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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for Brainomix 360 e-MRI, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on establishing substantial equivalence to a predicate device (iSchemaView's RAPID) and does not explicitly list quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, Dice score with thresholds) or present detailed reported device performance in this summary. Instead, the "Performance Testing Summary" section indicates that "extensive performance validation testing and validation testing was conducted" and that "Brainomix 360 e-MRI met all design requirements and specifications."

However, the "Technological Characteristics" table directly compares the functionalities and capabilities of the proposed device against the predicate. This comparison implicitly serves as a form of acceptance criteria, where the proposed device is deemed acceptable if its features align with or are a subset of the predicate's, and risks are appropriately managed.

Characteristic/Parameter	Predicate Device (RAPID)	Brainomix 360 e-MRI (Proposed Device)	Implicit Acceptance Criteria (based on equivalence)	Reported Device Performance (as stated in document)
Product Code	LLZ	LLZ	Must match predicate's product code.	Met (LLZ)
Regulation	21 CFR. §892.2050	21 CFR. §892.2050	Must match predicate's regulation number.	Met (21 CFR. §892.2050)
Indications for Use	Image processing software for viewing, processing, and analysis of brain images (CT Perfusion and MRI inc. DWI & Dynamic Analysis Module), visualizing local water diffusion and parameters related to tissue flow/blood volume. Used by trained professionals.	Image processing software for viewing, processing, and analysis of images (MRI inc. PWI & DWI), visualizing local water diffusion and parameters related to tissue flow/blood volume. Used by trained professionals. (Note: No CT capabilities)	Must be substantially similar; subset of predicate's OK.	Substantially similar, but without CT capabilities, which is presented as reducing risks.
Functional Overview	Visualization and study of tissue changes in digital images captured by CT and MRI. Provides viewing and quantification.	Same but with no CT capabilities.	Must align, accepting a subset.	Met (MRI visualization, viewing, quantification, analysis, and reporting)
Environment of Use	Clinical/Hospital environment	Same	Must match.	Met (Clinical/Hospital environment)
Primary Users	Trained professionals (physicians, medical technicians)	Same	Must match.	Met (Trained professionals - physicians, medical technicians)
Basic PACS Functions	View, process, analyze medical images. Performs standard PACS functions (querying, listing).	Same	Must match.	Met (Same as predicate, indicating ability to view, process, and analyze, and perform standard PACS functions)
Computer Platform	Standard off-the-shelf server or virtual server	Same	Must match.	Met (Standard off-the-shelf server or virtual server)
DICOM Compliance	Yes	Same	Must match.	Met (Fully DICOM compliant, NEMA PS 3.1 - 3.20)
Data Acquisition	Acquires medical image data from DICOM compliant imaging devices and modalities	Same	Must match.	Met (Acquires medical image data from DICOM compliant imaging devices and modalities)
Data/Image Types	MRI, CT	MRI (No CT)	Must be a subset or equivalent.	Met (MRI data, specifically PWI and DWI)
CT Capabilities	CT Perfusion (CTP)	None	Proposed device does not require CT capabilities.	Met (By not having CT capabilities, aligns with its specific indications for use)
MRI Capabilities	Diffusion Weighted Image (DWI) Perfusion Weighted Image (PWI)	Same	Must match.	Met (DWI and PWI (referred to as DSC in the device description))
Computed Parameters (PWI)	CBF, CBV, MTT, Tmax	Same (CBF, CBV, MTT, Tmax) + TTP (additional)	Must include predicate's; additional is acceptable.	Met (Includes predicate's parameters and adds TTP)
Computed Parameters (DWI)	ADC, Trace, Isotropic DWI (isoDWI), Fractional Anisotropy (FA) and Color FA	ADC, Trace, Isotropic DWI (isoDWI) (No FA and Color FA)	Must include relevant; subset is often acceptable if not critical difference.	Met (Provides ADC, Trace, isoDWI, which are key for DWI analysis, with the absence of FA/Color FA not constituting a substantial difference for the intended use.)
Measurement Tools (MRI)	AIF/VOF, Time-course, Motion Correction, Mask, Volumetry, Mismatch volume/ratio, Hypoperfusion intensity ratio, Export files to PACS/DICOM, Acquire, transmit, process, store.	Same (excluding CT Measurement Tools, and replacing "Volumetry" with "Region of Interest (ROI) and Volumetry")	Must match or be functionally equivalent.	Met (Provides AIF/VOF, Time-course, Motion Correction, Mask, ROI and Volumetry, Mismatch volume/ratio, Export files to PACS/DICOM, Acquire, transmit, process, store.)

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature) for the validation studies. It only generally refers to "extensive performance validation testing."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

The document does not mention or describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. Therefore, no effect size of human readers' improvement with vs. without AI assistance is provided. The submission focuses on standalone device performance and substantial equivalence to a predicate.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, a standalone performance evaluation was done. The "Performance Testing Summary" states: "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." This implies that the algorithm's output was assessed independently.

7. The Type of Ground Truth Used:

The document does not explicitly specify the type of ground truth used (e.g., expert consensus, pathology, outcomes data). Given the nature of image processing software for analyzing MRI data (PWI and DWI), it is highly probable that ground truth would have been established through expert review and interpretation of the imaging data, potentially with reference to clinical outcomes or other diagnostic information, but this is not confirmed in the summary provided.

8. The Sample Size for the Training Set:

The document does not provide any information regarding the sample size for the training set. It focuses on the validation for substantial equivalence rather than the development process.

9. How the Ground Truth for the Training Set Was Established:

The document does not provide information on how the ground truth for the training set was established, as it does not address the training set at all.

Summary

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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

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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

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Indications for Use

Submission Number (if known)

K231656

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.

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.

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/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

K231656

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 WayOxford, OX2 0JJUnited Kingdom
Official contact:	Zsolt Szrnka+44 (0)1865 582730zszrnka@brainomix.com
Device Trade Name:	Brainomix 360 e-MRI
Device Common Name:	Brainomix 360 e-MRI
Classification:	Device Class: IIPrimary Product Code: LLZRegulation 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.

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.

Device Description

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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.

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 forUse	iSchemaView's RAPID is an image processingsoftware package to be used by trainedprofessionals, including but not limited tophysicians 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 andimages are acquired through DICOM compliantimaging devices.iSchemaView's RAPID provides both viewing andanalysis capabilities for functional and dynamicimaging datasets acquired with CT Perfusion andMRI including a Diffusion Weighted MRI (DWI)Module and a Dynamic Analysis Module (dynamiccontrast enhanced imaging data for MRI and CT).The DWI Module is used to visualize local waterdiffusion properties from the analysis ofdiffusion-weighted MRI data.The Dynamic Analysis Module is used forvisualization and analysis of dynamic imagingdata, showing properties of changes in contrastover time. This functionality includes calculationof parameters related to tissue flow (perfusion)and tissue blood volume.	Brainomix 360 e-MRI is an image processingsoftware package to be used by trainedprofessionals, including but not limited tophysicians and medical technicians.The software runs on a standard off-the-shelfcomputer or a virtual platform, such as VMware,and can be used to perform image viewing,processing, and analysis of images. Data andimages are acquired through DICOM compliantimaging devices. This includes DICOM filesuploaded through a web browser interface.Brainomix 360 e-MRI provides both viewing andanalysis capabilities for imaging datasetsacquired with MRI including Perfusion WeightedImaging (PWI) and Diffusion Weighted Imaging(DWI).The DWI MRI analysis capabilities are used tovisualize local water diffusion properties from theanalysis of diffusion-weighted MRI data.The MRI PWI analysis capabilities are forvisualization and analysis of dynamic imagingdata, showing properties of changes in contrastover time. This functionality includes calculationof parameters related to tissue flow (perfusion)and tissue blood volume.
FunctionalOverview	The software package that provides for thevisualization and study of changes of tissue indigital images captured by CT and MRI. Thesoftware provides viewing and quantification.	Same but with no CT capabilities.
Environment ofUse	Clinical/Hospital environment	Same
Primary Users	Trained professionals - including but not limitedto physicians and medical technicians	Same
PACS Functionality
Basic PACSFunctions	View process and analyze medical images.Performs standard PACS functions with respect to querying and listing.	Same
ComputerPlatform	Standard off-the-shelf server or virtual server	Same
DICOMcompliance	Yes	Same
DataAcquisition	Acquires medical image data from DICOM compliant imaging devices and modalities	Same
Data/ImageTypes	Magnetic Resonance Image (MRI)Computed Tomography (CT)	SameNone
CT	CT Perfusion (CTP)	None
MRI	Diffusion Weighted Image (DWI)Perfusion Weighted Image (PWI)	Same
Computed Parameter Maps
Perfusion CTand PerfusionMRI	Cerebral blood flow (CBF)Cerebral blood volume (CBV)Mean Transit Time (MTT)Tissue residue function time to peak (Tmax)	SameSameSameSameTime 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	SameSameSameNone
Measurement Tools
MRI and CTTools	Arterial input function (AIF)/ Venous output function (VOF)Time-courseMotion CorrectionMaskVolumetry analysisVolumetric comparison between regions(Mismatch volume/ratio, relative mismatch, hypoperfusion intensity ratio)Export perfusion and diffusion files to PACS and DICOM file systemsAcquire, transmit, process, and store medical images	SameSameSameSameRegion of Interest (ROI) and VolumetrySameSameSameCT 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.

Regulation Number and Section

§ 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).