Brainomix 360° e-CTA 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 standard "off-the-shel" hardware (physical or virtualized) and can be used to perform image viewing, processing and analysis of images are acquired through DICOM compliant imaging devices.

Brainomix 360° e-CTA provides viewing and analysis capabilities for imaging datasets acquired with CTA (CT Angiography).

Brainomix 360° e-CTA is not intended for mobile diagnostic use.

Device Description

Brainomix 360° e-CTA is a medical image visualization and processing software package compliant with the DICOM standard and running on an off-the-shelf physical or virtual server.

Brainomix 360° e-CTA allows for the visualization, analysis and post-processing of DICOM compliant CTA images which, when interpreted by a trained physician or medical technician, may yield information useful in clinical decision making.

Brainomix 360° e-CTA provides a wide range of basic image viewing, processing and manipulation functions, through multiple output formats. Functionality includes image registration and visualization of large cerebral vessels to provide an analysis of hemispheric difference via contralateral comparison (displayed as a relative percentage).

Brainomix 360° e-CTA can connect with other DICOM-compliant devices, for example to transfer CTA scans from a Picture Archiving and Communication System (PACS) to Brainomix 360° e-CTA software for processing.

Results and images can be sent to a PACS via DICOM transfer and can be viewed on a PACS workstation or via a web user interface on any machine contained and accessed within a hospital network and firewall and with a connection to the Brainomix 360° e-CTA software (e.g. a LAN connection)

Brainomix 360° e-CTA notification capabilities enable clinicians to preview images through via e-mail notification with result image attachments.

Images that are previewed via e-mail are compressed, are for informational purposes only, and not intended for diagnostic use beyond notification.

Brainomix 360° e-CTA is not intended for mobile diagnostic use. Notified clinicians are responsible for viewing non-compressed images on a diagnostic viewer and engaging in appropriate patient evaluation and relevant discussion with a treating physician before making care-related decisions or requests.

AI/ML Overview

The provided text, a 510(k) summary for Brainomix 360° e-CTA, states that no clinical testing or non-clinical bench performance testing was carried out, submitted, or referenced for this submission. Instead, the device's performance is demonstrated through software and algorithm verification and validation. Therefore, it's not possible to provide acceptance criteria or details about a study proving the device meets those criteria from this document in the way typically expected for clinical validation.

The document focuses on demonstrating substantial equivalence to a predicate device (iSchemaView RAPID) based on similar technological characteristics and intended use, rather than presenting a performance study with specific acceptance criteria and detailed results.

However, based on the information provided regarding the Brainomix 360° e-CTA, I can infer the implied acceptance criteria related to its software and algorithm functionality, and describe what the document says about its performance:

Implied Acceptance Criteria and Reported Device Performance (Based on Software/Algorithm Verification and Validation)

Acceptance Criteria Category (Implied)	Specific Criteria (Inferred from device description)	Reported Device Performance (Summary from document)
Image Processing and Visualization	Accurate and reliable processing of DICOM compliant CTA images.	"Brainomix 360° e-CTA provides viewing and analysis capabilities for imaging datasets acquired with CTA (CT Angiography)." "Brainomix 360° e-CTA includes similar CTA processing features and technological characteristics as compared to the predicate device." "Algorithm validation testing has additionally been performed using phantom data with known properties."
Output Interpretation Support	Generation of information useful for clinical decision making (e.g., contralateral comparison for hemispheric difference).	"Functionality includes image registration and visualization of large cerebral vessels to provide an analysis of hemispheric difference via contralateral comparison (displayed as a relative percentage)." "When interpreted by a trained physician or medical technician, [results] may yield information useful in clinical decision making."
Interoperability	Adherence to DICOM standard for image acquisition, transfer, and viewing. Compatibility with PACS.	"Data and images are acquired through DICOM compliant imaging devices." "Brainomix 360° e-CTA can connect with other DICOM-compliant devices, for example to transfer CTA scans from a Picture Archiving and Communication System (PACS) to Brainomix 360° e-CTA software for processing." "Results and images can be sent to a PACS via DICOM transfer and can be viewed on a PACS workstation..." "Design, risk management, verification and Validation for Brainomix 360° e-CTA has been carried out... in adherence to the DICOM standard."
System Compatibility	Software runs on standard "off-the-shelf" hardware (physical or virtualized).	"The software runs on standard 'off-the-shelf' hardware (physical or virtualized)."
Safety and Effectiveness	No new questions of safety or effectiveness compared to predicate; suitable for intended use.	"The differences in technological characteristics for the proposed device do not raise any new or unanswered questions of safety or effectiveness." "Software verification and validation and algorithmic testing and risk management demonstrates that Brainomix 360° e-CTA is safe and effective for use as intended and described in its indications for use."

Addressing Specific Information Requests based on the provided text:

A table of acceptance criteria and the reported device performance: See table above. It is derived from the descriptions of device functionality and the overall conclusion that software/algorithm verification and validation was performed.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in the document. The document states "Algorithm validation testing has additionally been performed using phantom data with known properties." This implies a test set of phantom data, but the size is not given.
- Data Provenance: Not specified. "Phantom data" suggests simulated or manufactured data, rather than patient data with a country of origin. The document does not indicate if this was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable for phantom data, as ground truth for phantom data is defined by its known properties. The document does not mention any expert review or ground truth establishment by human readers for the algorithm validation described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable based on the description of testing (software and algorithm verification/validation with phantom data). No human adjudication process is 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: No. The document explicitly states: "No clinical testing or non-clinical bench performance testing has been carried out, submitted or referenced for this submission." This indicates no MRMC study was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, implicitly. The "Algorithm validation testing" using "phantom data with known properties" would represent a standalone performance evaluation of the algorithm's ability to process and analyze the images based on the defined properties of the phantom data. However, quantitative performance metrics (e.g., accuracy, precision, sensitivity, specificity) specific to this standalone performance are not provided in the summary.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): The ground truth for the "Algorithm validation testing" was based on "known properties" of phantom data. This is a controlled, synthetic ground truth, not derived from clinical expert consensus, pathology, or outcomes data.
The sample size for the training set: Not specified. The document does not provide details about a training set, as it focuses on verification and validation rather than the development and training of a machine learning model. While it uses the term "algorithmic testing," it doesn't describe an AI model development cycle with explicit training data.
How the ground truth for the training set was established: Not applicable, as detailed information on a training set or its ground truth establishment is not provided in this regulatory summary.

Summary

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May 28, 2020

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Brainomix Limited % Gwilym Owen Head of Quality and Regulatory Suites 11-14 Suffolk House, 263 Banbury Road Oxford. Oxfordshire OX2 7HN UNITED KINGDOM

Re: K192692

Trade/Device Name: Brainomix 360° e-CTA Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: April 30, 2020 Received: May 7, 2020

Dear Gwilym Owen:

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.

For

Thalia T. Mills, Ph.D. 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

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Indications for Use

510(k) Number (if known) K192692

Device Name Brainomix 360° e-CTA

Indications for Use (Describe)

Brainomix 360° e-CTA provides viewing and analysis capabilities for imaging datasets acquired with CTA (CT Angiography).

Brainomix 360° e-CTA is not intended for mobile diagnostic use.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X 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 graphic above the word "Brainomix". The brain graphic is divided vertically, with the left half colored green and the right half colored red. The word "Brainomix" is written in a simple, sans-serif font and is positioned directly below the brain graphic.

Suites 11-14 Suffolk House 263 Banbury Road Oxford OX2 7HN

K192692

510(K) Summary of Safety and Effectiveness

Date of summary:	30th April 2020
Submitter's name:	Brainomix Limited
Submitter's address:	Brainomix Limited, Suites 11-14 Suffolk House, 263 Banbury road,Oxford. OX2 7HN. United Kingdom
Submitter's contact:	Gwilym Owen
Telephone number:	+44 (0)1865 582730
Device Proprietary Name:	Brainomix 360° e-CTA
Device Common Name(s):	PACS - Medical Imaging Software
Classification Name:	Class II: Picture Archiving and Communications System(892.2050) Product Code: LIZ

Brainomix 360° e-CTA is Substantially Equivalent to the following Legally Marketed device:

Predicate Devices

510(k) Number	Trade Name	Manufacturer
K172477	iSchemaView RAPID	iSchemaView Inc

Indications for Use

Brainomix 360° e-CTA 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 standard "offthe-shelf" hardware (physical or virtualized) and can be used to perform image viewing, processing and analysis of images. Data and images are acquired through DICOM compliant imaging devices.

Brainomix 360° e-CTA provides viewing and analysis capabilities for imaging datasets acquired with CTA (CT Angiography).

Brainomix 360° e-CTA is not intended for mobile diagnostic use.

Device Description and Technological Characteristics

Brainomix 360° e-CTA is a medical image visualization and processing software package compliant with the DICOM standard and running on an off-the-shelf physical or virtual server.

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Image /page/4/Picture/1 description: The image shows the logo for Brainomix. The logo consists of a stylized brain graphic above the word "Brainomix". The brain graphic is split vertically, with the left half colored green and the right half colored red. The word "Brainomix" is written in a simple, sans-serif font.

Suites 11-14 Suffolk House 263 Banbury Road Oxford OX2 7HN

Brainomix 360° e-CTA notification capabilities enable clinicians to preview images through via e-mail notification with result image attachments.

Images that are previewed via e-mail are compressed, are for informational purposes only, and not intended for diagnostic use beyond notification.

Substantial Equivalence Discussion

Brainomix 360° e-CTA 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-CTA and the predicate device have substantially similar intended use as both perform image processing of CTA data to visualize large cerebral vessels and analyze hemispheric difference via contralateral comparison. Both devices can quantify the presence of the contrast agent within the brain and indicate the difference (ratio) in contrast-agent concentration between the hemispheres.

The primary difference between the proposed device and the predicate device is that Brainomix 360° e-CTA offers a sub-set of the indications for use and functionality of the predicate device.

Where the predicate offers visualisation and analysis capabilities for MRI and CTP data, the proposed device does not and therefore the risks associated with this type of analysis capability for MRI and CTP data are not applicable to the proposed device.

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Image /page/5/Picture/0 description: The image shows the logo for Brainomix. The logo consists of a stylized brain graphic above the word "Brainomix". The brain graphic is split vertically, with the left half colored green and the right half colored red. The word "Brainomix" is written in a simple, sans-serif font.

Suites 11-14 Suffolk House 263 Banbury Road Oxford OX2 7HN

Brainomix 360° e-CTA includes similar CTA processing features and technological characteristics as compared to the predicate device. Where technological differences exist, these are predominantly where the predicate device offers more features, functionality and a broader set of imaging indications as compared to the proposed device. The differences in technological characteristics for the proposed device do not raise any new or unanswered questions of safety or effectiveness.

We therefore conclude that the proposed device is substantially equivalent to the predicate device.

Characteristic/Parameter	Brainomix 360° e-CTA –Proposed Device	iSchemaView RAPID - PredicateDevice (K172477)
Product Code	LLZ	LLZ
Regulation	21 CFR 892.2050	21 CFR 892.2050
Indications for Use	Brainomix 360° e-CTA is animage processing softwarepackage to be used by trainedprofessionals, including, butnot limited to physicians andmedical technicians. Thesoftware runs on standard "off-the-shelf" hardware (physicalor virtualized) and can be usedto perform image viewing,processing and analysis ofimages. Data and images areacquired through DICOMcompliant imaging devices.Brainomix 360° e-CTA providesviewing and analysiscapabilities for imagingdatasets acquired with CTA (CTAngiography).Brainomix 360° e-CTA is notintended for mobile diagnosticuse.	iSchemaView's RAPID is animage processing softwarepackage to be used by trainedprofessionals, including but notlimited to physicians andmedical technicians.The software runs on a standardoff-the-shelf computer or avirtual platform, such asVMware, and can be used toperform image viewing,processing and analysis ofimages. Data and images areacquired through DICOMcompliant imaging devices.The iSchemaView RAPIDprovides both viewing andanalysis capabilities forfunctional and dynamic imagingdatasets acquired with CTPerfusion (CT-P), CTAngiography (CTA), and MRIincluding a Diffusion WeightedMRI (DWI) Module and aDynamic Analysis Module(dynamic contrast-enhancedimaging data for MRI and CT).
Characteristic/Parameter	Brainomix 360° e-CTA –Proposed Device	iSchemaView RAPID - PredicateDevice (K172477)
Environment of use	Clinical/Hospital environment	Clinical/Hospital environment
Energy used and/ordelivered	None - software onlyapplication. The softwareapplication does not deliver ordepend on energy delivered toor from patients	None - software onlyapplication. The softwareapplication does not deliver ordepend on energy delivered toor from patients
Human Factors	Designed to be used by trainedclinicians	Designed to be used by trainedclinicians
Design: SupportedModalities for imageprocessing and visualization	CTA	CT, MRI, CTA, CTP
Design: PACS functionality	View process and analyzemedical images. performsstandard PACS functions withrespect to querying and listing	same
Design: DICOM compliance	Yes	Yes
Design: Computer Platform	Standard off-the-shelf server orvirtual server	same
Design: Data acquisition	Acquires medical image datafrom DICOM compliant imagingdevices and modalities	same
Acquisition and modalitiesfeatures: MRI	No	Diffusion Weighted Image (DWI)Dynamic Analysis tissue flow(perfusion) and tissue bloodvolume
Acquisition and modalitiesfeatures: CTP	No	CTP cerebral blood flow andblood volume
Characteristic/Parameter	Brainomix 360° e-CTA –Proposed Device	iSchemaView RAPID - PredicateDevice (K172477)
Acquisition and modalities features: CTA	CTA large vessel density analysis	CTA large vessel density analysis
Additional tools	Arterial input function(AIF)Venous output function(VOF) – CTA	Arterial input function(AIF)Venous output function(VOF) - MRI
Functional overview	Brainomix 360° e-CTA is asoftware package that providesfor the study of changes oftissue in digital imagescaptured by CT. Brainomix 360°e-CTA provides viewing andquantification for CTA images.	RAPID is a software packagethat provides for thevisualization and study ofchanges of tissue in digitalimages captured by CT and MRI.RAPID providesviewing and quantification.
Materials	N/A - Software only device	same
Biocompatibility	N/A – Software only device	same
Sterility	N/A – Software only device	same
Electrical Safety	N/A - Software only device	same
Mechanical Safety	N/A - Software only device	same
Chemical Safety	N/A - Software only device	same
Thermal Safety	N/A - Software only device	same
Radiation Safety	N/A - Software only device	same

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Image /page/6/Picture/0 description: The image shows the logo for Brainomix. The logo consists of a stylized brain shape, with the left hemisphere colored green and the right hemisphere colored red. Below the brain image, the word "Brainomix" is written in a simple, sans-serif font.

Suites 11-14 Suffolk House 263 Banbury Road Oxford OX2 7HN

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Image /page/7/Picture/0 description: The image shows the logo for Brainomix. The logo consists of an image of a brain that is split down the middle, with the left half colored green and the right half colored red. Below the image of the brain, the word "Brainomix" is written in a simple, sans-serif font.

Suites 11-14 Suffolk House 263 Banbury Road Oxford OX2 7HN

Testing

Brainomix 360° e-CTA is tested against its user needs and intended use by the successful execution of planned software verification and validation testing included in this submission. Algorithm validation testing has additionally been performed using phantom data with known properties.

The results of software verification and validation and algorithmic testing demonstrate that Brainomix 360° e-CTA has met all design requirements and specifications associated with the intended use of the software.

Design, risk management, verification and Validation for Brainomix 360° e-CTA has been carried out in compliance with the requirements of CFR 21 Part 820 and in adherence to the DICOM standard.

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Image /page/8/Picture/0 description: The image shows the logo for Brainomix. The logo consists of a stylized brain graphic, with the left hemisphere colored green and the right hemisphere colored red. Below the brain graphic, the word "Brainomix" is written in a simple, sans-serif font.

Brainomix Limited Suites 11-14 Suffolk House 263 Banbury Road Oxford OX2 7HN

Performance Data

No clinical testing or non-clinical bench performance testing has been carried out, submitted or referenced for this submission. As Brainomix 360° e-CTA is a stand-alone software device, testing for Brainomix 360° e-CTA is captured within software and algorithm verification and validation.

Conclusion

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