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

The Endovascular Stent Planning Software application is intended for use with CT (computed tomography) images to assist medical professionals in the analysis, treatment and follow-up of aortic vascular disorders that may require a stent procedure. The software provides 3D segmentation of the aorta and initializes stent measurements based on a template provided by the stent manufacturers. The user can review the 2D and 3D images, verify and correct the results of the segmentation and initialization, and generate a report with the stent measurements.

Device Description

The Endovascular Stent Planning software is intended for use with CT (computed tomography) images to assist medical professionals in the analysis, treatment and follow-up of aortic vascular disorders that may require a stent procedure. The endovascular stent planning application module enables visualization and measurements of the aortic vessel for evaluation, treatment and follow up for aortic vascular disorders that may require a stent procedure. The software performs automated 3D segmentation of the aorta and initializes stent measurements based on a template provided by the stent manufacturers. The physicians can review the 2D and 3D images, verify and correct the results of the segmentation and initialization, and generate a report with the stent measurements, in a fast and efficient manner.

The software provides imaging information as an assist to the physician. The software does not provide diagnostic information or determine recommended medical care. In summary, the software provides:

Automated segmentation of the aortic vessel, including thrombus with centerline . and contour editing tools
. Stent-graft templates for abdominal and thoracic aortic aneurysms
User-quided workflow with automated identification of anatomical landmarks and automated initialization of endovascular measurements (diameters, lengths, angles, volumes) based on the stent template selection, with easy centerline and contour editing tools
Auto-populated reporting worksheet with selected stent template measurements ●
Key measurements that helps medical professionals to identify location of . fenestrations to support fenestrated stent planning by adding the clock angle tool and the clock angle overlay functionality
. Create new, add/or modify, stent planning templates with the Custom Device Template Editor
Data tables export results to CSV ●
Multi-study support for longitudinal comparison ●
3D measurement overview for streamlined communication of results ●
Volume measurements for pre and post aneurysmal size measurement ●
Workflows for pre-treatment (stent, surgery) planning and post-treatment follow ● up, including a side-by-side comparative review layout and longitudinal measurements

AI/ML Overview

The provided documentation is a 510(k) Summary for the Endovascular Stent Planning Software (K143079), which is primarily an update to an already cleared device (K091498) to add a "Clock Angle" tool. As such, the document focuses on demonstrating substantial equivalence rather than presenting a full de novo study with detailed performance metrics against acceptance criteria.

The document does not explicitly list acceptance criteria in a table format with corresponding reported device performance metrics for the "Endovascular Stent Planning Software" as a whole. Instead, it describes a process of verification and validation to show that the new feature (Clock Angle tool) does not negatively impact the previously cleared device's safety and effectiveness.

Here's an analysis based on the provided text for the new Clock Angle tool and the overall software:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table with explicit acceptance criteria and quantitative performance metrics for the Clock Angle tool or the overall device in the way a typical clinical study would. The non-clinical testing focuses on demonstrating that the software operates "according to its requirements" and that the modifications do not raise new questions of safety or effectiveness.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: The document mentions "previously acquired medical images" for verification and validation but does not specify a sample size for the test set used for validating the software, or specifically the Clock Angle tool.
Data Provenance: Not specified. It refers to "previously acquired medical images," but no details on country of origin, whether it was retrospective or prospective, or patient demographics are provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: The "External Validation" section states that "experienced medical professionals evaluated the application." The plural "professionals" suggests more than one, but an exact number is not specified.
Qualifications of Experts: They are described as "experienced medical professionals." No further details on their specific qualifications (e.g., specialty, years of experience) are provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe a formal adjudication method for ground truth establishment. It states that "Both validators confirmed that the Fenestrated Stent Planning using Endovascular Stent Planning software was safe and effective and met the intended use." This suggests a consensus or affirmation, but not a structured adjudication process.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The document states, "The subject of special 510(k) notification, Endovascular Stent Planning software, did not require clinical studies to support safety and effectiveness of the software." The emphasis is on demonstrating substantial equivalence to the predicate device, not on improved human reader performance with AI assistance. The software is described as an "assist," but its impact on human reader performance is not quantified.

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

The document focuses on the software assisting medical professionals, with users reviewing and correcting results. While verification and validation tests were performed on the software, the "External Validation" section refers to "experienced medical professionals evaluated the application." This suggests a human-in-the-loop evaluation for the external validation. Therefore, a purely standalone performance evaluation is not explicitly described as the primary validation for this submission. The software performs automated segmentation and initializes measurements, but users retain control for review and correction.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the "External Validation," the ground truth appears to be established by the "experienced medical professionals" confirming that the software "was safe and effective and met the intended use." This is closest to expert consensus/opinion regarding the software's functionality and utility for its intended purpose of assistance. It is not based on pathology or long-term outcomes data presented in this document.

8. The sample size for the training set

The document does not specify a sample size for any training set. This 510(k) is for a modification to an already cleared device, and the focus is on the added feature within the context of the existing system. Details about the original training set for the predicate device (K091498) are not provided in this specific document.

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

As no training set information is provided, the method for establishing its ground truth is also not specified.

Summary

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

December 4, 2014

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

Re: K143079

Trade/Device Name: Endovascular Stent Planning Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 24, 2014 Received: October 27, 2014

Dear Mr. Shah:

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

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

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

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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,

Robert A Ochs

for

Janine M. Morris 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) K143079

Device Name Endovascular Stent Planning Software

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

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

Purpose ofSubmission:	Vital Images, Inc. hereby submits this special 510(k) to provide anotification submission for proposed software changes in the already510(k) cleared Endovascular Stent Planning software (K091498).
Submitter:	Vital Images, Inc.5850 Opus ParkwaySuite 300Minnetonka, MN, 55343-4414
EstablishmentRegistration:	2134213
Contact Person:	Parthiv ShahSr. Regulatory Affairs SpecialistPhone : 952-487-9574Fax: 952-487-9510E-mail: pshah@vitalimages.com
510(k) Type:	Special
Summary Date:	October 24, 2014
Device Trade Name:	Endovascular Stent Planning Software
Device CommonName:	Radiological Image Processing Software
DeviceClassificationName:	System, Image Processing, Radiological
RegulatoryDescription:	Picture Archiving and Communications System
Regulation Number:	21 CFR 892.2050
Product Code:	LLZ
RegulatoryClassification:	Class II

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Image /page/4/Picture/0 description: The image shows the word "VITAL" in large, bold, black letters. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The word "VITAL" is the main focus of the image, with the company affiliation provided as additional context.

Predicate Device:

Predicate Device	Manufacturer	FDA 510(k) number
Endovascular Stent Planning(Legally Marketed Device)	Vital Images, Inc.	K091498

Device Description:

The software provides imaging information as an assist to the physician. The software does not provide diagnostic information or determine recommended medical care. In summary, the software provides:

Automated segmentation of the aortic vessel, including thrombus with centerline . and contour editing tools
. Stent-graft templates for abdominal and thoracic aortic aneurysms
User-quided workflow with automated identification of anatomical landmarks and automated initialization of endovascular measurements (diameters, lengths, angles, volumes) based on the stent template selection, with easy centerline and contour editing tools
Auto-populated reporting worksheet with selected stent template measurements ●
Key measurements that helps medical professionals to identify location of . fenestrations to support fenestrated stent planning by adding the clock angle tool and the clock angle overlay functionality
. Create new, add/or modify, stent planning templates with the Custom Device Template Editor
Data tables export results to CSV ●
Multi-study support for longitudinal comparison ●
3D measurement overview for streamlined communication of results ●
Volume measurements for pre and post aneurysmal size measurement ●
Workflows for pre-treatment (stent, surgery) planning and post-treatment follow ● up, including a side-by-side comparative review layout and longitudinal measurements

Intended Use / Indications for Use:

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

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segmentation of the aorta and initializes stent measurements based on a template provided by the stent manufacturers. The user can review the 2D and 3D images, verify and correct the results of the segmentation and initialization, and generate a report with the stent measurements.

Rationale for Adding Clock Angle Tool in the Software

Typically, a vascular surgeon or interventional cardiologist is responsible for all necessary stent planning procedures, which includes identifying necessary anatomical measurements from patient's CT scan data for proper size stent selection including fenestrated stents, which is required for patients whose aneurysm begins close to the renal arteries (i.e. an inadequate length of suitable aorta for the standard stent.) The surgeon/ cardiologist prefer to have a "Clock Angle" tool in the software that can provide additional measurements required to fill order sheet for ordering fenestrated stent.

The clock angle tool provides a special set of measurements required on fenestrated stent sizing worksheet. The Clock Angle tool provides a time relative to a noon marker. This provides information for designating vessel locations relative to a common frame of reference.

Generally, the responsible surgeon/cardiologist and manufacturer will re-verify software provided measurements by other standardized methods before finalizing fenestrated stent sizing for a patient.

Intended for Disease / Condition / Patient Population:

The Endovascular Stent Planning Software application is intended for assisting medical professionals in the analysis, treatment and follow-up of aortic vascular disorders that may require a stent procedure.

Substantial Equivalence Comparison:

Criteria	Legally Marketed DeviceEndovascular Stent PlanningSoftware (K091498)	Modified SubjectDevice	Comparison
Device Type /Classification Name	System, Image Processing,Radiological	System, ImageProcessing,Radiological	Same
Common Name	Radiological ImageProcessing Software	Radiological ImageProcessing Software	Same
Regulation /Classification Number	21 CFR 892.2050	21 CFR 892.2050	Same
Product Code	LLZ	LLZ	Same
Classification	Class II	Class II	Same
Review Panel	Radiology	Radiology	Same
Criteria	Legally MarketedDeviceEndovascular StentPlanning Software(K091498)	Modified SubjectDevice	Comparison
Indications for Use	Vitrea® is a medicaldiagnostic system thatallows the processing,review, analysis,communication andmedia interchange ofmulti-dimensionaldigital imagesacquired from avariety of imagingdevices. Vitrea is notmeant for primaryimage interpretation inmammography. Vitreahas the followingadditional indication:	Vitrea® is a medicaldiagnostic system thatallows the processing,review, analysis,communication andmedia interchange ofmulti-dimensionaldigital imagesacquired from avariety of imagingdevices. Vitrea is notmeant for primaryimage interpretation inmammography. Vitreahas the followingadditional indication:The EndovascularStent PlanningSoftware application isintended for use withCT (computedtomography) imagesto assist medicalprofessionals in theanalysis, treatmentand follow-up of aorticvascular disorders thatmay require a stentprocedure. Thesoftware provides 3Dsegmentation of theaorta and initializesstent measurementsbased on a templateprovided by the stentmanufacturers.	Same
Criteria	Legally MarketedDeviceEndovascular StentPlanning Software(K091498)	Modified SubjectDevice	Comparison
	The user can reviewthe 2D and 3Dimages, verify andcorrect the results ofthe segmentation andinitialization, andgenerate a report withthe stentmeasurements.	The user can reviewthe 2D and 3Dimages, verify andcorrect the results ofthe segmentation andinitialization, andgenerate a report withthe stentmeasurements.

Regulatory Comparison .

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Intended Use Comparison ●

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Technology Comparison ●

Feature	Legally MarketedDeviceEndovascular StentPlanning Software(K091498)	Modified SubjectDevice	Comparison
Vessel segmentationof the aortic vessel,including thrombusand centerlineextraction	Yes	Yes	Same
Custom ormanufacture stentgraft specificworksheet templates	Yes	Yes	Same
YesInitialization ofendovascularmeasurements		Yes	Same
Display of image sideYesby side in 3D andMPR		Yes	Same
YesManual centerlineand contour editingtools		Yes	Same
Feature	Legally Marketed DeviceEndovascular StentPlanning Software(K091498)	Modified SubjectDevice	Comparison
Sequential viewing	Yes	Yes	Same
Diameter, Area,Lengths, Stenosismeasurements	Yes	Yes	Same
Tortuosity, Angle,Volumemeasurements	Yes	Yes	Same
Intensity (HU) basedcolor coding of vessellumen and wallregions	Yes	Yes	Same
DICOM Modality	CT	CT	Same
HardwareRequirements	Identical to Vitreaplatform	Identical to Vitreaplatform	Same
SoftwareRequirements	Identical to Vitreaplatform	Identical to Vitreaplatform	Same
Tool: RulerIt provides a lengthmeasurementbetween 2points. Usedcommonly fordiameters of vessels.	Yes	Yes	Same
Tool: LengthIt provides a lengthbetween 2 centerlinepoints along thecenterline.	Yes	Yes	Same
Feature	Legally MarketedDeviceEndovascular StentPlanning Software(K091498)	Modified SubjectDevice	Comparison
Tool: AngleIt provides an angle indegrees derived from3 points which create2 line segments.	Yes	Yes	Same
Tool: VolumeIt provides a volumeof a given region byadding all the voxelscontained within theregion of interest.	Yes	Yes	Same

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Image /page/9/Picture/0 description: The image shows the word "VITAL" in large, bold, black letters. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The word "VITAL" is the main focus of the image, with the company affiliation provided as additional context.

● Differences in Technology

Feature	Legally MarketedDeviceEndovascular StentPlanning Software(K091498)	Modified SubjectDevice	Comparison
Tool: Clock AngleIt provides a timerelative to a noonmarker. This is a wayof designating vessellocations relative to acommon frame ofreference.	No	Yes	The added featuredoes not affect theintended use orfundamental scientifictechnology of alreadycleared EndovascularStent PlanningSoftware (K091498).

● Substantial Equivalence Analysis

The addition of Clock Angle tool and related measurements do not affect the intended use or alter the fundamental scientific technology of legally marketed Endovascular Stent Planning software (K091498). The modified Endovascular Stent Planning software has the same indications for use, principle of operation, and performs the same technological functions as already cleared Endovascular Stent Planning software - K091498 (Predicate Device). The modifications are not consequential from the standpoint of device operation, safety, effectiveness or intended use.

Any minor differences noted have been explained and do not raise any new questions of safety or effectiveness when used as labeled. The implemented design mitigations,

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labeling, and the performed verification and validation tests demonstrate the safety and efficacy of the device is equivalent to the predicate device. Based on the comparison data and test data. Vital Images believes the subject device should be found substantially equivalent to the predicate device.

Summary of Non-Clinical Tests:

The changes to the Endovascular Stent Planning software was designed developed and tested according to written procedures that included applying risk management. Software testing was completed to ensure the new feature operates according to its requirements.

Testing included verification, validation, and evaluation on previously acquired medical images. The following quality assurance measures were applied to the development:

Risk Management
. Requirements reviews
Code designs ●
Code reviews .
Design reviews ●
Verification of the software - that included performance, phantom, and safety testing
Validation of the software that included simulated usability testing by independent ● experienced medical professionals.

Risk Management:

Each risk pertaining to this feature 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 the post market information contained in our Clinical Evaluation Report, injury or death is very rare for our product and products similar to ours. Because of this history and 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 ●
The medical benefits of the device outweigh the residual risk for each individual risk ● and all risks together
o The overall residual risk for the project 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 and requirements. As a part of creating the test cases, the verification team reviewed and monitored the Requirements Traceability Matrix ("RTM") to ensure coverage of the items within the RTM.

Validation:

The software validation team's primary goal was assuring the software conforms to user needs and intended use. The validation team conducted workflow testing that provided evidence that the system requirements and features were implemented, reviewed and met.

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Image /page/11/Picture/1 description: The image shows the word "VITAL" in large, bold, black letters. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The word "VITAL" is the main focus of the image, with the company affiliation provided as additional context.

External Validation:

During external validation of enhanced Endovascular Stent Planning software, experienced medical professionals evaluated the application. Both validators confirmed that the Fenestrated Stent Planning using Endovascular Stent Planning software was safe and effective and met the intended use of assisting medical professionals in the analysis, treatment, and follow-up of aortic vascular disorders that may require a stent procedure.

Summary of Clinical Tests:

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

Cyber and Information Security:

Confidentiality .
The Vitrea platform (K071331) relies on built in Windows Login security to limit access to the system. The Vitrea platform can only be installed and configured by an administrator of the Windows machine.
. Intearitv
The Vitrea platform complies with the DICOM standard for transfer and storage of this data and does not modify the contents of DICOM instances. The Vitrea platform identifies the data it produces, marking and encoding the appropriate DICOM fields.
o Availabilitv
The Vitrea platform is always available to the logged on user as long as the Windows machine itself is properly maintained.
Accountability
The Vitrea platform includes an audit capability that enables accountability by tracking authenticated and authorized user operations along with information accessed. Vitrea audit logs are time stamped, enabling correlation with Windows system logging to track information accessed by a user.

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 Endovascular Stent Planning 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 inMedicine (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

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Standard No.	StandardsOrganization	Standard Title	Version	Date
IEC 62304:2006(RecognitionNumber 13-32)	AAMI / ANSI/ IEC	Medical Device Software -Software Life CycleProcesses (Software /Informatics)	2006	08/20/2012

Conclusion:

Vital Images believes that Endovascular Stent Planning software application has a substantially equivalent intended use, indications for use, principle of operation, and technological characteristics as the predicate device. Any minor differences noted have been explained and do not raise any new questions of safety or effectiveness as the predicate device. The implemented design mitigations, labeling, and performed tests demonstrate the safety and efficacy of the device in comparison to the predicate device. Based on the comparison data and test data Vital Images believes, the subject device should be found substantially equivalent to the predicate device. The Endovascular Stent Planning software device is as safe and effective as 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).