(55 days)
The separately-licensed CT Colonography option is intended for closely examining the lumen of the colon using features such as auto-segmentation, axial imaging, multi-planar reformatting, fly-through, simultaneous display of prone and supine images, and transparent wall view.
Vitrea® CT Colon Analysis software generates 2D and 3D images of the colon to allow close examination of the lumen of the colon, thereby increasing the speed and ease of locating and analyzing suspected polyps, masses and lesions. Vitrea®CT Colon Analysis software has the following features:
- . Auto-seqmentation of the colon
- . Segmentation editing
- . Axial imaging, multi-planar reformatting and 3D views
- . Manual and automatic endoluminal fly-through of the colon
- . Eye-based navigation for performing fly-through and target-based navigation for examining POI and Reverse View mode
- MPR eye placement to adjust view direction down lumen
- . Transparent wall view of the colon with a field-of-view cone to act as a reference during fly-through
- . Dual Volume Viewer window format for side-by-side comparison of prone and supine studies
- Ability to mark points in the colon with arrows; arrow are hidden from view when you fly too close
- SPACE BAR to step through images containing arrows
- Prone/supine registration .
- . Polyp Probe tool to select and characterize polyps
- Polyp assessment using the C-RADS guidelines
- . Fly-through image batches and digital movies
- Special report template that contains an anatomically-labeled diagram of the colon for . easier documentation of findings, as well as a C-RADS report template
- . Fly-through keyboard shortcuts
- . Automatic fluid/stool tagging and subtraction
Vitrea® CT Colon Analysis software deploys from the Vitrea® Platform, cleared under K150258, Vitrea®, Version 7.0 Medical Image Processing Software. The software provides imaging information as an assistance to the physician. The software does not provide diagnosis or determine the recommended medical care.
Here's an analysis of the acceptance criteria and study information for the Vitrea® CT Colon Analysis software, based on the provided document:
Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" with quantitative metrics directly linked to the device's performance for functions like auto-segmentation accuracy, polyp detection sensitivity, or specificity. Instead, the document focuses on demonstrating substantial equivalence to a predicate device and a reference device, primarily through feature comparison and qualitative assessment of enhancements.
The core "acceptance criteria" from the document's perspective appear to be:
- The software successfully performs its described functions (auto-segmentation, multi-planar reformatting, fly-through, simultaneous display of prone and supine images, transparent wall view, Electronic Bowel Cleansing).
- The new Electronic Bowel Cleansing (EBC) feature does not negatively impact the device's safety or effectiveness compared to the predicate.
- The device adheres to relevant standards (DICOM, IEC 62304, ISO 14971).
- The medical benefits outweigh the residual risks.
Given this, the "reported device performance" is largely qualitative and focused on functionality and safety rather than specific quantitative metrics.
| Acceptance Criteria (Inferred from document) | Reported Device Performance |
|---|---|
| - Device successfully generates 2D and 3D images of the colon.- Device successfully performs features such as auto-segmentation, axial imaging, multi-planar reformatting, fly-through, simultaneous display of prone and supine images, and transparent wall view. - Device successfully performs Electronic Bowel Cleansing (EBC) (automatic fluid/stool tagging and subtraction). - EBC feature does not affect intended use, indications for use, or fundamental scientific technology of the cleared predicate. - EBC feature does not raise new questions of safety or effectiveness. - The risk of incorrectly removing polyps when hiding tagged material in 3D is acceptably low (observed 0% during validation). - Device is safe and effective as the predicate device. - Device compiles with voluntary recognized consensus standards (DICOM, ISO 14971, IEC 62304). | - Software generates 2D and 3D images as described.- All listed features (auto-segmentation, axial imaging, multi-planar reformatting, fly-through, simultaneous display of prone and supine images, transparent wall view) are successfully implemented and function. - Electronic Bowel Cleansing functions by electronically removing residual fecal material tagged with an agent. - The added EBC feature does not alter the intended use, indications for use, or fundamental scientific technology. - Verification and validation testing demonstrated the modified device is as safe and effective as the predicate, raising no different questions of safety and effectiveness. - "The risk of incorrectly removing polyps when hiding tagged material in 3D (which was observed 0% of the time during our validation) has been mitigated because the polyps can still be seen in 2D." - Device operates according to defined requirements and fulfills standards. |
Study Details for Vitrea® CT Colon Analysis software (focus on Electronic Bowel Cleansing feature):
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: "datasets based on real patient data and phantoms." The specific number of real patient datasets or phantoms is not provided in this summary.
- Data Provenance: "real patient data and phantoms." The country of origin is not specified. The studies were likely retrospective as they refer to "real patient data" being used for testing.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document mentions "experienced professionals" for usability testing as part of internal validation and "experienced users" for external validation. However, it does not specify the exact number or qualifications of experts used to establish the ground truth for the test set (e.g., diagnosis of polyps, accurate segmentation). The ground truth establishment for the EBC feature likely involved comparing the "cleansed" images to the original data and potentially to expert assessments, but the details are not provided.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- No adjudication method details are provided in this summary.
-
If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
- No MRMC comparative effectiveness study is explicitly mentioned for the enhancement (Electronic Bowel Cleansing). The general clinical performance tests "demonstrate performance, safety, and effectiveness," but it's not described as a comparative MRMC study measuring human reader improvement with/without AI assistance. The statement "The risk of incorrectly removing polyps when hiding tagged material in 3D (which was observed 0% of the time during our validation) has been mitigated because the polyps can still be seen in 2D" suggests some form of evaluation but not necessarily a formal MRMC study on reader performance.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, implicitly. The "Verification" section confirms "Test cases were executed against the system features and requirements" and "Validation of the software that included phantom testing." The "Internal Validation and Phantom Testing" section also states "Internal validation included internal user acceptance testing using real scans as well as synthetic phantoms. The validation criteria covered image qualitative comparison of segmentation to previous releases, quantitative evaluation of polyp diameter accuracy using phantom datasets, and run time performance evaluation." This indicates algorithm-only performance assessment.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the Electronic Bowel Cleansing feature, the ground truth appears to be based on "real patient data and phantoms." For "quantitative evaluation of polyp diameter accuracy using phantom datasets," it would be the known dimensions within the phantoms. For "image qualitative comparison of segmentation," it would be comparison to previous releases or potentially expert-reviewed segmentation. Explicit pathology or outcomes data as ground truth for the EBC feature's "acceptance" is not specified here, though the general product's goal is to aid in detecting "suspected polyps, masses and lesions."
-
The sample size for the training set:
- The document does not provide information on the sample size used for training the algorithms, nor does it explicitly state if machine learning was used for the EBC feature (though the term "algorithm" is used). This document focuses on the validation of the enhanced feature rather than the initial development of the core CT Colon Analysis algorithms.
-
How the ground truth for the training set was established:
- Not specified, as information regarding a dedicated training set is not provided in this summary.
{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 graphic of three human profiles facing right, stacked on top of each other. The graphic is positioned inside a circular border, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the border.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 16, 2016
Vital Images, Inc. % Ms. Alexis Erazo Regulatory Affairs Specialist 5850 Opus Parkway, Suite 300 MINNETONKA MN 55343-4414
Re: K160150 Trade/Device Name: Vitrea CT Colon Analysis Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 20, 2016 Received: January 21, 2016
Dear Ms. Erazo:
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. 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
{1}------------------------------------------------
or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K160150
Device Name Vitrea CT Colon Analysis
Indications for Use (Describe)
The separately-licensed CT Colonography option is intended for closely examining the lumen of the colon using features such as auto-segmentation, axial imaging, multi-planar reformatting, fly-through, simultaneous display of prone and supine images, and transparent wall view.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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 text is centered below the word "VITAL". The logo appears to be for a medical company.
510K Summary
This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part 807.92(c).
| Basis for theSubmission: | Vital Images, Inc. hereby submits this Traditional 510(k) to provide anotification submission for proposed software changes in the already510(k) cleared K052632 VITREA2 Version 3.8 (CT ColonographyApplication). |
|---|---|
| Submitter: | Vital Images, Inc.5850 Opus Parkway, Suite 300Minnetonka, MN, 55343-4414 |
| EstablishmentRegistration: | 2134213 |
| Contact Person: | Alexis ErazoRegulatory Affairs SpecialistPhone : 952-487-9774Fax: 952—487—9510E-mail: aerazo@vitalimages.com |
| 510(k) Type: | Traditional |
| Summary Date: | January 20, 2016 |
| Device Trade Name: | Vitrea® CT Colon Analysis |
| Device CommonName/ RegulatoryDescription: | Radiological Image Processing Software |
| Device ClassificationName: | System, Image Processing, Radiological |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | LLZ |
| RegulatoryClassification: | Class II |
| Device Panel: | Radiology |
Predicate Device(s):
| Predicate Device | Manufacturer | FDA 510(k) Number |
|---|---|---|
| VITREA2, Version 3.8Medical Image ProcessingSystem (CT Colonography) | Vital Images, Inc.5850 Opus Parkway, Suite 300Minnetonka, MN 55343 | K052632 |
{4}------------------------------------------------
Image /page/4/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 letters in the word "VITAL" are all capitalized, and the dot above the "i" is a circle.
Reference Device(s):
| Reference Device | Manufacturer | FDA 510(k) Number |
|---|---|---|
| syngo.CT Colonography | Siemens Medical Solutions USA, Inc.51 Valley Stream ParkwayMalvern, PA 19355 | K140920 |
Device Description:
Vitrea® CT Colon Analysis software generates 2D and 3D images of the colon to allow close examination of the lumen of the colon, thereby increasing the speed and ease of locating and analyzing suspected polyps, masses and lesions. Vitrea®CT Colon Analysis software has the following features:
- . Auto-seqmentation of the colon
- . Segmentation editing
- . Axial imaging, multi-planar reformatting and 3D views
- . Manual and automatic endoluminal fly-through of the colon
- . Eye-based navigation for performing fly-through and target-based navigation for examining POI and Reverse View mode
- MPR eye placement to adjust view direction down lumen
- . Transparent wall view of the colon with a field-of-view cone to act as a reference during fly-through
- . Dual Volume Viewer window format for side-by-side comparison of prone and supine studies
- Ability to mark points in the colon with arrows; arrow are hidden from view when you fly too close
- SPACE BAR to step through images containing arrows
- Prone/supine registration .
- . Polyp Probe tool to select and characterize polyps
- Polyp assessment using the C-RADS guidelines
- . Fly-through image batches and digital movies
- Special report template that contains an anatomically-labeled diagram of the colon for . easier documentation of findings, as well as a C-RADS report template
- . Fly-through keyboard shortcuts
- . Automatic fluid/stool tagging and subtraction
Vitrea® CT Colon Analysis software deploys from the Vitrea® Platform, cleared under K150258, Vitrea®, Version 7.0 Medical Image Processing Software. The software provides imaging information as an assistance to the physician. The software does not provide diagnosis or determine the recommended medical care.
Intended Use / Indications for Use:
The separately-licensed CT Colonography option is intended for closely examining the lumen of the colon using features such as auto-segmentation, axial imaging, multi-planar reformatting, flythrough, simultaneous display of prone and supine images, and transparent wall view.
048 Updated 510(k) Summary
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the word "VITAL" in black, with the "i" having a dot above it. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in red. The text is centered and the font is sans-serif.
Intended for Disease / Condition / Patient Population:
The software provides trained Radiologists, Clinicians or Technologist with a robust dedicated suite of software tools to aid in the creation of evidence to support these physicians with their screening and assessment of adult patients with suspected colon pathologies (i.e. suspicious polyps, masses, and lesions).
Rationale for Additions and Enhancements to CT Colonography Software:
Vitrea users, require an intuitive, accurate, and efficient application to review, investigate, and problem solve their colonography exams in order to provide information for the referring clinicians. Many patients are unable to complete full evacuation of fecal material and residual liquids in the colon, which can obscure potential lesions and pathology. Vital customers have repeatedly requested to have functionality to electronically remove this residual material from the colon in order to fully evaluate the colon for any abnormalities. When viewing the colon in either 2D or 3D it is very important to see all aspects of the colon, so Vital is introducing "Bowel Cleansing" as a means to remove any residual materials that may inhibit a reader from fully visualizing all aspects of the colon interior. Vital customers will now be able to electronically remove any residual fecal material that has been tagged with a tagging agent.
Substantial Equivalence Comparison:
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Characteristic | Vitrea® CT ColonAnalysis Software | VITREA2, Version3.8 Medical ImageProcessing System(CT Colonography)K052632 | Comparison |
| Classification Name | System, ImageProcessing,Radiological | System, ImageProcessing,Radiological | Same |
| Regulatory Number | 892.2050 | 892.2050 | Same |
| Product Code | LLZ | LLZ | Same |
| Classification | Class II | Class II | Same |
| Review Panel | Radiology | Radiology | Same |
| Decision Date | Under Review | December 15, 2005 | Predicate andReferencedevices arecleared |
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 font size.
Indications for Use Comparison with Predicate Device:
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Criteria | Vitrea® CT Colon AnalysisSoftware | VITREA2, Version 3.8Medical ImageProcessing System (CTColonography) K052632 | Comparison |
| Indications forUse | The separately-licensed CTColonography option isintended for closelyexamining the lumen of thecolon using features such asauto-segmentation, axialimaging, multi-planarreformatting, fly-through,simultaneous display ofprone and supine images,and transparent wall view. | The separately-licensed CTColonography option isintended for closelyexamining the lumen of thecolon using features suchas auto-segmentation, axialimaging, multi-planarreformatting, fly-through,simultaneous display ofprone and supine images,and transparent wall view. | Same |
| Intended Users | Radiologists, Clinicians orTechnologist | Radiologists, Clinicians orTechnologist | Same |
| PatientPopulation | Adult patients withsuspected colon pathologies | Patients with suspectedcolon pathologies | Similar |
| Subject Device | Predicate Device | ||
| Criteria/Feature | Vitrea® CT ColonAnalysis Software | VITREA2, Version 3.8Medical ImageProcessing System (CTColonography)K052632 | Comparison |
| Modality | |||
| CT | Yes | Yes | Same |
| Data Loading | |||
| DICOM | Yes | Yes | Same |
| Ability to load one ortwo series of chestCT exam | Yes | Yes | Same |
| Data Viewing Support | |||
| 2D ImagingReal-time windowlevel, zoom andpan | Yes | Yes | Same |
| 3D ImagingVolume renderingwith window-level,rotate, zoom anpan | Yes | Yes | Same |
| Features and Capabilities | |||
| 3D MeasurementsManual contourvolumes anddiameter | Yes | Yes | Same |
| 2D MeasurementsRuler and ROItools with statistics | Yes | Yes | Same |
| 3D/Axial Review | Yes | Yes | Same |
| Dual Volume Viewer | Yes | Yes | Same |
| Endoluminal Fly-Through | Yes | Yes | Same |
| Subject Device | Predicate Device | ||
| Criteria/Feature | Vitrea® CT ColonAnalysis Software | VITREA2, Version 3.8Medical ImageProcessing System (CTColonography)K052632 | Comparison |
| Target-basednavigation forexamining a POI | Yes | Yes | Same |
| Eye-based navigationfor performing fly-throughs | Yes | Yes | Same |
| Assisted navigation | Yes | Yes | Same |
| Reverse view mode | Yes | Yes | Same |
| Fly-through imagesbatches and digitalmovies | Yes | Yes | Same |
| Viewer auto rotationto keep gravity | Yes | Yes | Same |
| MPR eye placementto adjust viewdirection down lumen | Yes | Yes | Same |
| Multi-plannerreformattingAny user definedlinear plane, MIPand average | Yes | Yes | Same |
| Auto-cine | Yes | Yes | Same |
| Save workflowRestorable statefrom usersnapshots,including multiplevolume sessions | Yes | Yes | Same |
| PrintingPrinting tostandard windowsprinters | Yes | Yes | Same |
| Subject Device | Predicate Device | ||
| Criteria/Feature | Vitrea® CT ColonAnalysis Software | VITREA2, Version 3.8Medical ImageProcessing System (CTColonography)K052632 | Comparison |
| Ease of useVisualization presets for typical image review procedures Click-Drag-Click ruler interaction When In fly Though, click on tissue rotates to look at the crosshair "decoupled" eye and crosshair | Yes | Yes | Same |
| ViewersAbility to not update MPRs while flying, only updates when you stop flying Lock MPR Cine Displays x, y, z, value for crosshair position to lower right of viewers | Yes | Yes | Same |
| Viewing capacitiesMPR viewing of candidates Endoluminal viewing of candidates with | Yes | Yes | Same |
| Subject Device | Predicate Device | ||
| Criteria/Feature | Vitrea® CT ColonAnalysis Software | VITREA2, Version 3.8Medical ImageProcessing System (CTColonography)K052632 | Comparison |
| viewing"technology | |||
| HardwareRequirements | Identical to the Vitrea®Platform | Identical to the Vitrea®Platform | Same |
| SoftwareRequirements | Identical to the Vitrea®Platform | Identical to the Vitrea®Platform | Same |
| Performance Testing | |||
| Nonclinical TestingSafety andPerformanceStandards | Yes.The subject device isdesigned to fulfill therequirements of thefollowing standardsDICOM, IEC 62304, andISO 14971. | Yes.The CT Colonographysoftware within VITREA2,Version 3.8 was designedto fulfill the requirementsof the following standardsDICOM, IEC 62304, andISO 14971. | Same. |
| Software Verificationand Validation | Yes.Vital has completed andprovided SoftwareDocumentation for aModerate Level ofConcern software perFDA's GuidanceDocument "Guidance forthe Content of PremarketSubmissions for SoftwareContained in MedicalDevices" issued on May11, 2005 | Yes.The K052632 Submissioncontained SoftwareDocumentation for aModerate Level ofConcern software perFDA's GuidanceDocument "Guidance forthe Content of PremarketSubmissions for SoftwareContained in MedicalDevices" issued on May11, 2005 | Same.PleasereferenceAttachments_035-043 for moredetails. |
| Clinical Testing | Yes.Clinical performance testswere conducted todemonstrateperformance, safety, andeffectiveness of the CTColon Analysis ElectronicBowel Cleansing featureusing datasets based on | Yes.Clinical performance testswere conducted todemonstrate performance,safety, and effectivenessof the CT Colonographysoftware within VITREA2,Version 3.8. | Same.PleasereferenceAttachment_036VLC-08319 AColon ElectronicBowel CleansingAlgorithmVerification andValidation andAttachment_039 |
| Subject Device | Predicate Device | ||
| Criteria/Feature | Vitrea® CT ColonAnalysis Software | VITREA2, Version 3.8Medical ImageProcessing System (CTColonography)K052632 | Comparison |
| real patient data andphantoms. | VLC-08836 AVitrea CT ColonEBC Verificationand ValidationSummary formore details. |
{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 dot on the "i" in "VITAL" is a circle.
Similarities in Technology with Predicate Device:
{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 dot on the "i" in "VITAL" is a circle.
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the word "VITAL" in a bold, sans-serif font. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. The letters of the word "VITAL" are black, and the dot on the "i" is white.
{10}------------------------------------------------
Image /page/10/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.
{11}------------------------------------------------
Image /page/11/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 logo is simple and professional, likely representing a company or organization.
Differences in Technology with the Predicate Device:
| Criteria | Subject Device | Predicate Device | |
|---|---|---|---|
| Vitrea® CT ColonAnalysis Software | VITREA2, Version3.8 Medical ImageProcessing System(CT Colonography)K052632 | Comparison | |
| Electronic BowelCleansing | Yes | No | Predicate device doesnot contain theautomatic fluid/stooltagging and subtractionfeature.The added feature doesnot affect the intendeduse, indications for use,or fundamental scientifictechnology of thealready cleared CTColonography K052632. |
Similarities in Technology with the Reference Device:
The Electronic Bowel Cleansing enhancement features, subject of this 510(k) Submission, are highlighted in yellow color.
| Feature/Criteria | Subject Device | Reference Device | Comparison |
|---|---|---|---|
| Modality | Vitrea® CT ColonAnalysis Software | syngo.CT Colonography(K140920) | |
| CT | Yes | Yes | Same |
| Subject Device | Reference Device | Comparison | |
| Feature/Criteria | Vitrea® CT ColonAnalysis Software | syngo.CT Colonography(K140920) | |
| Data Loading | |||
| DICOM | Yes | Yes | Same |
| Data Viewing Support | |||
| 2D Imaging | Yes | Yes | Same |
| 3D Imaging | Yes | Yes | Same |
| Features and Capabilities | |||
| Flythrough View | Yes | YesPanoramic EndoluminalView | Same |
| Stool Tagging | Yes | Yes | Same |
| Filet View | Yes | YesVirtual Dissection | Same |
| Cube View | Yes | Yes.Polyp Lens | Same |
| Electronic BowlCleansing | Yes | YesStool Subtraction | Same |
| Paging | Yes | YesNavigation through the CTVolume Data Sets | Same |
| Semi-AutomaticMeasurements | Yes | Yes | Same |
| Movie Reporting | Yes | Yes | Same |
| Volume Rendering | Yes | YesVolume RenderingTechnique (VRT) | Same |
| Size measurementsof polyps | Yes | Yes | Same |
| Segmentation inGlobal View | Yes | Yes | Same |
| Feature/Criteria | Subject DeviceVitrea® CT ColonAnalysis Software | Reference Devicesyngo.CT Colonography(K140920) | Comparison |
| Flythrough Cut Plane | Yes | YesPolyp Enhanced Viewing(PEV) | Same |
| MultiplanarReconstruction(MPR) | Yes | Yes | Same |
| Flythrough | Yes | YesVirtual Flight | Same |
| Performance Testing | |||
| Nonclinical Testing | Yes. | Yes. | Same. |
| Safety andPerformanceStandards | The subject device isdesigned to fulfill therequirements of thefollowing standardsDICOM, IEC 62304, andISO 14971. | The syngo.CTColonography wasdesigned to fulfill therequirements of thefollowing standardsDICOM, IEC 62304, andISO 14971. | Same. |
| Software Verificationand Validation | Yes.Vital has completed andprovided SoftwareDocumentation for aModerate Level ofConcern software perFDA's GuidanceDocument "Guidance forthe Content of PremarketSubmissions for SoftwareContained in MedicalDevices" issued on May11, 2005 | Yes.The K140920 Submissioncontained SoftwareDocumentation for aModerate Level ofConcern software perFDA's GuidanceDocument "Guidance forthe Content of PremarketSubmissions for SoftwareContained in MedicalDevices" issued on May11, 2005 | Same.PleasereferenceAttachments_035-043 for moredetails. |
| Clinical Testing | Yes.Clinical performance testswere conducted todemonstrateperformance, safety, andeffectiveness of the CTColon Analysis ElectronicBowel Cleansing featureusing datasets based on | Yes.Clinical performance testswere conducted todemonstrate performance,safety, and effectivenessof syngo.CTColonography. Testingwas provided to cover avariety of clinical situationsthat would be seen in daily | Similar.PleasereferenceAttachment_036VLC-08319 AColon ElectronicBowel CleansingAlgorithmVerification andValidation and |
| Feature/Criteria | Subject DeviceVitrea® CT ColonAnalysis Software | Reference Devicesyngo.CT Colonography(K140920) | Comparison |
| real patient data andphantoms. | clinical use of the subjectdevice. | Attachment_039VLC-08836 AVitrea CT ColonEBC Verificationand ValidationSummary formore details. |
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the word "VITAL" in a bold, sans-serif font. The letters are black, except for the dot above the "i", which is white. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font.
{13}------------------------------------------------
Image /page/13/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 perfect circle.
Page: 048-11 (of 15)
{14}------------------------------------------------
Image /page/14/Picture/0 description: The image shows the word "VITAL" in black, with a red subtitle that reads "A Toshiba Medical Systems Group Company". The letters of the word "VITAL" are large and bold, with a dot above the "i". The subtitle is in a smaller font and is located directly below the main word.
Summary of Non-Clinical Tests:
The Vitrea® CT Colon Analysis software was designed, 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 Colon Analysis software:
- Risk Management ●
- Requirements Reviews ●
- . Code Designs
- Code Development Testing
- . Code Reviews
- Desian 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 the Electronic Bowel Cleansing 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. 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:
- The medical benefits of the device outweigh the residual risk for each individual risk and ● all risks together
- . All risks have been reduced as low as possible
- The overall residual risk for the 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
048_Updated 510(k) Summary
{15}------------------------------------------------
Image /page/15/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 dot above the "i" in "VITAL" is a perfect circle.
and monitored the Requirements Traceability Matrix (RTM) to ensure coverage of the items within the RTM. Reference Attachment 013 Summary of Performed Verification Tests with results.
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 properly to conform to the intended use. Reference Attachment 015 Summary of Performed Validation Tests with results.
Internal Validation and Phantom Testing:
The software validation team provided internal validation of Vitrea® CT Colon Analysis software. Internal validation included internal user acceptance testing using real scans as well as synthetic phantoms. The validation criteria covered image qualitative comparison of segmentation to previous releases, quantitative evaluation of polyp diameter accuracy using phantom datasets, and run time performance evaluation. Reference Attachment_014 Summary of Performed Phantom Tests with results.
External Validation:
During external validation of the CT Colon Analysis software, experienced users evaluated the auto-segmentation, axial imaging, multi-planar reformatting, fly-through viewing, simultaneous display of prone and supine images, and transparent wall view among other features. Each user felt that the Vitrea® CT Colon Analysis software meets the users' expectations and conforms to the intended use. Reference Attachment 015 Summary of Performed Validation Tests with results.
Summary of Clinical Tests:
The subject of this 510(k) notification, Vitrea® CT Colon Analysis software, did not require clinical studies to support safety and effectiveness of the software.
Cyber and Information Security:
Confidentiality
The Vitrea® platform (K150258) 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.
{16}------------------------------------------------
Image /page/16/Picture/0 description: The image shows the word "VITAL" in a bold, sans-serif font. The "i" in "VITAL" is lowercase and has a circular dot above it. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font.
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 in Medicine(DICOM) Set (Radiology) | 3 | 03/16/2012 |
| ISO 14971:2007(RecognitionNumber 5-70) | AAMI / ANSI/ ISO | Medical Devices -Applications of RiskManagement to MedicalDevices | 2007 | 03/16/2012 |
| IEC 62304:2006(RecognitionNumber 13-32) | AAMI / ANSI/ IEC | Medical Device Software -Software Life CycleProcesses (Software /Informatics) | 2006 | 08/20/2012 |
The Vitrea® CT Colon Analysis software complies with the following voluntary recognized consensus standards:
Substantial Equivalence Analysis Conclusion:
Vital Images believes that the Electronic Bowel Cleansing feature is only an enhancement to the predicate device, as the predicate (CT Colonography software cleared within K052632 VITREA2, Version 3.8) already contained the capability to identify and review visible polyps in different views. The basic workflow hasn't changed due to this enhancement. The predicate allowed the user to navigate through the colon and interrogate polyps in 2D and 3D viewers. This enhancement is an optional tool, which now allows the tagged material to allow the user to see the polyps more clearly (the ones that were covered by tagged material). It is important to note that the tagged material will not be necessarily hidden in all viewers because the user has the capability to control when or if they want it hidden. The user can toggle tagged material on or off in 2D and 3D views so it is up to the user to have it hidden in both, hidden in 3D only or visible in both. The risk of incorrectly removing polyps when hiding tagged material in 3D (which was observed 0% of the time during our validation) has been mitigated because the polyps can still be seen in 2D. Therefore, Vital believes this enhancement does not alter the fundamental scientific technology, safety or intended use of the device.
Furthermore, the verification and validation testing performed demonstrated the modified device is as safe and effective as the predicate device and does not raise different questions of safety
{17}------------------------------------------------
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 letters in the word "VITAL" are all capitalized except for the "i", which is lowercase and has a dot above it.
and effectiveness than the predicate device (CT Colonography software within K052632 VITREA2, Version 3.8).
Vital Images believes the Vitrea® CT Colon Analysis software application has the same intended use, indications for use, principle of operation, and technological characteristics as the legally marketed predicate device K052632 VITREA2, Version 3.8 Medical Image Processing System (CT Colonography). The addition of the Electronic Bowel Cleansing feature is similar to the already cleared reference device Siemen's syngo.CT Colonography (K140920).
Any noted minor differences have been explained and do not raise any different questions of safety or effectiveness when used as labeled. The implemented design controls, risk management activities, labeling, and performed verification tests demonstrate the safety and efficacy of the subject device. Based on the comparison information provided above, Vital Images believes the subject device should be found substantially equivalent to the predicate device.
§ 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).