(488 days)
No reference devices were used in this submission.
Yes
The summary explicitly states "Mentions AI, DNN, or ML: Yes".
No
The device is an image processing software for enhancing MRI images for visualization of bone structures, not for directly treating a condition or disease.
No
The "Intended Use / Indications for Use" section explicitly states: "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." It is for image enhancement, not 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 processes existing MRI data and outputs DICOM images, indicating it is purely software-based and does not include any hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens obtained from the human body. The description clearly states that BoneMRI is an image processing software that analyzes MRI images acquired from patients. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The intended use is image enhancement and visualization. The primary function is to process existing MRI images to improve the visualization of bone structures. This is distinct from diagnostic tests that analyze biological markers or characteristics in specimens to provide information about a patient's health status.
- The output is a processed image. The device produces DICOM images with enhanced bone contrast, not a diagnostic result based on the analysis of a biological specimen.
Therefore, BoneMRI falls under the category of medical image processing software, not an In Vitro Diagnostic device.
No
The provided text does not contain any explicit statement 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 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.
Product codes (comma separated list FDA assigned to the subject device)
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 orthopaedic 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
SubtleMR software implements an image enhancement algorithm using convolutional neural network based filtering. Original images are enhanced by running through a cascade of filter banks, where thresholding and scaling operations are applied. Separate neural network based filters are obtained for noise reduction and sharpness increase. The parameters of the filters were obtained through an image guided optimization process.
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.
Input Imaging Modality
MRI
Anatomical Site
pelvic region, which includes the boney anatomy of the sacrum, hip bones and femoral heads.
Indicated Patient Age Range
Adults
Intended User / Care Setting
imaging experts, such as radiologists or orthopaedic surgeons, typically in a physician's office.
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
Quantitative voxel-by-voxel validation of BoneMRI was performed on imaging data from 61 patients, consisting of the BoneMRI and CT of the same patient, acquired during the previously conducted clinical investigations. MRIguidance conducted the validations based on an in-house developed algorithm validation pipeline, the core validation framework. The objective was to validate the quantitative accuracy of BoneMRI for the pelvic region using rigorous, objective, and unbiased statistical tests. The endpoints were the metrics that described the accuracy of 3D bone morphology, radiodensity, and radiodensity contrast versus co-registered CT scans in terms of voxel-by-voxel HUs and standard deviations around these HU values.
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
- Studies that utilized retrospective clinical data to demonstrate the software enhanced imaging quality in MR images via an enhancement of bone.
Quantitative voxel-by-voxel validation of BoneMRI was performed on imaging data from 61 patients, consisting of the BoneMRI and CT of the same patient. The results demonstrate clinically acceptable accuracy on all of the endpoints. The data provided demonstrate that BoneMRI application v1.2 can accurately reconstruct the 3D bone morphology with a mean absolute cortical delineation error below 1.0 mm on average; accurately reconstruct the tissue radiodensity with a mean deviation below 10 HU on average and a mean deviation below 55 HU for bone specifically; accurately reconstruct the tissue radiodensity contrast with a mean HU correlation coefficient above 0.80 on average and a mean HU correlation coefficient above 0.75 for bone specifically.
CONCLUSION: BoneMRI demonstrates accurate bone morphology, radiodensity, and radiodensity contrast. Thus, BoneMRI is a useful tool to qualitatively and quantitatively assess the pelvic region.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
mean absolute cortical delineation error below 1.0 mm
mean deviation below 10 HU on average
mean deviation below 55 HU for bone specifically
mean HU correlation coefficient above 0.80 on average
mean HU correlation coefficient above 0.75 for bone specifically
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
December 22, 2021
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
MRIguidance B.V % Suji Shetty Executive Vice President Maxis Medical 7052 Hollow Lake Way San Jose, California 95120
Re: K202404
Trade/Device Name: BoneMRI Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH Dated: November 29, 2021 Received: November 30, 2021
Dear Suji 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
1
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 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,
Jessica Lamb, Ph.D. Assistant 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
2
Indications for Use
510(k) Number (if known) K202404
Device Name BoneMRI
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 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.
| 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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3
5.0 510(K) STATEMENT/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: K202404
I. 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 MRIguidance B.V. Email: marijn@mriguidance.com Tel .: +31 610 505 649 Date Prepared: December 22, 2021
Official Correspondant
Dr. Sujith Shetty Executive Vice President MAXIS LLC Email: sjshetty(@maxismedical.com
II. Device Information
| Trade Name: | BoneMRI |
|---|---|
| Common Name: | MRI image enhancement software |
| Classification name: | Picture archiving and Communication system (21CRF892.2050) |
| Regulatory Class: | Class II |
| Product Code: | QIH |
4
III. Predicate Device
| Name | Manufacturer | 510(k)# |
|---|---|---|
| SubtleMR | Subtle Medical, Inc. | K191688 |
This predicate has not been subject to a design-related recall. No reference devices were used in this submission.
IV. 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 orthopaedic 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.
V. 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 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.
VI. 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 SubtleMR are presented below. We have included the attributes suggested in FDA's website guidance for this comparison.
| Name | Manufacturer | 510(k)# |
|---|---|---|
| SubtleMR | Subtle Medical, Inc. | K191688 |
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A. Intended Use
| | Predicate Device
SubtleMR | Subject Device
BoneMRI | Comment |
|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | SubtleMR is an image
processing software
that can be used for
image enhancement in
MRI images. It can be
used to reduce image
noise for head, spine,
neck, and knee MRI,
or increase image
sharpness for non-
contrast-enhanced
head MRI. | BoneMRI is an image
processing software
that can be used for
image enhancement in
MR images. It can be
used to visualize the
bone structures in MR
images with enhanced
contrast with respect
to the surrounding soft
tissue | Similar -
Intended uses are
the same for Image
enhancements for
MRI. But the
intended use
differences does
not affect the
safety and
effectiveness of the
device when used
as labeled and is
similar to the
predicate use. |
| 21CFR Section | 892.2050 | 892.2050 | The same |
| Product Code | LLZ | QIH | Similar |
| Target Population | Adults | Adults | The same |
B. Technological Characteristics
| | Predicate Device
SubtleMR | 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 | SubtleMR software
implements an image
enhancement
algorithm using
convolutional neural
network based
filtering. Original
images are enhanced
by running through a
cascade of filter | MRIguidance
software implements
an image
enhancement
algorithm using
convolutional neural
network. Original
images are enhanced
by running them
through a cascade of | Different –
The algorithm while
using similar
methodology, uses
different filters and
outputs to enhance
the image. The
difference does not
affect the safety and |
| | Predicate Device
SubtleMR | Subject Device
BoneMRI | Comment |
| | banks, where
thresholding and
scaling operations are
applied. Separate
neural network based
filters are obtained
for noise reduction
and sharpness
increase. The
parameters of the
filters were obtained
through an image
guided optimization
process. | 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. | effectiveness of the
device when used as
labeled and is similar
to the predicate use. |
| 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 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 |
6
7
VII. Performance Data:
BoneMRI conducted the following performance testing:
- Software verification and validation testing 1.
-
- Studies that utilized retrospective clinical data to demonstrate the software enhanced imaging quality in MR images via an enhancement of bone.
BoneMRI Pelvic region - Voxel-bv-Voxel analysis
Quantitative voxel-by-voxel validation of BoneMRI was performed on imaging data from 61 patients, consisting of the BoneMRI and CT of the same patient, acquired during the previously conducted clinical investigations. MRIguidance conducted the validations based on an in-house developed algorithm validation pipeline, the core validation framework. The objective was to validate the quantitative accuracy of BoneMRI for the pelvic region using rigorous, objective, and unbiased statistical tests. The endpoints were the metrics that described the accuracy of 3D bone morphology, radiodensity, and radiodensity contrast versus co-registered CT scans in terms of voxel-by-voxel HUs and standard deviations around these HU values. The results demonstrate clinically acceptable accuracy on all of the endpoints.
The data provided demonstrate that BoneMRI application v1.2 can accurately reconstruct the 3D bone morphology with a mean absolute cortical delineation error below 1.0 mm on average; accurately reconstruct the tissue radiodensity with a mean deviation below 10 HU on average and a mean deviation below 55 HU for bone specifically; accurately reconstruct the tissue radiodensity contrast with a mean HU correlation coefficient above 0.80 on average and a mean HU correlation coefficient above 0.75 for bone specifically.
CONCLUSION: BoneMRI demonstrates accurate bone morphology, radiodensity, and radiodensity contrast. Thus, BoneMRI is a useful tool to qualitatively and quantitatively assess the pelvic region.
VIII. Conclusions:
BoneMRI, based on the indications for use, product performance, and clinical information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate device. The two devices have similar technological characteristics: both algorithms use 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 technological characteristics, as well as performance data and verification and validation activities demonstrating that BoneMRI is as safe and effective as the predicate, and does not raise different questions of safety and effectiveness.