(38 days)
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, 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 a medical image viewer software application, available on the Vitrea software platform cleared by K150258. The application allows qualified clinicians, including physicians, radiologists and technologists, to display, navigate, manipulate and quantify medical images obtained from MRI, CT, CR, DX, RG, RF, XA, PET, and PET/CT modalities.
The Multi-Modality Viewer provides an overview of the study, facilitates side-by-side comparison including priors, allows clinicians to record evidence and return to previous evidence, and provides easy access to other Vitrea applications for further analysis.
The provided document, a 510(k) summary for the "Multi Modality Viewer" software, primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving those criteria are met for new features that would typically involve a performance study.
The device is an update to an existing medical image viewer, and the clearance is based on the argument that new features (support for additional modalities like PET, PET/CT, CR, DX, RG, RF, XA) do not raise new questions of safety and effectiveness because similar functionalities exist in previously cleared reference devices.
Therefore, the document explicitly states: "The subject of this 510(k) notification, Multi Modality Viewer software, did not require clinical studies to support safety and effectiveness of the software."
However, it does mention "Verification and Validation" activities and "Performance Standards" in a general sense. Based on the provided text, I can extract the following information about general testing and the device's performance, as much as is available:
1. Table of Acceptance Criteria and Reported Device Performance:
Since no specific quantitative acceptance criteria or detailed performance metrics are provided for the new features in the context of a dedicated performance study, the "acceptance criteria" here are inferred from the general statements about software development and verification. The device's "performance" is reported as meeting these general standards.
| Acceptance Criteria (Inferred from General Software Practices) | Reported Device Performance (as stated in the document) |
|---|---|
| Feature functions according to its requirements. | "Verification confirmed that the feature functions according to its requirements." |
| Operates on the Vitrea software platform without degrading existing functionality. | "Software testing was completed to ensure the Multi Modality Viewer software functions according to its requirements and operates on the Vitrea software platform without degrading the existing functionality of the Vitrea software platform." |
| Meets all product release criteria. | "The Multi Modality Viewer software has achieved all product release criteria." |
| Risks are reduced as low as possible and probability of occurrence of harm is "Improbable." | "Every risk has been reduced as low as possible and has been evaluated to have a probability of occurrence of harm of at least 'Improbable.'" |
| Unresolved defects do not compromise safety and effectiveness. | "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." |
| Medical benefits outweigh residual risk. | "The medical benefits of the device outweigh the residual risk for each individual risk and all risks together." |
| Compliance with DICOM standard for transfer and storage of data. | "The Vitrea software platform complies with the DICOM standard for transfer and storage of this data and does not modify the contents of DICOM instances." |
| Compliance with recognized consensus standards (IEC 62304, ISO 14971, NEMA PS 3.1-3.20). | "The Multi Modality Viewer software complies with the following voluntary recognized consensus standards: PS 3.1- 3.20 (2011), ISO 14971:2007, IEC 62304:2006." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a distinct "test set" with a particular sample size for a performance study related to the new features. The testing mentioned is "internal verification and external validation" which included "simulated usability testing by experienced professionals." No details about the number of cases or data provenance (country of origin, retrospective/prospective) for these tests are provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
No specific number of experts or their detailed qualifications are provided for establishing ground truth for a test set. The document refers to "experienced professionals" for "simulated usability testing."
4. Adjudication Method for the Test Set:
No adjudication method (e.g., 2+1, 3+1, none) is mentioned as no specific performance study test set is described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No MRMC comparative effectiveness study is mentioned. The document explicitly states: "The subject of this 510(k) notification, Multi Modality Viewer software, did not require clinical studies to support safety and effectiveness of the software."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device is a medical image viewer software. Its function is to display, navigate, manipulate, and quantify medical images for clinicians. It is not an algorithm that performs automated detection or diagnosis. Therefore, a standalone (algorithm only) performance study as typically understood for AI algorithms would not be applicable and is not mentioned. Its performance is intrinsically tied to human interaction.
7. The Type of Ground Truth Used:
As no specific performance study with a dedicated test set is described, there is no mention of the type of ground truth used (e.g., expert consensus, pathology, outcomes data). The validation focuses on the software's ability to function as intended and display data from new modalities accurately, which relies on adherence to standards and internal software verification.
8. The Sample Size for the Training Set:
This device is image viewer software, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Therefore, no training set size is mentioned.
9. How the Ground Truth for the Training Set Was Established:
As there is no training set for this type of device, this information is not applicable.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 26, 2017
Vital Images, Inc. % Ms. Susan Atwood Principal Quality Engineer 5850 Opus Parkway, Suite 300 MINNETONKA ME 55343
Re: K163574
Trade/Device Name: Multi Modalitv Viewer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 16, 2016 Received: December 19, 2016
Dear Ms. Atwood:
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.
Michael O'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
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Indications for Use
510(k) Number (if known)
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, 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
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 obtain510(k) clearance for the Multi Modality Viewer software which issubstantially equivalent to the FDA cleared Multi Modality Viewer(previous version) Software (K161419). |
|---|---|
| Submitter: | Vital Images, Inc.5850 Opus Parkway, Suite 300Minnetonka, MN, 55343-4414 |
| EstablishmentRegistration: | 2134213 |
| Contact Person: | Susan AtwoodPrincipal Quality EngineerPhone: 952-487-9759Fax: 952-487-9510E-mail: satwood@vitalimages.com |
| Alternate 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: | December 16, 2016 |
| Device Trade Name: | Multi Modality Viewer |
| Device CommonName/ RegulatoryDescription: | 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 ViewerSoftware | Vital Images, Inc. | K161419 |
Reference Device(s):
| Reference Device | Manufacturer | FDA 510(k) Number |
|---|---|---|
| Mirada RT (marketed asMirada XD) | MIRADA MEDICAL LTD.Mill StreetInnovation HouseOxford, Oxfordshire, GB Ox2 0JX | K102687 |
| VitalConnect | Vital Images, Inc.5850 Opus Parkway, Suite 300,Minnetonka, Minnesota 55343 U.S.A. | K071362 |
Device Description:
Multi Modality Viewer is a medical image viewer software application, available on the Vitrea software platform cleared by K150258. The application allows qualified clinicians, including physicians, radiologists and technologists, to display, navigate, manipulate and quantify medical images obtained from MRI, CT, CR, DX, RG, RF, XA, PET, and PET/CT modalities.
The Multi-Modality Viewer provides an overview of the study, facilitates side-by-side comparison including priors, allows clinicians to record evidence and return to previous evidence, and provides easy access to other Vitrea applications for further analysis.
Existing Features:
General image display:
- Display of images, volumes, and time sequences from MRI and CT modalities ●
- 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 .
- Display of high-resolution (1024 matrix) CT images .
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 ●
- Automatic linking of series with the same frame of reference ●
- Manually set reference point for linking separately acquired series ●
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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 ●
- Image flip, rotate clockwise/counterclockwise, invert
- Demographics more, less, on/off, reference lines on/off, linking on/off
Measurement, annotation, and snapshots:
- . Ruler, angle, and Cobb angle measurement
- Ellipse ROI and freehand ROI with pixel value statistics ●
- HU measurement for CT ●
- 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
- Direct access to MRI Stitching application ●
- . Access to all other applications on Vitrea system
New Features Since the Last 510(k) Clearance K161419:
General image display:
- Display of images and time sequences from projection modalities (CR, DX, RG, RF, and ● XA)
- . Display of PET images in grayscale or with a color map
- Display of PET/CT images acquired with the same frame of reference ●
- Fused display of PET/CT images acquired with the same frame of reference ●
- Rotating MIP display of PET hotspots .
Image cross-reference and comparison:
-
Linking of PET hotspots in MIP and MPR views ●
Measurement, annotation, and snapshots: -
SUV measurement for PET .
Derived series and specialized tools: -
Image subtraction of two compatible series .
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, 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.
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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.
Substantial Equivalence Comparison:
Regulatory Comparison:
| Subject Device | PredicateDevice | |||
|---|---|---|---|---|
| Characteristic | Multi ModalityViewer | Multi ModalityViewer(K161419) | 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 | May 20, 2016 | Predicate deviceis cleared |
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| Indications for Use Comparison with Predicate Device: | |
|---|---|
| ------------------------------------------------------- | -- |
| Criteria | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Multi Modality Viewer | Multi Modality Viewer (K161419) | ||
| 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, 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 a software application within Vitrea that allows the examination and manipulation of a series of medical images obtained from MRI and 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. | SimilarAdded support for the ability to examine and manipulate medical images obtained from CR, DX, RG, RF, XA, PET and PET/CT modalities which was not part of the predicate device's indications for use. |
| Intended Users | Physicians, Radiologists, Clinicians or Technologists | Physicians, Radiologists, Clinicians or Technologists | Same |
| Patient Population | Multi Modality Viewer is medical image viewer software. Therefore, particular information on the intended disease, condition, and patient population is not applicable. | Multi Modality Viewer is medical image viewer software. Therefore, particular information on the intended disease, condition, and patient population is not applicable. | Same |
| Modality Support | MRI, CT, CR, DX, RG, RF, XA, PET and PET/CT | MRI and CT | SimilarAdded support for the ability to examine and manipulate medical images obtained from CR, DX, RG, RF, XA, PET and PET/CT modalities which was not part of the predicate device's |
| Criteria | Subject Device | Predicate Device | Comparison |
| Multi ModalityViewer | Multi Modality Viewer(K161419) | ||
| 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 |
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Similarities in Technology with Predicate Device:
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|--|
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| Criteria | Multi ModalityViewer | Multi Modality Viewer(K161419) | |
| Color Image Display | Yes | Yes | Same |
| SimultaneousMultiple StudiesReview | Yes | Yes | Same |
| Cross-referenceLines Support | Yes | Yes | Same |
| Display of SelectedImages, Series, orEntire Study | Yes | Yes | Same |
| Comparison ofMultiple Series orStudies | 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 WindowLevel/Width Setting | Yes | Yes | Same |
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| Subject Device | Predicate Device | ||
|---|---|---|---|
| Criteria | Multi Modality Viewer | Multi Modality Viewer (K161419) | Comparison |
| Measurement of Distance | Yes | Yes | Same |
| Measurement of Angle | Yes | Yes | Same |
| Measurement of Cobb Angle | Yes | Yes | Same |
| Identification and Display of Ellipse Regions of Interest (ROIs) | Yes | Yes | Same |
| Identification and Display of Freehand Regions of Interest (ROIs) | Yes | Yes | Same |
| Manual Registration | Yes | Yes | Same |
| Image subtraction of two series/datasets | Yes | Yes | Same |
| Study and Series Linking | Yes | Yes | Same |
| Semi-automated Image Stitching | Yes | Yes | Same |
| Time Intensity Analysis | Yes | Yes | Same |
| Batch Save of MPR Reformats | Yes | Yes | Same |
| Examination and manipulation of a series of medical images obtained from MRI and CT datasets | Yes | Yes | Same |
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| Differences in Technology with the Predicate Device: |
|---|
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| Criteria | Multi Modality Viewer | Multi Modality Viewer (K161419) | |
| Feature: Support for PET and PET/CT Modality Data | Yes | No | Multi Modality Viewer allows the examination and manipulation of medical images obtained from PET and PET/CT scanners in addition to MRI and CT scanners.Note: The added PET and PET/CT modalities are similar to the features available on the Mirada XD software (“Reference Device”), which was cleared by the FDA under K102687. Therefore, this added feature does not raise different questions of safety and effectiveness. |
| Feature: Support for CR, DX, RG, RF, and XA Modality Data | Yes | No | Multi Modality Viewer allows the examination and manipulation of medical images obtained from CR, DX, RG, RF, and XA modalities in addition to MRI and CT scanners.Note: The added CR, DX, RG, RF, and XA modalities are similar to the features available on the VitalConnect 4.1 software (“Reference Device”), which was cleared by the FDA |
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| Criteria | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Multi Modality Viewer | Multi Modality Viewer (K161419) | ||
| under K071362.Therefore, this addedfeature does not raisedifferent questions ofsafety andeffectiveness. |
Similarities in Technology with the Reference Device
| Subject Device | Reference Device | Comparison | |
|---|---|---|---|
| Criteria | Multi Modality Viewer | Mirada XD (K102687) | |
| Modality | |||
| Support for PETand PET/CTModality Data | Yes | Yes | Same |
| Support forfollowingmeasurements:• Becqerel permilliliter (BQML)• SUV body weight(SUVbw)• SUV bodysurface area(SUVbsa)• SUV lean bodymass (SUVIbm) | Yes | Yes | Same |
| PET/CT FusionView | Yes | Yes | Same |
| PET/CT FusionBlending | Yes | Yes | Same |
| Window/widthFunctionality forPET & CT Images | Yes | Yes | Same |
| PET & CTwindow/widthPresets | Yes | Yes | Same |
| Zoom Image | Yes | Yes | Same |
| Subject Device | Reference Device | Comparison | |
| Criteria | Multi Modality Viewer | Mirada XD (K102687) | |
| Scroll Image | Yes | Yes | Same |
| Pan Image | Yes | Yes | Same |
| Focus Tool(triangulate) | Yes | Yes | Same |
| RulerMeasurement Tool | Yes | Yes | Same |
| Ellipse ROI | Yes | Yes | Same |
| Fixed ROI | Yes | Yes | Same |
| Label | Yes | Yes | Same |
| Arrow | Yes | Yes | Same |
| Reset Image | Yes | Yes | Same |
| Snapshots | Yes | Yes | Same |
| View Current andPrior Scans | Yes | Yes | Same |
| CT & PET MPRDisplay &Manipulation | Yes | Yes | Same |
| PET MIP Display &Manipulation | Yes | Yes | Same |
| CT & PET 2DViews | Yes | Yes | Same |
| PET Color Overlay | Yes | Yes | Same |
| Update/correctParameters(height, weight,dose) | Yes | Yes | Same |
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Image /page/14/Picture/1 description: The image shows the word "VITAL" in black letters. The "i" in "VITAL" has a red dot above it. The font is sans-serif and the letters are evenly spaced. The background is white.
Similarities in Technology with the Reference Device
| Subject Device | Reference Device | Comparison | |
|---|---|---|---|
| Criteria | Multi Modality Viewer | VitalConnect(K071362) | |
| Modality | |||
| Support for CR,DX, RF, RG, andXA Modality Data | Yes | Yes | Same |
Software Development Environment Description:
The Multi Modality Viewer software was designed, and tested according to IEC 62304:2004 standard for Medical Device Software: Software Life Cycle Processes.
The following design control measures were applied to the development of the Multi Modality Viewer software:
- Risk Management
- Software 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 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 at least "Improbable." Because of the risk control measures, it is believed that the risk for the Multi Modality Viewer software as a whole, is extremely low.
During the final risk management review, the following conclusions were reached:
- All Occurrence Factors for Hazards were mitigated as low as possible ●
- 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.
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Verification and Validation:
The software was designed, developed, tested, verified, and validated according to written procedures. Verification confirmed that the feature functions according to its requirements.
Software testing was completed to ensure the Multi Modality Viewer software functions according to its requirements and operates on the Vitrea software platform without degrading the existing functionality of the Vitrea software platform. Performance testing for the Multi Modality Viewer software included internal verification and external validation. The Multi Modality Viewer software has achieved all product release criteria.
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:
Confidentiality
The Vitrea software platform (K150258) relies on built in Windows Login security to limit access to the system. The Vitrea software platform can only be installed and configured by an administrator of the Windows machine.
Integrity
The Vitrea software 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 software platform is always available to the logged on user as long as the Windows machine itself is properly maintained.
Accountability
The Vitrea software platform includes an audit capability that enables accountability by tracking authenticated and authorized user operations along with information accessed. Vitrea software platform audit logs are time stamped, enabling correlation with Windows system logging to track information accessed by a user.
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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 (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 |
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 (K161419). The added features to allow for the examination and manipulation images obtained from PET and PET/CT scanners is similar to the features in the reference device, Mirada RT which was cleared by the FDA under K102687. Additionally, the ability to view and manipulate images obtained from CR, DX, RG, RG and XA scanners is similar to the feature in the reference device, VitalConnect, which was cleared by the FDA under K071362.
Furthermore, 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 addition of the examination and manipulation of a series of medical images obtained from CR, DX, RG, RF, XA, PET, and PET/CT scanners in the Multi Modality Viewer software does not alter the fundamental scientific technology, safety or intended use of the device.
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).