(21 days)
Multi Modality Viewer is an option within Vitrea that allows the examination of a series of medical images obtained from MRI, CT, CR, DX, RG, RF, US, XA, PET, and PET/CT scanners. The option also enables clinicians to compare multiple series for the same patient, side-by-side, and switch to other integrated applications to further examine the data.
Multi Modality Viewer is an option within Vitrea that allows the examination and manipulation of a series of medical images obtained from MRI, CT, CR, DX, RG, RF, US, XA, PET, and PET/CT scanners. The option also enables clinicians to compare multiple series for the same patient, side-by-side, and switch to other integrated applications to further examine the data.
The Multi Modality Viewer provides an overview of the study, facilitates side-by-side comparison including priors, allows reformatting of image data, enables clinicians to record evidence and return to previous evidence, and provides easy access to other Vitrea applications for further analysis.
Here's a breakdown of the acceptance criteria and study information for the Multi Modality Viewer, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of numerical "acceptance criteria" for performance metrics in the typical sense (e.g., sensitivity, specificity, accuracy thresholds). Instead, it focuses on functional capabilities and states that verification and validation testing confirmed the software functions according to requirements and that "no negative feedback was received," and "Multi Modality Viewer was rated as equal to or better than the reference devices."
The acceptance is primarily based on establishing substantial equivalence to predicate and reference devices, demonstrating that the new features function as intended and do not raise new questions of safety or effectiveness.
| Feature/Criterion | Acceptance Standard (Implied) | Reported Device Performance/Conclusion |
|---|---|---|
| Overall Safety & Effectiveness | Safe and effective for its intended use, comparable to predicate and reference devices. | Clinical validations demonstrated clinical safety and effectiveness. |
| Functional Equivalence | New features operate according to defined requirements and functions similarly to or better than features in reference devices. | Verification testing confirmed software functions according to requirements. External validation evaluators confirmed sufficiency of software to read images and rated it "equal to or better than" reference devices. |
| No Negative Feedback | No negative feedback from clinical evaluators regarding functionality or image quality of new features. | "No negative feedback received from the evaluators." |
| Substantial Equivalence | Device is substantially equivalent to predicate and reference devices regarding intended use, clinical effectiveness, and safety. | "This validation demonstrates substantial equivalence between Multi Modality Viewer and its predicate and reference devices with regards to intended use, clinical effectiveness and safety." |
| Risk Management | All risks reduced as low as possible; overall residual risk acceptable; benefits outweigh risks. | "All risks have been reduced as low as possible. The overall residual risk for the software product is deemed acceptable. The medical benefits of the device outweigh the residual risk..." |
| Software Verification (Internal) | Software fully satisfies all expected system requirements and features; all risk mitigations function properly. | "Verification testing confirmed the software functions according to its requirements and all risk mitigations are functioning properly." |
| Software Validation (Internal) | Software conforms to user needs and intended use; system requirements and features implemented properly. | "Workflow testing... provided evidence that the system requirements and features were implemented properly to conform to the intended use." |
| Cybersecurity | Follows FDA guidance for cybersecurity in medical devices, including hazard analysis, mitigations, controls, and update plan. | Follows internal documentation based on FDA Guidance: "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." |
| Compliance with Standards | Complies with relevant voluntary consensus standards (DICOM, ISO 14971, IEC 62304). | The device "complies with the following voluntary recognized consensus standards" (DICOM, ISO 14971, IEC 62304 listed). |
| New features don't raise new safety/effectiveness questions | New features are similar enough to existing cleared features in predicate/reference devices that they don't introduce new concerns. | For each new feature (Full volume MIP, Volume image rendering, 3D Cutting Tool, Clip Plane Box, bone/base segmentation tools, 1 Click Visible Seed, Automatic table segmentation, Automatic bone segmentation, US 2D Cine Viewer, Automatic Rigid Registration), the document states that the added feature "does not raise different questions of safety and effectiveness" due to similarity with a cleared reference device. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document repeatedly mentions "anonymized datasets" but does not specify the number of cases or images used in the external validation studies.
- Data Provenance: The data used for the external validation studies were "anonymized datasets." The country of origin is not explicitly stated, but the evaluators were from "three different clinical locations." Given Vital Images, Inc. is located in Minnetonka, MN, USA, it's highly probable the data and clinical locations are from the United States. The studies were likely retrospective as they involved reviewing "anonymized datasets" rather than ongoing patient enrollment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Three evaluators.
- Qualifications of Experts: The evaluators were "from three different clinical locations" and are described as "experienced professionals" in the context of simulated usability testing and clinical review. Their specific medical qualifications (e.g., radiologist, specific years of experience) are not explicitly detailed in the provided text.
4. Adjudication Method for the Test Set
The document does not describe an explicit "adjudication method" for establishing ground truth or resolving discrepancies between experts in the traditional sense. The phrase "no negative feedback received from the evaluators" and "Multi Modality Viewer was rated as equal to or better than the reference devices" suggests a consensus or individual evaluation model, but not a specific adjudication protocol like 2+1 or 3+1. It appears the evaluations focused on confirming functionality and subjective quality rather than comparing against a pre-established ground truth for a diagnostic task.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not explicitly stated to have been done in the context of measuring improvement with AI vs. without AI assistance.
- The "Substantial Equivalence Validation" involved three evaluators comparing the subject device against its predicate and reference devices. However, this comparison focused on functionality and image quality and aimed to show the equivalence or non-inferiority of the new device and its features, rather than quantifying performance gains due to AI assistance in human readers. The new features mentioned (like automatic segmentation or rigid registration) are components that might assist, but the study design wasn't an MRMC to measure the effect size of this assistance on human performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- The document describes "software verification testing" which confirms "the software functions according to its requirements." This implies a form of standalone testing for the algorithms and features. For example, "Automatic table segmentation" and "Automatic bone segmentation" are algorithms, and their functionality would have been tested independently.
- However, no specific performance metrics (e.g., accuracy, precision) for these algorithms in a standalone capacity are provided from these tests. The external validation was a human-in-the-loop setting where evaluators used the software.
7. The Type of Ground Truth Used
The external validation involved "clinical review of anonymized datasets" where evaluators assessed "functionality and image quality." For new features like segmentation or registration, the "ground truth" would likely be based on the expert consensus or judgment of the evaluators during their review of the anonymized datasets, confirming if the segmentation was accurate or if the registration was correct and useful. There is no mention of pathology, direct clinical outcomes data, or a separate "ground truth" panel.
8. The Sample Size for the Training Set
The document does not specify the sample size for the training set. It details verification and validation steps for the software but does not provide information about the development or training of any AI/ML components within the software. While features like "Automatic table segmentation" and "Automatic bone segmentation" likely involve machine learning, the document does not elaborate on their training data.
9. How the Ground Truth for the Training Set Was Established
Since the document does not specify the training set or imply explicit AI/ML development in the detail often seen for deep learning algorithms, it does not describe how the ground truth for the training set was established.
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
Vital Images, Inc. Fei Li Regulatory Affairs Specialist 5850 Opus Parkway, Suite 300 MINNETONKA, MN 55343-4414
Re: K182230
Trade/Device Name: Multi Modality Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: August 16, 2018 Received: August 17, 2018
Dear Fei Li:
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 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
September 7, 2018
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devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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,
Jeff Balyer
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) K182230
Device Name Multi Modality Viewer
Indications for Use (Describe)
Multi Modality Viewer is an option within Vitrea that allows the examination of a series of medical images obtained from MRI, CT, CR, DX, RG, RF, US, XA, PET, and PET/CT scanners. The option also enables clinicians to compare multiple series for the same patient, side-by-side, and switch to other integrated applications to further examine the data.
| 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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510K Summary, K182230
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 expandthe Indications for Use and to establish substantial equivalencebetween the Multi Modality Viewer Software (subject device) and theFDA cleared predicate device Multi Modality Viewer Software(K163574) and reference devices. |
|---|---|
| Submitter: | Vital Images, Inc.5850 Opus Parkway, Suite 300Minnetonka, MN, 55343-4414 |
| EstablishmentRegistration: | 2134213 |
| Contact Person: | Fei LiRegulatory Affairs SpecialistPhone: 952-487-9739Fax: 952-487-9510E-mail: fli@vitalimages.comAlternate Contact Person:Vince SwensonSr. Director of Quality and RegulatoryPhone: 952-487-9548Fax: 952-487-9510E-mail: vswenson@vitalimages.com |
| 510(k) Type: | Traditional |
| Summary Date: | August 16, 2018 |
| Device Trade Name: | Multi Modality Viewer |
| Device CommonName/ RequlatoryDescription: | Radiological Image Processing Software, Picture Archiving andCommunications System |
| Device ClassificationName: | System, Image Processing, Radiological |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | LLZ |
| RegulatoryClassification: | Class II |
| Device Panel: | Radiology |
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Predicate Device(s):
| Predicate Device | Manufacturer | FDA 510(k) Number |
|---|---|---|
| Multi Modality Viewer | Vital Images, Inc. | K163574 |
Reference Device(s):
| Reference Device | Manufacturer | FDA 510(k) Number |
|---|---|---|
| Vitrea AdvancedVisualization | Vital Images, Inc.5850 Opus Parkway, Suite 300,Minnetonka, Minnesota 55343 U.S.A. | K172855 |
| Vitrea View | Vital Images, Inc.5850 Opus Parkway, Suite 300,Minnetonka, Minnesota 55343 U.S.A. | K163232 |
| Mirada XD | MIRADA MEDICAL LTD.Mill StreetInnovation HouseOxford, Oxfordshire, GB Ox2 0JX | K101228 |
Device Description:
Multi Modality Viewer is an option within Vitrea that allows the examination and manipulation of a series of medical images obtained from MRI, CT, CR, DX, RG, RF, US, XA, PET, and PET/CT scanners. The option also enables clinicians to compare multiple series for the same patient, side-by-side, and switch to other integrated applications to further examine the data.
The Multi Modality Viewer provides an overview of the study, facilitates side-by-side comparison including priors, allows reformatting of image data, enables clinicians to record evidence and return to previous evidence, and provides easy access to other Vitrea applications for further analysis.
Features
General image display:
- Display of images, volumes, and time sequences from MR and CT modalities ●
- Display of images and time sequences from Projection Modality modalities (CR, DX, RF, ● RG, XA)
- Display of images and time sequences from Ultrasound modalities
- Display of PET images in grayscale or with a color map ●
- Display of PET-CT images acquired with the same frame of reference ●
- Display of derived modality images and secondary capture (SC) images ●
- 2D image display, MPR display, cine and 4D cine display for appropriate modalities
- Maximum, minimum, or average intensity projection for MPR with adjustable thickness ● and full volume Maximum Intensity Projection (MIP)
- . Fused display of PET-CT images acquired with the same frame of reference
- Full volume MIP display
- Display of high-resolution (1024 matrix) CT images
- . 3D Volume and Luminance image rendering
3D segmentation:
- Six planes interactive orthogonal clipping box ●
- Manual 3D volume cutting tool ●
- . Automated table segmentation
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- . Automated bone segmentation
- Segmentation correction tools .
Image cross-reference and comparison:
- Single MPR plane, 3-plane orthogonal MPR, and oblique MPR display ●
- Linked scrolling of MPR images and 2D images in the same plane ●
- Linked pan, zoom, and matched presentation of images in the same plane .
- Cross-reference lines and MPR cross-hairs to indicate orthogonal planes ●
- Focus tool to pinpoint the same location in all series ●
- Linking of PET hotspots in MIP and MPR views .
- Automatic linking of series with the same frame of reference .
- Automated rigid registration of current study and/or prior study(ies) with caching of ● automated registration result
- . Manually set reference point for linking separately acquired series
Hanging and viewing adjustments
- Ability to load only one study or including all priors ●
- . User-defined, flexible hanging layouts.
- Automatic initial hanging, manual hanging using drag & drop thumbnails ●
- Scroll, pan, zoom, W/L, W/L presets, fit to view, reset ●
- . lmage flip, rotate clockwise/counter clockwise, invert
- Demographics more, less, on/off, reference lines on/off, linking on/off .
Measurement, annotation, and snapshots:
- Length (ruler), angle, and Cobb angle measurement ●
- Ellipse ROI and freehand ROI with pixel value statistics .
- HU measurement for CT, SUV measurement for PET ●
- . Time-Intensity Analysis ROI
- . Arrow and text annotation
- Manual snapshots. Auto snapshot on measurement or annotation. .
- Ability to restore the presentation state of a snapshot
Derived series and specialized tools:
- MPR batch series generation ●
- lmage subtraction of two compatible series ●
- Direct access to MR Stitching application .
- . Access to all other applications on Vitrea system
Proposed Intended Use / Indications for Use:
Multi Modality Viewer is an option within Vitrea that allows the examination and manipulation of a series of medical images obtained from MRI, CT, CR, DX, RG, RF, US, XA, PET, and PET/CT scanners. The option also enables clinicians to compare multiple series for the same patient, side-by-side, and switch to other integrated applications to further examine the data.
Intended for Disease / Condition / Patient Population:
Multi Modality Viewer is medical image viewer software. Therefore, particular information on the intended for disease, condition, and patient population is not applicable.
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Key Changes from the last 510(k) clearance K163574:
The following features and tools were added to the Multi Modality Viewer software:
- Full volume MIP
- · Volume image rendering
- 3D Cutting Tool (Manual 3D Segmentation) .
- · Clip Plane Box (Orthogonal Clipping panes)
- · 2-click bone/base separation tool (2-click bone/base segmentation)
- · 1-click bone/base separation tool (1-click bone/base segmentation)
- · 1 Click Visible Seed (1-click segmentation)
- · Automatic table segmentation
- Automatic bone segmentation
- Head/Neck Extremities
- Chest/Abdominal/Pelvis
- US 2D Cine Viewer
- · Automatic Rigid Registration (Auto Linked Navigation of Current and Priors)
Substantial Equivalence Comparison:
Regulatory Comparison:
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Characteristic | Multi Modality Viewer | Multi Modality Viewer (K163574) | Comparison |
| Classification Name | System, Image Processing, Radiological | System, Image Processing, 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 | Jan 26, 2017 | Predicate device is cleared |
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FAL Vil
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| Criteria | Multi Modality Viewer | Multi Modality Viewer(K163574) | |
| Indications forUse | Multi Modality Viewer isan option within Vitreathat allows theexamination andmanipulation of a seriesof medical imagesobtained from MRI, CT,CR, DX, RG, RF, US, XA,PET, and PET/CTscanners. The option alsoenables clinicians tocompare multiple seriesfor the same patient,side-by-side, and switchto other integratedapplications to furtherexamine the data. | Multi Modality Viewer isan option within Vitreathat allows theexaminationand manipulation of aseries of medical imagesobtained from MRI, CT,CR, DX, RG, RF, XA,PET, and PET/CTscanners. The optionalso enables clinicians tocompare multiple seriesfor the same patient,side-by-side, and switchto other integratedapplications to furtherexamine the data. | SimilarAdded support for theability to examine andmanipulate medicalimages obtained fromUS modality whichwas not part of thepredicate device'sindications for use. |
| Intended Users | Qualified healthcareprofessionals including,but not restricted to,radiologists, non-radiology specialists,physicians andtechnologists. | Qualified healthcareprofessionals including,but not restricted to,radiologists, non-radiology specialists,physicians andtechnologists. | Same |
| PatientPopulation | Multi Modality Viewer ismedical image viewersoftware. Therefore,particular information ofintended for disease,condition, and patientpopulation is notapplicable. | Multi Modality Viewersoftware is medicalimage viewer software.Therefore, particularinformation of intendedfor disease, condition,and patient population isnot applicable. | Same |
| ModalitySupport | MRI, CT, CR, DX, RG,RF, US, XA, PET, andPET/CT | CT, MRI, CR, DX, RG,RF, XA, PET, andPET/CT | SimilarAdded support for theability to examine andmanipulate medicalimages obtained fromUS modality whichwas not part of thepredicate device's |
| Subject Device | Predicate Device | ||
| Criteria | Multi Modality Viewer | Multi Modality Viewer(K163574) | Comparison |
| Data Loading | |||
| ImageCommunicationStandard: DICOM | Yes | Yes | Same |
| Data Viewing Support | |||
| 2D Image Review | Yes | Yes | Same |
| 2D ComparativeReview | Yes | Yes | Same |
| Features and Capabilities | |||
| Multi-PlannerReformatting | Yes | Yes | Same |
| Maximum andMinimum IntensityProjection(MIP/MinIP) | Yes | Yes | Same |
| Image Editing,Setting, Saving | Yes | Yes | Same |
| Annotation &Tagging Tools(Label) | Yes | Yes | Same |
| Display Options(e.g. thickness) | Yes | Yes | Same |
| QuantitativeMeasurements | Yes | Yes | Same |
| Snapshot | Yes | Yes | Same |
| Cine Image Display | Yes | Yes | Same |
| Multi-frame Display | Yes | Yes | Same |
| Color Image Display | Yes | Yes | Same |
| Criteria | Subject DeviceMulti Modality Viewer | Predicate DeviceMulti Modality Viewer(K163574) | Comparison |
| Simultaneous Multiple Studies Review | Yes | Yes | Same |
| Cross-reference Lines Support | Yes | Yes | Same |
| Display of Selected Images, Series, or Entire Study | Yes | Yes | Same |
| Comparison of Multiple Series or Studies | Yes | Yes | Same |
| Scroll Image | Yes | Yes | Same |
| Zoom Image | Yes | Yes | Same |
| Pan Image | Yes | Yes | Same |
| Focus Image | Yes | Yes | Same |
| Rotate Image | Yes | Yes | Same |
| Flip Image - Vertical | Yes | Yes | Same |
| Flip Image - Horizontal | Yes | Yes | Same |
| Rotate Image - Clockwise | Yes | Yes | Same |
| Rotate Image - Counter-clockwise | Yes | Yes | Same |
| Invert Image | Yes | Yes | Same |
| Arrow | Yes | Yes | Same |
| Auto Window Level/Width Setting | Yes | Yes | Same |
| Measurement of Distance | Yes | Yes | Same |
| Subject Device | Predicate Device | ||
| Criteria | Multi Modality Viewer | Multi Modality Viewer(K163574) | Comparison |
| Measurement ofAngle | Yes | Yes | Same |
| Measurement ofCobb Angle | Yes | Yes | Same |
| Identification andDisplay of EllipseRegions of Interest(ROIs) | Yes | Yes | Same |
| Identification andDisplay of FreehandRegions of Interest(ROIs) | Yes | Yes | Same |
| Manual Registration | Yes | Yes | Same |
| Image subtraction oftwo series/datasets | Yes | Yes | Same |
| Study and SeriesLinking | Yes | Yes | Same |
| Semi-automatedImage Stitching | Yes | Yes | Same |
| Time IntensityAnalysis | Yes | Yes | Same |
| Batch Save ofMPR Reformats | Yes | Yes | Same |
| Examinationand manipulationof a series ofmedical imagesobtained fromMRI, CT, CR, DX,RF, RG, XA, PETand PET-CTdatasets | Yes | Yes | Same |
| Subject Device | PredicateDevice | ||
| Criteria | Multi ModalityViewer | Multi ModalityViewer(K163574) | Comparison |
| Full volume MIP | Yes | No | Added functionality of full volumeMIP visualization.Note: The Full volume MIP featureis the same as the feature availableon the Vitrea AdvancedVisualization software ("ReferenceDevice"), which was cleared by theFDA under K172855. Therefore,this added feature does not raisedifferent questions of safety andeffectiveness. |
| Volume imagerendering | Yes | No | Added Volume image rendering(Standard 3D rendering methodand Luminance rendering method)and accompanying presets.Note: The Volume image renderingmethodology is similar to themethodology available on the VitreaAdvanced Visualization software("Reference Device"), which wascleared by the FDA under K172855.Therefore, this added methodologydoes not raise different questions ofsafety and effectiveness. |
| 3D Cutting Tool(Manual 3DSegmentation) | Yes | No | Added functionality to assign voxelsrendered visible and within orwithout a user drawn region ofinterest to a distinct segmentationobject.Note: The 3D Cutting Tool featureis the same as the feature availableon the Vitrea AdvancedVisualization software ("ReferenceDevice"), which was cleared by theFDA under K172855. Therefore,this added feature does not raisedifferent questions of safety andeffectiveness. |
| Clip Plane Box(OrthogonalClipping panes) | Yes | No | Added functionality to display onlypart of the scanned volume in 3Drendering mode instead of theentire volume. |
| Subject Device | PredicateDevice | ||
| Criteria | Multi ModalityViewer | Multi ModalityViewer(K163574) | Comparison |
| Note: The clipping planes feature isthe same as the feature availableon the Vitrea AdvancedVisualization software ("ReferenceDevice"), which was cleared by theFDA under K172855. Therefore,this added feature does not raisedifferent questions of safety andeffectiveness. | |||
| 2-click bone/baseseparation tool(2-clickbone/basesegmentation) | Yes | No | Added functionality to separate twoconnected anatomical features, totwo distinct segmentation objects.Note: The 2-click bone/baseseparation tool is the same as thefeature available on the VitreaAdvanced Visualization software("Reference Device"), which wascleared by the FDA under K172855.Therefore, this added feature doesnot raise different questions ofsafety and effectiveness. |
| 1-click bone/baseseparation tool(1-clickbone/basesegmentation) | Yes | No | Added functionality to allow user totoggle visually isolated structuresfrom the Bone to the Basesegmentation object or vice versa.Note: The 2-click bone/baseseparation tool is the same as thefeature available on the VitreaAdvanced Visualization software("Reference Device"), which wascleared by the FDA under K172855.Therefore, this added feature doesnot raise different questions ofsafety and effectiveness. |
| 1 Click VisibleSeed (1-clicksegmentation) | Yes | No | Added functionality to toggle one oftwo non-connected anatomicalfeatures, to belong to the same or adistinct segmentation object as theother anatomical feature.Note: The 1 Click Visible Seedfeature is the same as the featureavailable on the Vitrea AdvancedVisualization software ("ReferenceDevice"), which was cleared by theFDA under K172855. |
| Criteria | Subject DeviceMulti ModalityViewer | PredicateDeviceMulti ModalityViewer(K163574) | Comparison |
| Automatic tablesegmentation | Yes | No | this added feature does not raisedifferent questions of safety andeffectiveness.Added algorithm for automaticrecognition of gantry tablestructures and isolating those in adedicated segmentation object.Note: The Automatic tablesegmentation feature is the sameas the feature available on theVitrea Advanced Visualizationsoftware ("Reference Device"),which was cleared by the FDAunder K172855. Therefore, thisadded feature does not raisedifferent questions of safety andeffectiveness. |
| Automatic bonesegmentation- Head/Neck- Extremities- Chest/Abdomi- nal/Pelvis | Yes | No | Added algorithm for automaticrecognition of bone anatomystructures and isolating those in adedicated segmentation object.Note: The Automatic bonesegmentation feature is the sameas the feature available on theVitrea Advanced Visualizationsoftware ("Reference Device"),which was cleared by the FDAunder K172855. Therefore, thisadded feature does not raisedifferent questions of safety andeffectiveness. |
| US 2D CineViewer | Yes | No | Added support for 2D display ofstatic and dynamic ultrasoundimages.Note: The US 2D Cine Viewerfeature is the same as the featureavailable on the Vitrea Viewsoftware ("Reference Device"),which was cleared by the FDAunder K163232. Therefore, thisadded feature does not raisedifferent questions of safety andeffectiveness. |
| Subject Device | PredicateDevice | ||
| Criteria | Multi ModalityViewer | Multi ModalityViewer(K163574) | Comparison |
| Automatic RigidRegistration(Auto LinkedNavigation ofCurrent andPriors) | Yes | No | Added algorithm for automatic rigidregistration of two or multiplestudies displayed in MM Viewer.Note: The Auto Linked Navigationof Current and Priors feature is thesame as the feature available onthe Mirada XD software("Reference Device"), which wascleared by the FDA under K101228.Therefore, this added feature doesnot raise different questions ofsafety and effectiveness. |
Indications for Use Comparison with Predicate Device:
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Similarities in Technology with Predicate Device:
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Image /page/10/Picture/1 description: The image shows the word "ViTAL" in a sans-serif font. The letters are black, except for the dot on the "i", which is red. The letters are evenly spaced and the word is centered.
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Differences in Technology with the Predicate Device:
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Similarities in Technology with the Reference Devices
| SubjectDevice | ReferenceDevice | Comparison | |
|---|---|---|---|
| Criteria | MultiModalityViewer | VitreaAdvancedVisualization(K172855) | |
| Full volume MIP | Yes | Yes | Same |
| Volume image rendering | Yes | Yes | SimilarThe Standard 3Drendering method addedis the same as 3Drendering method used inthe Vitrea AdvancedVisualization software("Reference Device"). TheLuminance 3D renderingmethod is another form of3D volume rendering andis an option in the MultiModality Viewer software("Subject Device"). Theverification and validationtesting performeddemonstrate the subjectdevice is safe andeffective and does notraise any differentquestions of safety andeffectiveness. |
| Criteria | SubjectDeviceMultiModalityViewer | ReferenceDeviceVitreaAdvancedVisualization(K172855) | Comparison |
| 3D Cutting Tool (Manual 3DSegmentation) | Yes | Yes | Same |
| Clip Plane Box (OrthogonalClipping panes) | Yes | Yes | Same |
| 2-click bone/base separationtool (2-click bone/basesegmentation) | Yes | Yes | Same |
| 1-click bone/base separationtool (1-click bone/basesegmentation) | Yes | Yes | Same |
| 1 Click Visible Seed (1-clicksegmentation) | Yes | Yes | Same |
| Automatic table segmentation | Yes | Yes | Same |
| Automatic bone segmentation- Head/Neck Extremities- Chest/Abdominal/Pelvis | Yes | Yes | Same |
| Criteria | SubjectDeviceMultiModalityViewer | ReferenceDeviceVitrea View(K163232) | Comparison |
| US 2D Cine Viewer | Yes | Yes | Same |
| Criteria | SubjectDeviceMultiModalityViewer | ReferenceDeviceMirada XD(K101228) | Comparison |
| Automatic Rigid Registration(Auto Linked Navigation ofCurrent and Priors) | Yes | Yes | Same |
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Software Development Enviornment Description:
The changes to the Multi Modality Viewer software were designed, and tested according to written procedures that included risk management. Software verification 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 Multi Modality Viewer software:
- Risk Management .
- Requirements Reviews
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- 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 simulated usability testing by experienced professionals.
Risk Management:
Each risk associated with the Multi Modality Viewer software 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 "Incredible". All risks for these modifications were collectively reviewed to determine if the benefits outweigh the risk. Based on Post Market information and because of the risk control measures included in these modifications, it is believed that the risk for these modifications as a whole are extremely low. Considering all risks against the benefits, it has been assessed that the benefits do outweigh the risks for these modifications.
During the design review, the following conclusions were reached:
- All risks have been reduced as low as possible. ●
- The overall residual risk for the software product is deemed acceptable.
- Of the unresolved defects remaining in the released application, each has been carefully . evaluated and it has been determined that the software can be used safely and effectively.
- . The medical benefits of the device outweigh the residual risk for each individual risk and all risks together.
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, requirements and risk mitigations. Verification testing confirmed the software functions according to its requirements and all risk mitigations are functioning properly.
Validation:
The software validation team's primary goal was to assure that 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.
External Validation:
Two sets of external validation were performed to ensure the clinical safety and effectiveness of the Multi Modality Viewer software.
The goals of the external validations were to:
- a) Establish the clinical safety and effectiveness of the Multi Modality Viewer software
- b) Establish the substantial equivalence between Multi Modality Viewer with the predicate and reference devices
- Clinical Effectiveness Validation a)
Three evaluators from three different clinical locations clinically reviewed anonymized datasets using the Multi Modality Viewer software. The reviewers were presented with a list of questions
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with regards to the functionality and image quality for the following software features: Full volume MIP, Clip Plane Box (Orthogonal Clipping pane), 2-click bone/base separation tool, 1-click bone/base separation tool, 1 Click Visible Seed (1-click segmentation), Automatic table segmentation and Automatic bone segmentation. 3D and Luminance rendering Automatic Rigid Registration (Auto Linked Navigation of Current and Priors)and basic ultrasound visualization support.
There was no negative feedback received from the evaluators. The evaluators confirmed the Multi Modality software was sufficient to read the images and the software was determined to remain safe and effective for its intended use.
Substantial Equivalence Validation b)
Three evaluators from three different clinical locations clinically reviewed anonymized datasets using the Multi Modality Viewer software, Vitrea Advanced Visualization software, Mirada XD software, and Vitrea View software. The evaluators were presented with a list of questions with regards to the functionality and image quality for the following software features: Full volume MIP, Clip Plane Box (Orthogonal Clipping pane), 3D Cutting Tool (Manual 3D Segmentation), 2-click bone/base separation tool, 1-click bone/base separation tool. 1 Click Visible Seed (1-click segmentation), Automatic table segmentation and Automatic bone segmentation, 3D and Luminance rendering, automatic registration and basic ultrasound visualization support.
There were no instances recorded where the subject device performed inferior to one of the reference devices. Multi Modality Viewer was rated as equal to or better than the reference devices. This validation demonstrates substantial equivalence between Multi Modality Viewer and its predicate and reference devices with regards to intended use, clinical effectiveness and safety.
The overall outcome of the clinical validations performed demonstrate the clinical safety and effectiveness of the Multi Modality Viewer software.
Summary of Clinical Tests:
The subject of this 510(k) notification, Multi Modality Viewer software, did not require clinical studies to support safety and effectiveness of the software.
Cyber and Information Security:
The Multi Modality Viewer software follows internal documentation which includes information based on the FDA Guidance: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
Internal documentation covers the following:
-
- Hazard analysis, mitigations, and design considerations pertaining to intentional and unintentional cybersecurity risks associated with your device, including:
- A specific list of all cybersecurity risks that were considered in the design of your ● device:
- A specific list and justification for all cybersecurity controls that were established ● for vour device.
-
- A traceability matrix that links your actual cybersecurity controls to the cybersecurity risks that were considered;
-
- A summary describing the plan for providing validated software updates and patches as needed throughout the lifecycle of the medical device to continue to assure its safety and effectiveness. The FDA typically will not need to review or approve medical device software changes made solely to strengthen cybersecurity.
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- A summary describing controls that are in place to assure that the medical device 4. software will maintain its integrity (e.g. remain free of malware) from the point of origin to the point at which that device leaves the control of the manufacturer; and
- Device instructions for use and product specifications related to recommended 5. cybersecurity controls appropriate for the intended use environment (e.g. anti-virus software, use of firewall).
Performance Standards:
The FDA has not established mandatory performance standards and no special controls exist for this device. General software verification and validation tests were conducted to confirm proper function of the device's features.
The Multi Modality Viewer software complies with the following voluntary recognized consensus standards:
| Standard No. | StandardsOrganization | Standard Title | Version | Date |
|---|---|---|---|---|
| PS 3.1- 3.20 (2016)(RecognitionNumber 12-300) | NEMA | Digital Imaging andCommunications in Medicine(DICOM) Set (Radiology) | 3 | 06/27/2016 |
| ISO 14971:2007/(R)2010(RecognitionNumber 5-70) | AAMI / ANSI/ ISO | Medical Devices -Applications of RiskManagement to MedicalDevices | 2007 | 06/27/2016 |
| 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 the Multi Modality Viewer software has a similar intended use, indications for use, principle of operation, and technological characteristics as the legally marketed, predicate device Multi Modality Viewer (K163574) and reference devices.
In addition.
- (1) The added features and tools for Full volume MIP, Volume image rendering, 3D Cutting Tool, Clip Plane Box, 2-click bone/base separation tool, 1-click bone/base separation tool, 1 Click Visible Seed, Automatic table segmentation and Automatic bone segmentation are similar to the features and tools in the reference device, Vitrea Advanced Visualization which was cleared by the FDA under K172855;
- (2) The addition of US 2D Cine Viewer which allows for the examination and manipulation images obtained from the Ultrasound modality is similar to the feature in the reference device. Vitrea View which was cleared by the FDA under K163232:
- (3) The added feature to allow for automated rigid registration of current study and/or prior study(ies) with caching of automated registration result is similar to the feature in the reference device, Mirada XD which was cleared by the FDA under K101228.
The verification and validation testing performed demonstrate the subject device is as safe and effective as the predicate and reference devices and does not raise any different questions of safety and effectiveness. Therefore, Vital believes the enhancements in the Multi Modality Viewer software does not alter the fundamental scientific technology, safety or intended use of the device.
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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 and validation 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).