design control measures were applied to the development of the Vitrea Software:

. Risk Management
Requirements Reviews ●
o Code Designs
Code Development Testing o
Code Reviews
Design Reviews
Verification of the Software ●

Risk Management:
Each risk pertaining to these modifications has been individually assessed to determine if the benefits outweigh the risk. Every risk has been reduced as low as possible. Based on Post Market information and because of the risk control measures included in these modifications, it is believed that the risk for these modifications as a whole is extremely low.

Verification:
The software verification team's primary goal was to assure that the software fully satisfies all expected system requirements and features. Test cases were executed against the system features and requirements. As a part of creating the test cases, the verification team reviewed and monitored the Requirements Traceability Matrix ("RTM") to ensure coverage of the items within the RTM.

Summary of Clinical Tests:
The subject of special 510(k) notification, Vitrea software, did not require clinical studies to support safety and effectiveness of the software.

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.

K071331

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

Regulation Number and Section

§ 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).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The graphic is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 5, 2015

Vital Images, Inc. % Parthiv Shah Sr. Regulatory Affairs Specialist 5850 Opus Parkway, Suite 300 MINNETONKA MN 55343

Re: K150258

Trade/Device Name: Vitrea®, Version 7.0 Medical Image Processing Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 4, 2015 Received: February 5, 2015

Dear Parthiv Shah:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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)

Device Name

Vitrea®, Version 7.0 Medical Image Processing Software

Indications for Use (Describe)

Vitrea is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea is not meant for primary image Interpretation in mammography.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the word "VITAL" in large, bold, black letters. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. The text is centered below the word "VITAL".

510(k) Summary

This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part 807.92(c)

| Purpose of
Submission: | Vital Images, Inc. hereby submits this special 510(k) to provide a
notification submission for proposed software changes in the already
510(k) cleared Vitrea software (K071331). |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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: | Special |
| Summary Date: | February 3, 2015 |
| Device Trade Name: | Vitrea, Medical Image Processing Software |
| Other Device Trade
Names: | Vitrea Enterprise Suite, VitreaCore, VitreaAdvanced, VitreaAdvanced fX,
VitreaWorkstation, VitreaWorkstation fX, VitreaExtend |
| Device Common
Name: | Radiological Image Processing Software |
| Device
Classification
Name: | System, Image Processing, Radiological |
| Regulatory
Description: | Picture Archiving and Communications System |
| 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 large, bold, black letters. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The word "VITAL" is the main focus of the image, with the company affiliation provided as additional context.

Predicate Device:

Predicate Device	Manufacturer	FDA 510(k) number
Vitrea, Medical Image
Processing Software,
Version 4.0
(Legally Marketed Device)	Vital Images, Inc.	K071331

Device Description:

Vitrea is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices.

The Vitrea system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including:

Retrieve image data over the network via DICOM ●
Display images that are automatically adapted to exam type via dedicated protocols ●
Select images for closer examination from a gallery of up to six 2D or 3D views
Interactively manipulate an image in real-time to visualize anatomy and pathology ●
Annotate, tag, measure, and record selected views
Output selected views to standard film or paper printers, or post a report to an intranet web server or export views to another DICOM device
. Retrieve reports that are archived on a Web server

Intended Use / Indications for Use:

Vitrea is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea is not meant for primary image interpretation in mammography.

Scope of Changes:

Vital Images is replacing / updating some components of Vitrea platform to utilize enhancements in software technology for better performance of the Vitrea software.

| # | Replaced Software Component
(Version 7.0) | Rationale for
Changes |
|---|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| 1 | Product Infrastructure
It is a collection of non-clinical applications that work on top of
the platform to provide common functions and assist with
overall workflow. | Redesigned for better
user experience and
support for web-based
applications. |
| # | Replaced Software Component
(Version 7.0) | Rationale for
Changes |
| | New Components: | |
| | Vitrea Client (AppShell):
Launches other applications and embeds the applications
within a common window. | |
| | Hosts product applications that allow the users to view the
Study List and launch various applications with DICOM data. | |
| | Study List:
Displays the list of patient data received from DICOM
modalities, associated evidence for patient studies, and
available applications to load data into. | |
| | 2 | |
| | Enhanced features: | application integration. |
| | Application Management:
Application Management is a key feature of the platform,
which is designed to let applications be installed, registered,
and licensed independently of the platform. | |
| | The AppManager component is also responsible for lifecycle
management (startup and shutting down idle/abandoned
sessions) for launched applications. | |
| | User Management:
User Management provides authentication and authorization,
auditing, user preferences, roles & group
management. These can be configured directly within the
platform, or integrated to external user management systems
such as Active Directory. | |
| | Data Access:
Data Access features include DICOM search, evidence
management, temporary data management, UID generation,
and session save/restore. | |
| | Systems Management: Systems Management consists of
system settings, configuring DICOM endpoints, installing
licenses, and configuring network security settings. | |
| # | Replaced Software Component
(Version 7.0) | Rationale for
Changes |
| | Workflow:
Workflow is an anticipatory processing feature which allows
applications to register for and perform batch processing when
new data arrives; for example extracting data from structure
reports, generating alternate representations (e.g. MPR
projections, bone removal), image analysis. | |
| 3 | CPU-Based Rendering Engine
A CPU-based rendering engine performs rendering using CPU
only. It does not require a GPU card to be present on the
system. In order to support deployments those do not have
GPU hardware or do not have access to GPU hardware, such
as virtual deployments, it is important to have a CPU-based
rendering engine.

New Component:

We have introduced an additional CPU-based rendering
engine. It is a software-based rendering engine used for
rendering patient data in clinical applications. | Newly added
rendering engine for
CPU rendering
support use for virtual
deployments. |
| 4 | DICOM Cache
This component keeps a local copy of DICOM images
received from PACS and/or modalities in order to provide fast
access for user applications to enable a good user
experience.

New Components:

Vitrea Information Management System (VIMS):
The VIMS is the communicator to the world outside the Vitrea
station. It connects to other systems via the DICOM standard.

VIMS is a separate process running on the Vitrea station that
is independent of the Vitrea application.

Communication to and from VIMS is done via Web Services.

The key features are DICOM receive (multi-byte data set
support), DICOM Export, Volume building, and DICOM print.

MINT:
The Medical Imaging Network Transport (MINT) protocol is a
server component for accessing DICOM data through web
services. | Replaced the old ECF
component for better
user experience and
improved functionality. |

Software Platform Components:

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Image /page/5/Picture/0 description: The image shows the word "VITAL" in bold, black letters. Below the word is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The logo is simple and clean, with a focus on the company name and affiliation.

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Image /page/6/Picture/0 description: The image shows the word "VITAL" in large, bold, black letters. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. The text is centered below the word "VITAL".

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Image /page/7/Picture/0 description: The image shows the word "VITAL" in large, bold, black letters. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. The logo appears to be a company logo.

Software Deployment:

| # | New Deployment
(version 7.0) | Reason for Changes |
|---|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| 5 | Multiple User Workstation Deployment
New Deployment:
Multi-user multi-modality departmental deployment of the
workstation, which allows multiple concurrent user access to
the workstation at the same time without degrading the
performance. | To extend the
capabilities of the
workstation to multiple
(currently up to 3)
concurrent users. |

Intended for Disease / Condition / Patient Population:

Vitrea system is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Therefore intended disease, conditions, or patient population information is not applicable.

Substantial Equivalence Comparison:

| Criteria | Legally Marketed Device
Vitrea, Medical Image
Processing Software,
version 4.0
(K071331)
(Predicate Device) | Modified Subject Device
Vitrea, Medical Image
Processing Software,
version 7.0 | Comparison |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|------------|
| Device Type /
Classification
Name | System, Image Processing,
Radiological | System, Image Processing,
Radiological | Same |
| Common
Name | Radiological Image
Processing Software | Radiological Image
Processing Software | Same |
| Regulation /
Classification
Number | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
| Product Code | LLZ | LLZ | Same |
| Classification | Class II | Class II | Same |
| Review Panel | Radiology | Radiology | Same |

● Regulatory Comparison

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Image /page/8/Picture/0 description: The image shows the word "VITAL" in large, bold, black letters. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. The word "VITAL" is the main focus of the image, with the company affiliation provided as additional context.

| Criteria | Legally Marketed Device
Vitrea, Medical Image
Processing Software,
version 4.0
(K071331)
(Predicate Device) | Modified Subject Device
Vitrea, Medical Image
Processing Software,
version 7.0 | Comparison |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for
Use | Vitrea is a medical diagnostic
system that allows the
processing, review, analysis,
communication and media
interchange of multi-
dimensional digital images
acquired from a variety of
imaging devices. Vitrea is not
meant for primary image
interpretation in
mammography. | Vitrea is a medical diagnostic
system that allows the
processing, review, analysis,
communication and media
interchange of multi-
dimensional digital images
acquired from a variety of
imaging devices. Vitrea is not
meant for primary image
interpretation in
mammography. | Same |

Intended Use Comparison ●

Device Description Comparison ●

| Device Description | Legally Marketed
Device
Vitrea, Medical
Image
Processing
Software,
version 4.0
(K071331)
(Predicate Device) | Modified
Subject Device
Vitrea, Medical
Image
Processing
Software,
version 7.0 | Comparison |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|------------|
| General Description: | | | |
| The Vitrea 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. | Same | Same | Same |
| Device Description | Legally Marketed
Device
Vitrea, Medical
Image
Processing
Software,
version 4.0
(K071331)
(Predicate Device) | Modified
Subject Device
Vitrea, Medical
Image
Processing
Software,
version 7.0 | Comparison |
| The Vitrea system provides multi-
dimensional visualization of digital
images to aid clinicians in their analysis
of anatomy and pathology. | Same | Same | Same |
| The Vitrea system user interface follows
typical clinical workflow patterns to
process, review, and analyze digital
images. | Same | Same | Same |
| Key Features: | | | |
| Retrieve image data over the network
via DICOM. | Same | Same | Same |
| Display images that are automatically
adapted to exam type via dedicated
protocols. | Same | Same | Same |
| Select images for closer examination
from a gallery of up to six 2D or 3D
views. | Same | Same | Same |
| Interactively manipulate an image in
real-time to visualize anatomy and
pathology. | Same | Same | Same |
| Annotate, tag, measure, and record
selected views. | Same | Same | Same |
| Output selected views to standard film
or paper printers, or post a report to an
intranet Web server or export views to
another DICOM device | Same | Same | Same |
| Retrieve reports that are archived on a
Web server. | Same | Same | Same |
| Software Functionality | Legally Marketed
Device
Vitrea, Medical
Image
Processing
Software,
version 4.0
(K071331)
(Predicate Device) | Modified
Subject Device
Vitrea, Medical
Image
Processing
Software,
version 7.0 | Comparison |
| General Features: | | | |
| Selection and loading a patient study
Component: "Study Directory" (old
name) / "AppShell / Vitrea Client and
Study List" (new name) | Same | Same | Same |
| Selection of protocol and preset for
patient study
Component: Gallery Window | Same | Same | Same |
| Visualization and analysis of patient
study
Component: Viewer Window | Same | Same | Same |
| Allows access to the visual, analysis,
and batch pages
Component: Viewer Window | Same | Same | Same |
| Segment, trim, sculpt, perform
measurements, and change display
settings
Component: Viewer Window | Same | Same | Same |
| Record images, batches of images, and
movies for physician reporting
Component: Viewer Window | Same | Same | Same |
| Creation of a report for the patient
study) data publishing and archiving
Component: Report Window | Same | Same | Same |
| Software Functionality | Legally Marketed
Device
Vitrea, Medical
Image
Processing
Software,
version 4.0
(K071331)
(Predicate Device) | Modified
Subject Device
Vitrea, Medical
Image
Processing
Software,
version 7.0 | Comparison |
| Review of report for any patient study
Component: Report Window | Same | Same | Same |
| Help on Vitrea software
Component: Help Window | Same | Same | Same |
| DICOM Compliance and Data
Management | Same | Same | Same |
| Data Security and HIPAA Compliance | Same | Same | Same |
| Picture Achieving and Communication
System (PACS) Information Sharing | Same | Same | Same |
| Multi-vendor scanner compatibility | Same | Same | Same |
| Integrated 2D and 3D visualization
measurements | Same | Same | Same |
| Interactive navigation in 3D | Same | Same | Same |
| Large data set capability, including the
ability to render multi-detector
computed tomography (MDCT) data | Same | Same | Same |
| Multi-modality Support | Same | Same | Same |
| Vitrea Basic Clinical Toolset: | | | |
| Retrieve image data over the network | Same | Same | Same |
| Display images that are automatically
adapted to exam type via dedicated
protocols | Same | Same | Same |
| Software Functionality | Legally Marketed
Device
Vitrea, Medical
Image
Processing
Software,
version 4.0
(K071331)
(Predicate Device) | Modified
Subject Device
Vitrea, Medical
Image
Processing
Software,
version 7.0 | Comparison |
| Select images for closer examination
from a gallery of up to six 2D or 3D
views | Same | Same | Same |
| Interactively manipulate an image in
real-time to visualize anatomy and
pathology | Same | Same | Same |
| Annotate, tag, measure, and record
selected views | Same | Same | Same |
| Output selected views to standard film
or paper printers, or post a report to an
Intranet | Same | Same | Same |
| Study List (old name- Study Directory Window): | | | |
| Automatic reading and display of
demographic and scanner information
including Patient, ID, Date, Time,
Series, Modality, Exam Type,
Thickness/Spacing, and the number of
images in the series | Same | Same | Same |
| Each patient entry can include multiple
series of image data | Same | Same | Same |
| Fully sortable listing of all studies
present on the system to optimize data
searching and selection for users, along
with user-specific filters | Same | Same | Same |
| Preview of an image of the selected
series to ensure its applicability | Same | Same | Same |
| Customization of the layout of study list
to each user's personal preference | Same | Same | Same |
| Software Functionality | Legally Marketed
Device
Vitrea, Medical
Image
Processing
Software,
version 4.0
(K071331)
(Predicate Device) | Modified
Subject Device
Vitrea, Medical
Image
Processing
Software,
version 7.0 | Comparison |
| Series thumbnail display indicating
available series | Same | Same | Same |
| Display of selected images, series, or
entire study and loading of multiple
series or studies for simultaneous
analysis and review | Same | Same | Same |
| Direct launch into 2D or 3D workflow for
a study or series | Same | Same | Same |
| Display image findings and reports in
the Evidence Manager | Same | Same | Same |
| Retrieve reports that are archived on a
Web server | Same | Same | Same |
| Gallery Window: | | | |
| Unique clinical protocols based on
anatomy, workflow, and image type | Same | Same | Same |
| Automatic pre-selection of clinical
protocol of images to exam type, as
indicated in the DICOM header fields | Same | Same | Same |
| Easy selection of up to six independent
2D and 3D views of selected image
data for review, optimized and rendered
based on the clinical protocol | Same | Same | Same |
| Ability to return to the Gallery window at
any time to select other views, or to
select alternative protocols | Same | Same | Same |
| Software Functionality | Legally Marketed Device
Vitrea, Medical Image Processing Software, version 4.0
(K071331)
(Predicate Device) | Modified Subject Device
Vitrea, Medical Image Processing Software, version 7.0 | Comparison |
| Customized presets that can be created in the Viewer window for display and selection in the Gallery window (one custom preset for each view available for any of the protocols) | Same | Same | Same |
| Viewer Window: | | | |
| A choice of four 2D review and four 3D display formats, as well as a 2D "All Exams" comparative viewer that allows the user to display up to nine series on the screen at once | Same | Same | Same |
| Pick tabs in both 2D comparative and 2D montage formats, allowing the user to change the orientation of the image views and the order of the series displayed in comparative viewing | Same | Same | Same |
| Simultaneous view of 3D volume-rendered projections and correlated multi-planar reformatted projections (MPRs) | Same | Same | Same |
| Orthogonal, Oblique, Double Oblique, and Curved MPRs | Same | Same | Same |
| Cross-reference lines (Crosshairs) to identify and correlate point of interest in all 2D and 3D views | Same | Same | Same |
| Ability to navigate, scroll, pan, cine, zoom, rotate, flip, invert interactively that lets the user select, edit, measure, annotate, and record the optimum 2D and 3D views for diagnosis and reporting | Same | Same | Same |
| Software Functionality | Legally Marketed
Device
Vitrea, Medical
Image
Processing
Software,
version 4.0
(K071331)
(Predicate Device) | Modified
Subject Device
Vitrea, Medical
Image
Processing
Software,
version 7.0 | Comparison |
| Navigation through or around the 3D
view selected (Fly-around, Fly-through,
Point-of-interest) | Same | Same | Same |
| Adjustment of window/level on screen
interactively | Same | Same | Same |
| Adjustment of a broad range of imaging
controls and displays such as rendering
(Normal, Min/Max Intensity Projections),
brightness, contrast, shading,
transparency, and color | Same | Same | Same |
| Image segmentation using any of
several segmentation methods
(trimming, freehand/box sculpting, semi-
automated vessel inclusion/bone
removal based on threshold and
connectivity) | Same | Same | Same |
| Variable size slab reformat and
rendering | Same | Same | Same |
| Annotation of the images with
embedded 3D arrows and text | Same | Same | Same |
| Distance measurements using ruler and
area and volume measurements using
ellipse or freehand ROI | Same | Same | Same |
| Keyboard shortcuts for many functions | Same | Same | Same |
| Creation of custom visualization presets
to appear in the Gallery Tab | Same | Same | Same |
| Software Functionality | Legally Marketed
Device
Vitrea, Medical
Image
Processing
Software,
version 4.0
(K071331)
(Predicate Device) | Modified
Subject Device
Vitrea, Medical
Image
Processing
Software,
version 7.0 | Comparison |
| Recording of selected views
(snapshots) for report generation and to
allow return to the same view at a later
time to continue the work done
previously; ability to record a multi-
volume snapshot for cases when
multiple series or volumes have been
loaded simultaneously | Same | Same | Same |
| Batch creation functionality that allows
2D, 3D, or 3D fly through batched
images or movies to print or be sent to
the report page | Same | Same | Same |
| Report Application: | | | |
| Report configuration in 1-on-1,4-on-1,
9-on-1, 12-on-1, 16-on-1, 20-on-1 and
24-on-1 image formats | Same | Same | Same |
| Report header that includes user
configurable information such as
Institution Name, Patient ID, Patient
Name, Referring Physician, Reading
Physician, Exam Type, Modality, Scan
Date, and Scan Time | Same | Same | Same |
| Inclusion or deletion of patient and
hospital information for filming purposes | Same | Same | Same |
| Slide Tray containing snapshots,
batches, and movies saved in the
Viewer window | Same | Same | Same |
| Snapshot restoration | Same | Same | Same |
| Movie preview | Same | Same | Same |
| Software Functionality | Legally Marketed
Device
Vitrea, Medical
Image
Processing
Software,
version 4.0
(K071331)
(Predicate Device) | Modified
Subject Device
Vitrea, Medical
Image
Processing
Software,
version 7.0 | Comparison |
| Electronic posting of reports to a Web
server | Same | Same | Same |
| Printing of the report on DICOM or
Postscript® format printers, exporting to
a DICOM image archive, posting on
Vitrea software's web server, recording
on a CD or a DVD, or exporting to a MS
Word document with a defined template | Same | Same | Same |
| Evidence Manager (old name- Review Window): | | | |
| Allows the user to view published Image
/ batch finding reports and related digital
movies | Same | Same | Same |
| Help Window: | | | |
| Provides on-line help manual, quick
reference and index in HTML format or
as PDF documents | Same | Same | Same |
| DICOM Data Management: | | | |
| DICOM conformance | Same | Same | Same |
| DICOM Storage as SCU & SCP
(receive and push) | Same | Same | Same |
| DICOM query/retrieve SCU (pulling
images from other DICOM devices) | Same | Same | Same |
| DICOM query/retrieve SCP (can serve
images to other vendor workstations) | Same | Same | Same |
| DICOM Connection Management | Same | Same | Same |
| Software Functionality | Legally Marketed
Device
Vitrea, Medical
Image
Processing
Software,
version 4.0
(K071331)
(Predicate Device) | Modified
Subject Device
Vitrea, Medical
Image
Processing
Software,
version 7.0 | Comparison |
| Save & Send images in DICOM | Same | Same | Same |
| PACS Interface: | | | |
| Provides an API targeting PACS
vendors for usage, and a new level of
integration in which Vitrea data can be
automatically (or more easily) stored
back to the PACS station | Same | Same | Same |
| Data Security and HIPAA Compliance: | | | |
| Software can de-identify patient data,
removing patient name and information
from the image | Same | Same | Same |
| Software controls workstation access
and reporting security | Same | Same | Same |
| Authentication and access controls
require users to enter a confidential
password to view both patient studies
and reports | Same | Same | Same |
| An audit log automatically records user
access, privilege, and operations | Same | Same | Same |
| Secured access (NT or domain -Login) | Same | Same | Same |
| User group preference and access
control | Same | Same | Same |

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Image /page/9/Picture/0 description: The image shows the word "VITAL" in black font. Below the word, in a smaller red font, is the text "A Toshiba Medical Systems Group Company". The text is centered below the word "VITAL".

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Image /page/10/Picture/0 description: The image shows the word "VITAL" in large, bold, black letters. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. The text is centered below the word "VITAL".

● Similarities in Technology

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Image /page/11/Picture/0 description: The image shows the word "VITAL" in large, bold, black letters. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. The text is centered below the word "VITAL".

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Image /page/14/Picture/0 description: The image shows the word "VITAL" in large, bold, black letters. Below the word, in smaller red letters, is the text "A Toshiba Medical Systems Group Company". The text is centered below the word "VITAL".

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Image /page/15/Picture/0 description: The image shows the word "VITAL" in black font. Below the word, in a smaller red font, is the text "A Toshiba Medical Systems Group Company". The text is centered below the word "VITAL".

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Image /page/16/Picture/0 description: The image shows the word "VITAL" in black font. Below the word, in a smaller red font, is the text "A Toshiba Medical Systems Group Company". The text is centered below the word "VITAL".

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Image /page/17/Picture/0 description: The image shows the word "VITAL" in black font. Below the word, in a smaller red font, is the text "A Toshiba Medical Systems Group Company". The text is centered below the word "VITAL".

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Image /page/18/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 text is centered.

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Image /page/19/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.

Differences ●

| Difference | Legally Marketed
Device
Vitrea, Medical
Image
Processing
Software,
version 4.0
(K071331)
(Predicate Device) | Modified Subject
Device
Vitrea, Medical
Image
Processing Software,
version 7.0 | Rationale for
Changes | Comparison |

------------	-------------------------------------------------------------------------------------------------------------------------------------	-----------------------------------------------------------------------------------------------	--------------------------	------------

Product Infrastructure

It is a collection of non-clinical applications that work on top of the platform to provide common functions and assist with overall workflow.

Functionality: Retrieve and load image data over the network or from datasets previously uploaded to the workstation.

| Difference:
Replacement of
software
component.
Note: Only
component is
replaced, no
change in basic
functionality. | Study Directory:
The Study Directory
window lets the user
retrieve and load
image data over the
network or from
datasets previously
uploaded to the
workstation. | Vitrea Client:
It launches other
applications and
embeds the
applications within a
common window.
It hosts application for
the product that allows
the user to view the
Study List and launch
various applications
with DICOM data.
Study List:
It displays the list of
patient data received
from DICOM
modalities, associated
evidence for patient
studies, and available
applications to load
data into. | Replaced the
old "Study
Directory"
component for
better user
experience and
support for
web-based
applications. | The
replacement
does not
affect the
intended use
or
fundamental
scientific
technology of
already
cleared
Vitrea
software
(K071331). |

--------------------------------------------------------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	-----------------------------------------------------------------------------------------------------------------------------------------	----------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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Image /page/20/Picture/0 description: The image shows the word "VITAL" in large, bold, black letters. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. The text is centered below the word "VITAL".

| Difference | Legally Marketed
Device
Vitrea, Medical
Image
Processing
Software,
version 4.0
(K071331)
(Predicate Device) | Modified Subject
Device
Vitrea, Medical
Image
Processing Software,
version 7.0 | Rationale for
Changes | Comparison |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Vitrea Services Platform (VSP)
It is a basic service platform for managing patient data, applications, licensing, and configuration.
Functionality: Managing patient data, applications, licensing, and configuration. | | | | |
| Difference:
Redesign of
software
component.
Note: No
change in basic
functionality. | Vitrea Services
Platform:
It is a basic service
platform for
managing patient
data, applications,
licensing, and
configuration. | Modified Vitrea
Services Platform:
It is a basic service
platform for managing
patient data,
applications, licensing,
and configuration.
Enhanced features:
• Application
Management
• User Management
• Data Access
• System
Management
• Workflow | Redesigned to
improve
manageability
and simplify
application
integration. | The
replacement
does not
affect the
intended use
or
fundamental
scientific
technology of
already
cleared
Vitrea
software
(K071331). |
| CPU-Based Rendering Engine
Functionality: A CPU-based rendering engine performs rendering using CPU only. It does not | | | | |
| require a GPU card to be present on the system. In order to support deployments that do not have
GPU hardware or do not have access to GPU hardware, such as virtual deployments, it is
important to have a CPU-based rendering engine. | | | | |
| Difference:
Addition of new
CPU-based
rendering
engine. | No CPU rendering
support.
Note: Vitrea 4.0 had
only GPU rendering
support. | New Component:
We have introduced
an additional CPU-
based rendering
engine. It is a
software-based
rendering engine used
for rendering patient
data in clinical
applications. | Newly added
rendering
engine for CPU
rendering
support use for
virtual
deployments. | The CPU
rendering
engine was
designed to
mirror the
behavior of
the GPU
rendering in
both image
quality and
performance. |
| Difference | Legally Marketed
Device
Vitrea, Medical
Image
Processing
Software,
version 4.0
(K071331)
(Predicate Device) | Modified Subject
Device
Vitrea, Medical
Image
Processing Software,
version 7.0 | Rationale for
Changes | Comparison |
| | | | | Although they
are not
identical, the
differences
are mostly
cosmetic and
do not affect
the intended
use or
fundamental
scientific
technology of
already
cleared
Vitrea
software
(K071331). |
| DICOM Cache | | | | |

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Image /page/21/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 text is centered and the word "VITAL" is the main focus of the image.

Functionality: This component keeps a local copy of DICOM images received from PACS and/or modalities, in order to provide fast access for user applications to enable a good user experience.

| Difference:
Replacement of
software
component.

Note: Only
component is
replaced, no
change in basic
functionality. | External
Communications
Framework (ECF):
The ECF is the
communicator to the
world outside the
Vitrea Workstation.
It connects to other
systems via the
DICOM standard.

ECF is a separate
process running on
the Vitrea
Workstation that is
independent of the | Vitrea Information
Management System
(VIMS):
The VIMS is the
communicator to the
world outside the
Vitrea Workstation. It
connects to other
systems via the
DICOM standard.

VIMS is a separate
process running on
the Vitrea Workstation
that is independent of
the Vitrea application. | Replaced the
old ECF
component for
better user
experience and
improved
functionality. | The
replacement
does not
affect the
intended use
or
fundamental
scientific
technology of
already
cleared
Vitrea
software
(K071331). |

-------------------------------------------------------------------------------------------------------------------------------------------------------	-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	---------------------------------------------------------------------------------------------------------	----------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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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 circle.

| Difference | Legally Marketed
Device
Vitrea, Medical
Image
Processing
Software,
version 4.0
(K071331)
(Predicate Device) | Modified Subject
Device
Vitrea, Medical
Image
Processing Software,
version 7.0 | Rationale for
Changes | Comparison | | | |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|
| | Vitrea application.
Communication to
and from ECF is
done via inter-
process messages
(through a CORBA-
based interface) and
not direct calls to
binary code. | Communication to and
from VIMS is done via
Web Services.
The key features are
DICOM receive (multi-
byte data set support),
DICOM Export,
Volume building, and
DICOM print.
MINT:
The Medical Imaging
Network Transport
(MINT) protocol is a
server component for
accessing DICOM
data through web
services. | | | | | |
| Multiple User Workstation Deployment | | | | | | | |
| Difference:
Addition of type
of software
deployment. | No Multiple User
workstation support | Multiple User
Workstation
Deployment
New Deployment.
Multi-user multi-
modality departmental
deployment of the
workstation, which
allows multiple
concurrent user
access to the
workstation at the
same time without
degrading the
performance. | To extend the
capabilities of
the workstation
to multiple
users. | The addition
of new
deployment
does not
affect the
intended use
or
fundamental
scientific
technology of
already
cleared
Vitrea
software
(K071331). | | | |

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Image /page/23/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.

Summary of Non-Clinical Tests:

The changes to the Vitrea software were designed, and tested according to written procedures that included applying risk management. Software testing was completed to ensure the new feature operates according to its requirements.

The following design control measures were applied to the development of the Vitrea Software:

. Risk Management
Requirements Reviews ●
o Code Designs
Code Development Testing o
Code Reviews
Design Reviews
Verification of the Software ●

Risk Management:

Each risk pertaining to these modifications has been individually assessed to determine if the benefits outweigh the risk. Every risk has been reduced as low as possible. Based on Post Market information and because of the risk control measures included in these modifications, it is believed that the risk for these modifications as a whole is extremely low.

Verification:

The software verification team's primary goal was to assure that the software fully satisfies all expected system requirements and features. Test cases were executed against the system features and requirements. As a part of creating the test cases, the verification team reviewed and monitored the Requirements Traceability Matrix ("RTM") to ensure coverage of the items within the RTM.

Summary of Clinical Tests:

The subject of special 510(k) notification, Vitrea software, did not require clinical studies to support safety and effectiveness of the software.

Cyber and Information Security:

Confidentiality .
The Vitrea platform relies on built-in Windows Login security to limit access to the system. The Vitrea platform can only be installed and configured by an administrator of the Windows machine.

Integrity o

The Vitrea platform complies with the DICOM standard for transfer and storage of this data and does not modify the contents of DICOM instances. New DICOM produced by Vitrea is identified as such with the appropriate manufacturer tags per the DICOM standard.

o Availability
The Vitrea platform is always available to the logged on user as long as the Windows machine itself is properly maintained.

● Accountability

The Vitrea platform includes an audit capability that enables accountability by tracking authenticated and authorized user operations along with information accessed. Vitrea audit logs are time stamped, enabling correlation with Windows system logging to track information accessed by a user.

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Image /page/24/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 letters of "VITAL" are spaced apart, and the dot above the "i" is a perfect circle.

Performance Standards:

The FDA has not established mandatory performance standards and no special controls exist for this device. General software verification and validation tests were conducted to confirm proper function of the device's features.

| Standard No. | Standards
Organization | Standard Title | Version | Date |
|---------------------------------------------------------|---------------------------|-------------------------------------------------------------------------------------------|---------|------------|
| PS 3.1-3.20
(2011)
(Recognition
Number 12-238) | NEMA | Digital Imaging and
Communications in
Medicine (DICOM) Set
(Radiology) | 3 | 03/16/2012 |
| ISO 14971:2007
(Recognition
Number 5-70) | AAMI / ANSI
/ ISO | Medical Devices -
Applications of Risk
Management to Medical
Devices | 2007 | 03/16/2012 |
| IEC 62304:2006
(Recognition
Number 13-32) | AAMI / ANSI
/ IEC | Medical Device Software -
Software Life Cycle
Processes (Software /
Informatics) | 2006 | 08/20/2012 |

The Vitrea software complies with the following voluntary recognized consensus standards:

Substantial Equivalence Analysis Conclusion:

The minor software enhancements do not affect the intended use or alter the fundamental scientific technology of legally marketed Vitrea software (K071331). The modified Vitrea software has the same indications for use, principle of operation, and performs the same technological functions as already cleared Vitrea software - K071331 (Predicate Device). The modifications are not consequential from the standpoint of device operation, safety, effectiveness or intended use.

Any minor differences noted have been explained and do not raise any new questions of safety or effectiveness when used as labeled. The implemented design mitigations, labeling, and the performed verification and validation tests demonstrate the safety and efficacy of the device is equivalent to the predicate device. Based on the comparison data and test data. Vital Images believes the subject device should be found substantially equivalent to the predicate device.