Vitrea Software Package is an application package developed for use on Vitrea®, a medical diagnostic system that allows the processing, review, analysis, communication and media interchange of multidimensional digital images acquired from a variety of imaging devices. Vitrea has the following indications:

The Cerebral Aneurysm Analysis application is intended to facilitate the extraction of user identified aneurysms on the cerebral arteries. The software can be used as an adjunct to diagnosis for the purposes of measurement of size and aspect ratio.

The MR Wall Motion Tracking application is intended to assist physicians with performing cardiac functional analysis based upon magnetic resonance images. It provides measurements of global and regional myocardial function that is used for patients with suspected heart disease.

The MR Coronary Tracking application is intended to assist physicians with performing coronary artery analysis for MR heart images which are intended for the qualitative and quantitative analysis of coronary arteries.

The SUREVolume Synthesis application is intended to load volume images acquired by whole-body X-ray CT scanners, X-ray angiography systems, and MRI systems and displays fusion images.

The Angio Viewer application displays image data acquired using an X-ray angiography system. It supports cine display, subtraction, and distance measurement.

The US Cardiac Fusion application enables fusion display of the analysis results obtained using the US 3D Wall Motion Tracking application and the CT Coronary Artery Analysis application.

The Ultrasound Clinical Applications are indication of structures, and dynamic processes with the human body using saved ultrasound DICOM images to provide image information for diagnosis.

The DE Stone Analysis application is intended to serve as an adjunct visualization tool for the differentiation between uric acid and non-uric acid stones greater than 3mm with Dual Energy CT studies.

The DE Composition Analysis application is intended to serve as an adjunct visualization tool for the uric acid presence within surrounding anatomical structures with Dual Energy CT studies.

Embolization Plan is a post processing software that is intended to assist physicians in the liver arterial tree using 3D images of CT or 3D images of Cone Beam CT (INFX-8000 Interventional Family) acquired by Toshiba or Canon Medical Systems. It provides tools to assist the user in analysis of these images. The output is intended to be an adjunct means that allows automatic and manual planning of the liver arterial vessels for guidance of the embolization procedure. The output is a 3D visualization of the hepatic arteries to high dense lesion in the liver.

Device Description

Vitrea Software Package, VSTP-001A, an application package developed for use on Vitrea, a medical image processing software, marketed by Vital Images, Inc. Vitrea Software Package, VSTP-001A, currently includes ten post processing applications, MR Wall Motion Tracking, Cerebral Aneurysm Analysis, MR Coronary Tracking, Sure Volume Synthesis, Angio Viewer, US Cardiac Fusion, Ultrasound Applications Package, Dual Energy Stone Analysis, Dual Energy Composition Analysis and Embolization Planning which use brain, body or cardiac image data, obtained from CT/XA/MR/US systems, to assist physicians in performing specialized measurements and analysis.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Dual Energy Stone Analysis and Embolization Plan applications, based on the provided text.

Dual Energy Stone Analysis

The device is the "Vitrea Software Package: DE Stone Analysis". The study demonstrates substantial equivalence to "Aquilion Dual Energy System Package" (K132813).

Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Intended Use: Differentiation between uric acid and non-uric acid stones greater than 3mm.	Subject Device (Vitrea Software Package: DE Stone Analysis): Intended to serve as an adjunct visualizationtool for the differentiation between uric acid and non-uricacid stones greater than 3mm with Dual Energy CT studies.Predicate Device (Aquilion Dual Energy System Package): The visualization of the differentiation between uric acid and non-uric acid stones greater than 3mm... is provided with the Dual Energysystem. When used by a qualified physician, a potential application is to determine the course of treatment.
Anatomical Region: Whole body.	Both Subject and Predicate devices are indicated for whole body.
Feature: Image Processing - Visualization of differentiation between uric acid and non-uric acid stones.	Subject Device: Image Processing - Visualization of the differentiation between uric acid and non-uric acid stones.Predicate Device: Image Processing - Visualization of the differentiation between Uric Acid and non-uric acid stones.
Image data format for image processing: DICOM format of CT image data.	Subject Device: DICOM format of CT image data.Predicate Device: Original format of CT image data (implicitly compatible with the system generating it).
Reconstruction/Viewing: MPR.	Subject Device: MPR.Predicate Device: MPR / 3D (MPR in DE Stone Analysis).
Segmentation: The region included in the range of set CT numbers is extracted.	Subject Device: The region included in the range of set CT numbers is extracted.Predicate Device: The region included in the range of set CT numbers is extracted. The compositions is extracted based on the composition setting.
Overall: Substantially equivalent performance to the predicate device.	Bench studies were conducted using sample data sets from the predicate device verification activities (K131823) and verifying that the outputs for both devices were substantially the same.

Sample Size and Data Provenance:
- Test Set Sample Size: Not explicitly stated, but the studies used "sample data sets from the predicate device verification activities (K131823)."
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). It refers to "predicate device verification activities," which might imply clinical data, but its nature isn't detailed.
Number of Experts and Qualifications: Not specified for this particular application.
Adjudication Method: Not specified.
MRMC Comparative Effectiveness Study: No, the text describes bench testing comparing outputs, not a human reader study.
Standalone Performance: Yes, the described "bench testing" compared the outputs of the subject and predicate devices, which implies standalone algorithmic performance.
Type of Ground Truth: The ground truth for this comparison was "outputs for both devices were substantially the same" when processed with the same input data. It implies a comparison against the predicate device's output as a form of "ground truth" or reference, rather than an independent gold standard like pathology.
Training Set Sample Size: Not specified.
Ground Truth for Training Set: Not specified.

Embolization Plan

The device is the "Embolization Plan" software application. The study demonstrates substantial equivalence to "Philips EmboGuide" (K142273).

Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Intended Use: Assist physicians in visualization and planning of liver arterial vessels for embolization procedures, using 3D images of CT or Cone Beam CT, and guiding embolization.(Primary function: determining feeder vessels).	Subject Device (Embolization Plan): ...intended to assist physicians in the visualization of the liver arterial tree using 3D images of CT or 3D images of Cone Beam CT... planning of the liver arterial vessels for guidance of the embolization procedure. The output is a 3D visualization of the hepatic arteries to high dense lesion in the liver.Predicate Device (EmboGuide): ...intended to assist physicians in performing embolization of hypervascular tumors in the liver using interventional X-ray. It provides tools to help the user with the analysis of 3D rotational angiography images. Its output is intended as an adjunct means to help with the planning and guidance of the embolization procedure.
Anatomical Region: Liver.	Both Subject and Predicate devices are indicated for the liver anatomical region.
Input: 3D images (CBCT for predicate).	Subject Device: CT / CBCT.Predicate Device: CBCT. (Note: The subject device expands input compatibility).
Reconstruction/Viewing: MPR / 3D.	Both Subject and Predicate devices support MPR / 3D.
Vessel tracking: Automatic/Manual.	Both Subject and Predicate devices support automatic/manual vessel tracking.
Distance measurement: Manual.	Both Subject and Predicate devices support manual distance measurement.
Overall: Effective in assisting clinicians to identify the required feeder vessels for embolization planning.	The resulting performance data demonstrated that the software was effective in assisting clinicians to identify the required feeder vessels for embolization planning.

Sample Size and Data Provenance:
- Test Set Sample Size: Not explicitly stated.
- Data Provenance: "sample data that was obtained from clinical institutions where local ethical controls were in place." This suggests retrospective clinical data, but the countries of origin are not specified.
Number of Experts and Qualifications: Not specified for this particular application.
Adjudication Method: "The data was reviewed and verified independently by a test group and a control group." This suggests an independent review, but the specific adjudication rules (e.g., 2+1) are not detailed.
MRMC Comparative Effectiveness Study: The study involved a "test group and a control group" reviewing data, and the device's effectiveness in "assisting clinicians" was evaluated. This implies a human-in-the-loop study, but the "effect size of how much human readers improve with AI vs without AI assistance" is not quantified in the provided text. It only states that the software "was effective in assisting clinicians."
Standalone Performance: While the software has standalone features, the referenced study explicitly evaluates its performance in "assisting clinicians," indicating a human-in-the-loop context. No purely standalone performance metrics are provided.
Type of Ground Truth: The ground truth was implicitly established through review and verification by the "test group and a control group" from clinical institutions. This suggests expert consensus based on clinical data.
Training Set Sample Size: Not specified.
Ground Truth for Training Set: Not specified.

Summary

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December 14, 2018

Canon Medical Systems Corporation Paul Biggins Director Regulatory Affairs Canon Medical Systems U.S.A 2441 Michelle Drive TUSTIN, CA 92780

Re: K182601

Trade/Device Name: Vitrea Software Package, VSTP-001A Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: LLZ Dated: November 9, 2018 Received: November 16, 2018

Dear Paul Biggins:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Hole 2. Nils

for Robert A. 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)

K182601

Device Name

Vitrea Software Package; VSTP-001A

Indications for Use (Describe)

The SUREVolume Synthesis application is intended to load volume images acquired by whole-body X-ray CT scanners, X-ray angiography systems, and MRI systems and displays fusion images.

The Angio Viewer application displays image data acquired using an X-ray angiography system. It supports cine display, subtraction, and distance measurement.

The US Cardiac Fusion application enables fusion display of the analysis results obtained using the US 3D Wall Motion Tracking application and the CT Coronary Artery Analysis application.

The Ultrasound Clinical Applications are indication of structures, and dynamic processes with the human body using saved ultrasound DICOM images to provide image information for diagnosis.

The DE Composition Analysis application is intended to serve as an adjunct visualization tool for the uric acid presence within surrounding anatomical structures with Dual Energy CT studies.

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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K182601

510(k) Summary

1. SUBMITTER'S NAME Canon Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550
1. OFFICIAL CORRESPONDENT Naofumi Watanabe Senior Manager, Regulatory Affairs and Vigilance
1. ESTABLISHMENT REGISTRATION 9614698

4. CONTACT PERSON

Paul Biggins Senior Director Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive Tustin, CA 92780 (714) 669-7808 (voice)

1. DATE PREPARED September 20, 2018
1. TRADE NAME(S) Vitrea Software Package, VSTP-001A
1. COMMON NAME Radiological Image Processing Software
1. DEVICE CLASSIFICATION Class II (per 21 CFR 892.2050, Picture Archiving and Communications System)
PRODUCT CODE/DESCRIPTION 9. 90LLZ / Picture Archiving and Communications System

10. PERFORMANCE STANDARD: None

11. PREDICATE DEVICES

Application	Predicate	510(k) Control#	Status
MR Wall Motion Tracking	VSTP-001A	K151093	Cleared
Cerebral Aneurysm Analysis(CT/XA Cerebral ArteryMorphological Analysis)	VSTP-001A	K151093	Cleared
MR Coronary Tracking	VSTP-001A	K171222	Cleared
suREVolume Synthesis	VSTP-001A	K173088	Cleared

Made For life

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Angio Viewer	VSTP-001A	K173088	Cleared
US Cardiac Fusion	VSTP-001A	K173088	Cleared
Ultrasound Application PackageApplication	VSTP-001APredicate	K180323510(K)Control #	ClearedStatus
Dual Energy Stone Analysis	Canon Aquilion	K132813	New
Dual Energy CompositionAnalysis	Canon Aquilion	K132813	New
Embolization Planning Tool	PhilipsEmboGuide	K142273	New

Primary Predicate Device: VSTP-001A, K180323 Reference Predicate Device: Canon Aquilion ONE; K1328131 Reference Predicate Device: Philips EmboGuide; K1422732

12. REASON FOR SUBMISSION

Modification - Porting of application software (DE) from a different class device'. Implementation of a new software application (Embolization Planning) 2.

13. DEVICE DESCRIPTION

14. INDICATIONS FOR USE

Vitrea Software Package is an application package developed for use on Vitrea®, a diagnostic system that allows the processing, review, analysis, medical communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. Vitrea has the following additional indications:

The Cerebral Aneurysm Analysis application is intended to facilitate the extraction and segmentation of user identified aneurysms on the cerebral arteries. The software can be used as an adjunct to diagnosis for the purposes of measurement of size and aspect ratio.

The MR Coronary Tracking application is intended to assist physicians with performing coronary artery analysis for MR heart images which are intended for the

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qualitative and quantitative analysis of coronary arteries.

The SUREVolume Synthesis application is intended to load volume images acquired by whole-body X-ray CT scanners, X-ray angiography systems, and MRI systems and displays fusion images.

The Angio Viewer application displays image data acquired using an X-ray angiography system. It supports cine display, subtraction, and distance measurement.

The US Cardiac Fusion application enables fusion display of the analysis results obtained using the US 3D Wall Motion Tracking application and the CT Coronary Artery Analysis application.

The Ultrasound Clinical Applications are indicated for the visualization of structures, and dynamic processes with the human body using saved ultrasound DICOM images to provide image information for diagnosis.

The DE Composition Analysis application is intended to serve as an adjunct visualization tool for the uric acid presence within surrounding anatomical structures with Dual Energy CT studies.

Embolization Plan is a post processing software that is intended to assist physicians in the visualization of the liver arterial tree using 3D images of CT or 3D images of Cone Beam CT (INFX-8000 Interventional Family) acquired by Toshiba or Canon Medical Systems. It provides tools to assist the user in analysis of these images. The output is intended to be an adjunct means that allows automatic and manual planning of the liver arterial vessels for quidance of the embolization procedure. The output is a 3D visualization of the hepatic arteries to high dense lesion in the liver.

15. SUBSTANTIAL EQUIVALANCE

The Dual Energy software applications included in the Vitrea Software Package, VSTP-001A. perform in a manner similar to and are intended for the same use (image processing) as the previously cleared Aquilion Dual Energy Software. The Dual Energay applicatons utilize the same formulas, algorithms and measurements as found on the predicate device. The porting of this software to the Vitrea Workstation required modifications to the GUI and acquiring images from the Vitrea Image Database (DiCOM). The subject and predicated devices are all post processing applications that are used to aid physicians with performing measurement and analysis of diagnotic images.

A complete comparison table for this application is included in this submission. See below for a brief comparison summary of technological characteristics of the devices:

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Dual Energy Stone Analysis

Item	VitreaSoftwarePackage:DE Stone Analysis	Aquilion Dual Energy System Package
	(Subject Device)	(K132813)
Intended Use	This software isintended to serve as anadjunct visualizationtool for thedifferentiation betweenuric acid and non-uricacid stones greater than3mm with Dual EnergyCT studies.	The Dual Energy System allows the system toacquire two CT images of the same anatomicallocation using distinct tube voltages and/ortube currents during two tube rotations. The x-ray dose will be the sum of the dose of eachtube rotation at its respective tube voltage andcurrent. Information regarding the materialcomposition of various organs, tissues, andcontrast materials may be gained from thedifferences in x-ray attenuation between thesedistinct energies.This information may also be used toreconstruct images at multiple energies withinthe available spectrum, and to reconstructbasis images that allow the visualization andanalysis of anatomical and pathologicalmaterials.The visualization of the differentiation betweenuric acid and non-uric acid stones greater than3mm and the visualization of uric acidpresence within surrounding anatomicalstructures is provided with the Dual Energysystem. When used by a qualified physician,a potential application is to determine thecourse of treatment.Performance of this device may be affected bybody size and motion artifacts.
AnatomicalRegion	whole body	whole body

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Feature	Image Processing- Visualization of thedifferentiationbetween uric acid andnon-uric acid stones	Scanning the same anatomical locationusing distinct tube voltages and/or tubecurrentsReconstruction of images at multipleenergies and basis images• Iodine Map• MonochromaticImage Processing• Visualization of the differentiation betweenUric Acid and non-uric acid stones• Visualization of uric acid concentrationswithin surrounding anatomical structure
Image dataformat forimageprocessing	DICOM format of CTimage data	Original format of CT image data
	MPR	MPR / 3D (MPR in DE Stone Analysis)
Segmentation	The region included inthe range of set CTnumbers is extracted.	• The region included in the range of set CTnumbers is extracted.• The compositions is extracted based on thecomposition setting.

Dual Energy Composition Analysis

Item	Vitrea SoftwarePackage:DE Composition Analysis(Subject Device)	Aquilion Dual Energy System Package(K132813)
Intended Use	This software isintended to serve as anadjunct visualizationtool for the uric acidpresence withinsurrounding anatomicalstructures with DualEnergy CT studies.	The Dual Energy System allows the system toacquire two CT images of the same anatomicallocation using distinct tube voltages and/or tubecurrents during two tube rotations. The x-raydose will be the sum of the dose of each tuberotation at its respective tube voltage andcurrent. Information regarding the materialcomposition of various organs, tissues, andcontrast materials may be gained from thedifferences in x-ray attenuation between thesedistinct energies.This information may also be used to reconstructimages at multiple energies within the available

		spectrum, and to reconstruct basis images thatallow the visualization and analysis of anatomicaland pathological materials.The visualization of the differentiation betweenuric acid and non-uric acid stones greater than3mm and the visualization of uric acid presencewithin surrounding anatomical structures isprovided with the Dual Energy system. Whenused by a qualified physician, a potentialapplication is to determine the course oftreatment.Performance of this device may be affected bybody size and motion artifacts.
AnatomicalRegion	whole body	whole body
Feature	Image Processing• Visualization of uricacid presence withinsurrounding anatomicalstructures	- Scanning the same anatomical location usingdistinct tube voltages and/or tube currents- Reconstruction of images at multiple energiesand basis images• Iodine Map• Monochromatic- Image Processing• Visualization of the differentiation betweenUric Acid and non-uric acid stones• Visualization of uric acid concentrationswithin surrounding anatomical structure
	Image dataformat forimageprocessing	DICOM format of CTimage data
	MPR /3D	MPR / 3D (MPR/3D in DE Composition Analysis)
Segmentation	The compositions isextracted based on thecomposition setting.	• The region included in the range of set CTnumbers is extracted.• The compositions is extracted based on thecomposition setting.

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Embolization Plan

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The Embolization Plan software application included in the VSTP-001A software has the same intended use as the Philips EmboGuide software. Both software applications use DICOM format images obtained using a 3D acquisition serve as an adjunct tool to assist the clinician in determining the feeder vessels during an embolization procedure. The main difference between the two software applications is the inclusion of the ability to use DICOM data and CBCT data on the subject device compared to CBCT data only for the predicate device.

A complete comparison table for this application is included in this submission. See below for a brief comparison summary of technological characteristics of the devices

Item	Embolization Plan	EmboGuide
	(Subject Device)	(K142273)
Intended Use	Embolization Plan is a post processingsoftware that is intended to assistphysicians in the visualization of theliver arterial tree using 3D images ofCT or 3D images of Cone Beam CTacquired by Toshiba or Canon MedicalSystems. It provides tools to assistthe user in analysis of these images.The output is intended to be anadjunct means that allows automaticand manual planning of the liverarterial vessels for guidance of theembolization procedure. The outputis a 3D visualization of the hepaticarteries to high dense lesion in theliver.	EmboGuide is a post processingsoftware medical device intended toassist physicians in performingembolization of hypervasculartumors in the liver usinginterventional X-ray. It provides toolsto help the user with the analysis of3D rotational angiography images. Itsoutput is intended as an adjunctmeans to help with the planning andguidance of the embolizationprocedure. It provides real timeoverlay of 3D rotational angiographyimages on live 2D X-ray images of thesame anatomy to supportdevice/catheter guidance.
	Anatomicalregion	liver	liver
	Input	CT / CBCT	CBCT
		MPR / 3D	MPR / 3D
	Vesseltracking	automaticmanual	automaticmanual
	Distance	manual	manual

16. SAFETY

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The device is designed and manufactured under the Quality System Requlations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the IEC62304 and IEC62366.

17. TESTING

The Dual Energy was subject to risk analysis and regression testing that was conducted through bench testing which are included in this submission to demonstrate that the requirements for the applications have been met. Bench studies were conducted using sample data sets from the predicate device verification activities (K131823) and verifying that the outputs for both devices were substantially the same.

The embolization plan was verified using sample data that was obtained from clinical institutions where local ethical controls were in place. The data was reviewed and verified independently by a test group and a control group. The resulting performance data demonstrated that the software was effective in assisting clinicians to identify the required feeder vessels for embolization planning.

This device is not subject to Cybersecurity Requirements as it has no access to an outside environment. All images being queued by the VSTP-001A are resident on the host Vitrea platform. The host Vitrea platform conducts all external data transactions and the Cybersecurity documentation is included for the Vitrea.

Software Documentation for a Moderate Level of Concern, per the FDA quidance document. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission.

18. CONSLUSION

The software applications included in the Vitrea Software Package, VSTP-001A, perform in a manner similar to and are intended for the same use as the predicate Based upon this information, conformance to standards, successful device completion of software validation, application of risk management and design controls and the performance data presented in this submission it is concluded that the subject device is substantially equivalent in safety and effectiveness to the predicate devices.

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).