(37 days)
MR Core is an option within Vitrea® that allows the examination of a series of medical images obtained from MRI 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.
MR Core allows intuitive navigation, quantification, and manipulation of medical images obtained from MRI scanners. This application enables clinicians to compare multiple series of the same patient, side-by-side, and switch to other integrated applications to further examine the data. It provides rich clinical tools to review images for efficient and effective patient care.
The provided document is a 510(k) summary for a medical device called "MR Core software." This document outlines the device's indications for use, its comparison to predicate and reference devices, and a summary of non-clinical tests conducted. However, it explicitly states that "The subject of traditional 510(k) notification, MR Core software, did not require clinical studies to support safety and effectiveness of the software."
Therefore, I cannot provide details on acceptance criteria and a study proving the device meets those criteria from this document. The document primarily focuses on demonstrating substantial equivalence to a predicate device (Softread Software K040305) and a reference device (Myrian K091001) through technological and functional comparisons, not through a standalone clinical performance study with specific acceptance criteria.
Despite the lack of explicit clinical performance study data, here's what can be inferred or stated based on the provided text regarding verification and validation:
1. Table of Acceptance Criteria and Reported Device Performance:
Since no clinical study with explicit performance metrics is mentioned, a table of acceptance criteria and reported device performance directly from a clinical study cannot be created. The document focuses on showing that the functional equivalency and design controls were met. Implicit "acceptance criteria" can be derived from the non-clinical tests described, which confirm that the software operates according to its requirements and fulfills its intended uses.
| Acceptance Criteria (Inferred from Non-Clinical Tests) | Reported Device Performance (as described in the document) |
|---|---|
| Software fully satisfies all expected system requirements and features. | Test cases executed against system features and requirements; Requirements Traceability Matrix (RTM) reviewed for coverage. |
| Software conforms to user needs and intended use. | Workflow testing conducted, providing evidence that system requirements and features were implemented, reviewed, and met. |
| Experienced medical professionals confirm MR Core software fulfills its intended uses. | All validators confirmed that the MR Core software fulfills its intended uses. |
| Benefits outweigh risks, and residual risks are acceptable. | Each risk assessed; benefits outweigh risks; all risks reduced as low as possible; overall residual risk deemed acceptable. |
| New features operate according to their requirements. | Software testing completed to ensure new features operate according to requirements. |
| Compliance with recognized consensus standards (DICOM, ISO 14971, IEC 62304). | MR Core software complies with listed voluntary recognized consensus standards. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated. The document mentions "previously acquired medical images" were used for verification, validation, and evaluation. It does not provide the number of images or cases.
- Data Provenance: Not explicitly stated. The medical images were "previously acquired," but their country of origin or whether they were retrospective or prospective is not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: "Experienced medical professionals" evaluated the application during external validation. The exact number is not specified.
- Qualifications of Experts: They are referred to as "experienced medical professionals." No specific qualifications (e.g., radiologist with X years of experience) are provided.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not explicitly mentioned. The document states, "All validators confirmed that the MR Core software fulfills its intended uses." This suggests a consensus or individual validation approach, but no formal adjudication process (like 2+1 or 3+1) is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states that "MR Core software, did not require clinical studies to support safety and effectiveness of the software." The validation involved experienced medical professionals reviewing the application, which is more akin to usability testing than a comparative effectiveness study measuring improved reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- The device is "Radiological Image Processing Software" and its intended use involves "examination and manipulation of a series of medical images obtained from MRI scanners" by clinicians. The features described (viewing, manipulation, analysis tools) are meant to be used by clinicians. The "external validation" involved "experienced medical professionals [evaluating] the application." Therefore, the focus is on a human-in-the-loop performance, not a standalone algorithm's diagnostic performance. There is no mention of an algorithm-only standalone performance evaluation.
7. The Type of Ground Truth Used:
- Given the nature of the device (image viewing and manipulation tools) and the non-clinical validation, the "ground truth" was centered on expert confirmation of functional correctness and fulfillment of intended use. This means the "ground truth" was established by expert consensus/opinion regarding whether the software tools worked as expected and met user needs, rather than a definitive medical diagnosis (e.g., pathology, outcomes data).
8. The Sample Size for the Training Set:
- Not applicable / not provided. The document describes a traditional 510(k) for a software device that primarily offers image viewing and manipulation functionalities, not an AI/ML algorithm that requires a training set. The descriptions relate to software engineering practices (requirements, code reviews, verification, validation) rather than machine learning model development.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable / not provided. As there is no mention of a training set for an AI/ML model, there is no discussion of how any "ground truth" for such a set was established.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 3, 2015
Vital Images, Inc. % Mr. Parthiv Shah Sr. Regulatory Affairs Specialist 5850 Opus Parkway, Suite 300 MINNETONKA MN 55343
Re: K151115
Trade/Device Name: MR Core Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 24, 2015 Received: April 27, 2015
Dear Mr. Shah:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert A Ochs
Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151115
Device Name MR Core software
Indications for Use (Describe)
MR Core is an option within Vitrea® that allows the examination of a series of medical images obtained from MRI 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)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part 807.92(c)
| Purpose ofSubmission: | Modifications to a legally marketed device (K040305) which are notqualified for a Special 510(k) notification |
|---|---|
| Submitter: | Vital Images, Inc.5850 Opus ParkwaySuite 300Minnetonka, MN, 55343-4414 |
| EstablishmentRegistration: | 2134213 |
| Contact Person: | Parthiv ShahSr. Regulatory Affairs SpecialistPhone: 952-487-9574Fax: 952-487-9510E-mail: pshah@vitalimages.com |
| 510(k) Type: | Traditional |
| Summary Date: | June 1, 2015 |
| Device Trade Name: | MR Core Software |
| Device CommonName: | Radiological Image Processing Software |
| DeviceClassificationName: | System, Image Processing, Radiological |
| RegulatoryDescription: | Picture Archiving and Communications System |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | LLZ |
| RegulatoryClassification: | Class II |
| Device Panel: | Radiology |
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Predicate Device:
| Predicate Device | Manufacturer | FDA 510(k) number |
|---|---|---|
| Softread Software(Legally Marketed Device) | Vital Images, Inc. | K040305 |
Reference Device:
| Reference Device | Manufacturer | FDA 510(k) number |
|---|---|---|
| Myrian(Legally Marketed Device) | Intrasense | K091001 |
Device Description:
MR Core allows intuitive navigation, quantification, and manipulation of medical images obtained from MRI scanners. This application enables clinicians to compare multiple series of the same patient, side-by-side, and switch to other integrated applications to further examine the data. It provides rich clinical tools to review images for efficient and effective patient care.
Key features:
General Viewing:
- . Linked 2D, MPR and 4D viewers for single and multi-study comparison
- Creation of retrievable evidence and snapshots
- . User defined flexible display protocols
Access to Advanced Applications and Workflows:
- . In-application access to advanced analysis applications
- . Evidence creation and sharing across workflows
General Image Display, Manipulation, and Analysis Tools:
- Maximum and Minimum Intensity Projection (MIP/MinIP) .
- Identification and Display of Regions of Interest (ROIs) .
- . CINE image display
- Multi-frame display ●
- Color image display ●
- Simultaneous multiple studies review .
- Cross-reference lines support
- . Display of selected images, series, or entire study
- Comparison of multiple series or studies
- . Scroll
- Pan ●
- Zoom ●
- Focus
- Flip (Vertically, horizontally) .
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- Invert ●
- Rotate (Clockwise, counter-clockwise) ●
- Arrow
- . Adjust Registration
- Window level/width selection and user configurable preset
- . Auto window level/width setting
- . Text/Arrow annotation (Label)
- Measurement of distance (Ruler), Angle, Cobb Angle, Ellipse ROI, and Freehand ROI ●
Specialized MR Tools:
- Image subtraction of two MR series/datasets ●
- . Semi-automated image stitching
- Study and series linking .
- Automatic registration o
- Register two different series or groups that do not share a frame of reference to O link them spatially
Intended Use / Indications for Use:
MR Core is an option within Vitrea® that allows the examination and manipulation of a series of medical images obtained from MRI 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.
Changes from the last 510(k) clearance K040305:
| No. | Change(s) | Rationale for Changes |
|---|---|---|
| 1 | Change-1: User InterfaceCompletely re-designed User Interface(UI) screen | To utilize enhancements in thesoftware technology for better lookand user experience. |
| 2 | Change-2: Stitching of MR dataAdded a new feature of "stitching" thatcombines MR images covering distinctcontiguous, or slightly overlapping,regions of the human body anatomy intoone or multiple images. | To combine separately acquiredimages into a single view for easierinterpretation. |
| 3 | Change-3: Restricted ModalitySupportMR Core only allows the examinationand manipulation of a series of medicalimages obtained from MRI scanners. | The current version of MR Core onlysupports MR modality. |
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| No. | Change(s) | Rationale for Changes |
|---|---|---|
| 4 | Change-4: Restricted FeaturesMR Core does not support “Image Filtering ” and “ Image Set Splitting ”(divide a single study into multiplestacks) features. | The current version of MR Core doesnot support “Image Filtering ” and“ Image Set Splitting ” features. |
Intended for Disease / Condition / Patient Population:
MR Core is a medical image viewer software device. Therefore, particular information regarding the disease, condition, and patient population are not applicable.
Substantial Equivalence Comparison:
- Regulatory Comparison with the Predicate Device
| Criteria | Predicate Device | Subject Device | Comparison |
|---|---|---|---|
| Softread Software(K040305) | MR Core Software | ||
| Device Type /Classification Name | System, ImageProcessing,Radiological | System, ImageProcessing,Radiological | Same |
| Common Name | RadiologicalImage ProcessingSoftware | Radiological ImageProcessing Software | Same |
| Regulation /Classification Number | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
| Product Code | LLZ | LLZ | Same |
| Classification | Class II | Class II | Same |
| Review Panel | Radiology | Radiology | Same |
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| Criteria | Predicate Device | Subject Device | Comparison |
|---|---|---|---|
| Softread Software(K040305) | MR Core Software | ||
| Indications for Use | Softread, is an optionwithin the Vitrea 2system and isintended to allow theexamination andmanipulation of aseries of 2D images ina variety of modalities,including CT, MR,CR/DR/DX, SC, US,NM, PET, XA, and RF,etc.The option alsoenables clinicians tocompare multipleseries' for the samepatient, side-by-side,and to switch to Vitreato further examine thedata in a 3D volume. | MR Core is an optionwithin Vitrea® thatallows the examinationand manipulation of aseries of medicalimages obtained fromMRI scanners.The option alsoenables clinicians tocompare multipleseries for the samepatient, side-by-side,and switch to otherintegrated applicationsto further examine thedata. | SameNote: TheIntended Usestatement of themodified softwareis a subset (i.e.only for MRdatasets) ofalready clearedIntended Use ofthe legallymarketed device. |
Intended Use Comparison with the Predicate Device .
Technology Comparison with the Predicate Device .
| Criteria | Predicate Device | Subject Device | Comparison |
|---|---|---|---|
| Softread Software(K040305) | MR Core Software | ||
| ImageCommunicationStandard: DICOM | Yes | Yes | Same |
| 2D Image Review | Yes | Yes | Same |
| 2D ComparativeReview | Yes | Yes | Same |
| Multi-PlannerReformatting | Yes | Yes | Same |
| Maximum andMinimum IntensityProjection(MIP/MinIP) | Yes | Yes | Same |
| Criteria | Predicate Device | Subject Device | Comparison |
| Softread Software(K040305) | MR Core Software | ||
| 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 |
| Report Generation | Yes | Yes | Same |
| Cine Image Display | Yes | Yes | Same |
| Multi-frame Display | Yes | Yes | Same |
| 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 |
| Criteria | Predicate Device | Subject Device | Comparison |
| Softread Software(K040305) | MR Core Software | ||
| 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 |
| Window Level/Width Selection and User Configurable Preset | Yes | Yes | Same |
| Auto Window Level/Width Setting | Yes | Yes | Same |
| 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 |
| Automatic Registration | Yes | Yes | Same |
| Adjust Registration | Yes | Yes | Same |
| Criteria | Predicate Device | Subject Device | Comparison |
| Softread Software (K040305) | MR Core Software | ||
| Image subtraction oftwo MRseries/datasets | Yes | Yes | Same |
| Study and SeriesLinking | Yes | Yes | Same |
| Ability to launchinginto Vitrea platformfor any advancedapplications | Yes | Yes | Same |
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Technology Comparison with the Reference Device .
| Criteria | Reference Device | Subject Device | Comparison |
|---|---|---|---|
| Myrian (K091001) | MR Core Software | ||
| Feature: Stitching | Yes | Yes | Same |
| Stitching featurecombines MRimages coveringdistinct contiguous,or slightlyoverlapping, regionsof the human bodyanatomy into one ormultiple images. | Note: Theadded"Stitching"feature is similarto the feature onthe alreadyclearedIntrasense,MYRIAN("Referencedevice")'s"ImageAlignment"feature byK091001.Therefore, theadded featuredoes not raisedifferentquestions ofsafety andeffectiveness. | ||
| Criteria | Predicate Device | Subject Device | Comparison |
| Softread Software(K040305) | MR Core Software | ||
| Feature: StitchingStitching featurecombines MRimages coveringdistinct contiguous,or slightlyoverlapping, regionsof the human bodyanatomy into one ormultiple images. | No | Yes | The added featuredoes not affect theintended use orfundamental scientifictechnology of alreadycleared Softreadsoftware (K040305).Note: The added"Stitching" feature issimilar to the featureon the alreadycleared Intrasense,MYRIAN ("Referencedevice")'s "ImageAlignment" feature byK091001. Therefore,the added featuredoes not raisedifferent questions ofsafety andeffectiveness. |
| Restricted ModalitySupportThe current versionof MR Core onlysupports MRmodality. | Multi-modality | MR | The support foradditional modalitiesis available in thepredicate device butnot in the subjectdevice.Therefore, they donot raise differentquestions of safetyand effectiveness ofthe subject device. |
| RestrictedFeaturesThe current versionof MR Core does notsupport "ImageFiltering" and "ImageSet Splitting"features. | • Image Filtering• Image SetSplitting | None | These additionalfeatures are availablein the predicatedevice but not in thesubject device.Therefore, they donot raise differentquestions of safety |
| Criteria | Predicate Device | Subject Device | Comparison |
| Softread Software(K040305) | MR Core Software | ||
| and effectiveness ofthe subject device. |
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Differences in Technology with the Predicate Device .
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● Substantial Equivalence Analysis
The enhancements in the software do not affect the intended use or alter the fundamental scientific technology of legally marketed Softread software (K040305). The modified Softread software (known as MR Core) has the same indications for use, principle of operation, and performs similar technological functions as the already cleared Softread software (K040305) (Predicate Device). The added "Stitching" feature is similar to the already cleared Intrasense, Myrian software (K091001) (Reference Device). The modifications are not consequential from the standpoint of device operation, safety, effectiveness or intended use.
Any minor differences noted have been explained and do not raise different questions of safety or effectiveness when used as labeled. The implemented design controls, risk management activities, labeling, and the performed verification and validation tests demonstrate the safety and efficacy of the device is equivalent to the predicate device. Based on the comparison data and test data, Vital Images believes the subject device should be found substantially equivalent to the predicate device.
Summary of Non-Clinical Tests:
The changes to the Softread software were designed, developed and tested according to written procedures that included applying risk management. Software testing was completed to ensure the new features operate according to their requirements.
Testing included verification, validation, and evaluation on previously acquired medical images. The following quality assurance measures were applied to the development:
- Risk Management .
- Requirements reviews ●
- Code designs
- Code reviews ●
- Design reviews ●
- Verification of the software that included performance and safety testing ●
- Validation of the software – that included simulated usability testing by independent experienced medical professionals.
Risk Management:
Each risk pertaining to this 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 at least "Remote". All risks for this feature were collectively reviewed to determine if the benefits outweigh the risk. Based on the post market information contained in our Clinical Evaluation Report, injury or death is very rare for our product and products similar to ours. Because of this history and 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.
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During the design review, the following conclusions were reached:
- All risks were reduced as low as possible ●
- The medical benefits of the device outweigh the residual risk for each individual risk . and all risks together
- . The overall residual risk for the project is deemed acceptable
Verification:
The software verification team's primary goal was to assure that the software fully satisfies all expected system requirements and features. Test cases were executed against the system features and requirements. As a part of creating the test cases, the verification team reviewed and monitored the Requirements Traceability Matrix ("RTM") to ensure coverage of the items within the RTM.
Validation:
The software validation team's primary goal was assuring the software conforms to user needs and intended use. The validation team conducted workflow testing that provided evidence that the system requirements and features were implemented, reviewed and met.
External Validation:
During external validation of MR Core software, experienced medical professionals evaluated the application. All validators confirmed that the MR Core software fulfills its intended uses.
Summary of Clinical Tests:
The subject of traditional 510(k) notification, MR Core 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.
. Intearitv
The Vitrea platform complies with the DICOM standard for transfer and storage of this data and does not modify the contents of DICOM instances.
. Availability
The Vitrea platform is always available to the logged on user as long as the Windows machine itself is properly maintained.
. Accountability
The Vitrea platform includes an audit capability that tracks authenticated and authorized user operations along with information on what data was accessed. Vitrea 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.
| Standard No. | StandardsOrganization | Standard Title | Version | Date |
|---|---|---|---|---|
| PS 3.1-3.20(2011)(RecognitionNumber 12-238) | NEMA | Digital Imaging andCommunications inMedicine (DICOM) Set(Radiology) | 3 | 03/16/2012 |
| ISO 14971:2007(RecognitionNumber 5-70) | AAMI / ANSI/ ISO | Medical Devices -Applications of RiskManagement to MedicalDevices | 2007 | 03/16/2012 |
| IEC 62304:2006(RecognitionNumber 13-32) | AAMI / ANSI/ IEC | Medical Device Software -Software Life CycleProcesses (Software /Informatics) | 2006 | 08/20/2012 |
The MR Core software complies with the following voluntary recognized consensus standards:
Conclusion:
Vital Images believes that the MR Core software application has the same intended use and indications and similar principle of operation, and technological characteristics as the predicate and reference devices. Any minor differences noted have been explained and do not raise different questions of safety or effectiveness when used as labeled. The implemented design controls, risk management activities, labeling, and performed tests demonstrate the safety and efficacy of the device in comparison to the predicate device. Based on the comparison data and test data, Vital Images believes the subject device should be found substantially equivalent to the predicate device. The MR Core software device is as safe and effective as 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).