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.

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

AI/ML Overview

Here's the analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device Name: Vitrea View
510(k) Number: K163232

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from Radiologists' Rating)	Reported Device Performance (Vitrea View vs. Reference System)
Visualization of the adipose and fibroglandular tissue	Met clinical equivalence for diagnostic quality
Visualization of the breast tissue and underlying pectoralis muscle	Met clinical equivalence for diagnostic quality
Image contrast for differentiation of subtle tissue density differences	Met clinical equivalence for diagnostic quality
Sharpness, assessment of the edges of fine linear structures, tissue borders and benign calcifications	Met clinical equivalence for diagnostic quality
Tissue visibility at the skin line	Met clinical equivalence for diagnostic quality
Artifacts due to image processing, detector failure and other external factors to the breast	Met clinical equivalence for diagnostic quality
Overall clinical image quality	Met clinical equivalence for diagnostic quality

2. Sample Size Used for the Test Set and Data Provenance:

Mammography Image Quality Validation: 50 studies.
- Data Provenance: Studies were "chosen randomly from existing patient studies obtained over a two-day time-frame at the designated Breast Imaging center." This indicates retrospective data from a specific imaging center.
Digital Breast Tomosynthesis Image Quality Validation: 50 studies.
- Data Provenance: Studies were "chosen randomly from existing patient studies obtained at the designated Breast Imaging center." This also indicates retrospective data from a specific imaging center.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

Mammography Image Quality Validation: Four experienced radiologists. No further specific qualifications (e.g., years of experience) are provided.
Digital Breast Tomosynthesis Image Quality Validation: Three experienced radiologists. No further specific qualifications are provided.

4. Adjudication Method for the Test Set:

The studies were multi-reader, multi-case tests where radiologists were asked to rate image quality equivalence. The text states:

"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."
"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."
This suggests a consensus or agreement among the radiologists was reached, rather than a formal adjudication method like a 2+1 or 3+1 rule. The criteria were rating the image quality on a scale of 1 to 3, but the specifics of how these individual ratings were combined or adjudicated to reach the overall "met clinical equivalence" conclusion are not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Yes, MRMC studies were done for both mammography and digital breast tomosynthesis. However, these were not comparative effectiveness studies evaluating human reader improvement with AI assistance. Instead, they were image quality equivalence studies comparing the device's display quality against a cleared predicate/reference device. The purpose was to show that images displayed by "Vitrea View software... met the clinical equivalence for diagnostic quality" when compared to a reference system displaying the same images. Therefore, an effect size of human improvement with AI vs. without AI is not applicable to these studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, the studies described were focused on the display quality of the Vitrea View software in conjunction with diagnostic monitors, for review by human radiologists. It was not a standalone algorithmic performance evaluation.

7. The Type of Ground Truth Used:

The ground truth was established by the subjective rating of "experienced radiologists" on the "overall clinical image quality" and other specific image quality parameters. This is effectively expert consensus on image quality and clinical equivalence for diagnostic use. It does not appear to involve pathology or outcomes data to define disease presence or absence.

8. The Sample Size for the Training Set:

The document does not specify a training set or its size. The studies described are verification and validation of the device's performance, not the training of a machine learning model.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as no training set or ground truth establishment for a training set is mentioned in the provided text.

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked on top of each other.

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

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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)

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 obtain510(k) clearance for the Vitrea View software which we believe issubstantially equivalent to the FDA cleared VitreaView (K150738).
Submitter:	Vital Images, Inc.5850 Opus Parkway, Suite 300Minnetonka, MN, 55343-4414
Establishment Registration:	2134213
Contact Person:	Fei LiRegulatory Affairs SpecialistPhone : 952-487-9539Fax: 952-487-9510E-mail: fli@vitalimages.comAlternate Contact Person:Vince SwensonSr. Director of Quality and RegulatoryPhone: 952-487-9548Fax: 952-487-9510E-mail: vswenson@vitalimages.com
510(k) Type:	Traditional
Summary Date:	November 16, 2016
Device Trade Name:	Vitrea View
Device Common Name/ Regulatory Description:	Picture Archiving and Communications System
Device Classification Name:	System, Image Processing, Radiological
Regulation Number:	21 CFR 892.2050
Product Code:	LLZ
Regulatory Classification:	Class II
Device Panel:	Radiology

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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 Company5995 Winward ParkwayAlpharetta, GA 30005	K140909
Phillips IntellispaceRadiology system	Philips Healthcare Informatics, Inc.4100 E 3rd Ave Ste 101Foster City, CA 94404	K111804

Device Description:

. 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.

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 ArchivingandCommunicationsSystem	Picture ArchivingandCommunicationsSystem	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 iscleared

Indications for Use Comparison with Predicate Device:

	Subject Device	Predicate Device
Criteria	Vitrea View	VitreaView (K150738)	Comparison
Indications for Use	Vitrea View software isa medical imageviewing andinformation distributionapplication thatprovides access,through the internetand within theenterprise to multi-modality softcopymedical images(includingmammography anddigital breasttomosynthesis),reports, and otherpatient-relatedinformation. This datais hosted withindisparate archives andrepositories fordiagnosis, review,communication, andreporting of DICOMand non-DICOM data.	VitreaView is amedical image viewingand informationdistribution applicationthat provides access,through the internetand within theenterprise to multi-modality softcopymedical images,reports, and otherpatient-relatedinformation. This datais hosted withindisparate archives andrepositories fordiagnosis, review,communication, andreporting of DICOMand non-DICOM data.Display monitors usedfor reading medicalimages for diagnosticpurposes must complywith the applicableregulatory approvalsand quality control	SimilarAdded support forVitrea View to be usedfor diagnostic viewingof mammographicimages and digitalbreast tomographyimages
	Lossy compressedmammography
Criteria	Subject Device	Predicate Device	Comparison
	Vitrea View	VitreaView (K150738)
	images and digitizedfilm screen imagesmust not be reviewedfor primary imageinterpretations.Mammographicimages may only beinterpreted using anFDA cleared displaythat meets technicalspecificationsreviewed andaccepted by FDA ordisplays accepted bythe appropriateregulatory agency forthe country in which itis used.Display monitors usedfor reading medicalimages for diagnosticpurposes must complywith the applicableregulatory approvalsand quality controlrequirements for theiruse and maintenance.Vitrea View software isindicated for use byqualified healthcareprofessionalsincluding, but notrestricted to,radiologists, non-radiology specialists,physicians andtechnologists.When accessingVitrea View softwarefrom a mobile device,images viewed are forinformational purposesonly and not intendedfor diagnostic use.	requirements for theiruse and maintenance.Lossy compressedmammographyimages and digitizedfilm screen imagesmust not be reviewedfor primary imageinterpretations.When accessingVitreaView from amobile device, imagesviewed are forinformational purposesonly and not intendedfor diagnostic use.
Intended Users	Qualified healthcareprofessionalsincluding, but notrestricted to,	Qualified healthcareprofessionalsincluding, but notrestricted to,	Same
Criteria	Subject Device	Predicate Device	Comparison
	Vitrea View	Vitrea View (K150738)
	radiologists, non-radiology specialists,physicians andtechnologists.	radiologists, non-radiology specialists,physicians andtechnologists.
Patient Population	Vitrea View software isa medical imageviewer software.Therefore, specificinformation on theintended disease,condition, and patientpopulation is notapplicable.	VitreaView is amedical image viewersoftware. Therefore,specific information onthe intended disease,condition, and patientpopulation is notapplicable.	Same
Modality Support	Multi-modality	Multi-modality	Same
Criteria	Description	Subject DeviceVitrea View	Predicate DeviceVitreaView(K150738)	Comparison
Annotation andMeasurementTools	• Line• Angle• Ruler• Arrow	Yes	Yes	Same
User InstallationRequirements	• Runs within browserusing HTML andJavaScript only• No installation isrequired on user'smachine	Yes	Yes	Same
Data TypeSupported	• DICOM• Non-DICOM	Yes	Yes	Same
Image View/Manipulation	• Image Zoom• Pan• Window Level• Auto WindowLevel• Reset• Scout Lines• Image Rotate• Image Flip• Magnify• Image Invert• Image Cine	Yes	Yes	Same
Data Encryption	• HTTPS• SSL	Yes	Yes	Same
PatientDemographicDisplay	Capable of displayingpatient demographicinformation	Yes	Yes	Same
Linking	Co-planar linking:• Autolink• Manual	Yes	Yes	Same
User andPasswordControl	Users can be managedvia an internaldatabase, activedirectory, or parentapplication	Yes	Yes	Same
Data SecurityAudit Trail	Stored on serverAudit trail logged	YesYes	YesYes	SameSame
Criteria	Description	Subject DeviceVitrea View	Predicate DeviceVitrea View(K150738)	Comparison
UserManagement	Database structureallows mapping users togroups internally ormapping externalgroups (AD, parentapplication) to internalgroups and role	Yes	Yes	Same
TransmissionModes	Via the web withInternet browsers	Yes	Yes	Same
File Type Used	JPEG for Lossy data PNG for Lossless data	Yes	Yes	Same
MPR Viewing	This viewing featureenables the display ofreformatted CT and MRimages into axial,coronal and sagittalorientations.	Yes	Yes	Same
3D VolumeRenderedViewing	This viewing featureenables the display of3D perspective views ofCT and MR image setsthat have beentransformed intovolumes. It alsoprovides presets toenable users to alter thevisualization parametersof the 3D views tohighlight features.	Yes	Yes	Same
Active TargetTool	This viewing featureprovides a facility toview a single targetlocation within multipleimages.	Yes	Yes	Same
CrosshairNavigation andSynchronization:	This viewing featureprovides a facility tosynchronize and scrollthrough multiple viewsat the same time.	Yes	Yes	Same
Ability to cloneimages side byside	Ability to clone imagesside by side.	Yes	Yes	Same
Criteria	Description	Subject DeviceVitrea View	PredicateDeviceVitrea View(K150738)	Comparison
Ability to closean image byclicking an "X”in the upper-leftportion of theviewport	Ability to close an imageby clicking an "X" in theupper-left portion of theviewport.	Yes	Yes	Same
Ability to selectlocale andlanguagesettings on thelogin screen	Ability to select localeand language settingson the login screen.	Yes	Yes	Same
Ability tocustomize thecolumns in thestudy directoryby selecting thedropdown arrowon the right sideof each column.	Ability to customize thecolumns in the studydirectory by selectingthe dropdown arrow onthe right side of eachcolumn.	Yes	Yes	Same
Help Tips	Proactive help tipsappear for 10-15seconds to educateusers on certainfunctionality that maynot be obvious to a newuser.	Yes	Yes	Same
Support for TIFFiles	Vitrea View can displayTIF files.	Yes	Yes	Same
Criteria	Description	Subject Device	Predicate Device	Comparison
		Vitrea View	VitreaView(K150738)
Tabletsupport forinformationpurposeonly(Not fordiagnostic use)	This viewing featureprovides access ofVitrea View softwareon various iOS andAndroid tabletdevices through thedefault internetbrowser. Keyfeatures 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
Diagnosticquality medicalimage review	Ability to providediagnostic qualitymedical image reviewfor multi-dimensionaldigital images acquiredfrom a variety ofimaging devices	Yes	Yes	Same
	Subject Device	Predicate Device
Criteria	Vitrea View	VitreaView(K150738)	Comparison
Feature: Support for diagnosticviewing of mammographicimages and digital breasttomography images	Yes	No	Expanded theIndications for Useto include the abilityto allow viewing ofmulti-modalityimages (includingmammography anddigital breasttomosynthesis) forreview anddiagnosis whenused in conjunctionwith monitorscleared by the FDA,and viewed byappropriatelyqualified personnel.
General Enhancements:(see below for detailed information)			The majority ofthese generalmodifications areenhancements topre-existingfunctionality orfeatures within thealready clearedVitreaView(K150738). Anynew functionalitydoes not alter thefundamentaltechnology anddoes not affect thesafety/effectiveness or theintended use forviewing multi-modality images.
• Enhancements in theadministration and supportof the product	Yes	No
• Ability to allow clinicians tocollaborate on images,information, and artifactsrelated to the imagingstudies using the VitreaView software	Yes	No
• User Centricenhancements	Yes	No
• PerformanceImprovements	Yes	No
• Licensing enhancements	Yes	No
• Better integration withEMRs by supporting moretargeted searchers withinthe launch and historysearch APIs	Yes	No
• Ability to record informationof users who accessed theVitrea View software andwhich studies they viewed	Yes	No
• Support for SQL Server2014	Yes	No
Criteria	Subject Device	Predicate Device
	Vitrea View	VitreaView(K150738)	Comparison
• Improvements inconnectivity to archivesincluding PACS, VNA andDICOMWeb	Yes	No
• View the UDI for VitreaView identification	Yes	No
• Add support for BreastTomography 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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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	McKessonRadiology(K140909)(Mammography)	PhillipsIntellispaceRadiologysystem(K111804)(Digital BreastTomosynthesis)	Comparison
Feature:Support fordiagnosticviewing ofmammographicimages	Yes	Yes	N/A	Same
Feature:Support fordiagnosticviewing ofdigital breasttomographyimages	Yes	N/A	Yes	Same
ClassificationName	Picture ArchivingandCommunicationsSystem	Picture ArchivingandCommunicationsSystem	Picture ArchivingandCommunicationsSystem	Same
RequlatoryNumber	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	Referencedevices arecleared
Indications forUse	Vitrea Viewsoftware is amedical image	McKessonRadiology™ ismedical image and	IntelliSpace PACS4.x is an imagemanagement	Similar
	Subject Device	Reference Device	Reference Device
Criteria	Vitrea View	McKessonRadiology(K140909)(Mammography)	PhillipsIntellispaceRadiologysystem(K111804)(Digital BreastTomosynthesis)	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 compressedmammography	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	McKessonRadiology(K140909)(Mammography)	PhillipsIntellispaceRadiologysystem(K111804)(Digital BreastTomosynthesis)	Comparison
	or displaysaccepted by theappropriateregulatory agencyfor the country inwhich it is used.Display monitorsused for readingmedical images fordiagnosticpurposes mustcomply with theapplicableregulatoryapprovals andquality controlrequirements fortheir use andmaintenance.Vitrea Viewsoftware isindicated for use byqualified healthcareprofessionalsincluding, but notrestricted to,radiologists, non-radiologyspecialists,physicians andtechnologists.When accessingVitrea Viewsoftware from amobile device,images viewed arefor informationalpurposes only andnot intended fordiagnostic use.	process anddisplay losslessand non-losslesscompressedmedical imagesprovided fromDICOMconformantmodalities such asX-Ray	that offers at least5 Mpixel resolutionand meets othertechnicalspecificationsreviewed andaccepted by FDA.
	Subject Device	Reference Device	Reference Device
Criteria	Vitrea View	McKessonRadiology(K140909)(Mammography)	PhillipsIntellispaceRadiologysystem(K111804)(Digital BreastTomosynthesis)	Comparison
		McKessonRadiology isindicated for useby qualifiedhealthcareprofessionalsincluding, but notrestricted to,radiologists, non-radiologyspecialists,physicians andtechnologists.

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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.	StandardsOrganization	Standard Title	Version	Date
PS 3.1- 3.20 (2011)(RecognitionNumber 12-238)	NEMA	Digital Imaging andCommunications in Medicine(DICOM) Set (Radiology)	3	03/16/2012
ISO 14971:2007(RecognitionNumber 5-70)	AAMI / ANSI/ ISO	Medical Devices -Applications of RiskManagement to MedicalDevices	2007	03/16/2012
IEC 62304:2006(RecognitionNumber 13-32)	AAMI / ANSI/ IEC	Medical Device Software -Software Life CycleProcesses (Software /Informatics)	2006	08/20/2012

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.

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).