(255 days)
Not Found
Unknown
The description mentions "preliminary automated regions of interest (ROIs)" and "calculates automated ROIs," which could potentially be implemented using AI/ML techniques. However, the document does not explicitly state the use of AI, ML, or related terms, nor does it provide details about training or inference methods that would confirm the use of these technologies. The term "automated" does not definitively indicate AI/ML.
No.
The device is described as an "assisted ROI drawing tool" and "image analysis" software used for "receiving, display, ROI selection, and analysis generation." Its function is to process and analyze medical images for diagnostic purposes, not to directly treat or prevent a medical condition.
Yes
The device aids in the analysis of medical images (MRE and Fat/Water images) to calculate statistical information for review, and this type of analysis is part of the diagnostic process.
Yes
The device is explicitly described as "MREplus+ Software" and its function is solely based on processing and analyzing image data. There is no mention of any accompanying hardware components that are part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The MREplus+ Software analyzes medical images (MRE and Fat/Water images) acquired from a patient's liver. It assists in the interpretation of these images by providing tools for ROI selection and analysis.
- Lack of Sample Analysis: The software does not analyze biological samples taken from the patient. Its input is image data generated by an MRI scanner.
Therefore, while the MREplus+ Software is a medical device used in the diagnostic process, it falls under the category of medical image analysis software rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MREplus+ Software is an assisted ROI drawing tool for liver MRE and Fat/Water images and is used for receiving, display, ROI selection, and analysis generation. It displays to a trained reader MRE and Fat Water images, preliminary ROIs that it calculates from these images, and statistical analysis calculated from the ROIs and images are presented in a way for review and, optionally, modification by the trained reader.
Product codes
LLZ
Device Description
The MREplus+ software is a tool for assisted Magnetic Resonance Elastography (MRE) and multipoint Dixon Fat/Water (FW) image analysis which calculates preliminary automated regions of interest (ROIs) and provides the environment for the trained readers to review the relevant MRE and FW information and approve or modify the ROIs. MREplus+ is intended to be used only with liver MRE and FW data. The inputs for MREplus+ are the MRE and FW images. In the case of MRE, this includes magnitude images (showing anatomy), wave images (showing wave propagation) with multiple time points across the wave cycle, and the elasticity and confidence images calculated by MRE's on-scanner MMDI algorithm or an offline MMDI packaged with MREplus+. In the case of FW, images include in-phase, out-of-phase, fat, water, fat fraction, and R2*. MREplus+ includes a DICOM receiver which can recognize and accept these images when sent from the MRI scanner or workstation using standard protocols. From these images, MREplus+ calculates automated ROIs. ROIs can be reviewed by an authorized trained reader for review, modification and approval. MREplus+ performs statistical calculations from the ROIs. MREplus+ outputs images, ROIs, and calculated results in an archive compatible report.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Elastography (MRE), multipoint Dixon Fat/Water (FW)
Anatomical Site
liver
Indicated Patient Age Range
all ages
Intended User / Care Setting
MRE-trained reader (e.g. technician or radiologist)
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
Validation Testing has been conducted using retrospective clinical data bases to compare MREplus+'s functional capabilities with the standard expert reviewer readings using the predicate device.
- MRE study involving 1347 patient cases where the patient profile included liver disease or suspicion of liver disease, inclusive of all ages, weight, and races. Images were collected at both 1.5T and 3T.
- Fat-Water study involving 92 patient cases, where recruited patents were undergoing bariatric surgery and FW results indicated a full range of liver fat content. Images were collected at both 1.5T and 3T.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification and Validation: MREplus+ has been extensively tested through the design verification and system validation phases of its development. Validation Testing has been conducted using retrospective clinical data bases to compare MREplus+'s functional capabilities with the standard expert reviewer readings using the predicate device. Studies included the following:
- MRE study involving 1347 patient cases where the patient profile included liver disease or suspicion of liver disease, inclusive of all ages, weight, and races. Images were collected at both 1.5T and 3T. MREplus+ demonstrated less than 1% processing failures and less than 20% ROI modifications.
- Fat-Water study involving 92 patient cases, where recruited patents were undergoing bariatric surgery and FW results indicated a full range of liver fat content. Images were collected at both 1.5T and 3T. In all cases MREplus+ was able to accurately and reliably calculate Fat Fraction from Fat-Water images.
MREplus+ has consistently proven to be an accurate software tool that facilitates liver MRE analysis with an accuracy of greater than 99% compared to the standard predicate methodology.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
MREplus+ demonstrated 99% compared to the standard predicate methodology.
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).
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Resoundant, Inc. % Mr. Bernard Horwath Regulatory Consultant HRG 4486 Timberline Ct VADNAIS HEIGHT MN 55127 August 1, 2019
Re: K183193
Trade/Device Name: MREplus+ Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: June 28, 2019 Received: July 2, 2019
Dear Mr. Horwath:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183193
Device Name
MREplus+ Software
Indications for Use (Describe)
MREplus+ Software is an assisted ROI drawing tool for liver MRE and Fat/Water images and is used for receiving, display, ROI selection, and analysis generation. It displays to a trained reader MRE and Fat Water images, preliminary ROIs that it calculates from these images, and statistical analysis calculated from the ROIs and images are presented in a way for review and, optionally, modification by the trained reader.
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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K183193
510(k) Summary Resoundant MREplus+ Software
| Date Prepared: | 25 June 2019 |
|---|---|
| Submitter: | Resoundant Inc. |
| 421 First Ave SW | |
| Suite 204W | |
| Rochester, MN 55902 | |
| Telephone: 507-322-0011 | |
| Contact: | Mr. Bernard Horwath |
| Regulatory Affairs Consultant | |
| 4486 Timberline Ct | |
| Vadnais Heights, MN 55127 | |
| Telephone: 651- 231-1761 | |
| Proprietary Name: | MREplus+ Software |
Common/Usual Name: System, Image Processing, Radiological
Regulation Name: Picture Archiving and Communications System 21 CFR 892.2050, Class II Product Code - LLZ System, Image Processing, Radiological
Description:
The MREplus+ software is a tool for assisted Magnetic Resonance Elastography (MRE) and multipoint Dixon Fat/Water (FW) image analysis which calculates preliminary automated regions of interest (ROIs) and provides the environment for the trained readers to review the relevant MRE and FW information and approve or modify the ROIs. MREplus+ is intended to be used only with liver MRE and FW data. The inputs for MREplus+ are the MRE and FW images. In the case of MRE, this includes magnitude images (showing anatomy), wave images (showing wave propagation) with multiple time points across the wave cycle, and the elasticity and confidence images calculated by MRE's on-scanner MMDI algorithm or an offline MMDI packaged with MREplus+. In the case of FW, images include in-phase, out-of-phase, fat, water, fat fraction, and R2*. MREplus+ includes a DICOM receiver which can recognize and accept these images when sent from the MRI scanner or workstation using standard protocols. From these images, MREplus+ calculates automated ROIs. ROIs can be reviewed by an authorized trained reader for review, modification and approval. MREplus+ performs statistical calculations from the ROIs. MREplus+ outputs images, ROIs, and calculated results in an archive compatible report.
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Indications for Use: MREplus+ Software is an assisted ROI drawing tool for liver MRE and Fat/Water images and is used for receiving, display, ROI selection, and analysis generation. It displays to a trained reader MRE and Fat/Water images, preliminary ROIs that it calculates from these images, and statistical analysis calculated from the ROIs and images. ROIs and images are presented in a way for review and, optionally, modification by the trained reader.
Substantial Equivalence:
The MREplus+ Software is substantially equivalent to the following predicate device:
Primary Predicate: GE Advantage Workstation 4.1 510(k): K020483 GE Medical Systems This predicate has not been subject to a design related recall.
Comparison with Predicate:
Both MREplus+ and the predicate software tools display MRE and FW images, provide the tools for drawing a ROI, calculate average stiffness from the ROI area, and allow DICOM archivecompatible images to be generated for the clinical report. ROI selection on both stations must be performed by trained readers. The scope of the GE Advantage Workstation 4.1 is broader, as it allows for display and analysis of images of multiple modalities, whereas MREplus+ works specifically with liver MRE and FW data.
The GE Advantage Workstation (GE AW) comes pre-installed on a dedicated workstation. It receives and stores medical DICOM images of multiple modalities transferred from a device with DICOM push capabilities (such as an MRI or CT scanner, or another GE AW). A trained user is able to select one of the stored image sets and display them using the system. Images from qualitative modalities may be used as an element in diagnosis directly. For quantitative modalities, such as MRE, the user uses the GE Advantage Workstation tools to select an ROI within the image and calculate values, such as size, mean value, or standard deviation, from it. The GE Advantage Workstation outputs the ROIs over the original images as DICOM images which are archived clinically as part of the report. The values calculated from the ROIs may be recorded by the user and entered into the report manually or be displayed as part of the output images. The clinical report is then used as an element in diagnosis.
MREplus+ is intended to be used only with liver MRE and FW data, so its scope is a subset of the scope of the GE Advantage Workstation. MREplus+ is installed on standard computers, servers, or workstations, which reside on the intranet of the institution and, similarly to the GE AW, have restricted login privileges. MREplus+ receives DICOM medical images transferred from MRI scanners or other sources and automatically pre-processes the received MRE images to generate automated ROIs. An authorized trained user, such as a technician or radiologist, can use MREplus+ to display an MRE or FW exam along with ROIs. The MREplus+ user reviews the ROIs in context of all acquired MRE or FW data, similarly to the fully-manual ROI drawing on the GE AW. The user may perform modifications or, if none are required, approves the ROIs. At this stage. MREplus+ generates and outputs an archive compatible report containing final ROIs overlaid on the input images and the calculated statistical values associated with ROI areas and underlying images.
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MREplus+ also supports direct generation of the archive compatible analysis report from the automated ROIs, for presentation to a radiologist in conjunction with other imaging data. This behavior can be enabled by the institution, and does not preclude subsequent review or modification of the ROIs and subsequent analysis.
A comparison of the devices is provided in the following table:
| Device Parameter | MREplus+ Software | GE Advantage Workstation 4.1 | Difference if any |
|---|---|---|---|
| 510(k) | K020483 | NA | |
| Classification | 21 CFR 892.2050, Class II | 21 CFR 892.2050, Class II | Same |
| Product Code | Product Code - LLZ | ||
| System, Image Processing, | |||
| Radiological | Product Code - LLZ | ||
| System, Image Processing, | |||
| Radiological | Same | ||
| Indications for | |||
| Use | MREplus+ is an assisted | ||
| ROI drawing tool for liver | |||
| MRE and Fat/Water images | |||
| and is used for receiving, | |||
| display, ROI selection, and | |||
| analysis generation. It | |||
| displays to a trained reader | |||
| MRE and Fat/Water images, | |||
| preliminary ROIs that it | |||
| calculates from these | |||
| images, and statistical | |||
| analysis calculated from the | |||
| ROIs and images. ROIs and | |||
| images are presented in a | |||
| way for review and, | |||
| optionally, modification by | |||
| the trained reader. These | |||
| values can be used as an | |||
| element in diagnosis of liver | |||
| disease. | The Advantage Workstation | ||
| 4.1 is a review station, which | |||
| allows selection, review, | |||
| processing, filming, and | |||
| media interchange of multi- | |||
| modality images from a | |||
| variety of diagnostic | |||
| imaging systems. When | |||
| interpreted by a trained | |||
| physician, filmed images | |||
| may be used as an element | |||
| for diagnosis. | Intended use is | ||
| substantially | |||
| equivalent. | |||
| MREplus+ is | |||
| intended for use | |||
| with liver MRE | |||
| and Fat/Water | |||
| data, which is a | |||
| subset of the | |||
| scope of | |||
| applications for | |||
| the GE | |||
| Advantage | |||
| Product | |||
| Configuration | Software | Workstation | MREplus+ is a |
| stand-alone | |||
| application, | |||
| whereas GE AW | |||
| comes pre- | |||
| installed on | |||
| dedicated | |||
| workstations | |||
| Operating system | Windows or Linux | Linux | MREplus+ as |
| stand-alone | |||
| application can | |||
| Input format | MRE and FW Liver DICOM | ||
| Images | Multi-modality DICOM | ||
| Images | be configured for | ||
| different OS, | |||
| whereas the GE | |||
| dedicated | |||
| workstation must | |||
| select an OS. | |||
| DICOM input is | |||
| the same, with | |||
| the MREplus+ | |||
| liver images | |||
| being a subset of | |||
| GE multi- | |||
| modality images | |||
| Output | MREplus+ report displays | ||
| DICOM images which | |||
| includes the generated ROIs | |||
| overlaid on the input images, | |||
| and the calculated liver | |||
| statistical values | Advantage Workstation 4.1 | ||
| allows for display of | |||
| DICOM images of user- | |||
| drawn ROIs overlaid on | |||
| input DICOM images, and | |||
| the calculated liver statistical | |||
| values | The output | ||
| images with | |||
| overlaid ROIs | |||
| and calculated | |||
| liver statistical | |||
| values are | |||
| substantially | |||
| equivalent. | |||
| Intended User | MRE-trained reader (e.g. | ||
| technician or radiologist) | MRE-trained reader (e.g. | ||
| technician or radiologist) | Same |
Feature and Technical Characteristic Comparison
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Software Information
The MREplus+ software has been developed in accordance with the "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices" for moderate level of concern. The Risk Management and Hazard Analysis combined with the appropriate testing and labeling mitigation measures taken indicate that the device is safe and effective and presents no new concerns.
The main activities in the software development process are described as follows.
- Software Description ●
- Level of Concern ●
- Hazard/Risk Analysis ●
- Software Requirements Specification ●
- Architecture Design Flow Chart
- Software Design Specification
- Traceability Analysis
- Software Development Life Cycle Plan ●
- Software Development Environment ●
- Software Design Verification/Validation Test ●
- Revision Level History ●
- Unresolved Anomalies ●
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Verification and Validation:
MREplus+ has been extensively tested through the design verification and system validation phases of its development. Validation Testing has been conducted using retrospective clinical data bases to compare MREplus+ 's functional capabilities with the standard expert reviewer readings using the predicate device. Studies included the following:
- . MRE study involving 1347 patient cases where the patient profile included liver disease or suspicion of liver disease, inclusive of all ages, weight, and races. Images were collected at both 1.5T and 3T. MREplus+ demonstrated 99% compared to the standard predicate methodology.
Conclusion:
Through the data and information presented. Resoundant Inc considers the MREplus+ Software substantially equivalent to the predicate device already on the market (cleared by the 510(k) process) in terms of indications for use, scientific technology, design, and functional performance and presents no new concerns about safety and effectiveness. The nonclinical and retrospective clinical validation tests conducted demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.