Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a medical image viewing and distribution software with standard viewing and collaboration tools. There is no mention of AI or ML capabilities for image analysis, diagnosis, or workflow optimization. The performance studies focus on image quality validation, not AI/ML performance metrics.

Therapeutic

No.
The device is described as medical image viewing and information distribution software for diagnosis, review, communication, and reporting, not for providing therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the software is used for "diagnosis, review, communication, and reporting of DICOM and non-DICOM data." It also specifies that "Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements." This indicates its role in diagnostic processes, although it also cautions against using it for primary interpretation of lossy compressed mammography and digitized film screen images.

SaMD (Software as a Medical Device)

Yes

The device is described as "Vitrea View software" and a "web-based, cross-platform, zero-footprint enterprise image viewer solution". While it relies on external hardware (computers, tablets, smartphones, and FDA-cleared displays for diagnostic use), the device itself is presented solely as software for viewing and distributing medical images and information. The description focuses on software features and architecture.

IVD (In Vitro Diagnostic)

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

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, or tissue) to provide information for diagnostic purposes.
Vitrea View's Function: The Vitrea View software is a medical image viewing and information distribution system. It accesses, displays, and distributes medical images and related patient information. It does not interact with or analyze biological specimens.
Intended Use: The intended use clearly states it's for "medical image viewing and information distribution" for "diagnosis, review, communication, and reporting of DICOM and non-DICOM data." This is focused on interpreting images, not analyzing biological samples.

Therefore, the Vitrea View software falls under the category of medical image management and viewing software, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Vitrea View software is a medical image viewing and information distribution that provides access, through the internet and within the enterprise to multi-modality softcopy medical images (including mammography and digital breast tomosynthesis), reports, and other patient-related information. This data is hosted within disparate archives and repositories for diagnosis, review, communication, and reporting of DICOM and non-DICOM data.

Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA or displays accepted by the appropriate regulatory agency for the country in which it is used.

Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance.

Vitrea View software is indicated for use by qualified healthcare professionals including, but not restricted to. radiologists, non-radiology specialists, physicians and technologists.

When accessing Vitrea View software from a mobile device, images viewed are for informational purposes only and not intended for diagnostic use.

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

LLZ

Device Description

The Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solution capable of displaying both DICOM and non-DICOM medical images. The Vitrea View software enables clinicians and other medical professionals to access patients' medical images with integrations into a variety of medical record systems, such as Electronic Health Record (EHR), Electronic Medical Record (EMR), Health Information Exchange (HIE), Personal Health Record (PHR), and image exchange systems. The Vitrea View software is a communication tool, which supports the physician in the treatment and planning process by delivering access to images at the point of care.

The Vitrea View software offers medical professionals an enterprise viewer for accessing imaging data in context with reports from enterprise patient health information databases, fosters collaboration, and provides workflows and interfaces appropriate for referring physicians and clinicians. IT departments will not have to install client systems, due to the web-based zero-footbrint nature of the Vitrea View software. The Virea View software offers scalability to add new users as demand grows, and may be deployed in a virtualized environment. Some of the general features include:

. Fast time-to-first-image

Contextual launch integration with single-sign-on ●
. Easy study navigation and search capability
Supports multi-modality vendor-neutral DICOM images
. Supports non-DICOM images
lmages display at full diagnostic quality (with appropriate hardware) ●
. Basic 2D review tools (zoom, pan, measure)
Basic 3D and MPR viewing ●
Radiology key images
. Comparative side-by-side review, regardless of image types
. Collaboration tools
. Leverages traditional DICOM as well as next-generation DICOMweb image transfer protocols
Enables federated access to across multiple data sources across multiple sites ●
. Web-based zero-footprint architecture
Secure Access on various Windows® and Mac computers through standard internet ● browsers
. Secure Access on various iOS®, Android™, and Windows® tablet devices through the device's Internet browser

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

multi-modality softcopy medical images (including mammography and digital breast tomosynthesis)

Anatomical Site

Breast

Indicated Patient Age Range

Not Applicable

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

Mammography Image Quality Validation:
This validation was a multi-reader, multi-case test with four experienced radiologists.
Fifty studies were chosen randomly from existing patient studies obtained over a two-day time-frame at the designated Breast Imaging center.
The radiologists were asked to rate the image quality equivalence of the Vitrea View software on a scale of 1 to 3 compared to the McKesson system for:

Visualization of the adipose and fibroglandular tissue
Visualization of the breast tissue and underlying pectoralis muscle
Image contrast for differentiation of subtle tissue density differences
Sharpness, assessment of the edges of fine linear structures, tissue borders and benign calcifications
Tissue visibility at the skin line
Artifacts due to image processing, detector failure and other external factors to the breast
Overall clinical image quality

Digital Breast Tomosynthesis Image Quality Validation:
This validation was a multi-reader, multi-case test with three experienced radiologists.
Fifty studies were chosen randomly from existing patient studies obtained at the designated Breast Imaging center.
The radiologists were asked to rate the image quality equivalence of the Vitrea View software on a scale of 1 to 3 compared to the Phillips Intellispace Radiology system for:

Visualization of the adipose and fibroglandular tissue
Visualization of the breast tissue and underlying pectoralis muscle
Image contrast for differentiation of subtle tissue density differences
Sharpness, assessment of the edges of fine linear structures, tissue borders and benign calcifications
Tissue visibility at the skin line
Artifacts due to image processing, detector failure and other external factors to the breast
Overall clinical image quality

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

The software was designed, developed, tested, verified, and validated according to written procedures. Verification confirmed that the feature functions according to its requirements.
Software testing was completed to ensure the Vitrea View software functions according to its requirements. Performance testing for the Vitrea View software included internal verification and external validation.

External validation was done to:
a) Establish the substantial equivalence between the Vitrea View software with the McKesson Radiology system ((K140909) reference device) to modify the current Vitrea View software indications to include viewing of diagnostic mammography images.
b) Establish the substantial equivalence between the Vitrea View software with the Phillips Intellispace Radiology system ((K111804) reference device) to modify the current Vitrea View software indications to include viewing of diagnostic digital breast tomography images.

Mammography Image Quality Validation:
Study Type: Multi-reader, multi-case test.
Sample Size: Fifty studies were chosen randomly from existing patient studies.
Key Results: The radiologists found all of the images displayed met the clinical equivalence for diagnostic quality when displayed using the Vitrea View software as compared to the same studies displayed using the McKesson system.

Digital Breast Tomosynthesis Image Quality Validation:
Study Type: Multi-reader, multi-case test.
Sample Size: Fifty studies were chosen randomly from existing patient studies.
Key Results: The radiologists found all of the images displayed met the clinical equivalence for diagnostic quality when displayed using Vitrea View as compared to the same studies using the sites existing Phillips Radiology system.

Overall, the testing performed on the Vitrea View software confirmed the software functions according to its requirements, conforms to the intended use and is safe and effective.

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.

K150738

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.

K140909, K111804

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

July 21, 2017

Vital Images, Inc. % Fei Li Regulatory Affairs Specialist 5850 Opus Parkway, Suite 300 MINNETONKA MN 55343

Re: K163232 Trade/Device Name: Vitrea View Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 14, 2017 Received: June 15, 2017

Dear Fei Li:

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. 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

1

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,

Michael D.'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) K163232

Device Name Vitrea View

Indications for Use (Describe)

Vitrea View software is a medical image viewing and information distribution that provides access, through the internet and within the enterprise to multi-modality softcopy medical images (including mammography and digital breast tomosynthesis), reports, and other patient-related information. This data is hosted within disparate archives and repositories for diagnosis, review, communication, and reporting of DICOM and non-DICOM data.

Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA or displays accepted by the appropriate regulatory agency for the country in which it is used.

Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance.

Vitrea View software is indicated for use by qualified healthcare professionals including, but not restricted to. radiologists, non-radiology specialists, physicians and technologists.

When accessing Vitrea View software from a mobile device, images viewed are for informational purposes only and not intended for diagnostic use.

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

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

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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 traditional 510(k) to obtain
510(k) clearance for the Vitrea View software which we believe is
substantially equivalent to the FDA cleared VitreaView (K150738). |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Vital Images, Inc.
5850 Opus Parkway, Suite 300
Minnetonka, MN, 55343-4414 |
| Establishment Registration: | 2134213 |
| Contact Person: | Fei Li
Regulatory Affairs Specialist
Phone : 952-487-9539
Fax: 952-487-9510
E-mail: fli@vitalimages.com

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Predicate Device(s):

Predicate Device	Manufacturer	FDA 510(k) Number
VitreaView	Vital Images, Inc.
5850 Opus Parkway, Suite 300,
Minnetonka, Minnesota 55343 U.S.A.	K150738

Reference Device(s):

Reference Device	Manufacturer	FDA 510(k) Number
McKesson Radiology	McKesson Medical Imaging Company
5995 Winward Parkway
Alpharetta, GA 30005	K140909
Phillips Intellispace
Radiology system	Philips Healthcare Informatics, Inc.
4100 E 3rd Ave Ste 101
Foster City, CA 94404	K111804

Device Description:

The Vitrea View software is a web-based, cross-platform, zero-footprint enterprise image viewer solution capable of displaying both DICOM and non-DICOM medical images. The Vitrea View software enables clinicians and other medical professionals to access patients' medical images with integrations into a variety of medical record systems, such as Electronic Health Record (EHR), Electronic Medical Record (EMR), Health Information Exchange (HIE), Personal Health Record (PHR), and image exchange systems. The Vitrea View software is a communication tool, which supports the physician in the treatment and planning process by delivering access to images at the point of care.

The Vitrea View software offers medical professionals an enterprise viewer for accessing imaging data in context with reports from enterprise patient health information databases, fosters collaboration, and provides workflows and interfaces appropriate for referring physicians and clinicians. IT departments will not have to install client systems, due to the web-based zero-footbrint nature of the Vitrea View software. The Virea View software offers scalability to add new users as demand grows, and may be deployed in a virtualized environment. Some of the general features include:

. Fast time-to-first-image

Contextual launch integration with single-sign-on ●
. Easy study navigation and search capability
Supports multi-modality vendor-neutral DICOM images
. Supports non-DICOM images
lmages display at full diagnostic quality (with appropriate hardware) ●
. Basic 2D review tools (zoom, pan, measure)
Basic 3D and MPR viewing ●
Radiology key images
. Comparative side-by-side review, regardless of image types
. Collaboration tools
. Leverages traditional DICOM as well as next-generation DICOMweb image transfer protocols
Enables federated access to across multiple data sources across multiple sites ●
. Web-based zero-footprint architecture
Secure Access on various Windows® and Mac computers through standard internet ● browsers
. Secure Access on various iOS®, Android™, and Windows® tablet devices through the device's Internet browser

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. Secure Access on various iOS and Android smartphones through the device's Internet browser

Intended Use / Indications for Use:

Vitrea View software is a medical image viewing and information application that provides access, through the internet and within the enterprise to multi-modality softcopy medical images (including mammography and digital breast tomosynthesis), reports, and other patient-related information. This data is hosted within disparate archives and repositories for diagnosis, review, communication, and reporting of DICOM and non-DICOM data.

Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA or displays accepted by the appropriate regulatory agency for the country in which it is used.

Display monitors used for reading medical images for diagnostic purposes must comply with the applicable requlatory approvals and quality control requirements for their use and maintenance.

Vitrea View software is indicated for use by qualified healthcare professionals including, but not restricted to, radiologists, non-radiology specialists, physicians and technologists.

When accessing Vitrea View software from a mobile device, images viewed are for informational purposes only and not intended for diagnostic use.

Intended for Disease / Condition / Patient Population:

Vitrea View software is a medical image viewer software. Therefore, specific information on the intended disease, condition, and patient population is not applicable.

Key Changes from the last 510(k) clearance K150738

Kev Changes include:

Support for diagnostic viewing of mammographic images and digital breast tomography ● images
. Enhancements in the administration and support of the product
Ability to allow clinicians to collaborate on images, information, and artifacts related to the ● imaging studies using the Vitrea View software
User Centric enhancements
Performance Improvements
Licensing enhancements
Better integration with EMRs by supporting more targeted searchers within the launch and history search APIs
. Ability to record information of users who accessed the Vitrea View software and which studies they viewed
. Add support for Breast Tomography SOP class
. Support for SQL Server 2014
Improvements in connectivity to archives including PACS, VNA and DICOMWeb .
. View the UDI for Vitrea View identification

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ViTAL

Substantial Equivalence Comparison:

Regulatory Comparison:

Characteristic	Subject Device	Predicate Device
	Vitrea View	VitreaView
(K150738)	Comparison
Classification Name	Picture Archiving
and
Communications
System	Picture Archiving
and
Communications
System	Same
Regulatory Number	892.2050	892.2050	Same
Product Code	LLZ	LLZ	Same
Classification	Class II	Class II	Same
Review Panel	Radiology	Radiology	Same
Decision Date	TBD	April 6, 2015	Predicate device is
cleared

Indications for Use Comparison with Predicate Device:

	Subject Device	Predicate Device
Criteria	Vitrea View	VitreaView (K150738)	Comparison
Indications for Use	Vitrea View software is
a medical image
viewing and
information distribution
application that
provides access,
through the internet
and within the
enterprise to multi-
modality softcopy
medical images
(including
mammography and
digital breast
tomosynthesis),
reports, and other
patient-related
information. This data
is hosted within
disparate archives and
repositories for
diagnosis, review,
communication, and
reporting of DICOM
and non-DICOM data.	VitreaView is a
medical image viewing
and information
distribution application
that provides access,
through the internet
and within the
enterprise to multi-
modality softcopy
medical images,
reports, and other
patient-related
information. This data
is hosted within
disparate archives and
repositories for
diagnosis, review,
communication, and
reporting of DICOM
and non-DICOM data.
Display monitors used
for reading medical
images for diagnostic
purposes must comply
with the applicable
regulatory approvals
and quality control	Similar
Added support for
Vitrea View to be used
for diagnostic viewing
of mammographic
images and digital
breast tomography
images
	Lossy compressed
mammography
Criteria	Subject Device	Predicate Device	Comparison
	Vitrea View	VitreaView (K150738)
	images and digitized
film screen images
must not be reviewed
for primary image
interpretations.
Mammographic
images may only be
interpreted using an
FDA cleared display
that meets technical
specifications
reviewed and
accepted by FDA or
displays accepted by
the appropriate
regulatory agency for
the country in which it
is used.
Display monitors used
for reading medical
images for diagnostic
purposes must comply
with the applicable
regulatory approvals
and quality control
requirements for their
use and maintenance.
Vitrea View software is
indicated for use by
qualified healthcare
professionals
including, but not
restricted to,
radiologists, non-
radiology specialists,
physicians and
technologists.
When accessing
Vitrea View software
from a mobile device,
images viewed are for
informational purposes
only and not intended
for diagnostic use.	requirements for their
use and maintenance.
Lossy compressed
mammography
images and digitized
film screen images
must not be reviewed
for primary image
interpretations.
When accessing
VitreaView from a
mobile device, images
viewed are for
informational purposes
only and not intended
for diagnostic use.
Intended Users	Qualified healthcare
professionals
including, but not
restricted to,	Qualified healthcare
professionals
including, but not
restricted to,	Same
Criteria	Subject Device	Predicate Device	Comparison
	Vitrea View	Vitrea View (K150738)
	radiologists, non-
radiology specialists,
physicians and
technologists.	radiologists, non-
radiology specialists,
physicians and
technologists.
Patient Population	Vitrea View software is
a medical image
viewer software.
Therefore, specific
information on the
intended disease,
condition, and patient
population is not
applicable.	VitreaView is a
medical image viewer
software. Therefore,
specific information on
the intended disease,
condition, and patient
population is not
applicable.	Same
Modality Support	Multi-modality	Multi-modality	Same
Criteria	Description	Subject Device
Vitrea View	Predicate Device
VitreaView
(K150738)	Comparison
Annotation and
Measurement
Tools	• Line
• Angle
• Ruler
• Arrow	Yes	Yes	Same
User Installation
Requirements	• Runs within browser
using HTML and
JavaScript only
• No installation is
required on user's
machine	Yes	Yes	Same
Data Type
Supported	• DICOM
• Non-DICOM	Yes	Yes	Same
Image View/
Manipulation	• Image Zoom
• Pan
• Window Level
• Auto Window
Level
• Reset
• Scout Lines
• Image Rotate
• Image Flip
• Magnify
• Image Invert
• Image Cine	Yes	Yes	Same
Data Encryption	• HTTPS
• SSL	Yes	Yes	Same
Patient
Demographic
Display	Capable of displaying
patient demographic
information	Yes	Yes	Same
Linking	Co-planar linking:
• Autolink
• Manual	Yes	Yes	Same
User and
Password
Control	Users can be managed
via an internal
database, active
directory, or parent
application	Yes	Yes	Same
Data Security
Audit Trail	Stored on server
Audit trail logged	Yes
Yes	Yes
Yes	Same
Same
Criteria	Description	Subject Device
Vitrea View	Predicate Device
Vitrea View
(K150738)	Comparison
User
Management	Database structure
allows mapping users to
groups internally or
mapping external
groups (AD, parent
application) to internal
groups and role	Yes	Yes	Same
Transmission
Modes	Via the web with
Internet browsers	Yes	Yes	Same
File Type Used	JPEG for Lossy data PNG for Lossless data	Yes	Yes	Same
MPR Viewing	This viewing feature
enables the display of
reformatted CT and MR
images into axial,
coronal and sagittal
orientations.	Yes	Yes	Same
3D Volume
Rendered
Viewing	This viewing feature
enables the display of
3D perspective views of
CT and MR image sets
that have been
transformed into
volumes. It also
provides presets to
enable users to alter the
visualization parameters
of the 3D views to
highlight features.	Yes	Yes	Same
Active Target
Tool	This viewing feature
provides a facility to
view a single target
location within multiple
images.	Yes	Yes	Same
Crosshair
Navigation and
Synchronization:	This viewing feature
provides a facility to
synchronize and scroll
through multiple views
at the same time.	Yes	Yes	Same
Ability to clone
images side by
side	Ability to clone images
side by side.	Yes	Yes	Same
Criteria	Description	Subject Device
Vitrea View	Predicate
Device
Vitrea View
(K150738)	Comparison
Ability to close
an image by
clicking an "X”
in the upper-left
portion of the
viewport	Ability to close an image
by clicking an "X" in the
upper-left portion of the
viewport.	Yes	Yes	Same
Ability to select
locale and
language
settings on the
login screen	Ability to select locale
and language settings
on the login screen.	Yes	Yes	Same
Ability to
customize the
columns in the
study directory
by selecting the
dropdown arrow
on the right side
of each column.	Ability to customize the
columns in the study
directory by selecting
the dropdown arrow on
the right side of each
column.	Yes	Yes	Same
Help Tips	Proactive help tips
appear for 10-15
seconds to educate
users on certain
functionality that may
not be obvious to a new
user.	Yes	Yes	Same
Support for TIF
Files	Vitrea View can display
TIF files.	Yes	Yes	Same
Criteria	Description	Subject Device	Predicate Device	Comparison
		Vitrea View	VitreaView
(K150738)
Tablet
support for
information
purpose
only
(Not for
diagnostic use)	This viewing feature
provides access of
Vitrea View software
on various iOS and
Android tablet
devices through the
default internet
browser. Key
features are:
Two-finger pinch to zoom and pan Touch and drag to scroll Double-tap to access Gesture menu Tap Carousel thumbnail, then tap Image Pane to swap images Ambient Lighting Check	Yes	Yes	Same
Diagnostic
quality medical
image review	Ability to provide
diagnostic quality
medical image review
for multi-dimensional
digital images acquired
from a variety of
imaging devices	Yes	Yes	Same
	Subject Device	Predicate Device
Criteria	Vitrea View	VitreaView
(K150738)	Comparison
Feature: Support for diagnostic
viewing of mammographic
images and digital breast
tomography images	Yes	No	Expanded the
Indications for Use
to include the ability
to allow viewing of
multi-modality
images (including
mammography and
digital breast
tomosynthesis) for
review and
diagnosis when
used in conjunction
with monitors
cleared by the FDA,
and viewed by
appropriately
qualified personnel.
General Enhancements:
(see below for detailed information)			The majority of
these general
modifications are
enhancements to
pre-existing
functionality or
features within the
already cleared
VitreaView
(K150738). Any
new functionality
does not alter the
fundamental
technology and
does not affect the
safety/
effectiveness or the
intended use for
viewing multi-
modality images.
• Enhancements in the
administration and support
of the product	Yes	No
• Ability to allow clinicians to
collaborate on images,
information, and artifacts
related to the imaging
studies using the Vitrea
View software	Yes	No
• User Centric
enhancements	Yes	No
• Performance
Improvements	Yes	No
• Licensing enhancements	Yes	No
• Better integration with
EMRs by supporting more
targeted searchers within
the launch and history
search APIs	Yes	No
• Ability to record information
of users who accessed the
Vitrea View software and
which studies they viewed	Yes	No
• Support for SQL Server
2014	Yes	No
Criteria	Subject Device	Predicate Device
	Vitrea View	VitreaView
(K150738)	Comparison
• Improvements in
connectivity to archives
including PACS, VNA and
DICOMWeb	Yes	No
• View the UDI for Vitrea
View identification	Yes	No
• Add support for Breast
Tomography SOP class	Yes	No

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Vitrea View Traditional 510(k) Pre-Market Notification

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Vitrea View Traditional 510(k) Pre-Market Notification

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Similarities in Technology with the Predicate Device:

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Image /page/11/Picture/0 description: The image shows the word "ViTAL" in a 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 horizontally aligned.

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Image /page/12/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 aligned horizontally.

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Image /page/13/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.

Differences in Technology with the Predicate Device:

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Similarities in Technology with the Reference Device

	Subject Device	Reference Device	Reference Device
Criteria	Vitrea View	McKesson
Radiology
(K140909)
(Mammography)	Phillips
Intellispace
Radiology
system
(K111804)
(Digital Breast
Tomosynthesis)	Comparison
Feature:
Support for
diagnostic
viewing of
mammographic
images	Yes	Yes	N/A	Same
Feature:
Support for
diagnostic
viewing of
digital breast
tomography
images	Yes	N/A	Yes	Same
Classification
Name	Picture Archiving
and
Communications
System	Picture Archiving
and
Communications
System	Picture Archiving
and
Communications
System	Same
Requlatory
Number	892.2050	892.2050	892.2050	Same
Product Code	LLZ	LLZ	LLZ	Same
Classification	Class II	Class II	Class II	Same
Review Panel	Radiology	Radiology	Radiology	Same
Decision Date	TBD	July 2, 2014	July 28, 2011	Reference
devices are
cleared
Indications for
Use	Vitrea View
software is a
medical image	McKesson
Radiology™ is
medical image and	IntelliSpace PACS
4.x is an image
management	Similar
	Subject Device	Reference Device	Reference Device
Criteria	Vitrea View	McKesson
Radiology
(K140909)
(Mammography)	Phillips
Intellispace
Radiology
system
(K111804)
(Digital Breast
Tomosynthesis)	Comparison
	viewing and	information	system intended
	information	management	to be used by
	distribution	software that is	trained
	application that	intended to	professionals.
	provides access,	receive, transmit,	including but not
	through the internet	store, archive,	limited to
	and within the	retrieve, manage,	physicians, nurses
	enterprise to multi-	display, print and	and medical
	modality softcopy	process digital	technicians.
	medical images	medical images,
	(including	digital medical	The system is a
	mammography and	video and	software package
	digital breast	associated patient	used with general
	tomosynthesis),	and medical	purpose
	reports, and other	information.	computing
	patient-related	McKesson	hardware to
	information. This	Radiology includes	acquire, store,
	data is hosted	a suite of	distribute, process
	within disparate	standalone, web-	and display
	archives and	enabled software	images and
	repositories for	components, and	associated data
	diagnosis, review,	is intended for	throughout a
	communication,	installation and use	clinical
	and reporting of	with off-the-shelf	environment. The
	DICOM and non-	hardware that	software performs
	DICOM data.	meets or exceeds	digital image
		minimum	processing,
	Lossy compressed
mammography	specifications.	measurement,
communication
	images and	McKesson	and storage.
	digitized film	Radiology
	screen images	Station™ is the	Lossy compressed
	must not be	primary software	mammographic
	reviewed for	component used	images and
	primary image	for processing and	digitized screen
	interpretations.	presentation of	images must not
	Mammographic	medical images on	be reviewed for
	images may only	display devices	primary image
	be interpreted	with network	interpretations.
	using an FDA	access to
	cleared display that	McKesson	Mammographic
	meets technical	Radiology.	images may only
	specifications	McKesson	be interpreted
	reviewed and	Radiology Station	using an FDA
	accepted by FDA	is intended to	approved monitor
	Subject Device	Reference Device	Reference Device
Criteria	Vitrea View	McKesson
Radiology
(K140909)
(Mammography)	Phillips
Intellispace
Radiology
system
(K111804)
(Digital Breast
Tomosynthesis)	Comparison
	or displays
accepted by the
appropriate
regulatory agency
for the country in
which it is used.
Display monitors
used for reading
medical images for
diagnostic
purposes must
comply with the
applicable
regulatory
approvals and
quality control
requirements for
their use and
maintenance.
Vitrea View
software is
indicated for use by
qualified healthcare
professionals
including, but not
restricted to,
radiologists, non-
radiology
specialists,
physicians and
technologists.
When accessing
Vitrea View
software from a
mobile device,
images viewed are
for informational
purposes only and
not intended for
diagnostic use.	process and
display lossless
and non-lossless
compressed
medical images
provided from
DICOM
conformant
modalities such as
X-Ray

                                                          | that offers at least

5 Mpixel resolution
and meets other
technical
specifications
reviewed and
accepted by FDA. | |
| | Subject Device | Reference Device | Reference Device | |
| Criteria | Vitrea View | McKesson
Radiology
(K140909)
(Mammography) | Phillips
Intellispace
Radiology
system
(K111804)
(Digital Breast
Tomosynthesis) | Comparison |
| | | McKesson
Radiology is
indicated for use
by qualified
healthcare
professionals
including, but not
restricted to,
radiologists, non-
radiology
specialists,
physicians and
technologists. | | |

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Summary of Non-Clinical Tests:

The Vitrea View software was designed, developed, and tested according to IEC 62304:2006 standard for Medical Device Software Life Cycle Processes. Vital Images' internal Agile Development Processes is summarized in the Vital Images' Agile Product Development Process (SOP-301.150).

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

. Risk Management
Software Requirements Reviews .
Code Designs ●
. Code Development Testing
Code Reviews
Design Reviews
Verification of the software - that included performance and safety testing
Validation of the software that included simulated usability testing by experienced ● professionals.

Risk Management:

Each risk pertaining to these features have been individually assessed to determine if the benefits outweigh the risk. Every risk has been reduced as low as possible and has been evaluated to have a probability of occurrence of harm of "Improbable." All risks for this feature were collectively reviewed to determine if the benefits outweigh the risk. Because of the risk control measures included in this feature, it is believed that the risk for the feature as a whole is extremely low. Taking into account all risks against the benefits of this feature, it has been assessed that the benefits do outweigh the risks for this feature.

During the design review, the following conclusions were reached:

All risks were reduced as low as possible .

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. The medical benefits of the device outweigh the residual risk for each individual risk and all risks together
. The overall residual risk for the project is deemed acceptable

Verification and Validation:

The software was designed, developed, tested, verified, and validated according to written procedures. Verification confirmed that the feature functions according to its requirements.

Software testing was completed to ensure the Vitrea View software functions according to its requirements. Performance testing for the Vitrea View software included internal verification and external validation.

External validation was done to:

a) Establish the substantial equivalence between the Vitrea View software with the McKesson Radiology system ((K140909) reference device) to modify the current Vitrea View software indications to include viewing of diagnostic mammography images.
Establish the substantial equivalence between the Vitrea View software with the Phillips b) Intellispace Radiology system ((K111804) reference device) to modify the current Vitrea View software indications to include viewing of diagnostic digital breast tomography images.

a) Mammography Image Quality Validation

The validation was a multi-reader, multi-case test with four experienced radiologists reviewing Digital Mammography X-Ray Image Storage SOP class studies. The validation used the already cleared McKesson Radiology system (K140909) in association with WIDE PN21IQS monitors (K052312), side by side with the Vitrea View software displayed on Barco Coronis Fusion 10MP monitors (K133984).

Fifty studies were chosen randomly from existing patient studies obtained over a two-day time-frame at the designated Breast Imaging center. The radiologists were asked to rate the image quality equivalence of the Vitrea View software on a scale of 1 to 3 compared to the McKesson system for:

1. Visualization of the adipose and fibroglandular tissue
1. Visualization of the breast tissue and underlying pectoralis muscle
Image contrast for differentiation of subtle tissue density differences 3.
Sharpness, assessment of the edges of fine linear structures, tissue borders and benign 4. calcifications
1. Tissue visibility at the skin line
Artifacts due to image processing, detector failure and other external factors to the breast 6.
Overall clinical image quality 7.

The radiologists found all of the images displayed met the clinical equivalence for diagnostic quality when displayed using the Vitrea View software as compared to the same studies displayed using the McKesson system.

b) Digital Breast Tomosynthesis Image Quality Validation

The validation was a multi-reader, multi-case test with three experienced radiologists reviewing Digital Breast Tomosynthesis Image SOP class studies. The validation used the already cleared Phillips Intellispace Radiology system (K111804) in association with Barco Nio 5MP MDCG-5221 monitors (K133984), side by side with the Vitrea View software displayed on Barco Mammo Tomosynthesis 5 MegaPixel MDMG-5221 monitors (K161229).

Fifty studies were chosen randomly from existing patient studies obtained at the designated Breast Imaging center. The radiologists were asked to rate the image quality equivalence of the Vitrea View software on a scale of 1 to 3 compared to the Phillips Intellispace Radiology system for:

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Visualization of the adipose and fibroglandular tissue 1.
1. Visualization of the breast tissue and underlying pectoralis muscle
Image contrast for differentiation of subtle tissue density differences 3.
1. Sharpness, assessment of the edges of fine linear structures, tissue borders and benign calcifications
1. Tissue visibility at the skin line
1. Artifacts due to image processing, detector failure and other external factors to the breast
1. Overall clinical image quality

The radiologists found all of the images displayed met the clinical equivalence for diagnostic quality when displayed using Vitrea View as compared to the same studies using the sites existing Phillips Radiology system.

Overall, the testing performed on the Vitrea View software confirmed the software functions according to its requirements, conforms to the intended use and is safe and effective.

Summary of Clinical Tests:

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

Cyber and Information Security

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

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.
A traceability matrix that links your actual cybersecurity controls to the cybersecurity risks that 2. were considered;
1. A summary describing the plan for providing validated software updates and patches as 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.q. remain free of malware) from the point of origin to the point at which that device leaves the control of the manufacturer; and
1. Device instructions for use and product specifications related to recommended cybersecurity controls appropriate for the intended use environment (e.g. anti-virus software, use of firewall).

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Performance Standards:

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

The Virea View 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 |

Substantial Equivalence Analysis Conclusion:

Vital Images believes the Vitrea View software has a similar intended use, indications for use, principle of operation, and technological characteristics as the legally marketed, predicate device VitreaView (K150738). The added feature to allow for viewing of mammography for review and diagnosis is substantially equivalent to the feature in the reference device, McKesson Radiology, which was cleared by the FDA under K140909. Additionally, the feature to allow for viewing of digital breast tomosynthesis for review and diagnosis is substantially equivalent to the Phillips Intellispace Radiology system, which was cleared by the FDA under K111804.

Furthermore, the verification and validation testing performed demonstrate the subject device is as safe and effective as the predicate and reference devices and does not raise any different questions of safety and effectiveness. Therefore, Vital believes the addition of the support for diagnostic viewing of mammographic images and digital breast tomography images in the Vitrea View software does not alter the fundamental scientific technology, safety or intended use of the device.

Any noted minor differences have been explained and 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 information provided above, Vital Images believes the subject device should be found substantially equivalent to the predicate device.