Brainomix 360 e-CTP 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-CTP provides viewing and analysis capabilities for imaging datasets acquired with CT Perfusion.

The CT Perfusion 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-CTP software allows for visualization of DICOM compliant CT (Computed Tomography) 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 consists of one processing module:

1. e-CTP Module- provides both analysis and viewing capabilities for brain CT Perfusion datasets for characterization of perfusion parameters in the image following the injection of a contrast bolus, and visualization of these parameters.

AI/ML Overview

The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria. It mentions "extensive performance validation testing and software verification and validation testing was conducted" and that "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 the Brainomix 360 e-CTP met all design requirements and specifications."

However, it does not provide the following information from your request:

A table of acceptance criteria and the reported device performance: No specific criteria or performance metrics are listed.
Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document states, "Brainomix 360 e-CTP software medical device may be used as a stand-alone tool," but it does not describe a standalone performance study.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
The sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

In summary, while the document asserts that testing was conducted and the device met requirements, it lacks the specific details requested regarding acceptance criteria, study design, and results.

Summary

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Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Brainomix Limited % Thais Sala First Floor, Seacourt Tower West way Oxford, Oxfordshire OX2 0JJ UNITED KINGDOM

June 1, 2023

Re: K223555

Trade/Device Name: Brainomix 360 e-CTP Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: May 3, 2023 Received: May 3, 2023

Dear Thais Sala:

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

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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

Jessica S. Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K223555

Device Name Brainomix 360 e-CTP

Indications for Use (Describe)

Brainomix 360 e-CTP is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians.

Brainomix 360 e-CTP provides viewing and analysis capabilities for imaging datasets acquired with CT Perfusion. The CT Perfusion 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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Image /page/3/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 "A" in BRAINOMIX is colored in a gradient from blue to green, while the rest of the letters are dark gray.

Brainomix 360 e-CTP 510(K) Summary K223555

Manufacturer:	Brainomix LimitedFirst Floor, Seacourt TowerWest WayOxford OX2 7HNUnited Kingdom
Contact:	Thais SalaRegulatory Affairs Manager+44 (0) 1865 582730
Prepared by:	MCRA, LLC803 7th St., NW, 3rd FloorWashington, DC 20001Office: 202.552.5800
Date Submitted:	May 03rd, 2023
Device Trade Name:	Brainomix 360 e-CTP
Device Common Name(s):	Brainomix 360 e-CTP
Classification:	Device Class: IIPrimary Product Code: LLZRegulation No.: 21 § CFR 892.2050
Classification Panel:	Radiology
Predicate Device:	Primary: RAPID (K121447)
Reference Device:	Viz CTP (K180161)

Device Description

The software consists of one processing module:

1. e-CTP Module- provides both analysis and viewing capabilities for brain CT Perfusion datasets for characterization of perfusion parameters in the image following the injection of a contrast bolus, and visualization of these parameters.

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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 split into two halves, with a gradient of light blue to dark blue. The word "BRAINOMIX" is in dark gray, except for the "AI" which is in light blue.

Indications For Use

Brainomix 360 e-CTP is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians.

Brainomix 360 e-CTP provides viewing and analysis capabilities for imaging datasets acquired with CT Perfusion.

Technological Characteristics

Brainomix 360 e-CTP is designed to receive CT 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-CTP software medical device may be used as a stand-alone 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 CT scan image storage and transmission, which is used for transmitting CT scans) may be used, there are two main groups of devices that e-CTP is intended to interact with:

. CT scanner workstation software
. PACS systems

The analysis consists of AIF and VOF selection, bolus arrival time definition and block-circulant deconvolution. Finally, post-processing parametric maps and volumetric results are generated. Thresholds are user-defined via a configuration/settings file.

Performance Testing Summary

Brainomix 360 e-CTP complies with 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 software verification and validation testing was conducted for the Brainomix 360 e-CTP 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 the Brainomix 360 e-CTP met all design requirements and specifications.

Substantial Equivalence

Brainomix 360 e-CTP 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

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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 teal color, while the letters "BRAI" in the word "BRAINOMIX" are also teal, and the rest of the letters are gray.

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-CTP and the predicate device have substantially similar intended use as both perform image processing of CT data.

Parameter	RAPID (K121447) - Predicate Device	Brainomix 360 e-CTP- 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, suchas VMware, and can be used to performimage viewing, processing and analysis ofbrain images. Data and images are acquiredthrough DICOM compliant imaging devices.iSchemaView's RAPID provides both viewingand analysis capabilities for functional anddynamic imaging datasets acquired with CTPerfusion and MRI including a DiffusionWeighted MRI (DWI) Module and a DynamicAnalysis Module (dynamic contrastenhanced imaging data for MRI and CT).The DWI Module is used to visualize localwater diffusion properties from the analysisof diffusion-weighted MRI data.The Dynamic Analysis Module is used forvisualization and analysis of dynamicimaging data, showing properties of changesin contrast over time. This functionalityincludes calculation of parameters related totissue flow (perfusion) and tissue bloodvolume.	Brainomix 360 e-CTP 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 asVMware, and can be used to perform imageviewing, processing, and analysis of images.Data and images are acquired through DICOMcompliant imaging devices. This includesDICOM files uploaded through a web browserinterface.Brainomix 360 e-CTP provides viewing andanalysis capabilities for imaging datasetsacquired with CT Perfusion.The CT Perfusion analysis capabilities are forvisualization and analysis of dynamic imagingdata, showing properties of changes incontrast over time. This functionality includescalculation of parameters related to tissueflow (perfusion) and tissue blood volume.
Functionaloverview	The software package that provides for thevisualization and study of changes of tissuein digital images captured by CT and MRI.The software provides viewing andquantification.	Same but with no MRI capabilities.
Environment ofuse	Clinical/Hospital environment	Same
Human Factors	Designed to be used by trained clinicians	Same
PACS Functionality
Parameter	RAPID (K121447) - Predicate Device	Brainomix 360 e-CTP- Proposed Device
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	Computed Tomography (CT) via DICOM formatMagnetic Resonance Image (MRI)	SameNone
Acquisition and Modalities Features
CT	CT Perfusion (CTP)	Yes
MRI	Diffusion Weighted Image (DWI)Perfusion Weighted Image (PWI)	None
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)	• relative Cerebral blood flow (rCBF)• relative Cerebral blood volume (rCBV)• Mean Transit Time (MTT)• Tissue residue function time to peak (Tmax)• Time to Peak (TTP)• Perfusion MRI: None
Diffusion MRI	• ADC• Trace of diffusion tensor (Trace)• Isotropic DWI (isoDWI)• Fractional Anisotropy (FA) and color FA	• None
Measurement Tools
Additional tools	• Arterial input function (AIF)/ Venous output function (VOF)• Time-course• Motion Correction• Mask• Region of interest (ROI) and Volumetry• Volumetric comparison between regions• Export perfusion and diffusion files to PACS and DICOM file systems• Acquire, transmit, process, and store medical images	• Arterial input function (AIF)/ Venous output function (VOF)• Time-course• Motion Correction• Mask• Volumetry analysis• Volumetric comparison between regions• Export perfusion and diffusion files to PACS and DICOM file systems• Acquire, transmit, process, and store medical images

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Image /page/6/Picture/0 description: The image shows the logo for BRAINOMIX. To the left of the company name is a teal-colored graphic that resembles a brain. The company name is in all caps, with the "A" in BRAINOMIX being a lighter teal color than the rest of the letters.

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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 "A" in "BRAINOMIX" is colored in a gradient from blue to green, while the rest of the letters are gray.

Conclusion:

In conclusion, the predicate device has the same technological characteristics and intended use as Brainomix 360 e-CTP. Brainomix 360 e-CTP 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-CTP 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).