(152 days)
No reference devices were used in this submission.
Yes
The summary 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 machine learning.
No.
The software is explicitly stated to not be used for diagnosis or monitoring of tumors, and it provides enhanced visual contrast of structures, which is an imaging quality, not a direct therapeutic action.
No
Explanation: The "Intended Use / Indications for Use" explicitly states that "BoneMRI is not to be used for diagnosis or monitoring of (primary or metastatic) tumors." Its purpose is for image enhancement to visualize bone structures with enhanced contrast, not for making a diagnosis.
Yes
The device is explicitly described as a "standalone image processing software application" and a "server application running in the clinic or hospital networks." It takes MRI images as input and outputs processed DICOM images. There is no mention of any accompanying hardware component that is part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that BoneMRI is an "image processing software" used for "image enhancement in MRI images" to "visualize the bone structures in MRI images with enhanced contrast." It explicitly states it is "not to be used for diagnosis or monitoring of (primary or metastatic) tumors." IVDs are typically used to perform tests on biological samples (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device processes medical images, not biological samples.
- Device Description: The description reinforces that it's "a standalone image processing software application" that "analyses 3D gradient echo MRI scans." It constructs "3D tomographic radiodensity contrast images." This aligns with image processing, not in vitro testing.
- Input: The input is "MRI images in DICOM format," which are medical images, not biological samples.
- Function: The function is to enhance the visualization of bone structures in MRI images. This is an image processing function, not a diagnostic test performed on a biological sample.
While the device uses AI/ML and provides quantitative metrics related to image accuracy (like delineation error and HU values), these are measures of the software's performance in processing images and enhancing visualization, not diagnostic results derived from a biological sample.
Therefore, based on the definition and typical characteristics of an IVD, BoneMRI does not fit that classification. It is a medical image processing software.
No
The clearance letter does not explicitly state that the FDA has reviewed, approved, or cleared 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 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.
Product codes (comma separated list FDA assigned to the subject device)
OIH
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 in the clinic or hospital networks. It returns the reconstructed BoneMRI images as DICOM images. 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 images
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 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.
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 73 patients.
The imaging data consists of the BoneMRI and a standard CT of 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 acquisition 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 unseen centers.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
BoneMRI conducted the following performance testing:
- Software verification and validation testing 1.
- Studies that utilized retrospective clinical data to demonstrate the software 2. enhanced imaging quality in MR images via an enhancement of bone.
BoneMRI Lumbar spine region – Voxel-by-Voxel analysis:
A quantitative voxel-by-voxel validation of BoneMRI was performed on imaging data from 73 patients.
The objective was to validate the quantitative accuracy of BoneMRI for the 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 co-registered CT scans (reference standard) 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
§ 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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November 16, 2022
MRIguidance B.V. % Sujith Shetty Executive Vice President MAXIS Medical 3031 Tisch Way, Suite 1010 SAN JOSE CA 95128
Re: K221762
Trade/Device Name: BoneMRI v1.4 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: OIH Dated: October 7, 2022 Received: October 11, 2022
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.
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
1
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.
Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT 8: 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) K221762
Device Name BoneMRI V1.4
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 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.
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/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 larger font and "guidance" in a smaller font. The logo is set against a blue background.
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: K221762
Applicant Information
MRIguidance B.V. Gildstraat 91a 3572 EL, Utrecht The Netherlands info@mriguidance.com www.mriguidance.com +31 854000810
Contact Person
Marijn van Stralen Chief Technology Officer MRIquidance B.V. Email: marijn@mriguidance.com Tel.: +31 610 505 649 Date Prepared: December 22, 2021
Official Correspondent
Dr. Sujith Shetty Executive Vice President MAXIS LLC Email: sjshetty@maxismedical.com
Device Information
| Trade Name: | BoneMRI application |
|---|---|
| Common Name: | MRI image enhancement software |
| Classification name: | Medical image management and processing |
| system (21CRF892.2050) | |
| Regulatory Class: | Class II |
| Product Code: | QIH |
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Image /page/4/Picture/1 description: The image is a logo for MRI guidance. The logo features a circle with an arrow pointing upwards and to the left. To the right of the circle, the text "MRI guidance" is written in a sans-serif font. The word "MRI" is in a darker shade of blue than the word "guidance."
Predicate Device
| Name | Manufacturer | 510(k)# |
|---|---|---|
| BoneMRI v1.2 | MRIguidance B.V. | K202404 |
odicato Dovico
This predicate has not been subject to a design-related recall. No reference devices were used in this submission.
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 in the clinic or hospital networks. It returns the reconstructed BoneMRI images as DICOM images. 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.
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Image /page/5/Picture/1 description: The image shows the logo for MRI guidance. The logo consists of a circle with an arrow pointing to the right inside of it. To the right of the circle, the text "MRI guidance" is written in a sans-serif font.
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 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.
Comparison of Technological Characteristics with the Predicate Device:
A comparison of the intended use, indication for use, and technological characteristics of the BoneMRI v1.4 application to the predicate device, BoneMRI v1.2, is presented below. We have included the attributes suggested in FDA's website guidance for this comparison.
| | Predicate Device
BoneMRI v1.2 | Subject Device
BoneMRI v1.4 | Comment |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| 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 respect to the | 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 | Similar –
BoneMRI
v1.4 has an
expanded
indications for
use
including the
boney structures
of the lumbar
spine. |
A. Intended Use
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Image /page/6/Picture/1 description: The image shows the logo for MRI guidance. The logo consists of a circle with an arrow pointing to the right and the text "MRI guidance" to the right of the circle. The text is in a sans-serif font and is white. The background is blue.
| | Predicate Device
BoneMRI v1.2 | Subject Device
BoneMRI v1.4 | Comment |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| | surrounding soft
tissue. It is to be
used in the pelvic
region, which
includes the boney
anatomy of the
sacrum, hip bones
and femoral heads.
Warning: BoneMRI
images are not
intended to replace
CT images and are
not to be used for
diagnosis or
monitoring of
(primary or
metastatic) tumors. | 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 | |
| 21CFR Section | 892.2050 | 892.2050 | The same |
| Product Code | QIH | QIH | The same |
| Target Population | Adults | Adults | The same |
B. Technological Characteristics
| Predicate Device BoneMRI v1.2 | Subject Device BoneMRI v1.4 | 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 |
| Predicate Device | |||
| BoneMRI v1.2 | Subject Device | ||
| BoneMRI v1.4 | Comment | ||
| 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 | None - enhanced | ||
| images are viewed | |||
| on existing PACS | The same | ||
| Predicate Device | |||
| BoneMRI v1.2 | Subject Device | ||
| BoneMRI v1.4 | Comment | ||
| 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 | |||
| depends on other | |||
| software systems. | |||
| Enhanced images | |||
| co-exist with the | |||
| original images. | 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 | |||
| depends on other | |||
| software systems. | |||
| Enhanced images | |||
| co-exist with the | |||
| original images. | The same |
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Image /page/8/Picture/1 description: The image shows the logo for MRI guidance. The logo consists of a circle with an arrow pointing to the right and the text "MRI guidance" to the right of the circle. The text is in a sans-serif font and is white. The background is blue.
Performance Data:
Previous performance testing to verify and validate the software of BoneMRI v1.2 for the pelvic and hip region was submitted and approved under K202404.
BoneMRI conducted the following performance testing:
- Software verification and validation testing 1.
- Studies that utilized retrospective clinical data to demonstrate the software 2. enhanced imaging quality in MR images via an enhancement of bone.
BoneMRI Lumbar spine region – Voxel-by-Voxel analysis
A quantitative voxel-by-voxel validation of BoneMRI was performed on imaging data from 73 patients. The demographics of the patient population is described in the table below.
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Image /page/9/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 right, followed by the text "MRI" in a larger font and "guidance" in a smaller font. The logo is in shades of blue and teal.
| Validation data demographics | |
|---|---|
| Number of patients | 73 |
| Indications | sacroiliitis, degenerative spine and pelvic |
| diseases, spondylolisthesis, radiculopathy, | |
| spondylosis and spinal fractures | |
| Gender | Male: 48% |
| Female: 52% | |
| Age | $50 \pm 15$ years |
| Data origin/Ethnicity | Europe |
| Asia |
The imaging data consists of the BoneMRI and a standard CT of 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 acquisition 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 unseen centers.
The objective was to validate the quantitative accuracy of BoneMRI for the 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 co-registered CT scans (reference standard) 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