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

Device Description

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

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

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

AI/ML Overview

The provided document is a 510(k) summary for Vitrea Advanced Visualization, Version 7.6. This documentation focuses on demonstrating substantial equivalence to a predicate device (Vitrea, Version 7.0 (K150258)) by detailing software changes, intended use, and technological similarities.

Crucially, this document does not describe acceptance criteria for device performance based on clinical outcomes or a study that specifically proves the device meets such criteria. Instead, it discusses:

Software Verification Testing: This ensures that new features operate according to defined requirements (functional and performance specifications internal to the company for the software itself).
Risk Management: Assessment of potential harms associated with software modifications and implementation of controls to reduce these risks.
Compliance with Standards: Adherence to recognized consensus standards like DICOM, ISO 14971, and IEC 62304.

The document explicitly states: "The subject of this 510(k) notification, Vitrea Advanced Visualization software, did not require clinical studies to support safety and effectiveness of the software." This indicates that there are no clinical acceptance criteria or studies providing device performance metrics in the way you've outlined.

Given this, I cannot provide details on your specific requests for acceptance criteria, device performance, sample sizes for test sets, expert-established ground truth, adjudication methods, MRMC studies, standalone performance, or training set ground truth. These are typically associated with clinical performance studies, which were not conducted or required for this 510(k) submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the software's functional and technical requirements and the verification testing performed to confirm these requirements are met.

Below is a table summarizing the information that is available regarding the device's assessment, which relates to software functionality and risk, rather than clinical performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria and performance reported here are for software functionality and safety features, not clinical diagnostic performance, as clinical studies were not required or performed for this 510(k) submission.

Acceptance Criteria Category	"Acceptance Criteria" (as implied by document)	Reported Device Performance (as described in document)
Software Functionality	New features operate according to defined requirements.	Software verification testing confirmed the software functions according to its requirements.
Risk Management	Potential risks are assessed, benefits outweigh residual risk, risks are as low as possible.	Each risk assessed individually; benefits outweigh risk; all risks reduced "as low as possible"; overall residual risk deemed acceptable.
Cybersecurity	Adherence to cybersecurity guidance (FDA Guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices).	Follows internal documentation based on FDA Guidance; includes hazard analysis, mitigations, controls, traceability, software update plan, integrity controls, and IFU recommendations.
Compliance with Standards	Compliance with specified voluntary recognized consensus standards.	Complies with NEMA DICOM (PS 3.1-3.20), AAMI/ANSI/ISO 14971:2007 (Risk Management), and AAMI/ANSI/IEC 62304:2006 (Software Life Cycle Processes).
Intended Use Equivalence	Similar intended use to predicate device.	Identical Indications for Use statement as the predicate device (Vitrea, Version 7.0 K150258).
Technological Equivalence	Similar principle of operation and technological characteristics to predicate device.	Detailed comparison table shows "Same" across numerous software functionalities (e.g., selection/loading study, visualization, analysis, reporting, DICOM compliance, data security).
Safety and Effectiveness Equivalence	Does not raise different questions of safety or effectiveness compared to the predicate device.	Verification/validation testing, risk management, and labeling demonstrate safety and efficacy. Changes do not alter fundamental scientific technology, safety, or intended use.

2. Sample size used for the test set and the data provenance

Not applicable for clinical performance. For software verification, the "test set" and "data provenance" would refer to the specific test cases and data used for software testing, which are internal to the manufacturer and not detailed in this 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no clinical test set for diagnostic performance was used.

4. Adjudication method for the test set

Not applicable, as no clinical test set for diagnostic performance was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The document explicitly states no clinical studies were performed. This device is described as "Radiological Image Processing Software" and not an AI-assisted diagnostic tool that would typically undergo such studies.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable, as this is software for processing and visualization, not a standalone diagnostic algorithm requiring performance evaluation. No clinical studies were done.

7. The type of ground truth used

Not applicable, as no clinical outcome-based ground truth was established. For software verification, "ground truth" implies the expected output or behavior according to the software requirements.

8. The sample size for the training set

Not applicable, as no clinical studies or machine learning model training are described in this 510(k) summary.

9. How the ground truth for the training set was established

Not applicable, as no training set for a machine learning model is mentioned or elaborated upon.

Summary

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

October 5, 2017

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

Re: K172855

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

Dear Ms. Ryan:

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

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

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

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D. O'Hara
For

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

Enclosure

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Indications for Use

510(k) Number (if known) K172855

Device Name

Vitrea Advanced Visualization, Version 7.6

Indications for Use (Describe)

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 theSubmission:	Vital Images, Inc. hereby submits this special 510(k) to provide anotification submission for proposed software changes in the already510(k) cleared Vitrea Advanced Visualization software (K150258)
Submitter:	Vital Images, Inc.5850 Opus Parkway, Suite 300Minnetonka, MN, 55343-4414
EstablishmentRegistration:	2134213
Contact Person:	Katie RyanSr. Regulatory Affairs SpecialistPhone: 952-487-9793Fax: 952-487-9510E-mail: kryan@vitalimages.comAlternate Contact Person:Vince SwensonSr. Director of Quality and RegulatoryPhone: 952-487-9548Fax: 952-487-9510E-mail: vswenson@vitalimages.com
510(k) Type:	Special
Summary Date:	October 4, 2017
Device Trade Name:	Vitrea Advanced Visualization, Version 7.6
Device CommonName/ RegulatoryDescription:	Radiological Image Processing Software
Device ClassificationName:	System, Image Processing, Radiological
Regulation Number:	21 CFR 892.2050
Product Code:	LLZ
RegulatoryClassification:	Class II
Device Panel:	Radiology

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Predicate Device(s):

Predicate Device	Manufacturer	FDA 510(k) Number
Vitrea®, Version 7.0Medical Image ProcessingSoftware	Vital Images, Inc.5850 Opus Parkway, Suite 300Minnetonka, MN 55343	K150258

Device Description:

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

Intended Use / Indications for Use:

Intended for Disease / Condition / Patient Population:

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

Key Changes from last 510k clearance K150258

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

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

009 510(k) Summary

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

Substantial Equivalence Comparison:

Regulatory Comparison:

	Subject Device	Predicate Device
Characteristic	Vitrea AdvancedVisualizationVersion 7.6	Vitrea SoftwareVersion 7.0(K150258)	Comparison
Classification Name	System, ImageProcessing,Radiological	System, ImageProcessing,Radiological	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	Under Review	March 5, 2015	Predicate deviceis cleared

Indications for Use Comparison with Predicate Device:

	Subject Device	Predicate Device
Criteria	Vitrea AdvancedVisualizationVersion 7.6	Vitrea SoftwareVersion 7.0 (K150258)	Comparison
Indications forUse	Vitrea is a medicaldiagnostic system thatallows the processing,review, analysis,communication and mediainterchange of multi-dimensional digital imagesacquired from a variety ofimaging devices. Vitrea isnot meant for primary imageinterpretation inmammography.	Vitrea is a medicaldiagnostic system thatallows the processing,review, analysis,communication and mediainterchange of multi-dimensional digital imagesacquired from a variety ofimaging devices. Vitrea isnot meant for primaryimage interpretation inmammography.	Same
Intended Users	Qualified healthcareprofessionals including, butnot restricted to, radiologists,non-radiology specialists,	Qualified healthcareprofessionals including, butnot restricted to,radiologists, non-radiology	Same

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Criteria	Subject Device	Predicate Device	Comparison
	Vitrea AdvancedVisualizationVersion 7.6	Vitrea SoftwareVersion 7.0 (K150258)
	physicians andtechnologists.	specialists, physicians andtechnologists.

Similarities in Technology with Predicate Device:

	Subject Device	Predicate Device
Software Functionality	Vitrea AdvancedVisualizationVersion 7.6	Vitrea SoftwareVersion 7.0(K150258)	Comparison
General Features:
Selection and loading a patient studyComponent: AppShell / Vitrea Clientand Study List	Yes	Yes	Same
Selection of protocol and preset forpatient studyComponent: Gallery Window	Yes	Yes	Same
Visualization and analysis of patientstudyComponent: Viewer Window	Yes	Yes	Same
Allows access to the visual, analysis,and batch pagesComponent: Viewer Window	Yes	Yes	Same
Segment, trim, sculpt, performmeasurements, and change displaysettingsComponent: Viewer Window	Yes	Yes	Same
Record images, batches of images, andmovies for physician reportingComponent: Viewer Window	Yes	Yes	Same
Software Functionality	Subject DeviceVitrea AdvancedVisualizationVersion 7.6	Predicate DeviceVitrea SoftwareVersion 7.0(K150258)	Comparison
Creation of a report for the patientstudy) data publishing and archivingComponent: Report Window	Yes	Yes	Same
Review of report for any patientstudyComponent: Report Window	Yes	Yes	Same
Help on Vitrea softwareComponent: Help Window	Yes	Yes	Same
DICOM Compliance and DataManagement	Yes	Yes	Same
Data Security and HIPAACompliance	Yes	Yes	Same
Multi-vendor scanner compatibility	Yes	Yes	Same
Integrated 2D and 3D visualizationmeasurements	Yes	Yes	Same
Interactive navigation in 3D	Yes	Yes	Same
Large data set capability, includingthe ability to render multi-detectorcomputed tomography (MDCT) data	Yes	Yes	Same
Multiple User WorkstationDeployment	Yes	Yes	Same
Multi-modality Support	Yes	Yes	Same
Vitrea Advanced Visualization Basic Clinical Toolset:
Retrieve image data over the network	Yes	Yes	Same
Display images that are automaticallyadapted to exam type via dedicatedprotocols	Yes	Yes	Same
Select images for closer examinationfrom a gallery of up to six 2D or 3Dviews	Yes	Yes	Same
	Subject Device	Predicate Device
Software Functionality	Vitrea AdvancedVisualizationVersion 7.6	Vitrea SoftwareVersion 7.0(K150258)	Comparison
Interactively manipulate an image inreal-time to visualize anatomy andpathology	Yes	Yes	Same
Annotate, tag, measure, and recordselected views	Yes	Yes	Same
Output selected views to standard filmor paper printers, or post a report to anIntranet	Yes	Yes	Same
Study List:
Automatic reading and display ofdemographic and scanner informationincluding Patient, ID, Date, Time,Series, Modality, Exam Type,Thickness/Spacing, and the number ofimages in the series	Yes	Yes	Same
Each patient entry can include multipleseries of image data	Yes	Yes	Same
Fully sortable listing of all studiespresent on the system to optimize datasearching and selection for users, alongwith user-specific filters	Yes	Yes	Same
Preview of an image of the selectedseries to ensure its applicability	Yes	Yes	Same
Customization of the layout of study listto each user's personal preference	Yes	Yes	Same
Series thumbnail display indicatingavailable series	Yes	Yes	Same
Display of selected images, series, orentire study and loading of multipleseries or studies for simultaneousanalysis and review	Yes	Yes	Same
Direct launch into 2D or 3D workflow fora study or series	Yes	Yes	Same
	Subject Device	Predicate Device
Software Functionality	Vitrea AdvancedVisualizationVersion 7.6	Vitrea SoftwareVersion 7.0(K150258)	Comparison
Display image findings and reports inthe Evidence Manager	Yes	Yes	Same
Retrieve reports that are archived on aWeb server	Yes	Yes	Same
Gallery Window:
Unique clinical protocols based onanatomy, workflow, and image type	Yes	Yes	Same
Automatic pre-selection of clinicalprotocol of images to exam type, asindicated in the DICOM header fields	Yes	Yes	Same
Easy selection of independent 2D and3D views of selected image data forreview, optimized and rendered basedon the clinical protocol	Yes	Yes	Same
Ability to return to the Gallery window atany time to select other views, or toselect alternative protocols	Yes	Yes	Same
Customized presets that can be createdin the Viewer window for display andselection in the Gallery window (onecustom preset for each view availablefor any of the protocols)	Yes	Yes	Same
Viewer Window:
A choice of four 2D review and four 3Ddisplay formats, as well as a 2D "AllExams" comparative viewer that allowsthe user to display up to nine series onthe screen at once	Yes	Yes	Same
Pick tabs in both 2D comparative and 2Dmontage formats, allowing the user tochange the orientation of the imageviews and the order of the seriesdisplayed in comparative viewing	Yes	Yes	Same
Simultaneous view of 3D volume-rendered projections and correlated	Yes	Yes	Same
	Subject Device	Predicate Device
Software Functionality	Vitrea AdvancedVisualizationVersion 7.6	Vitrea SoftwareVersion 7.0(K150258)	Comparison
multi-planar reformatted projections(MPRs)
Orthogonal, Oblique, Double Oblique,and Curved MPRs	Yes	Yes	Same
Cross-reference lines (Crosshairs) toidentify and correlate point of interest inall 2D and 3D views	Yes	Yes	Same
Ability to navigate, scroll, pan, cine,zoom, rotate, flip, invert interactively thatlets the user select, edit, measure,annotate, and record the optimum 2Dand 3D views for diagnosis and reporting	Yes	Yes	Same
Navigation through or around the 3Dview selected (Fly-around, Fly-through,Point-of-interest)	Yes	Yes	Same
Adjustment of window/level on screeninteractively	Yes	Yes	Same
Adjustment of a broad range of imagingcontrols and displays such as rendering(Normal, Min/Max Intensity Projections),brightness, contrast, shading,transparency, and color	Yes	Yes	Same
Image segmentation using any ofseveral segmentation methods(trimming, freehand/box sculpting, semi-automated vessel inclusion/boneremoval based on threshold andconnectivity)	Yes	Yes	Same
Variable size slab reformat andrendering	Yes	Yes	Same
Annotation of the images withembedded 3D arrows and text	Yes	Yes	Same
Distance measurements using ruler andarea and volume measurements usingellipse or freehand ROI	Yes	Yes	Same
Keyboard shortcuts for many functions	Yes	Yes	Same
	Subject Device	Predicate Device
Software Functionality	Vitrea AdvancedVisualizationVersion 7.6	Vitrea SoftwareVersion 7.0(K150258)	Comparison
Creation of custom visualization presetsto appear in the Gallery Tab	Yes	Yes	Same
Recording of selected views(snapshots) for report generation and toallow return to the same view at a latertime to continue the work donepreviously; ability to record a multi-volume snapshot for cases whenmultiple series or volumes have beenloaded simultaneously	Yes	Yes	Same
Batch creation functionality that allows2D, 3D, or 3D fly through batchedimages or movies to print or be sent tothe report page	Yes	Yes	Same
Report Application:
configurationReportinvariousreporting displays	Yes	Yes	Same
Report header that includes userconfigurable information such asInstitution Name, Patient ID, PatientName, Referring Physician, ReadingPhysician, Exam Type, Modality, ScanDate, and Scan Time	Yes	Yes	Same
Inclusion or deletion of patient andhospital information for filming purposes	Yes	Yes	Same
Slide Tray containing snapshots,batches, and movies saved in theViewer window	Yes	Yes	Same
Movie preview	Yes	Yes	Same
Electronic posting of reports to a Webserver	Yes	Yes	Same
	Subject Device	Predicate Device
Software Functionality	Vitrea AdvancedVisualizationVersion 7.6	Vitrea SoftwareVersion 7.0(K150258)	Comparison
Printing of the report on DICOM orPostscript® format printers, exporting toa DICOM image archive, posting onVitrea software's web server, recordingon a CD or a DVD, or exporting to a MSWord document with a defined template	Yes	Yes	Same
Evidence Manager:
Allows the user to view published Image/ batch finding reports and related digitalmovies	Yes	Yes	Same
Snapshot restoration	Yes	Yes	Same
Help Window:
Provides on-line help manual, quickreference and index in HTML format oras PDF documents	Yes	Yes	Same
DICOM Data Management:
DICOM conformance	Yes	Yes	Same
DICOM Storage as SCU & SCP(receive and push)	Yes	Yes	Same
DICOM query/retrieve SCU (pullingimages from other DICOM devices)	Yes	Yes	Same
DICOM query/retrieve SCP (can serveimages to other vendor workstations)	Yes	Yes	Same
DICOM Connection Management	Yes	Yes	Same
Save & Send images in DICOM	Yes	Yes	Same
Data Security and HIPAA Compliance:
Software Functionality	Subject DeviceVitrea AdvancedVisualizationVersion 7.6	Predicate DeviceVitrea SoftwareVersion 7.0(K150258)	Comparison
Software can de-identify patient data,removing patient name and informationfrom the image	Yes	Yes	Same
Software controls workstation accessand reporting security	Yes	Yes	Same
Authentication and access controlsrequire users to enter a confidentialpassword to view both patient studiesand reports	Yes	Yes	Same
Secured access (NT or domain -Login)	Yes	Yes	Same
User group preference and accesscontrol	Yes	Yes	Same
Vitrea Advanced Visualization Components:
CPU-Based Rendering Engine	Yes	Yes	Same
Vitrea Information ManagementSystem (VIMS)	Yes	Yes	Same
Medical Imaging Network Transport(MINT)	Yes	Yes	Same
Vitrea Services Platform (VSP)	Yes	Yes	Same

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ViTAL

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Vil

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ViTAL

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Summary of Non-Clinical Tests:

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

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

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

Risk Management:

Each risk pertaining to the modifications to the Vitrea Advanced Visualization software has been individually assessed to determine if the benefits outweigh the risk. Every risk has been reduced as low as possible and has been evaluated to have a probability of occurrence of harm of "Improbable." All risks for this feature were collectively reviewed to determine if the benefits outweigh the risk. Based on Post Market information and because of the risk control measures included in these modifications, it is believed that the risk for these modifications as a whole is extremely low. Considering all risks against the benefits of this feature, it has been assessed that the benefits do outweigh the risks for this feature.

During the design review, the following conclusions were reached:

The medical benefits of the device outweigh the residual risk for each individual risk and ● all risks together
. All risks have been reduced as low as possible
The overall residual risk for the software product is deemed acceptable ●

Verification:

The software verification team's primary goal was to assure that the software fully satisfies all expected system requirements and features. Test cases were executed against the system features, requirements and risk mitigations. Verification testing confirmed the software functions according to its requirements and all risk mitigations are functioning properly.

Summary of Clinical Tests:

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

Cyber and Information Security:

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

009 510(k) Summary

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Internal documentation covers the following:

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

Performance Standards:

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

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

Standard No.	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

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Substantial Equivalence Analysis Conclusion:

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

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

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

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).