Vitrea® CT Myocardial Perfusion is intended to assist a trained user for the visualization of hypo/hyper dense areas in patients with angina or with a previous myocardial infarction to assess the disease state and treatment. This software provides semi-automated heart and left ventricle segmentation and color polar maps of the myocardial tissue.

The information provided is intended to be qualitative in nature and, when used by a qualified physician, may aid in the identification of myocardial enhancement defects and the follow up of such findings.

Device Description

Vitrea CT Myocardial Perfusion is a post-processing software option for the already cleared Vitrea software platform (K071331). It leverages the existing Vitrea platform functionalities such as Multi-Planar Reconstruction (MPR) images, Maximum Intensity Projections (MIP) and volume rendering.

Vitrea CT Myocardial Perfusion enables the visualization and analysis of perfusion defects in the myocardium. The software is intended for use with cardiac CT (Computed Tomography) studies to analyze cardiovascular anatomy and pathology and to assess the presence of hypo/hyper dense areas of myocardial tissue.

The software visualization tools provide semi-automated heart and Left Ventricle (LV) segmentation, and color overlay and polar maps of the myocardial tissue based on the Hounsfield attenuation (HU) values. The software displays the values associated with the generation of the Perfusion Index (PI) and Transmural Perfusion Ratio (TPR) maps. Perfusion Index (PI) is the ratio of the Mean Myocardial CT value to the LV blood pool CT value. Transmural Perfusion Ratio (TPR) is provided as a ratio per sector of the Endocardial CT value to the mean Epicardial CT value. The defect size scoring tool allows a user to delineate one or more contiguous 3D regions within the myocardium for independent size measurements. The user may observe the interpolated result as they are constructing the defect.

The software analysis tools include measurements and comparison ratios. The CT Myocardial Perfusion application allows users to load one or two volumes. In dual-volume cases, the volumes are displayed based on time. It also includes reporting tools for formatting findings and user selected areas of interest.

AI/ML Overview

The provided text describes the Vitrea CT Myocardial Perfusion software, its intended use, a comparison to predicate devices, and the non-clinical tests performed for its 510(k) submission. However, it does not contain specific acceptance criteria or a study that directly proves the device meets those criteria with numerical performance metrics.

The document states that clinical studies were not required to support the safety and effectiveness of the software. Instead, it relies on design control measures, software verification and validation, and internal/external validation using phantoms and experienced users.

Therefore, providing a table of acceptance criteria and reported device performance, sample sizes for test sets, number of experts, adjudication methods, MRMC study results, standalone performance, type of ground truth, training set size, or how training set ground truth was established is not possible based on the provided text. This information is typically found in clinical study reports or detailed validation documentation, which is not present here.

Summary of available information regarding testing:

Table of acceptance criteria and reported device performance: Not explicitly stated with numerical performance. The document describes general quality assurance activities rather than specific performance metrics against pre-defined acceptance criteria.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: "various phantoms and patient based CT datasets" were used for internal validation, and "experienced users" for external validation. No specific number of cases or patients is provided.
- Data Provenance: Not specified.
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):
- For external validation, "experienced users" evaluated the software. No specific number or qualifications are provided beyond "experienced users."
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
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 MRMC study was mentioned. The document explicitly states that "clinical studies to support safety and effectiveness of the software" were not required.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The software aims to "assist a trained user," implying a human-in-the-loop application. No standalone algorithm performance is reported.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For internal validation, numerical quantities were verified using "CT semi-synthetic phantoms and patient based CT datasets." For external validation, "experienced users evaluated" the software. This suggests a form of expert review or comparison to phantom-derived ground truth, but not pathology or outcomes data.
The sample size for the training set: Not applicable and not mentioned, as the documentation focuses on verification and validation of a software enhancement, not the development of a de novo AI algorithm that requires a separate training set. The existing Vitrea platform is leveraging cleared functionalities.
How the ground truth for the training set was established: Not applicable and not mentioned.

In conclusion, the document details the rigorous design control measures, software verification, and validation activities (including phantom testing and usability testing by experienced users) undertaken to ensure the software met its requirements and user needs. However, it does not present a formal study with quantitative acceptance criteria and corresponding performance data as might be found in a clinical trial or a performance validation study for a device with specific objective performance claims. The basis for clearance appears to be substantial equivalence to predicate devices and adherence to quality system regulations, rather than specific performance against numerical criteria.

Summary

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

April 17, 2015

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

Re: K150104

Trade/Device Name: Vitrea CT Myocardial Perfusion Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: II Product Code: JAK, LLZ Dated: January 19, 2015 Received: January 20, 2015

Dear Parthiv 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

Robert Ochs. Ph.D. Acting 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) K150104

Device Name Vitrea® CT Myocardial Perfusion

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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)

Basis for theSubmission:	Modifications to a legally marketed device which are not qualified for aSpecial 510(k) notification
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:	Traditional
Summary Date:	March 31, 2015
Device Trade Name:	Vitrea® CT Myocardial Perfusion Software
Device CommonName / RegulatoryDescription:	An accessory of Computed Tomography X-ray System
DeviceClassificationName:	System, X-ray, Tomography, Computed
Regulation Number:	21 C.F.R. 892.1750
Primary ProductCode:	JAK
Secondary ProductCode:	LLZ
RegulatoryClassification:	Class II
Device Panel:	Radiology

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Predicate Devices:

Predicate Device(s)	Predicate Type	Manufacturer	FDA 510(k)number
MyoPerfusion, CSMP-001A	PrimaryPredicateDevice	Toshiba MedicalSystems Corporation	K132523
CT Myocardial Analysis	SecondaryPredicateDevice	Vital Images, Inc.	K112531

Device Description:

Intended Use / Indications for Use:

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Intended for Disease / Condition / Patient Population:

The software provides Radiologists and Cardiologists with a robust dedicated suite of software tools to aid in the creation of evidence to support these physicians with their assessment of cardiac disease and functions for patients with angina or those who have had a previous myocardial infarction.

Substantial Equivalence Comparison:

. Regulatory Comparison

Characteristic	Vitrea CTMyocardialPerfusionsoftware(SubmissionSubject)	MyoPerfusion,CSMP-001A(K132523)(PredicateDevice-1)PrimaryPredicate Device	CT MyocardialAnalysis(K112531)(PredicateDevice-2)SecondaryPredicate Device	Noted Differences
ClassificationName	Computedtomographyx-ray System	Computedtomographyx-ray System	Picture ArchivingandCommunicationsSystem	NoneNote: The subjectdevice has both JAKand LLZ productcodes.
RegulatoryNumber	892.1750	892.1750	892.2050	NoneNote: The subjectdevice has both JAKand LLZ productcodes.
Product Code	Primary: JAKSecondary:LLZ	JAK	LLZ	None
Classification	Class II	Class II	Class II	None
Review Panel	Radiology	Radiology	Radiology	None
Decision Date	Under Review	December 12,2013	November 18,2011	Both predicates arecleared.
Characteristic	Vitrea CT MyocardialPerfusion software(Submission Subject)	MyoPerfusion,CSMP-001A (K132523)(Predicate Device-1)	Noted Differences
Intended Use	Vitrea® CT MyocardialPerfusion is intendedto assist a trained userfor the visualization ofhypo/hyper denseareas in patients withangina or with aprevious myocardialinfarction to assessthe disease state andtreatment. Thissoftware providessemi-automated heartand left ventriclesegmentation andcolor polar maps ofthe myocardial tissue.The informationprovided is intended tobe qualitative in natureand, when used by aqualified physician,may aid in theidentification ofmyocardialenhancement defectsand the follow up ofsuch findings.	This software isintended to be used forthe visualization of non-reversible perfusiondefects (hypo/hyperdense areas) inpatients with angina orwith a previousmyocardial infarct.Included software toolsmay aid a trained userin monitoring thedisease state andtreatment over time.This software providesmaps and the valuesused to generate themaps.The informationprovided is intended tobe qualitative in natureand when used by aqualified physician mayaid in the identificationof myocardialenhancement defectsand the follow up ofsuch findings.	None
IntendedUsers	Radiologists andCardiologists	Radiologists andCardiologists	None
PatientPopulation	Patients with angina orthose who have had aprevious myocardialinfarction	Patients with angina orthose who have had aprevious myocardialinfarction	None
ModalitySupport	CT	CT	None
Characteristic	Vitrea CT MyocardialPerfusion software(Submission Subject)	CT Myocardial Analysis(K112531)(Predicate Device-2)	Noted Differences
Intended Use	Vitrea® CT MyocardialPerfusion is intendedto assist a trained userfor the visualization ofhypo/hyper denseareas in patients withangina or with aprevious myocardialinfarction to assessthe disease state andtreatment. Thissoftware providessemi-automated heartand left ventriclesegmentation andcolor polar maps ofthe myocardial tissue.The informationprovided is intended tobe qualitative in natureand, when used by aqualified physician,may aid in theidentification ofmyocardialenhancement defectsand the follow up ofsuch findings.	Vitrea® CT MyocardialAnalysis is an imageanalysis softwareapplication for cardiacComputer Tomography(CT) studies tovisualize cardiovascularanatomy and pathologyand to highlight andcolor code thepresence of hypo/hyperdense areas ofmyocardial tissue.	NoneThe language of IntendedUse has been updated tobe similar with the 510(k)cleared predicate productsavailable in the US market.
IntendedUsers	Radiologists andCardiologists	Radiologists andCardiologists	None
PatientPopulation	Patients with angina orthose who have had aprevious myocardialinfarction	Patients with angina orthose who have had aprevious myocardialinfarction	None
ModalitySupport	CT	CT	None
Characteristic	Vitrea CT MyocardialPerfusion software(Submission Subject)	MyoPerfusion,CSMP-001A (K132523)(Predicate Device-1)	Noted Differences
DeviceDescription	Vitrea CT MyocardialPerfusion is a post-processing softwareoption for the alreadycleared Vitreasoftware platform(K071331).It leverages existingVitrea® functionalitysuch as Multi-PlanarReconstruction (MPR)images, MaximumIntensity Projections(MIP) and volumerendering.Vitrea CT MyocardialPerfusion enables thevisualization andanalysis of perfusiondeficits in themyocardium. Thesoftware is intendedfor use with cardiacCT (ComputedTomography) studiesto analyzecardiovascularanatomy andpathology and toassess the presenceof hypo/hyper denseareas of myocardialtissue.The softwarevisualization toolsprovide semi-automated heart andleft ventriclesegmentation, andcolor overlay and polarmaps of themyocardial tissue	This device processesECG-gated contrastenhanced cardiac scandata using MPRgenerated imagesaccording to the cardiacaxis.The software generatespolar maps, perfusionindex (PI) map andTransmural PerfusionRation (TPR) mapsbased upon themeasured CT values ofthe tissue within thespecified region ofinterest.The software displaysthe values associatedwith the generation ofthe Perfusion Index andTPR Maps.PI is the ratio of theMean Myocardial CTvalue to the LV bloodpool CT value.TPR is provided as aratio per sector of theEndocardial CT valueto the mean EpicardialCT value.	NoneNote:The added key features,except Defect Size Scoringtool, are similar to thosewhich are available in the510(k) cleared PredicateDevice-1.
Characteristic	Vitrea CT MyocardialPerfusion software(Submission Subject)	MyoPerfusion,CSMP-001A (K132523)(Predicate Device-1)	Noted Differences
	based on theHounsfield attenuation(HU) values.
	The software displaysthe values associatedwith the generation ofthe Perfusion Index(PI) and TransmuralPerfusion Ratio (TPR)maps.
	PI is the ratio of theMean Myocardial CTvalue to the LV bloodpool CT value.
	TPR is provided as aratio per sector of theEndocardial CT valueto the mean EpicardialCT value.
	The software analysistools includemeasurements andcomparison ratios.
	The CT MyocardialPerfusion applicationallows to load one ortwo volumes. In dual-volume cases, thevolumes are displayedbased on time. Vitrealabels the volumes asSeries1 (earlieracquisition time) andSeries2 (lateracquisition time).
	It also includesreporting tools forformatting findings anduser selected areas ofinterest.

Characteristic	Vitrea CT MyocardialPerfusion software(Submission Subject)	CT Myocardial Analysis(K112531)(Predicate Device-2)	Noted Differences
DeviceDescription	Vitrea CT MyocardialPerfusion is a post-processing softwareoption for the alreadycleared Vitreasoftware platform(K071331).It leverages existingVitrea® functionalitysuch as Multi-PlanarReconstruction (MPR)images, MaximumIntensity Projections(MIP) and volumerendering.Vitrea CT MyocardialPerfusion enables thevisualization andanalysis of perfusiondeficits in themyocardium. Thesoftware is intendedfor use with cardiacCT (ComputedTomography) studiesto analyzecardiovascularanatomy andpathology and toassess the presenceof hypo/hyper denseareas of myocardialtissue.The softwarevisualization toolsprovide semi-automated heart andleft ventriclesegmentation, andcolor overlay and polarmaps of themyocardial tissue	Vitrea® CT MyocardialAnalysis is a post-processing softwareoption for the Vitrea®software platform.It leverages existingVitrea® functionalitysuch as Multi PlanarReconstruction (MPR)images, MaximumIntensity Projections(MIP) and volumerendering.Vitrea® CT MyocardialAnalysis enables thevisualization andanalysis of themyocardium. It assistsin analyzing thehyper/hypo denseareas of myocardialtissue. Its visualizationtools includesegmentation, colorcoding, and polarmaps. Its analysis toolsinclude measurementsand comparison ratios.It also includesreporting tools forformatting findings anduser selected areas ofinterest.	● Two polar map plots i.e.TPR and Pl are addedin the already clearedMyocardial Analysissoftware (K112531)● Additional 3D Fusionoverlay feature isprovided for betterviewing of cardiacvessels over coloredattenuation data● Additional Defect SizeScoring tool is providedfor quantifying size ofindividual defects withinthe myocardium● The software nowautomatically segmentsthe Left Ventricle (LV)Blood Pool in all loadedvolumes● The software allows toedit automaticallygenerated LV BloodPool attenuation value(LV HU) for eachloaded volumeNote:The added key features,except Defect Size Scoringtool, are similar to thosewhich are available in the510(k) cleared PredicateDevice-1.
Characteristic	Vitrea CT MyocardialPerfusion software(Submission Subject)	CT Myocardial Analysis(K112531)(Predicate Device-2)	Noted Differences
	based on theHounsfield attenuation(HU) values.
	The software displaysthe values associatedwith the generation ofthe Perfusion Index(PI) and TransmuralPerfusion Ratio (TPR)maps.
	PI is the ratio of theMean Myocardial CTvalue to the LV bloodpool CT value.
	TPR is provided as aratio per sector of theEndocardial CT valueto the mean EpicardialCT value.
	The software analysistools includemeasurements andcomparison ratios.The CT MyocardialPerfusion applicationallows to load one ortwo volumes. In dual-volume cases, thevolumes are displayedbased on time. Vitrealabels the volumes asSeries1 (earlieracquisition time) andSeries2 (lateracquisition time).
	It also includesreporting tools forformatting findings anduser selected areas ofinterest.
Characteristic	Vitrea CTMyocardialPerfusionsoftware(SubmissionSubject)	MyoPerfusion,CSMP-001A(K132523)(PredicateDevice-1)PrimaryPredicateDevice	CT MyocardialAnalysis(K112531)(PredicateDevice-2)SecondaryPredicateDevice	NotedDifferences
Post-processing analysis software	✓	✓	✓	None
2D or 3D CT angiography images/data derived from DICOM 3.0 CTscans	✓	✓	✓	None
Support for single or dual volumeexams	✓	✓	✓	None
Conventional navigation on 2D and 3Dviews, change of layouts, adaptwindow level values for CTangiography images	✓	✓	✓	None
Segment heart structures	✓	✓	✓	None
Edit and correct segmented regions	✓	✓	✓	None
Semi-Automatic segmentation ofmyocardium	✓	✓	✓	None
Support for single or dual volumeexams	✓	✓	✓	None
Characteristic	Vitrea CTMyocardialPerfusionsoftware(SubmissionSubject)	MyoPerfusion,CSMP-001A(K132523)(PredicateDevice-1)PrimaryPredicateDevice	CT MyocardialAnalysis(K112531)(PredicateDevice-2)SecondaryPredicateDevice	NotedDifferences
View:
Cardiac views:Multi-Planar Reconstruction (MPR)planes to short/long axis, MaximumIntensity Projection (MIP) formats	✓	✓	✓	None
Ability to view cardiac vessels overcolored attenuation data	✓	✓	✓	None
Functional Parameters:
Provides automatic quantified values (HU values) of perfusion results for:
Comparison Ratios	✓	✓	✓	None
Myocardial Mass	✓	✓	✓	None
Myocardial Volume	✓	✓	✓	None
Hypo-attenuated Volume	✓	✓	✓	None
Color Overlay:Color codes the myocardial tissue toshow hypo/hyper dense areas in themyocardial tissue of the heart ontoMPR and 3D images	✓	✓	✓	None
Polar Maps:17-segment or detailed bulls-eye plotsfor display of myocardial parameters	✓	✓	✓	None
Reporting Tools:Functionality for editing values ofclinical findings such as location,characteristics, pathology, user	✓	✓	✓	None
Characteristic	Vitrea CTMyocardialPerfusionsoftware(SubmissionSubject)	MyoPerfusion,CSMP-001A(K132523)(PredicateDevice-1)PrimaryPredicateDevice	CT MyocardialAnalysis(K112531)(PredicateDevice-2)SecondaryPredicateDevice	NotedDifferences
assigned classifications to simplifyreport population, and report
Templates for summarization offindings etc
Ability to take Snapshots	V	V	V	None
Ability to export image to a PACSdevice	V	V	V	None
Ability to save images to localcomputer	V	V	V	None

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Intended Use Comparison with the Predicate Device-1 (Primary Predicate Device) ●

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● Intended Use Comparison with the Predicate Device-2 (Secondary Predicate Device)

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● Device Description Comparison with the Predicate Device-1 (Primary Predicate Device)

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Device Description Comparison with the Predicate Device-2 (Secondary Predicate ● Device)

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● Similarities in Technology

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Image /page/14/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.

Characteristic	Vitrea CTMyocardialPerfusionsoftware(SubmissionSubject)	MyoPerfusion,CSMP-001A(K132523)(PredicateDevice-1)PrimaryPredicateDevice	CT MyocardialAnalysis(K112531)(PredicateDevice-2)SecondaryPredicateDevice	NotedDifferences
Perfusion Index (PI) map	✓	✓	x	The added
Transmural Perfusion Ratio (TPR)map	✓	✓	x	key features,except DefectSize Scoringtool, aresimilar tothose whichare availablein the 510(k)clearedPredicate
LV Blood Pool to Region	✓	✓	x
LV HU	✓	✓	x
3D Fusion view	✓	✓	x
Defect Size Scoring tool	✓	x	x	Device-1.

Differences .

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Summary of Non-Clinical Tests:

The changes to the Vitrea CT Myocardial Analysis (i.e. Vitrea CT Myocardial Perfusion) software were designed, developed, and tested according to written procedures that included risk management. Software testing was completed to ensure the new features operate according to defined requirements.

The following design control measures were applied to the development of the Vitrea CT Myocardial Perfusion software:

Risk Management ●
Requirements Reviews ●
Code Designs ●
Code Development Testing ●
. Code Reviews
Design Reviews ●
Verification of the software that included performance and safety testing ●
Validation of the software that included phantom testing and simulated usability testing . by experienced professionals.

Risk Management:

Each risk pertaining to these features have been individually assessed to determine if the benefits outweigh the risk. Every risk has been reduced as low as possible and has been evaluated to have a probability of occurrence of harm of "Improbable." All risks for this feature were collectively reviewed to determine if the benefits outweigh the risk. Because of the risk control measures included in this feature, it is believed that the risk for the feature as a whole is extremely low. Taking into account all risks against the benefits of this feature, it has been assessed that the benefits do outweigh the risks for this feature.

During the design review, the following conclusions were reached:

All risks were reduced as low as possible .
The medical benefits of the device outweigh the residual risk for each individual risk and . all risks together
. The overall residual risk for the project is deemed acceptable

Verification:

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.

Internal Validation (Phantom Testing):

The software validation team provided internal validation of Vitrea CT Myocardial Perfusion software. Internal validation included internal user acceptance testing using various phantoms. Results of numerical quantities calculated by CT Myocardial Perfusion were verified using CT semi-synthetic phantoms and patient based CT datasets.

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External Validation:

During external validation of the Myocardial Perfusion software, experienced users evaluated the seven-up layout, six-up scoring layout and the classification of the Transmural Perfusion Ratio (TPR). Each user felt that the Vitrea CT Myocardial Perfusion software enables the user to assess and quantify myocardial perfusion abnormalities.

Summary of Clinical Tests:

The subject of this 510(k) notification, Vitrea CT Myocardial Perfusion 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.

. Integrity

The Vitrea platform complies with the DICOM standard for transfer and storage of this data and does not modify the contents of DICOM instances. New DICOM produced by Vitrea is identified as such with the appropriate manufacturer tags per the DICOM standard.

Availability ●

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.

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

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

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Image /page/17/Picture/0 description: The image shows the word "VITAL" in black font. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in red font. The dot above the "i" in "VITAL" is a circle.

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

Substantial Equivalence Analysis Conclusion:

Vital Images believes that Vitrea CT Myocardial Perfusion software application has a substantially equivalent intended use, indications for use and technological characteristics as the predicate devices. Any minor differences noted have been explained and do not raise any new questions of safety or effectiveness as the predicate devices. The implemented design controls, risk management and performed testing demonstrate the Vitrea CT Myocardial Perfusion software device is as safe and effective as both predicate devices. Based on the comparison data and test data Vital Images believes, the subject device should be found substantially equivalent to the predicate devices.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.