(84 days)
Not Found
No
The summary describes standard image processing and analysis techniques for MRI data (DWI and PWI/DSC) and does not mention AI, ML, or related terms. The performance studies focus on the accuracy of parameter representation, not on the performance of an AI/ML model.
No
This device is image processing software intended to aid in diagnosis, not to provide therapy or treatment.
Yes
The "Device Description" explicitly states that the software "allows for visualization... as an aid to physician diagnosis," indicating its role in assisting in the diagnostic process.
Yes
The device is described as a software package that runs on standard off-the-shelf computers or virtual platforms and processes images acquired from DICOM-compliant imaging devices. There is no mention of proprietary hardware included with the device.
Based on the provided information, this device is NOT an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: IVDs are designed to examine specimens taken from the human body, such as blood, urine, tissue, etc., to provide information about a person's health.
- This device analyzes medical images: The Brainomix 360 e-MRI software processes and analyzes medical images (MRI scans) acquired from a patient. It does not interact with or analyze biological samples.
- The intended use and device description focus on image processing and analysis: The documentation clearly states the software's purpose is for viewing, processing, and analyzing MRI images to aid in physician diagnosis.
Therefore, while it is a medical device used in a clinical setting to assist in diagnosis, it falls under the category of medical image processing software, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Brainomix 360 e-MRI is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians.
The software runs on a standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, and analysis of images. Data and images are acquired through DICOM compliant imaging devices. This includes DICOM files uploaded through a web browser interface.
Brainomix 360 e-MRI provides both viewing and analysis capabilities for imaging datasets acquired with MRI including Perfusion Weighted Imaging (PWI) and Diffusion Weighted Imaging (DWI).
The DWI MRI analysis capabilities are used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data.
The MRI PWI analysis capabilities are for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume.
Product codes
LLZ
Device Description
Brainomix 360 e-MRI software allows for visualization of DICOM compliant MRI (Mage Resonance) digital images. The software has been designed to run with off-the-shelf physical or virtual servers and provides for viewing, quantification, analysis, and reporting, as an aid to physician diagnosis.
The software system consists of platform functionality and the e-MRI processing module. It provides both analysis and viewing capabilities for functional and dynamic imaging datasets acquired with MR including Diffusion Weighted Imaging (DWI) and Dynamic Susceptibility Contrast (DSC), which is the term used in the Brainomix 360 e-MRI software for perfusion-weighted imaging technique. The DWI capabilities are for visualization of local water diffusion properties from the analysis of diffusion-weighted MR data. The DSC capabilities are for the characterization of perfusion parameters in the injection of a contrast bolus, and visualization of these parameters.
e-MRI provides a wide range of basic image viewing, processing and manipulation functions, through multiple output formats. The Brainomix 360 platform has been designed to connect with other DICOM-compliant devices. This functionality enables the transfer of MRI scans from a Picture Archiving and Communication System (PACS) to Brainomix 360 e-MRI software for processing.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
Brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained professionals, including but not limited to physicians and medical technicians. Clinical/Hospital environment.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Extensive performance validation testing and validation testing was conducted for the Brainomix 360 e-MRI module. This performance validation testing demonstrated that the module provides accurate representation of key processing parameters under a range of clinically relevant parameters and perturbations associated with the intended use of the software. Software performance, validation and verification testing demonstrated that Brainomix 360 e-MRI met all design requirements and specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 30, 2023
Brainomix Limited % Zsolt Szrnka Regulatory Affairs Manager First Floor Seacourt Tower West Way Oxford, OX2 0JJ UNITED KINGDOM
Re: K231656
Trade/Device Name: Brainomix 360 e-MRI Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: May 30, 2023 Received: June 7, 2023
Dear Zsolt Szrnka:
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
1
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
Brainomix 360 e-MRI
Indications for Use (Describe)
Brainomix 360 e-MRI is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians.
The software runs on a standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, and analysis of images. Data and images are acquired through DICOM compliant imaging devices. This includes DICOM files uploaded through a web browser interface.
Brainomix 360 e-MRI provides both viewing and analysis capabilities for imaging datasets acquired with MRI including Perfusion Weighted Imaging (PWI) and Diffusion Weighted Imaging (DWI).
The DWI MRI analysis capabilities are used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data.
The MRI PWI analysis capabilities are for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume.
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
Image /page/3/Picture/0 description: The image shows the logo for BRAINOMIX. The logo consists of a teal-colored brain-shaped icon on the left, followed by the word "BRAINOMIX" in a sans-serif font. The "A" in "BRAINOMIX" is stylized with a teal gradient, while the rest of the letters are in a dark gray color.
Brainomix Limited First Floor, Seacourt Tower, West Way Oxford OX2 0JJ, United Kingdom
510(K) Summary Brainomix 360 e-MRI
| Date Prepared: | June 6, 2023 |
|---|---|
| Applicant's name: | Brainomix Limited |
| Applicant's address: | First Floor, Seacourt Tower, West Way |
| Oxford, OX2 0JJ | |
| United Kingdom | |
| Official contact: | Zsolt Szrnka |
| +44 (0)1865 582730 | |
| zszrnka@brainomix.com | |
| Device Trade Name: | Brainomix 360 e-MRI |
| Device Common Name: | Brainomix 360 e-MRI |
| Classification: | Device Class: II |
| Primary Product Code: LLZ | |
| Regulation No.: 21 § CFR 892.2050 | |
| Classification Panel: | Radiology Devices |
| Predicate Device: | iSchemaView's RAPID (K121447) |
Intended Use / Indications for Use
Brainomix 360 e-MRI is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians.
The software runs on a standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, and analysis of images. Data and images are acquired through DICOM compliant imaging devices. This includes DICOM files uploaded through a web browser interface.
Brainomix 360 e-MRI provides both viewing and analysis capabilities for imaging datasets acquired with MRI including Perfusion Weighted Imaging (PWI) and Diffusion Weighted Imaging (DWI).
The DWI MRI analysis capabilities are used to visualize local water diffusion properties from the analysis of diffusionweighted MRI data.
The MRI PWI analysis capabilities are for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume.
Device Description
4
Image /page/4/Picture/0 description: The image shows the logo for BRAINOMIX. The logo consists of a stylized brain icon on the left, followed by the word "BRAINOMIX" in a sans-serif font. The brain icon is a gradient of blue and green, and the letters "AI" in "BRAINOMIX" are also in the same gradient. The rest of the letters are in a dark gray color.
Brainomix 360 e-MRI software allows for visualization of DICOM compliant MRI (Mage Resonance) digital images. The software has been designed to run with off-the-shelf physical or virtual servers and provides for viewing, quantification, analysis, and reporting, as an aid to physician diagnosis.
The software system consists of platform functionality and the e-MRI processing module. It provides both analysis and viewing capabilities for functional and dynamic imaging datasets acquired with MR including Diffusion Weighted Imaging (DWI) and Dynamic Susceptibility Contrast (DSC), which is the term used in the Brainomix 360 e-MRI software for perfusion-weighted imaging technique. The DWI capabilities are for visualization of local water diffusion properties from the analysis of diffusion-weighted MR data. The DSC capabilities are for the characterization of perfusion parameters in the injection of a contrast bolus, and visualization of these parameters.
e-MRI provides a wide range of basic image viewing, processing and manipulation functions, through multiple output formats. The Brainomix 360 platform has been designed to connect with other DICOM-compliant devices. This functionality enables the transfer of MRI scans from a Picture Archiving and Communication System (PACS) to Brainomix 360 e-MRI software for processing.
Technological Characteristics
Brainomix 360 e-MRI is a standalone software application designed to receive MRI perfusion scans and apply algorithms to automatically produce several outputs which the user can then review and assess as part of a broader diagnostic and treatment decision making process.
Brainomix 360 e-MRI software may be used as a standalone tool, however, for streamlined integration in clinical use, the software may communicate with other DICOM-compliant medical devices through the DICOM Network Integration Module. While any DICOM-compliant medical device supporting the appropriate DICOM functionality (particularly MRI scan image storage and transmitting MRI scans) may be used, there are two main groups of devices that e-MRI is intended to interact with:
- MRI scanner workstation software
- PACS systems
The software uses image and signal processing software techniques to process a brain perfusion scan captured by a standard MRI scanner. The software applies pre-processing, filtering, AIF (Arterial Input Function) / VOF (Venous Output Function) detection, and deconvolution algorithms to process the scans and create an output report and processed images for review.
If a DWI scan is provided, the e-MRI module applies pre-processing, registration, filtering, and computation of an ADC (Apparent Diffusion Coefficient) map, together with the region of restricted diffusion, from the analysis of diffusion-weighted MR data.
Performance Testing Summary
Brainomix 360 e-MRI complies with DICOM (Digital Imaging and Communications in Medicine) - Developed by the American College of Radiology and the National Electrical Manufacturers Association. NEMA PS 3.1 - 3.20.
Additionally, extensive performance validation testing and validation testing was conducted for the Brainomix 360 e-MRI module. This performance validation testing demonstrated that the module provides accurate representation of key processing parameters under a range of clinically relevant parameters and
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Image /page/5/Picture/0 description: The image shows the logo for BRAINOMIX. The logo consists of a stylized brain icon on the left, followed by the word "BRAINOMIX" in a sans-serif font. The brain icon is a gradient of blue and green, while the text is black.
perturbations associated with the intended use of the software. Software performance, validation and verification testing demonstrated that Brainomix 360 e-MRI met all design requirements and specifications.
Substantial Equivalence
Brainomix 360 e-MRI and the predicate have substantially similar technological characteristics in that both devices are software packages used for image processing and run on standard physical and/or virtual servers. Both are intended to be used by trained physicians and provide image viewing, processing and analysis of DICOM compliant images from DICOM compliant imaging devices.
Both Brainomix 360 e-MRI and the predicate device have substantially similar intended use as both perform image processing of MRI data.
| Characteristic/
| Parameter | RAPID (K121447) – Predicate Device | Brainomix 360 e-MRI - Proposed Device |
|---|---|---|
| Product Code | LLZ | LLZ |
| Regulation | 21 CFR. §892.2050 | 21 CFR. §892.2050 |
| Indications for | ||
| Use | iSchemaView's RAPID is an image processing | |
| software package to be used by trained | ||
| professionals, including but not limited to | ||
| physicians and medical technicians. |
The software runs on a standard "off-the-shelf"
computer or a virtual platform, such as VMware,
and can be used to perform image viewing,
processing and analysis of brain images. Data and
images are acquired through DICOM compliant
imaging devices.
iSchemaView's RAPID provides both viewing and
analysis capabilities for functional and dynamic
imaging datasets acquired with CT Perfusion and
MRI including a Diffusion Weighted MRI (DWI)
Module and a Dynamic Analysis Module (dynamic
contrast enhanced imaging data for MRI and CT).
The DWI Module is used to visualize local water
diffusion properties from the analysis of
diffusion-weighted MRI data.
The Dynamic Analysis Module is used for
visualization and analysis of dynamic imaging
data, showing properties of changes in contrast
over time. This functionality includes calculation
of parameters related to tissue flow (perfusion)
and tissue blood volume. | Brainomix 360 e-MRI is an image processing
software package to be used by trained
professionals, including but not limited to
physicians and medical technicians.
The software runs on a standard off-the-shelf
computer or a virtual platform, such as VMware,
and can be used to perform image viewing,
processing, and analysis of images. Data and
images are acquired through DICOM compliant
imaging devices. This includes DICOM files
uploaded through a web browser interface.
Brainomix 360 e-MRI provides both viewing and
analysis capabilities for imaging datasets
acquired with MRI including Perfusion Weighted
Imaging (PWI) and Diffusion Weighted Imaging
(DWI).
The DWI MRI analysis capabilities are used to
visualize local water diffusion properties from the
analysis of diffusion-weighted MRI data.
The MRI PWI analysis capabilities are for
visualization and analysis of dynamic imaging
data, showing properties of changes in contrast
over time. This functionality includes calculation
of parameters related to tissue flow (perfusion)
and tissue blood volume. |
| Functional
Overview | The software package that provides for the
visualization and study of changes of tissue in
digital images captured by CT and MRI. The
software provides viewing and quantification. | Same but with no CT capabilities. |
| Environment of
Use | Clinical/Hospital environment | Same |
| Primary Users | Trained professionals - including but not limited
to physicians and medical technicians | Same |
| PACS Functionality | | |
| Basic PACS
Functions | View process and analyze medical images.
Performs standard PACS functions with respect to querying and listing. | Same |
| Computer
Platform | Standard off-the-shelf server or virtual server | Same |
| DICOM
compliance | Yes | Same |
| Data
Acquisition | Acquires medical image data from DICOM compliant imaging devices and modalities | Same |
| Data/Image
Types | Magnetic Resonance Image (MRI)
Computed Tomography (CT) | Same
None |
| CT | CT Perfusion (CTP) | None |
| MRI | Diffusion Weighted Image (DWI)
Perfusion Weighted Image (PWI) | Same |
| Computed Parameter Maps | | |
| Perfusion CT
and Perfusion
MRI | Cerebral blood flow (CBF)
Cerebral blood volume (CBV)
Mean Transit Time (MTT)
Tissue residue function time to peak (Tmax) | Same
Same
Same
Same
Time to Peak (TTP)
Perfusion CT: None |
| Diffusion MRI | Apparent Diffusion Coefficient (ADC)
Trace of diffusion tensor (Trace)
Isotropic DWI (isoDWI)
Fractional Anisotropy (FA) and Color FA | Same
Same
Same
None |
| Measurement Tools | | |
| MRI and CT
Tools | Arterial input function (AIF)/ Venous output function (VOF)
Time-course
Motion Correction
Mask
Volumetry analysis
Volumetric comparison between regions
(Mismatch volume/ratio, relative mismatch, hypoperfusion intensity ratio)
Export perfusion and diffusion files to PACS and DICOM file systems
Acquire, transmit, process, and store medical images | Same
Same
Same
Same
Region of Interest (ROI) and Volumetry
Same
Same
Same
CT Measurement Tools: None |
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Image /page/6/Picture/0 description: The image shows the logo for BRAINOMIX. The logo consists of a stylized brain icon on the left, followed by the word "BRAINOMIX" in a sans-serif font. The brain icon is a gradient of light blue to dark blue, while the letters "BRAI" are light blue and the letters "NOMIX" are dark gray.
Where the proposed device and the predicate differ in technological characteristics, is that Brainomix 360 e-MRI offers a sub-set of the indications for use and functionality of the predicate device. Where the predicate offers visualisation and analysis capabilities for CT perfusion data, the proposed device does not and therefore the risks associated with this type of analysis capability for CT perfusion data are not applicable to the proposed device.
Conclusion
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Image /page/7/Picture/0 description: The image shows the logo for BRAINOMIX. The logo consists of a stylized brain icon on the left, followed by the word "BRAINOMIX" in a sans-serif font. The brain icon and the "A" in "BRAINOMIX" are colored in a gradient of light blue to dark blue, while the rest of the text is dark gray.
In conclusion, the predicate device has the same technological characteristics and intended use as Brainomix 360 e-MRI. Brainomix 360 e-MRI is therefore substantially equivalent to the selected predicate device and does not raise any questions of safety or effectiveness.
Software verification and validation and algorithmic testing and risk management demonstrates that Brainomix 360 e-MRI is safe and effective for use as intended and described in its indications for use.