(28 days)
Yes
The document explicitly states that the software implements an image enhancement algorithm using a "convolutional neural network" and "separate neural network-based filters," which are forms of artificial intelligence/machine learning.
No.
The device is an image processing software that enhances the visualization of bone structures in MRI images for diagnostic purposes, not for direct therapeutic intervention.
No
BoneMRI is explicitly stated as "not to be used for diagnosis or monitoring of (primary or metastatic) tumors." Its purpose is image enhancement and visualization, not diagnostic interpretation.
Yes
The device is explicitly described as a "standalone image processing software application" and a "server application running on the clinic or hospital networks." While it has hardware requirements (specific GPU hardware), the device itself is the software, not the hardware it runs on. It processes existing MRI data and outputs images for viewing on standard medical imaging software.
Based on the provided information, this device, BoneMRI, is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The core function of an IVD is to analyze biological samples like blood, urine, tissue, etc., to provide information about a person's health.
- BoneMRI processes medical images. The input for BoneMRI is MRI images, which are generated by a medical imaging scanner and represent the internal structure of the body. It does not analyze biological specimens.
- The intended use is image processing and enhancement. The description clearly states that BoneMRI is "image processing software" used for "image enhancement in MRI images" to "visualize the bone structures." This is a function related to medical imaging, not in vitro analysis.
Therefore, BoneMRI falls under the category of medical imaging software or image processing software, not an In Vitro Diagnostic device.
No
The input text does not contain any explicit statement that the FDA has reviewed and cleared or approved a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
BoneMRI is an image processing software that can be used for image enhancement in MRI images. It can be used to visualize the bone structures in MRI images with enhanced contrast with surrounding soft tissue. It is to be used in the pelvic region, which includes the bony anatomy of the sacrum, hip bones and femoral heads; and the lumbar spine region, which includes the bony anatomy of the vertebrae from L3 to S1. BoneMRI is not to be used for diagnosis or monitoring of (primary or metastatic) tumors. Warning: BoneMRI images are not intended to replace CT images.
Product codes
QIH
Device Description
The BoneMRI application is a standalone image processing software application that analyses 3D gradient echo MRI scans acquired with a dedicated MRI scan protocol. From the analysis, 3D tomographic radiodensity contrast images, called BoneMRI images, are constructed.
The BoneMRI images can be used to visualize the bone structures in MR images with enhanced contrast with respect to the surrounding soft tissue. The application is designed to be used by imaging experts, such as radiologists or orthopedic surgeons, typically in a physician's office.
The BoneMRI application is a server application running on the clinic or hospital networks. It is available as fully on-premise software with specific GPU hardware requirements, or partly running as a managed service, for which the environment in which the managed modules run is controlled by MRIguidance, but the managed service will not receive protected health information (PHI). Within the hospital network, the application communicates with a DICOM compatible imaging archive (e.g., a PACS) to receive input MRI and to return BoneMRI images. Reading of the resulting BoneMRI images is performed using reqular DICOM compatible medical imaging viewing software.
The application uses an algorithm to detect bone images from MRIs obtained using a specific acquisition sequence. The algorithm training sets included information from multiple clinical sites, multiple anatomies, and multiple scanners to ensure that the trained algorithm was robust with respect to the approved indications for use. None of the data used in the training dataset was used subsequently in the validation dataset.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
MRI
Anatomical Site
pelvic region, which includes the bony anatomy of the sacrum, hip bones and femoral heads; and the lumbar spine region, which includes the bony anatomy of the vertebrae from L3 to S1.
Indicated Patient Age Range
Adults
Intended User / Care Setting
imaging experts, such as radiologists or orthopedic surgeons, typically in a physician's office.
Description of the training set, sample size, data source, and annotation protocol
The algorithm training sets included information from multiple clinical sites, multiple anatomies, and multiple scanners. Training and test datasets were selected and maintained to be appropriately independent of one another. All training and validation activities were recorded to ensure independence.
Description of the test set, sample size, data source, and annotation protocol
A quantitative voxel-by-voxel validation of BoneMRI was performed on imaging data from 101 and 103 patients for the pelvic region and lumbar spine region, respectively. The imaging data consist of the BoneMRI and CT images from the same patient in the same anatomical region, acquired during previously conducted clinical investigations. The validations were conducted by MRIguidance based on an algorithm to detect bone images from MRIs obtained using a specific sequence. Validation was performed on data from independent sites (cross-site validation) to ensure that validation was performed on data from centers that did not provide training data.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing included: 1. Software verification and validation testing, and 2. Studies that utilized retrospective clinical data to demonstrate the software enhanced imaging quality in MR images via an enhancement of bone.
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005.
Quantitative voxel-by-voxel validation was performed on imaging data from 101 and 103 patients for the pelvic region and lumbar spine region, respectively.
Key Results:
- Accurately reconstruct the 3D bone morphology with a mean absolute cortical delineation error below 1.0 mm on average.
- Accurately reconstructs the tissue radiodensity, with a mean deviation below 25 HU on average and a mean deviation below 55 HU specifically for bone.
- Accurately reconstructs the tissue radiodensity contrast, with a mean HU correlation coefficient above 0.75 specifically for bone.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
February 22, 2023
MRIguidance B.V. % Sujith Shetty Executive Vice President MAXIS Medical 3031 Tisch Way, Suite 1010 San Jose, California 95128
Re: K230197
Trade/Device Name: BoneMRI v1.6 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: January 25, 2023 Received: January 25, 2023
Dear Sujith Shetty:
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.
1
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 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 medical devices and radiation-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.
Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name BoneMRI v1.6
Indications for Use (Describe)
BoneMRI is an image processing software that can be used for image enhancement in MRI images. It can be used to visualize the bone structures in MRI images with enhanced contrast with surrounding soft tissue. It is to be used in the pelvic region, which includes the bony anatomy of the sacrum, hip bones and femoral heads; and the lumbar spine region, which includes the bony anatomy of the vertebrae from L3 to S1. BoneMRI is not to be used for diagnosis or monitoring of (primary or metastatic) tumors.
Warning: BoneMRI images are not intended to replace CT images.
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) | ☐ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/1 description: The image shows the logo for MRI Guidance. The logo consists of a circle with an arrow pointing to the upper right, followed by the text "MRI guidance". The text is in a sans-serif font, with "MRI" in a larger, bolder font than "guidance". The logo is in shades of blue.
5.1 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CRF 807.92.
510(k) number: K230197 5.2
5.3 Applicant Information
MRIguidance B.V. Maliesingel 23 3581 BG, Utrecht The Netherlands info@mriguidance.com www.mriquidance.com +31 681741711
5.4 Contact Person
Marijn van Stralen Chief Technology Officer MRIguidance B.V. Email: marijn@mriguidance.com Tel.: +31 610 505 649 Date Prepared: January 27, 2023
Official Correspondent 5.5
Dr. Sujith Shetty Executive Vice President MAXIS LLC Email: sjshetty@maxismedical.com
5.6 Device Information
| Trade Name: | BoneMRI v1.6 |
|---|---|
| Common Name: | MRI image enhancement software |
| Classification Name: | Medical image management and processing system |
| Regulation Number: | 21 CRF 892.2050 |
| Regulatory Class: | Class II |
| Product Code: | QIH |
4
Image /page/4/Picture/1 description: The image shows the logo for MRI guidance. The logo consists of a circle with an arrow pointing to the upper left, followed by the text "MRI" in a bold, sans-serif font, and the word "guidance" in a lighter, sans-serif font. The logo is in a teal color and is set against a dark blue background.
5.7 -Predicate Device
| Name | Manufacturer | 510(k)# |
|---|---|---|
| BoneMRI v1.4 | MRIquidance B.V. | K221762 |
This predicate has not been subject to a design-related recall. No reference devices were used in this submission.
5.8 Device Description
The BoneMRI application is a standalone image processing software application that analyses 3D gradient echo MRI scans acquired with a dedicated MRI scan protocol. From the analysis, 3D tomographic radiodensity contrast images, called BoneMRI images, are constructed.
The BoneMRI images can be used to visualize the bone structures in MR images with enhanced contrast with respect to the surrounding soft tissue. The application is designed to be used by imaging experts, such as radiologists or orthopedic surgeons, typically in a physician's office.
The BoneMRI application is a server application running on the clinic or hospital networks. It is available as fully on-premise software with specific GPU hardware requirements, or partly running as a managed service, for which the environment in which the managed modules run is controlled by MRIquidance, but the managed service will not receive protected health information (PHI). Within the hospital network, the application communicates with a DICOM compatible imaging archive (e.g., a PACS) to receive input MRI and to return BoneMRI images. Reading of the resulting BoneMRI images is performed using reqular DICOM compatible medical imaging viewing software.
The application uses an algorithm to detect bone images from MRIs obtained using a specific acquisition sequence. The algorithm training sets included information from multiple clinical sites, multiple anatomies, and multiple scanners to ensure that the trained algorithm was robust with respect to the approved indications for use. None of the data used in the training dataset was used subsequently in the validation dataset.
Indications for Use 5.9
BoneMRI is an image processing software that can be used for image enhancement in MRI images. It can be used to visualize the bone structures in MRI images with
5
Image /page/5/Picture/0 description: The image shows the logo for MRI Guidance. The logo consists of a circle with an arrow pointing up and to the right, followed by the text "MRI" in a larger font and "guidance" in a smaller font. The logo is in a teal color and is set against a dark blue background.
enhanced contrast with respect to the surrounding soft tissue. It is to be used in the pelvic region, which includes the bony anatomy of the sacrum, hip bones, and femoral heads; and the lumbar spine region, which includes the bony anatomy of the vertebrae from L3 to S1. BoneMRI is not to be used for diagnosis or monitoring of (primary or metastatic) tumors.
Warning: BoneMRI images are not intended to replace CT images.
5.10 Comparison of Technological Characteristics with the Predicate Device:
A comparison of the intended use, indication for use, and technological characteristics of the BoneMRI application to the predicate device, BoneMRI v1.4, is presented below. We have included the attributes suggested in FDA's website guidance for this comparison.
A. Intended Use
| | Predicate Device
BoneMRI v1.4 | Subject Device
BoneMRI | Comment |
|---------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Intended Use | BoneMRI is an image
processing software that can
be used for image
enhancement in MRI
images. It can be used to
visualize the bone structures
in MRI images with
enhanced contrast with
respect to the surrounding
soft tissue. It is to be used in
the pelvic region, which
includes the bony anatomy
of the sacrum, hip bones
and femoral heads; and the
lumbar spine region, which
includes the bony anatomy
of the vertebrae from L3 to
S1. BoneMRI is not to be
used for diagnosis or
monitoring of (primary or
metastatic) tumors.
Warning: BoneMRI images
are not intended to replace
CT images. | BoneMRI is an image
processing software that can
be used for image
enhancement in MRI
images. It can be used to
visualize the bone structures
in MRI images with
enhanced contrast with
respect to the surrounding
soft tissue. It is to be used in
the pelvic region, which
includes the bony anatomy
of the sacrum, hip bones
and femoral heads; and the
lumbar spine region, which
includes the bony anatomy
of the vertebrae from L3 to
S1. BoneMRI is not to be
used for diagnosis or
monitoring of (primary or
metastatic) tumors.
Warning: BoneMRI images
are not intended to replace
CT images. | The same |
| 21CFR Section | 892.2050 | 892.2050 | The same |
| Product Code | QIH | QIH | The same |
6
Image /page/6/Picture/0 description: The image shows the logo for MRI guidance. The logo consists of a circle with an arrow pointing to the right and up, followed by the text "MRI guidance". The text is in a sans-serif font and is a lighter shade of blue than the background.
Special 510(k) Notification
| | Predicate Device
BoneMRI v1.4 | Subject Device
BoneMRI | Comment |
|-------------------|----------------------------------|---------------------------|----------|
| Target Population | Adults | Adults | The same |
B. Technological Characteristics
| | Predicate Device
BoneMRI v1.4 | Subject Device
BoneMRI | Comment |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Device Nature | Software package | Software package | The same |
| Operating System | Linux | Linux | The same |
| Data input | MRI images in DICOM
format | MRI images in DICOM
format | The same |
| Data output | MRI images in DICOM
format | MRI images in DICOM
format | The same |
| Processing
Algorithms | MRIguidance software
implements an image
enhancement algorithm
using convolutional neural
network. Original images are
enhanced by running them
through a cascade of filter
banks, where thresholding
and scaling operations are
applied. Separate neural
network-based filters are
obtained to assign a
Hounsfield Unit (HU) value
to a single volume element,
based on intensity and
contextual information. The
parameters of the model
were obtained through an
algorithm development
pipeline. | MRIguidance software
implements an image
enhancement algorithm
using convolutional neural
network. Original images are
enhanced by running them
through a cascade of filter
banks, where thresholding
and scaling operations are
applied. Separate neural
network-based filters are
obtained to assign a
Hounsfield Unit (HU) value
to a single volume element,
based on intensity and
contextual information. The
parameters of the model
were obtained through an
algorithm development
pipeline. | The same |
| User Interface | None - enhanced images
are viewed on existing
PACS workstations | None - enhanced images
are viewed on existing
PACS workstations | The same |
| Workflow | The software operates on
DICOM files on the file
system, enhances the
images, and stores the
enhanced images on the file
system. The receipt of
original DICOM image files
and delivery of enhanced
images as DICOM files | The software operates on
DICOM files on the file
system, enhances the
images, and stores the
enhanced images on the file
system. The receipt of
original DICOM image files
and delivery of enhanced
images as DICOM files | The same |
7
Image /page/7/Picture/0 description: The image contains the logo for MRI guidance. The logo consists of a circle with an arrow pointing to the upper right inside of it. To the right of the circle are the words "MRI guidance" stacked on top of each other.
| Predicate Device
BoneMRI v1.4 | Subject Device
BoneMRI | Comment |
|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|---------|
| depends on other software
systems. Enhanced images
co-exist with the original
images. | depends on other software
systems. Enhanced images
co-exist with the original
images. | |
5.11 Performance Data:
BoneMRI conducted the following performance testing:
-
- Software verification and validation testing
-
- Studies that utilized retrospective clinical data to demonstrate the software enhanced imaging quality in MR images via an enhancement of bone.
Software verification and validation testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005.
Performance validation
A quantitative voxel-by-voxel validation of BoneMRI was performed on imaging data from 101 and 103 patients for the pelvic region and lumbar spine region, respectively. The demographics of the patient population are described in the table below.
| Validation data demographics | ||
|---|---|---|
| Anatomy | Pelvic region | Lumbar spine region |
| Number of patients | 101 | 103 |
| Indications | Sacroiliitis, developmental hip | |
| dysplasia, avascular necrosis | ||
| of femoral head and femoral | ||
| acetabular impingement. | Sacroiliitis, degenerative spine | |
| diseases, spondylolisthesis, | ||
| radiculopathy, spondylosis and | ||
| spinal fractures. | ||
| Gender | Male: 73 | |
| Female: 28 | Male: 49 | |
| Female: 54 | ||
| Age | $52 \pm 21$ years | $55 \pm 15$ years |
| Data origin/Ethnicity | USA, Europe, Asia | USA, Europe, Asia |
8
Image /page/8/Picture/1 description: The image shows the logo for MRI Guidance. The logo consists of a circle with an arrow pointing upwards and to the left, followed by the text "MRI" in a larger font and "guidance" in a smaller font below it. The logo is in shades of blue and teal.
The imaging data consist of the BoneMRI and CT images from the same patient in the same anatomical region, acquired during previously conducted clinical investigations. The validations were conducted by MRIguidance based on an algorithm to detect bone images from MRIs obtained using a specific sequence.
Training and test datasets were selected and maintained to be appropriately independent of one another. All training and validation activities were recorded to ensure independence. In addition, validation was performed on data from independent sites (cross-site validation) to ensure that validation was performed on data from centers that did not provide training data.
The objective was to validate the quantitative accuracy of BoneMRI for the pelvic region and lumbar spine region using rigorous, objective, and unbiased statistical tests comparing bone morphology, radiodensity, and radiodensity contrast in BoneMRI and CT images. Therefore, the endpoints of this testing were the metrics that described the accuracy of 3D bone morphology, radiodensity, and radiodensity contrast versus coregistered CT scans in terms of voxel-by-voxel HUs and standard deviations around these HU values.
The results from the validation testing were compared to the accuracy acceptance criteria, specified below, and were found to fall within the pre-specified acceptance criteria (p