K Number
K172855
Device Name
Vitrea Advanced Visualization, Version 7.6
Manufacturer
Date Cleared
2017-10-05

(15 days)

Product Code
Regulation Number
892.2050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
Device Description
The Vitrea Advanced Visualization software 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 Advanced Visualization system provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The Vitrea Advanced Visualization user interface follows typical clinical workflow patterns to process, review, and analyze digital images, including: - Retrieve image data over the network via DICOM - Display of images in dedicated protocols which are automatically adapted based on exam type - Select images for closer examination from a gallery of 2D or 3D views - Interactively manipulate an image in real-time to visualize anatomy and pathology - Annotate, 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
More Information

Not Found

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

No

Explanation: The device is described as a "medical diagnostic system" and its function is to process, review, and analyze digital images to aid clinicians in their analysis of anatomy and pathology. It does not provide any form of therapy or treatment.

Yes
The device is explicitly described as a "medical diagnostic system" in multiple sections of the provided text, including "Intended Use / Indications for Use" and "Device Description".

Yes

The device description explicitly states "The Vitrea Advanced Visualization software is a medical diagnostic system..." and details its functions as software-based processing, review, and analysis of digital images. There is no mention of accompanying hardware components included with the device itself.

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

Here's why:

  • IVD definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for diagnostic purposes.
  • Device description: The Vitrea system processes, reviews, and analyzes digital images acquired from imaging devices (like CT, MRI, etc.). It does not interact with or analyze biological specimens.
  • Intended Use: The intended use is for processing, review, analysis, communication, and media interchange of multi-dimensional digital images. This aligns with medical imaging analysis, not in vitro testing.

Therefore, the Vitrea Advanced Visualization software falls under the category of medical image processing and analysis software, not an In Vitro Diagnostic device.

N/A

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

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

  • Retrieve image data over the network via DICOM ●
  • Display of images in dedicated protocols which are automatically adapted based on exam ● type
  • . Select images for closer examination from a gallery of 2D or 3D views
  • Interactively manipulate an image in real-time to visualize anatomy and pathology ●
  • Annotate, 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

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Qualified healthcare professionals including, but not restricted to, radiologists, non-radiology specialists, physicians and technologists.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The changes to the Vitrea Advanced Visualization software were designed, developed, and tested according to written procedures that included risk management. Software verification testing was completed to ensure the new features operate according to defined requirements.

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, requirements and risk mitigations. Verification testing confirmed the software functions according to its requirements and all risk mitigations are functioning properly.

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.

K150258

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).

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected by flowing lines that resemble hair or fabric. The image is surrounded 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

October 5, 2017

Vital Images, Inc. % Ms. Katie Ryan Sr. Regulatory Affairs Specialist 5850 Opus Parkway, Suite 300 MINNETONKA MN 55343-4414

Re: K172855

Trade/Device Name: Vitrea Advanced Visualization, Version 7.6 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 19, 2017 Received: September 20, 2017

Dear Ms. Ryan:

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

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

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

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.

Michael D. O'Hara
For

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172855

Device Name

Vitrea Advanced Visualization, Version 7.6

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510K Summary

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

| Basis for the
Submission: | Vital Images, Inc. hereby submits this special 510(k) to provide a
notification submission for proposed software changes in the already
510(k) cleared Vitrea Advanced Visualization software (K150258) |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Vital Images, Inc.
5850 Opus Parkway, Suite 300
Minnetonka, MN, 55343-4414 |
| Establishment
Registration: | 2134213 |
| Contact Person: | Katie Ryan
Sr. Regulatory Affairs Specialist
Phone: 952-487-9793
Fax: 952-487-9510
E-mail: kryan@vitalimages.com
Alternate Contact Person:
Vince Swenson
Sr. Director of Quality and Regulatory
Phone: 952-487-9548
Fax: 952-487-9510
E-mail: vswenson@vitalimages.com |
| 510(k) Type: | Special |
| Summary Date: | October 4, 2017 |
| Device Trade Name: | Vitrea Advanced Visualization, Version 7.6 |
| Device Common
Name/ Regulatory
Description: | Radiological Image Processing Software |
| 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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Predicate Device(s):

Predicate DeviceManufacturerFDA 510(k) Number
Vitrea®, Version 7.0
Medical Image Processing
SoftwareVital Images, Inc.
5850 Opus Parkway, Suite 300
Minnetonka, MN 55343K150258

Device Description:

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

  • Retrieve image data over the network via DICOM ●
  • Display of images in dedicated protocols which are automatically adapted based on exam ● type
  • . Select images for closer examination from a gallery of 2D or 3D views
  • Interactively manipulate an image in real-time to visualize anatomy and pathology ●
  • Annotate, 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.

Intended for Disease / Condition / Patient Population:

Vitrea Advanced Visualization 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.

Key Changes from last 510k clearance K150258

The following list contains the key changes since the last 510k. These changes were made to improve user experience, performance and regulatory compliance:

  • . Improvements to the Study List and data launching workflows
  • Enhancements to export and save to media workflows ●
  • Reporting enhancements for printing ●
  • Support for STL file generation and exporting (output anatomical model is not for diagnostic use)
  • Improved efficiency and performance of data handling
  • Licensing enhancements
  • High resolution monitor support ●

009 510(k) Summary

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  • System Health and Performance monitoring tool ●
  • Enhancements to PACS integrations and workflows ●
  • . Support for upgrades
  • Display of the UDI for Vitrea Advanced Visualization .
  • . Addition of Vitrea Extend and Vitrea Enterprise deployments

Substantial Equivalence Comparison:

Regulatory Comparison:

Subject DevicePredicate Device
CharacteristicVitrea Advanced
Visualization
Version 7.6Vitrea Software
Version 7.0
(K150258)Comparison
Classification NameSystem, Image
Processing,
RadiologicalSystem, Image
Processing,
RadiologicalSame
Regulatory Number892.2050892.2050Same
Product CodeLLZLLZSame
ClassificationClass IIClass IISame
Review PanelRadiologyRadiologySame
Decision DateUnder ReviewMarch 5, 2015Predicate device
is cleared

Indications for Use Comparison with Predicate Device:

Subject DevicePredicate Device
CriteriaVitrea Advanced
Visualization
Version 7.6Vitrea Software
Version 7.0 (K150258)Comparison
Indications for
UseVitrea 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 UsersQualified healthcare
professionals including, but
not restricted to, radiologists,
non-radiology specialists,Qualified healthcare
professionals including, but
not restricted to,
radiologists, non-radiologySame

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CriteriaSubject DevicePredicate DeviceComparison
Vitrea Advanced
Visualization
Version 7.6Vitrea Software
Version 7.0 (K150258)
physicians and
technologists.specialists, physicians and
technologists.

Similarities in Technology with Predicate Device:

Subject DevicePredicate Device
Software FunctionalityVitrea Advanced
Visualization
Version 7.6Vitrea Software
Version 7.0
(K150258)Comparison
General Features:
Selection and loading a patient study
Component: AppShell / Vitrea Client
and Study ListYesYesSame
Selection of protocol and preset for
patient study
Component: Gallery WindowYesYesSame
Visualization and analysis of patient
study
Component: Viewer WindowYesYesSame
Allows access to the visual, analysis,
and batch pages
Component: Viewer WindowYesYesSame
Segment, trim, sculpt, perform
measurements, and change display
settings
Component: Viewer WindowYesYesSame
Record images, batches of images, and
movies for physician reporting
Component: Viewer WindowYesYesSame
Software FunctionalitySubject Device
Vitrea Advanced
Visualization
Version 7.6Predicate Device
Vitrea Software
Version 7.0
(K150258)Comparison
Creation of a report for the patient
study) data publishing and archiving
Component: Report WindowYesYesSame
Review of report for any patient
study
Component: Report WindowYesYesSame
Help on Vitrea software
Component: Help WindowYesYesSame
DICOM Compliance and Data
ManagementYesYesSame
Data Security and HIPAA
ComplianceYesYesSame
Multi-vendor scanner compatibilityYesYesSame
Integrated 2D and 3D visualization
measurementsYesYesSame
Interactive navigation in 3DYesYesSame
Large data set capability, including
the ability to render multi-detector
computed tomography (MDCT) dataYesYesSame
Multiple User Workstation
DeploymentYesYesSame
Multi-modality SupportYesYesSame
Vitrea Advanced Visualization Basic Clinical Toolset:
Retrieve image data over the networkYesYesSame
Display images that are automatically
adapted to exam type via dedicated
protocolsYesYesSame
Select images for closer examination
from a gallery of up to six 2D or 3D
viewsYesYesSame
Subject DevicePredicate Device
Software FunctionalityVitrea Advanced
Visualization
Version 7.6Vitrea Software
Version 7.0
(K150258)Comparison
Interactively manipulate an image in
real-time to visualize anatomy and
pathologyYesYesSame
Annotate, tag, measure, and record
selected viewsYesYesSame
Output selected views to standard film
or paper printers, or post a report to an
IntranetYesYesSame
Study List:
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 seriesYesYesSame
Each patient entry can include multiple
series of image dataYesYesSame
Fully sortable listing of all studies
present on the system to optimize data
searching and selection for users, along
with user-specific filtersYesYesSame
Preview of an image of the selected
series to ensure its applicabilityYesYesSame
Customization of the layout of study list
to each user's personal preferenceYesYesSame
Series thumbnail display indicating
available seriesYesYesSame
Display of selected images, series, or
entire study and loading of multiple
series or studies for simultaneous
analysis and reviewYesYesSame
Direct launch into 2D or 3D workflow for
a study or seriesYesYesSame
Subject DevicePredicate Device
Software FunctionalityVitrea Advanced
Visualization
Version 7.6Vitrea Software
Version 7.0
(K150258)Comparison
Display image findings and reports in
the Evidence ManagerYesYesSame
Retrieve reports that are archived on a
Web serverYesYesSame
Gallery Window:
Unique clinical protocols based on
anatomy, workflow, and image typeYesYesSame
Automatic pre-selection of clinical
protocol of images to exam type, as
indicated in the DICOM header fieldsYesYesSame
Easy selection of independent 2D and
3D views of selected image data for
review, optimized and rendered based
on the clinical protocolYesYesSame
Ability to return to the Gallery window at
any time to select other views, or to
select alternative protocolsYesYesSame
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)YesYesSame
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 onceYesYesSame
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 viewingYesYesSame
Simultaneous view of 3D volume-
rendered projections and correlatedYesYesSame
Subject DevicePredicate Device
Software FunctionalityVitrea Advanced
Visualization
Version 7.6Vitrea Software
Version 7.0
(K150258)Comparison
multi-planar reformatted projections
(MPRs)
Orthogonal, Oblique, Double Oblique,
and Curved MPRsYesYesSame
Cross-reference lines (Crosshairs) to
identify and correlate point of interest in
all 2D and 3D viewsYesYesSame
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 reportingYesYesSame
Navigation through or around the 3D
view selected (Fly-around, Fly-through,
Point-of-interest)YesYesSame
Adjustment of window/level on screen
interactivelyYesYesSame
Adjustment of a broad range of imaging
controls and displays such as rendering
(Normal, Min/Max Intensity Projections),
brightness, contrast, shading,
transparency, and colorYesYesSame
Image segmentation using any of
several segmentation methods
(trimming, freehand/box sculpting, semi-
automated vessel inclusion/bone
removal based on threshold and
connectivity)YesYesSame
Variable size slab reformat and
renderingYesYesSame
Annotation of the images with
embedded 3D arrows and textYesYesSame
Distance measurements using ruler and
area and volume measurements using
ellipse or freehand ROIYesYesSame
Keyboard shortcuts for many functionsYesYesSame
Subject DevicePredicate Device
Software FunctionalityVitrea Advanced
Visualization
Version 7.6Vitrea Software
Version 7.0
(K150258)Comparison
Creation of custom visualization presets
to appear in the Gallery TabYesYesSame
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 simultaneouslyYesYesSame
Batch creation functionality that allows
2D, 3D, or 3D fly through batched
images or movies to print or be sent to
the report pageYesYesSame
Report Application:
configuration
Report
in
various
reporting displaysYesYesSame
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 TimeYesYesSame
Inclusion or deletion of patient and
hospital information for filming purposesYesYesSame
Slide Tray containing snapshots,
batches, and movies saved in the
Viewer windowYesYesSame
Movie previewYesYesSame
Electronic posting of reports to a Web
serverYesYesSame
Subject DevicePredicate Device
Software FunctionalityVitrea Advanced
Visualization
Version 7.6Vitrea Software
Version 7.0
(K150258)Comparison
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 templateYesYesSame
Evidence Manager:
Allows the user to view published Image
/ batch finding reports and related digital
moviesYesYesSame
Snapshot restorationYesYesSame
Help Window:
Provides on-line help manual, quick
reference and index in HTML format or
as PDF documentsYesYesSame
DICOM Data Management:
DICOM conformanceYesYesSame
DICOM Storage as SCU & SCP
(receive and push)YesYesSame
DICOM query/retrieve SCU (pulling
images from other DICOM devices)YesYesSame
DICOM query/retrieve SCP (can serve
images to other vendor workstations)YesYesSame
DICOM Connection ManagementYesYesSame
Save & Send images in DICOMYesYesSame
Data Security and HIPAA Compliance:
Software FunctionalitySubject Device
Vitrea Advanced
Visualization
Version 7.6Predicate Device
Vitrea Software
Version 7.0
(K150258)Comparison
Software can de-identify patient data,
removing patient name and information
from the imageYesYesSame
Software controls workstation access
and reporting securityYesYesSame
Authentication and access controls
require users to enter a confidential
password to view both patient studies
and reportsYesYesSame
Secured access (NT or domain -Login)YesYesSame
User group preference and access
controlYesYesSame
Vitrea Advanced Visualization Components:
CPU-Based Rendering EngineYesYesSame
Vitrea Information Management
System (VIMS)YesYesSame
Medical Imaging Network Transport
(MINT)YesYesSame
Vitrea Services Platform (VSP)YesYesSame

7

ViTAL

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Image /page/9/Picture/0 description: The image shows the word "VITAL" in black font. The "i" in "VITAL" has a red dot above it. The letters are evenly spaced and the word is centered in the image. The background is white.

10

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11

Vil

12

13

ViTAL

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Image /page/14/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 red. The letters are evenly spaced and the word is centered.

Summary of Non-Clinical Tests:

The changes to the Vitrea Advanced Visualization software were designed, developed, and tested according to written procedures that included risk management. Software verification testing was completed to ensure the new features operate according to defined requirements.

The following design control measures were applied to the development of the Vitrea Advanced Visualization software:

  • Risk Management ●
  • Requirements Reviews ●
  • Code Designs ●
  • Code Development Testing ●
  • Code Reviews ●
  • Design Reviews ●
  • . Verification of the software

Risk Management:

Each risk pertaining to the modifications to the Vitrea Advanced Visualization software has 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. 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. Considering 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:

  • The medical benefits of the device outweigh the residual risk for each individual risk and ● all risks together
  • . All risks have been reduced as low as possible
  • The overall residual risk for the software product 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, requirements and risk mitigations. Verification testing confirmed the software functions according to its requirements and all risk mitigations are functioning properly.

Summary of Clinical Tests:

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

Cyber and Information Security:

The Vitrea Advanced Visualization software follows internal documentation which includes information based on the FDA Guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.

009 510(k) Summary

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Image /page/15/Picture/0 description: The image shows the word "VITAL" in black letters. The "i" in "VITAL" has a red dot above it. The letters are bold and sans-serif. The background is white.

Internal documentation covers the following:

    1. Hazard analysis, mitigations, and design considerations pertaining to intentional and unintentional cybersecurity risks associated with your device, including:
    • A specific list of all cybersecurity risks that were considered in the design of your device:
    • . A specific list and justification for all cybersecurity controls that were established for vour device.
    1. A traceability matrix that links your actual cybersecurity controls to the cybersecurity risks that were considered;
  • A summary describing the plan for providing validated software updates and patches as ဒေ needed throughout the lifecycle of the medical device to continue to assure its safety and effectiveness. The FDA typically will not need to review or approve medical device software changes made solely to strengthen cybersecurity.
    1. A summary describing controls that are in place to assure that the medical device software will maintain its integrity (e.g. remain free of malware) from the point of origin to the point at which that device leaves the control of the manufacturer; and
  • Device instructions for use and product specifications related to recommended 5. cybersecurity controls appropriate for the intended use environment (e.g. anti-virus software, use of firewall).

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.

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

| 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 |

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Image /page/16/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 red. The letters are evenly spaced and the word is centered.

Substantial Equivalence Analysis Conclusion:

Vital Images believes the Vitrea Advanced Visualization software has a similar intended use, indications for use, principle of operation, and technological characteristics as the legally marketed, predicate device Vitrea (K150258).

Furthermore, the verification and validation testing performed demonstrates the subject device is as safe and effective as the predicate device and does not raise any different questions of safety and effectiveness. Therefore, Vital believes the enhancements in the Vitrea Advanced Visualization software do not alter the fundamental scientific technology, safety or intended use of the device.

Each change was evaluated for the impact to the safety and effectiveness of the software. It was concluded that the changes do not raise any different questions of safety or effectiveness when used as labeled. The implemented design controls, risk management activities, labeling, and performed verification and validation tests demonstrate the safety and efficacy of the subject device. Based on the comparison provided above, Vital Images believes the subject device should be found substantially equivalent to the predicate device.