(88 days)
Not Found
No
The description focuses on semi-automatic and manual tools for image analysis and measurement, with no mention of AI or ML algorithms.
No.
The software is an image analysis toolbox for quantitative analysis and visualization of MRI studies; it does not provide any therapy.
Yes
The device provides tools for quantitative analysis of atherosclerotic carotid arteries from MRI studies, and its output is used to "support the decision-making process in clinical practice," which aligns with the definition of a diagnostic device. It processes medical images to extract information relevant to a disease state.
Yes
The device description explicitly states that MRI-PlaqueView is an "image analysis software toolbox" and operates on a "Windows XP platform that may be installed on a standalone PC, PACS or other medical imaging system." It reads images from "DICOM-compliant medical devices" but does not include any hardware components itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: IVDs are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- This device analyzes medical images: The MRI-PlaqueView software processes and analyzes medical images (MRI scans) of carotid arteries. It does not interact with or analyze biological samples.
The device falls under the category of medical image analysis software, which is a different type of medical device than an IVD.
N/A
Intended Use / Indications for Use
The MRI-PlaqueView software provides a set of post-processing tools to assist trained cardiologists and radiologists in the quantitative analysis of atherosclerotic carotid arteries from 1.5T or 3.0T magnetic resonance imaging (MRI) studies acquired with a combination of one or more contrast weightings such as T1, T2, Proton Density, and Time of Flight. Users of MRI-Plaque View perform semiautomatic delineation of lumen and outer vessel wall boundaries. Users may also perform semi-automatic, user configurable segmentation or manual drawing for delineation of atherosclerotic plaque components within the vessel wall. Users may edit the results on the fly. The software enables length, thickness, and area and volume measurements of the vessel wall as well as quantification of user-indicated areas. MRI-Plaque View further aids in the visualization of atherosclerotic arteries (for example, through maximum intensity projections) of MRI data and color-coded maps of segmented arteries. When interpreted by a trained physician, the output of this image analysis toolbox can be used to support the decision-making process in clinical practice or to support investigations in clinical research and trials.
Product codes
LLZ
Device Description
MRI-PlaqueView is an image analysis software toolbox that facilitates visualization and quantitative analysis of MR images of carotid arteries acquired on 1.5T or 3.0T scanners. MRI-PlaqueView provides a set of image review, delineation, registration, editing, visualization, and measurement tools. The MRI-Plaque View user interface is designed to follow typical clinical workflow patterns to review, process, edit, validate, analyze, and visualize digital images and to present, distribute and save the findings.
The software application operates on a Windows XP platform that may be installed on a standalone PC, PACS or other medical imaging system. The software is designed to read MRI images from DICOM-compliant medical devices distributed by various OEM vendors.
The input to the system consists of one to six standard MRI series, which provide information through use of different MRI contrast weightings, such as T1, T2, Proton Density, and TOF weighted images
Once the user has selected a region of interest (ROI) for analysis, the MRI-PlaqueView tools will help to delineate the lumen and outer wall boundaries using either semi-automatic boundary detection or manual drawing/editing tools
The software provide the user an option to further analyze the multiple contrast weighted MRI data using either semi-automated algorithms or manual drawing/editing tools to segment and label the internal structure of the vessel wall, delineating calcified and soft plaque regions.
To facilitate the use of multiple contrast weighted data, the software displays the identified contours simultaneously on original images from all available series. Automated and user-controlled registration functions enable mapping of contours from one contrast weighting to another.
The quantitative measurements this software provides include volumes, thicknesses, maximal areas, and area ratios of the different regions outlined. The software also supports review and visualization of the data using standard rendering techniques, such as maximum intensity projections. The analysis results (both contours and quantitative measurements) can be saved in separate files to facilitate restoring previous works for subsequent sessions, and for reporting results.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Carotid arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained cardiologists and radiologists in clinical practice or clinical research and trials.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
0
DEC 0 5 2008
510(k) Summary
This 510(k) summary is submitted in accordance with the requirements of 21 CFR Part 807.92, Subpart E.
1. Identification of Submitter:
| Submitter: | VPDiagnostics |
|---|---|
| Address: | 819 Virginia Street |
| Suite 2209 | |
| Seattle, WA | |
| Phone: | 206-428-6160 |
| Fax: | 866-278-3299 |
| Contact: | Michael Hartmann |
| Title: | Vice President, Business & Product Development |
| Phone: | Corporate: 206-428-6160 |
| Mobile: 857-928-4551 | |
| Fax: | 866-278-3299 |
Summary Date: June 19, 2008
2. Identification of Product:
| Device Name: | MRI-PlaqueView |
|---|---|
| Device Common Name: | System, Image Processing, Radiological |
| Device Classification: | 21 CFR 892.2050, Class II, LLZ |
| Manufacturer: | VPDiagnostics |
3. Predicate Devices
MRI-PlaqueView provides viewing and post-acquisition image analysis of userselected regions of interest on MR images. This software medical device is substantially equivalent to the following devices:
Model: Vitrea Version 4.0 with SUREPlaque Manufacturer: Vital Images 510K Number: K071331
| Model: | QPlaque-MR |
|---|---|
| Manufacturer: | Medis |
| 510K Number: | K073156 |
1
4. Device Description:
MRI-PlaqueView is an image analysis software toolbox that facilitates visualization and quantitative analysis of MR images of carotid arteries acquired on 1.5T or 3.0T scanners. MRI-PlaqueView provides a set of image review, delineation, registration, editing, visualization, and measurement tools. The MRI-Plaque View user interface is designed to follow typical clinical workflow patterns to review, process, edit, validate, analyze, and visualize digital images and to present, distribute and save the findings.
The software application operates on a Windows XP platform that may be installed on a standalone PC, PACS or other medical imaging system. The software is designed to read MRI images from DICOM-compliant medical devices distributed by various OEM vendors.
The input to the system consists of one to six standard MRI series, which provide information through use of different MRI contrast weightings, such as T1, T2, Proton Density, and TOF weighted images
Once the user has selected a region of interest (ROI) for analysis, the MRI-PlaqueView tools will help to delineate the lumen and outer wall boundaries using either semi-automatic boundary detection or manual drawing/editing tools
The software provide the user an option to further analyze the multiple contrast weighted MRI data using either semi-automated algorithms or manual drawing/editing tools to segment and label the internal structure of the vessel wall, delineating calcified and soft plaque regions.
To facilitate the use of multiple contrast weighted data, the software displays the identified contours simultaneously on original images from all available series. Automated and user-controlled registration functions enable mapping of contours from one contrast weighting to another.
The quantitative measurements this software provides include volumes, thicknesses, maximal areas, and area ratios of the different regions outlined. The software also supports review and visualization of the data using standard rendering techniques, such as maximum intensity projections. The analysis results (both contours and quantitative measurements) can be saved in separate files to facilitate restoring previous works for subsequent sessions, and for reporting results.
2
5. Indications for Use
The MRI-PlaqueView software provides a set of post-processing tools to assist trained cardiologists and radiologists in the quantitative analysis of atherosclerotic carotid arteries from 1.5T or 3.0T magnetic resonance imaging (MRI) studies acquired with a combination of one or more contrast weightings such as T1, T2, Proton Density, and Time of Flight. Users of MRI-Plaque View perform semiautomatic delineation of lumen and outer vessel wall boundaries. Users may also perform semi-automatic, user configurable segmentation or manual drawing for delineation of atherosclerotic plaque components within the vessel wall. Users may edit the results on the fly. The software enables length, thickness, and area and volume measurements of the vessel wall as well as quantification of user-indicated areas. MRI-Plaque View further aids in the visualization of atherosclerotic arteries (for example, through maximum intensity projections) of MRI data and color-coded maps of segmented arteries. When interpreted by a trained physician, the output of this image analysis toolbox can be used to support the decision-making process in clinical practice or to support investigations in clinical research and trials.
6. Comparison with Predicate Devices
MRI-PlaqueView is substantially equivalent to several software applications that analyze and measure regions of interest in magnetic resonance or CT images. The predicate devices include
K071331- Vital Images Vitrea Version 4.0 with SUREPLAOUE (Appendix A) K073156 -Medis OPlaque-MR) (Appendix B)
Vital Images Vitrea Version 4.0 has been classified under 21 CFR 892.2050 as a Class II medical device
Medis OPlaque-MR has been classified under 21 CFR 892.1000 as a Class II medical device.
Both of these devices provide automated and interactive analysis tools to delineate and make measurements of size (volume, area, thickness) of regions of interest (ROL) in magnetic resonance (Medis OPlaque MR) or CT images (Vital Images Vitrea) and provide visualization and reporting utilities for the results. Both of these devices specifically address ROI measurements in blood vessels and specifically address measurement of ROIs within atherosclerotic plaque for CT (Vital Images Vitrea) and magnetic resonance images (Medis OPlaque-MR) respectively. Both provide substantially equivalent indications for use and have been developed with substantially equivalent mathematical algorithms.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with three wavy lines forming a shape resembling a bird or abstract figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - (USA)" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 5 2008
Mr. Michael Hartmann VP, Product and Business Development VPDiagnostics, Inc. 819 Virgina St., Suite 2209 SEATTLE WA 98101
Re: K082607
Trade/Device Name: MRI-PlaqueView Regulation Number: 21 CFR 892.2050
Regulation Name: Picture archiving and communications system Regulatory Class: II
Product Code: LLZ
Dated: September 4, 2008 Received: September 8, 2008
Dear Mr. Hartmann:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
4
Page 2
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part.807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Arputh Thang
Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indication(s) for Use Statement
510(k) Number:
4
To be assigned LOB 2607
Device Name:
MRI-PlaqueView
Indications for Use:
The MRI-PlaqueView software provides a set of post-processing tools to assist trained cardiologists and radiologists in the quantitative analysis of atherosclerotic carotid arteries from 1.5T or 3.0T magnetic resonance imaging (MRI) studies acquired with a combination of one or more contrast weightings such as T1, T2, Proton Density, and Time of Flight. Users of MRI-Plaque View perform semiautomatic delineation of lumen and outer vessel wall boundaries. Users may also perform semi-automatic, user configurable segmentation or manual drawing for delineation of atherosclerotic plaque components within the vessel wall. Users may edit the results on the fly. The software enables length, thickness, area, and volume measurements of the vessel wall as well as quantification of user-indicated areas. MRI-PlaqueView further aids in the visualization of atherosclerotic arteries (for example, through maximum intensity projections) of MRI data and color-coded maps of segmented arteries. When interpreted by a trained physician, the output of this image analysis toolbox can be used to support the decision-making process in clinical practice or to support investigations in clinical research and trials.
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Haber Resmer
(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devices
510(k) Number K08260