Who is the manufacturer of BoneMRI v1.4?

Mrlguidance B.V. filed the 510(k) submission for BoneMRI v1.4 (K221762).

What is the FDA product code for BoneMRI v1.4?

QIH. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for BoneMRI v1.4?

510(k) clearance (submission type: Traditional).

Does BoneMRI v1.4 use AI or machine learning?

Yes. BoneMRI v1.4 (K221762) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like BoneMRI v1.4?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like BoneMRI v1.4 get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

BoneMRI v1.4

K221762 · Mrlguidance B.V. · QIH · Nov 16, 2022 · Radiology

Device Facts

Record ID	K221762
Device Name	BoneMRI v1.4
Applicant	Mrlguidance B.V.
Product Code	QIH · Radiology
Decision Date	Nov 16, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

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.

Device Story

BoneMRI is standalone image processing software; analyzes 3D gradient echo MRI scans; constructs 3D tomographic radiodensity contrast images (BoneMRI images). Used in clinic/hospital networks by radiologists or orthopedic surgeons; operates on DICOM files. Software uses convolutional neural network to assign Hounsfield Unit (HU) values to volume elements based on intensity and context. Output is DICOM images viewed on existing PACS. Enhances bone visualization relative to soft tissue; assists clinical assessment of bone morphology and radiodensity. Does not replace CT; not for tumor diagnosis/monitoring.

Clinical Evidence

Retrospective validation study using 73 patients (48% male, 52% female; mean age 50±15 years). Data included patients with sacroiliitis, degenerative spine/pelvic diseases, spondylolisthesis, radiculopathy, spondylosis, and spinal fractures. BoneMRI images compared to co-registered CT scans (reference standard). Results: mean absolute cortical delineation error <1.0 mm; mean radiodensity deviation <25 HU (overall) and <55 HU (bone); mean HU correlation coefficient >0.75 for bone. All endpoints met pre-specified acceptance criteria (p<0.05).

Technological Characteristics

Software package running on Linux. Inputs/outputs: DICOM MRI images. Core technology: Convolutional neural network (CNN) image enhancement. Processing: Cascade of filter banks with thresholding and scaling; neural network-based filters assign Hounsfield Unit (HU) values to volume elements. Connectivity: Server-based application within hospital/clinic networks. No hardware components.

Indications for Use

Indicated for adult patients requiring visualization of bone structures in the pelvic region (sacrum, hip bones, femoral heads) and lumbar spine (L3-S1) via MRI. Not for diagnosis or monitoring of primary or metastatic tumors.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

BoneMRI v1.2 (K202404)

Related Devices

K202404 — BoneMRI · Mriguidance B.V. · Dec 22, 2021
K230197 — BoneMRI v1.6 · Mriguidance B.V. · Feb 22, 2023
K233030 — BoneMRI · Mriguidance B.V. · Mar 1, 2024
K083691 — BONEVUE · Micromri, Inc. · Feb 25, 2009
K203279 — Veuron-Brain-mN1 · Heuron Co., Ltd. · Jul 12, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG" in a larger, bold blue font. Below that is the word "ADMINISTRATION" in a smaller, regular blue font. 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) | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | |-------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------| #### 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 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 | {4}------------------------------------------------ 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. {5}------------------------------------------------ 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 {6}------------------------------------------------ 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 | {7}------------------------------------------------ {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 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. {9}------------------------------------------------ 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<0.05). {10}------------------------------------------------ The results demonstrate clinically acceptable accuracy on each of these endpoints. The data provided demonstrate that BoneMRI application can - o accurately reconstruct the 3D bone morphology with a mean absolute cortical delineation error below 1.0 mm on average; - o accurately reconstructs the tissue radiodensity, with a mean deviation below 25 HU on average and a mean deviation below 55 HU specifically for bone; - o accurately reconstructs the tissue radiodensity contrast, with a mean HU correlation coefficient above 0.75 specifically for bone. CONCLUSION: BoneMRI demonstrates accurate bone morphology, radiodensity, and radiodensity contrast. Thus, BoneMRI is a useful tool to qualitatively and quantitatively assess the lumbar spine region. #### Conclusions: BoneMRI v1.4, based on the indications for use, product performance, and clinical information provided in this notification, has been shown to be substantially equivalent to the currently marketed predicate device, its predecessor, BoneMRI v1.2. The two devices have the same technological characteristics: both algorithms use the same image-based reconstruction, and both methods have optimized parameters to ensure the robustness of the algorithm. This 510(k) submission includes information on the BoneMRI v1.4 technological characteristics, as well as performance data and verification and validation activities demonstrating that BoneMRI is as safe and effective as the predicate. This evaluation did not raise any new issues pertaining to safety or effectiveness.