(37 days)
No
The summary describes standard image viewing and manipulation tools, and explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device is described as software for viewing and manipulating images obtained from MRI scanners, intended for diagnostic purposes rather than providing therapy.
No
The primary function of MR Core is to allow clinicians to view, navigate, quantify, and manipulate medical images obtained from MRI scanners, and compare them side-by-side. It does not state that it diagnoses medical conditions or provides interpretations of the images beyond aiding in their examination.
Yes
The device is described as "MR Core software" and its function is the examination, comparison, and manipulation of medical images. The description focuses solely on software functionalities and does not mention any accompanying hardware components that are part of the device itself.
Based on the provided information, it is highly unlikely that this device is an IVD (In Vitro Diagnostic). Here's why:
- Intended Use/Indications for Use: The description focuses on the examination and comparison of medical images obtained from MRI scanners. This is a tool for clinicians to visualize and analyze existing images, not to perform a test on a biological sample to diagnose a condition.
- Device Description: The description reinforces the idea of image navigation, quantification, and manipulation. These are image processing and viewing functions, not diagnostic tests performed on biological specimens.
- Input Imaging Modality: The input is MRI images, which are generated by a medical imaging scanner, not from a biological sample.
- Lack of Biological Sample Processing: There is no mention of processing blood, urine, tissue, or any other biological sample, which is a core characteristic of IVDs.
- Focus on Image Analysis: The tools described are for reviewing and analyzing images, not for detecting or measuring substances in a biological sample.
In summary, IVDs are used to perform tests on biological samples to provide information for diagnosis, monitoring, or screening. This device is a software tool for viewing and analyzing medical images, which falls under the category of medical image processing and viewing software.
N/A
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.
Product codes
LLZ
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 include: 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), 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 - Register two different series or groups that do not share a frame of reference to link them spatially).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinicians
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Testing included verification, validation, and evaluation on previously acquired medical images.
Summary of Performance Studies
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.
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.
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.
The subject of traditional 510(k) notification, MR Core software, did not require clinical studies to support safety and effectiveness of the software.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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.
1
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
2
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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Image /page/3/Picture/0 description: The image shows the word "VITAL" in bold, black letters. Below the word, in smaller, red letters, is the text "A Toshiba Medical Systems Group Company". The text is centered below the word "VITAL".
510(k) Summary
This 510(k) summary is submitted in accordance with the requirements of 21 C.F.R. Part 807.92(c)
| Purpose of
Submission: | Modifications to a legally marketed device (K040305) which are not
qualified for a Special 510(k) notification |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Vital Images, Inc.
5850 Opus Parkway
Suite 300
Minnetonka, MN, 55343-4414 |
| Establishment
Registration: | 2134213 |
| Contact Person: | Parthiv Shah
Sr. Regulatory Affairs Specialist
Phone: 952-487-9574
Fax: 952-487-9510
E-mail: pshah@vitalimages.com |
| 510(k) Type: | Traditional |
| Summary Date: | June 1, 2015 |
| Device Trade Name: | MR Core Software |
| Device Common
Name: | Radiological Image Processing Software |
| Device
Classification
Name: | System, Image Processing, Radiological |
| Regulatory
Description: | Picture Archiving and Communications System |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | LLZ |
| Regulatory
Classification: | Class II |
| Device Panel: | Radiology |
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Image /page/4/Picture/0 description: The image shows the word "VITAL" in bold, black letters. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The letters are spaced out evenly and the text is centered.
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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Image /page/5/Picture/0 description: The image shows the word "VITAL" in large, bold, black letters. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. The letters of the word "VITAL" are spaced apart, and the dot on the "i" is a circle.
- 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 Interface | |
| Completely re-designed User Interface | ||
| (UI) screen | To utilize enhancements in the | |
| software technology for better look | ||
| and user experience. | ||
| 2 | Change-2: Stitching of MR data | |
| Added a new feature of "stitching" that | ||
| combines MR images covering distinct | ||
| contiguous, or slightly overlapping, | ||
| regions of the human body anatomy into | ||
| one or multiple images. | To combine separately acquired | |
| images into a single view for easier | ||
| interpretation. | ||
| 3 | Change-3: Restricted Modality | |
| Support | ||
| MR Core only allows the examination | ||
| and manipulation of a series of medical | ||
| images obtained from MRI scanners. | The current version of MR Core only | |
| supports MR modality. |
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Image /page/6/Picture/0 description: The image shows the word "VITAL" in bold, black letters. The "i" in "VITAL" has a black dot above it. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font.
| No. | Change(s) | Rationale for Changes |
|---|---|---|
| 4 | Change-4: Restricted Features | |
| MR Core does not support “Image Filtering ” and “ Image Set Splitting ” | ||
| (divide a single study into multiple | ||
| stacks) features. | The current version of MR Core does | |
| not 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, Image | ||
| Processing, | |||
| Radiological | System, Image | ||
| Processing, | |||
| Radiological | Same | ||
| Common Name | Radiological | ||
| Image Processing | |||
| Software | Radiological Image | ||
| Processing 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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Image /page/7/Picture/1 description: The image shows the word "VITAL" in black font. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in red font. The dot on the "i" in "VITAL" is a circle.
| Criteria | Predicate Device | Subject Device | Comparison |
|---|---|---|---|
| Softread Software | |||
| (K040305) | MR Core Software | ||
| Indications for Use | Softread, is an option | ||
| within the Vitrea 2 | |||
| system and is | |||
| intended to allow the | |||
| examination and | |||
| manipulation of a | |||
| series of 2D images in | |||
| a variety of modalities, | |||
| including CT, MR, | |||
| CR/DR/DX, SC, US, | |||
| NM, PET, XA, and RF, | |||
| etc. | |||
| The option also | |||
| enables clinicians to | |||
| compare multiple | |||
| series' for the same | |||
| patient, side-by-side, | |||
| and to switch to Vitrea | |||
| to further examine the | |||
| data in a 3D volume. | 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. | Same | ||
| Note: The | |||
| Intended Use | |||
| statement of the | |||
| modified software | |||
| is a subset (i.e. | |||
| only for MR | |||
| datasets) of | |||
| already cleared | |||
| Intended Use of | |||
| the legally | |||
| marketed 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 | ||
| Image | |||
| Communication | |||
| Standard: DICOM | Yes | Yes | Same |
| 2D Image Review | Yes | Yes | Same |
| 2D Comparative | |||
| Review | Yes | Yes | Same |
| Multi-Planner | |||
| Reformatting | Yes | Yes | Same |
| Maximum and | |||
| Minimum Intensity | |||
| Projection | |||
| (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 |
| Quantitative | |||
| Measurements | 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 |
| 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 |
| 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 of | |||
| two MR | |||
| series/datasets | Yes | Yes | Same |
| Study and Series | |||
| Linking | Yes | Yes | Same |
| Ability to launching | |||
| into Vitrea platform | |||
| for any advanced | |||
| applications | Yes | Yes | Same |
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Image /page/10/Picture/0 description: The image shows the word "VITAL" in large, bold, black letters. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. The text is centered below the word "VITAL".
Technology Comparison with the Reference Device .
| Criteria | Reference Device | Subject Device | Comparison |
|---|---|---|---|
| Myrian (K091001) | MR Core Software | ||
| Feature: Stitching | Yes | Yes | Same |
| Stitching feature | |||
| combines MR | |||
| images covering | |||
| distinct contiguous, | |||
| or slightly | |||
| overlapping, regions | |||
| of the human body | |||
| anatomy into one or | |||
| multiple images. | Note: The | ||
| added | |||
| "Stitching" | |||
| feature is similar | |||
| to the feature on | |||
| the already | |||
| cleared | |||
| Intrasense, | |||
| MYRIAN | |||
| ("Reference | |||
| device")'s | |||
| "Image | |||
| Alignment" | |||
| feature by | |||
| K091001. | |||
| Therefore, the | |||
| added feature | |||
| does not raise | |||
| different | |||
| questions of | |||
| safety and | |||
| effectiveness. | |||
| Criteria | Predicate Device | Subject Device | Comparison |
| Softread Software | |||
| (K040305) | MR Core Software | ||
| Feature: Stitching | |||
| Stitching feature | |||
| combines MR | |||
| images covering | |||
| distinct contiguous, | |||
| or slightly | |||
| overlapping, regions | |||
| of the human body | |||
| anatomy into one or | |||
| multiple images. | No | Yes | The added feature |
| does not affect the | |||
| intended use or | |||
| fundamental scientific | |||
| technology of already | |||
| cleared Softread | |||
| software (K040305). | |||
| Note: The added | |||
| "Stitching" feature is | |||
| similar to the feature | |||
| on the already | |||
| cleared Intrasense, | |||
| MYRIAN ("Reference | |||
| device")'s "Image | |||
| Alignment" feature by | |||
| K091001. Therefore, | |||
| the added feature | |||
| does not raise | |||
| different questions of | |||
| safety and | |||
| effectiveness. | |||
| Restricted Modality | |||
| Support | |||
| The current version | |||
| of MR Core only | |||
| supports MR | |||
| modality. | Multi-modality | MR | The support for |
| additional modalities | |||
| is available in the | |||
| predicate device but | |||
| not in the subject | |||
| device. | |||
| Therefore, they do | |||
| not raise different | |||
| questions of safety | |||
| and effectiveness of | |||
| the subject device. | |||
| Restricted | |||
| Features | |||
| The current version | |||
| of MR Core does not | |||
| support "Image | |||
| Filtering" and "Image | |||
| Set Splitting" | |||
| features. | • Image Filtering | ||
| • Image Set | |||
| Splitting | None | These additional | |
| features are available | |||
| in the predicate | |||
| device but not in the | |||
| subject device. | |||
| Therefore, they do | |||
| not raise different | |||
| questions of safety | |||
| Criteria | Predicate Device | Subject Device | Comparison |
| Softread Software | |||
| (K040305) | MR Core Software | ||
| and effectiveness of | |||
| the subject device. |
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Image /page/11/Picture/0 description: The image shows the word "VITAL" in bold, black letters. Below the word is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The logo is simple and professional, likely representing a company or organization.
Differences in Technology with the Predicate Device .
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Image /page/12/Picture/0 description: The image shows the word "VITAL" in all capital letters. The "i" in vital has a dot above it. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller font size. The word "VITAL" is in black, and the phrase below it is in red.
● 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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Image /page/13/Picture/0 description: The image shows the word "VITAL" in a bold, sans-serif font. The letters are black, and the dot on the "i" is a perfect circle. Below the word "VITAL" is the text "A Toshiba Medical Systems Group Company" in a smaller, red font. The text is centered below the word "VITAL".
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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Image /page/14/Picture/0 description: The image shows the word "VITAL" in large, bold, black letters. Below the word "VITAL" is the phrase "A Toshiba Medical Systems Group Company" in a smaller, red font. The letters are spaced out evenly, and the text is centered.
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. | Standards
Organization | Standard Title | Version | Date |
|---------------------------------------------------------|---------------------------|-------------------------------------------------------------------------------------------|---------|------------|
| PS 3.1-3.20
(2011)
(Recognition
Number 12-238) | NEMA | Digital Imaging and
Communications in
Medicine (DICOM) Set
(Radiology) | 3 | 03/16/2012 |
| ISO 14971:2007
(Recognition
Number 5-70) | AAMI / ANSI
/ ISO | Medical Devices -
Applications of Risk
Management to Medical
Devices | 2007 | 03/16/2012 |
| IEC 62304:2006
(Recognition
Number 13-32) | AAMI / ANSI
/ IEC | Medical Device Software -
Software Life Cycle
Processes (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.