Who is the manufacturer of Endovascular Stent Planning Software?

Vital Images, Inc. filed the 510(k) submission for Endovascular Stent Planning Software (K143079).

What is the FDA product code for Endovascular Stent Planning Software?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Endovascular Stent Planning Software?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Endovascular Stent Planning Software?

Endovascular Stent Planning (K091498).

Who can help prepare an FDA 510(k) submission like Endovascular Stent Planning Software?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Endovascular Stent Planning Software

K143079 · Vital Images, Inc. · LLZ · Dec 4, 2014 · Radiology

Device Facts

Record ID	K143079
Device Name	Endovascular Stent Planning Software
Applicant	Vital Images, Inc.
Product Code	LLZ · Radiology
Decision Date	Dec 4, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

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

Software application for CT image analysis in aortic vascular disorders; assists in stent procedure planning and follow-up. Inputs: CT images. Processing: Automated 3D segmentation of aorta; centerline extraction; initialization of measurements (diameters, lengths, angles, volumes) based on manufacturer-provided stent templates; clock angle tool for fenestrated stent planning. Outputs: 2D/3D visualizations, measurement reports, CSV data tables. Used in clinical settings by physicians (vascular surgeons/interventional cardiologists). Workflow: User reviews, verifies, and edits automated segmentation/measurements; generates reports. Benefits: Streamlined planning for complex aortic cases, including fenestrated stents; improved accuracy in measurement and communication of anatomical landmarks.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including software verification, validation, and simulated usability testing by experienced medical professionals.

Technological Characteristics

Radiological image processing software; operates on the Vitrea platform. Features automated 3D segmentation, centerline extraction, and stent-graft template integration. Connectivity: DICOM standard compliant. Standards: ISO 14971:2007 (Risk Management), IEC 62304:2006 (Software Life Cycle), NEMA PS 3.1-3.20 (DICOM).

Indications for Use

Indicated for medical professionals analyzing, treating, and following up on aortic vascular disorders requiring stent procedures, using CT images. No specific age or gender restrictions.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

Endovascular Stent Planning (K091498)

Related Devices

K091498 — VITREA ENDOVASCULAR STENT PLANNING SOFTWARE · Vital Images, Inc. · Jun 5, 2009
K250337 — AiORTA - Plan · ViTAA Medical Solutions, Inc. · Oct 30, 2025
K254207 — AiORTA - Plan v2.0 · ViTAA Medical Solutions, Inc. · Mar 30, 2026
K200626 — VesselIQ Xpress · GE Medical Systems SCS · Feb 16, 2021
K200515 — syngo.CT Cardiac Planning · Siemens Medical Soultions USA, Inc. · Mar 25, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ 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 stylized caduceus symbol, which features a staff with a snake winding around it, overlaid with three human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. 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. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K143079 Device Name Endovascular Stent Planning Software ### Indications for Use (Describe) Vitrea® is a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea is not meant for primary image interpretation in mammography. 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. 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "VITAL" in large, bold, black letters. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. The dot on the "i" in "VITAL" is a circle. # 510(k) Summary This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part 807.92(c) | Purpose of Submission: | Vital Images, Inc. hereby submits this special 510(k) to provide a notification submission for proposed software changes in the already 510(k) cleared Endovascular Stent Planning software (K091498). | |-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Vital Images, Inc. 5850 Opus Parkway Suite 300 Minnetonka, MN, 55343-4414 | | Establishment Registration: | 2134213 | | Contact Person: | Parthiv Shah Sr. Regulatory Affairs Specialist Phone : 952-487-9574 Fax: 952-487-9510 E-mail: pshah@vitalimages.com | | 510(k) Type: | Special | | Summary Date: | October 24, 2014 | | Device Trade Name: | Endovascular Stent Planning Software | | Device Common Name: | Radiological Image Processing Software | | Device Classification Name: | System, Image Processing, Radiological | | Regulatory Description: | Picture Archiving and Communications System | | Regulation Number: | 21 CFR 892.2050 | | Product Code: | LLZ | | Regulatory Classification: | Class II | {4}------------------------------------------------ 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 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 ### 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: 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 {5}------------------------------------------------ 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 Device Endovascular Stent Planning Software (K091498) | Modified Subject Device | Comparison | |---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Device Type / Classification Name | System, Image Processing, Radiological | System, Image Processing, Radiological | Same | | Common Name | Radiological Image Processing Software | Radiological Image Processing 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 Marketed Device Endovascular Stent Planning Software (K091498) | Modified Subject Device | Comparison | | 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: | 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. | Same | | Criteria | Legally Marketed Device Endovascular Stent Planning Software (K091498) | Modified Subject Device | Comparison | | | 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. | 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. | | #### Regulatory Comparison . {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "VITAL" in a bold, sans-serif font. The "i" in "VITAL" has a circular dot above it. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. #### Intended Use Comparison ● {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "VITAL" in large, bold, black letters. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. The text is centered below the word "VITAL". #### Technology Comparison ● | Feature | Legally Marketed Device Endovascular Stent Planning Software (K091498) | Modified Subject Device | Comparison | |--------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|---------------------------------|------------| | Vessel segmentation of the aortic vessel, including thrombus and centerline extraction | Yes | Yes | Same | | Custom or manufacture stent graft specific worksheet templates | Yes | Yes | Same | | Yes Initialization of endovascular measurements | | Yes | Same | | Display of image side Yes by side in 3D and MPR | | Yes | Same | | Yes Manual centerline and contour editing tools | | Yes | Same | | Feature | Legally Marketed Device Endovascular Stent Planning Software (K091498) | Modified Subject Device | Comparison | | Sequential viewing | Yes | Yes | Same | | Diameter, Area, Lengths, Stenosis measurements | Yes | Yes | Same | | Tortuosity, Angle, Volume measurements | Yes | Yes | Same | | Intensity (HU) based color coding of vessel lumen and wall regions | Yes | Yes | Same | | DICOM Modality | CT | CT | Same | | Hardware Requirements | Identical to Vitrea platform | Identical to Vitrea platform | Same | | Software Requirements | Identical to Vitrea platform | Identical to Vitrea platform | Same | | Tool: Ruler It provides a length measurement between 2 points. Used commonly for diameters of vessels. | Yes | Yes | Same | | Tool: Length It provides a length between 2 centerline points along the centerline. | Yes | Yes | Same | | Feature | Legally Marketed Device Endovascular Stent Planning Software (K091498) | Modified Subject Device | Comparison | | Tool: Angle It provides an angle in degrees derived from 3 points which create 2 line segments. | Yes | Yes | Same | | Tool: Volume It provides a volume of a given region by adding all the voxels contained within the region of interest. | Yes | Yes | Same | {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "VITAL" in large, bold, black letters. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. The text is centered below the word "VITAL". {9}------------------------------------------------ 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 Marketed Device Endovascular Stent Planning Software (K091498) | Modified Subject Device | Comparison | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Tool: Clock Angle It provides a time relative to a noon marker. This is a way of designating vessel locations relative to a common frame of reference. | No | Yes | The added feature does not affect the intended use or fundamental scientific technology of already cleared Endovascular Stent Planning Software (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, {10}------------------------------------------------ Image /page/10/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 text is centered and the background is white. The logo is simple and modern. 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. {11}------------------------------------------------ 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. | Standards Organization | Standard Title | Version | Date | |----------------------------------------------------------|---------------------------|---------------------------------------------------------------------------------|---------|------------| | PS 3.1- 3.20 (2011) (Recognition Number 12-238) | NEMA | Digital Imaging and Communications in Medicine (DICOM) Set (Radiology) | 3 | 03/16/2012 | | ISO 14971:2007 (Recognition Number 5-70) | AAMI / ANSI / ISO | Medical Devices - Applications of Risk Management to Medical Devices | 2007 | 03/16/2012 | {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the word "VITAL" in large, bold, black letters. The dot on the "i" is a perfect circle. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The text is centered. | Standard No. | Standards Organization | Standard Title | Version | Date | |-------------------------------------------------|---------------------------|-------------------------------------------------------------------------------------------|---------|------------| | IEC 62304:2006 (Recognition Number 13-32) | AAMI / ANSI / IEC | Medical Device Software - Software Life Cycle Processes (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.