(171 days)
The text states "Reference Device(s) Not Found". Therefore, there are no reference devices to list.
Yes
The device description explicitly states that Brainomix 360 e-CTA processes images using "Al/ML algorithms". Additionally, the "Summary of Performance Studies" section includes a study titled "AI/ML Comparison Digital Phantom Validation" which compares the proposed device with a CNN (Convolutional Neural Network), a type of AI/ML model, against the predicate device without a CNN.
No.
The device is an image processing software that provides information for clinical decision making; it does not directly treat a condition or restore function.
No
The device description explicitly states: "Images that are previewed via e-mail are compressed, are for informational purposes only, and not intended for diagnostic use beyond notification." and "Brainomix 360 e-CTA is not intended for mobile diagnostic use." Furthermore, it mentions that the processed images "may yield information useful in clinical decision making" when interpreted by a professional, implying it is a tool to aid, but not make, a diagnosis.
Yes
The device is explicitly described as a "software package" that runs on "standard 'off the-shelf' hardware (physical or virtualized)". It processes images acquired from DICOM compliant imaging devices, but the device itself is the software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description clearly states that Brainomix 360 e-CTA processes and analyzes images acquired through DICOM compliant imaging devices (specifically CTA scans of the brain). It does not analyze biological samples like blood, urine, or tissue.
- The intended use is image processing and analysis. The software provides tools for viewing, processing, and analyzing medical images to provide information useful in clinical decision making. This is distinct from the purpose of an IVD, which is to provide information about a patient's health status through the examination of biological specimens.
Therefore, while it is a medical device used in a clinical setting, it falls under the category of medical image processing software rather than an In Vitro Diagnostic.
No
The letter does not explicitly state that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / 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 "off the-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.
Brainomix 360 e-CTA vessel density asymmetry ratio applies only to the MCA region.
Product codes
LLZ, OIH
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 processes the images using Al/ML algorithms where the input channels will help the software distinguish bone from vessels and reduce image grain.
Brainomix 360 e-CTA automatically provides a colored overlay to provide a visual reference of the MCA hemisphere of the brain with lower vessel density, and corresponding contrast intensity measurements and estimated phase.
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 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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
CTA (CT Angiography)
Anatomical Site
MCA region (brain/cerebral vessels)
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
A sample size of 308 Computed Tomography (CTA) brain scans (studies) were obtained from clinical sites in the U.S. The majority of studies came from Boston Medical Centre (BMC), or from referring hospitals in the Massachusetts area (N=179). The remaining studies came from Mayo Clinic Rochester (MCR; N=129). The patient cohort was enriched to ensure the distribution of clinical and demographic variables (e.g., age, gender, race) allows generalizability to the patient population for whom use is intended.
The imaging was collected on a variety of different scanner models and manufacturers (Table 8). The dataset included 133 cases from SIEMENS scanners, 96 from GE scanners, 76 from Philips scanners and 4 from Canon/Toshiba scanners.
The slice thickness distribution was median 0.75mm [IQR: 0.625 – 0.8] with a minimum of 0.5mm (n=2) and a maximum of 1mm (n=42). In-plane (axial) resolution showed a range of 0.381mm to 0.72mm with a median of 0.49mm. Four different tube voltage (KvP, peak kilovoltage) values were encountered in the dataset (90KvP n=6, 100KvP, n=64; 120KvP n=137 and 140KvP, n=99). Tube current was median of 526mA [IQR: 445mA - 645mA]. With respect to contrast phase during acquisition, 62 studies were Early Arterial (EA), 130 Peak Arterial (PA), 110 in Equilibrium phase (EQ), 3 in Peak Venous (PV), and 3 in Late Venous (LV). All the images used a standard or a soft (low-pass filter) convolution kernel for reconstruction (e.g., STANDARD in GE MEDICAL SYSTEMS).
Summary of Performance Studies
Study Type: Digital phantom validation, AI/ML Comparison Digital Phantom Validation, Standalone Performance Study (retrospective).
Sample Size:
Digital phantom validation: Not explicitly stated, implied to be at least 18 (for AI/ML comparison).
Standalone Performance Study: 308 Computed Tomography (CTA) brain scans (studies).
Key Results:
Digital phantom validation:
Left-MAE: 6.444 ( 0
Right MAE: 6.278 (Proposed) vs 6.889 (Predicate) - Difference: 0.611 > 0
These results corroborate that the algorithm approach of the proposed device is safe, effective and does not raise different questions of safety and effectiveness to Brainomix 360 e-CTA while slightly improving its performance.
Standalone Performance Study:
The 308 cases were all successfully processed with the algorithm.
Vessels DSC: 0.955 (0.953, 0.957)
Parenchyma DSC: 0.999 (0.999, 1.000)
Performance metrics by subgroups (age, gender, race/ethnicity, clinical site, scanner manufacturer, presence of stenosis) consistently showed high DSC values for both vessels and parenchyma, indicating robust performance across varied patient and imaging characteristics.
The standalone performance testing demonstrated that the proposed device provides accurate vessel and parenchyma delineation masks against the predicate device (head-to-head comparison) under a range of clinically relevant variables associated with the intended use of the software. These results corroborate that the algorithm approach of the proposed device adds no risks to Brainomix 360 e-CTA while slightly improving its performance.
Key Metrics
Mean Absolute Error (MAE)
Dice Similarity Score (DSC)
Predicate Device(s)
Brainomix 360 e-CTA (K192692), Rapid (K233582)
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).
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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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below that.
Brainomix Limited Zsolt Szrnka Regulatory Affairs Manager First Floor, Seacourt Tower West Way Oxford, OX2 0JJ United Kingdom
January 6, 2025
Re: K242123
Trade/Device Name: Brainomix 360 e-CTA Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ, OIH Dated: November 22, 2024 Received: November 27, 2024
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Re"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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
2
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 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
3
Indications for Use
Submission Number (if known)
Device Name
Brainomix 360 e-CTA
Indications for Use (Describe)
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-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.
Brainomix 360 e-CTA vessel density asymmetry ratio applies only to the MCA region.
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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K242123
Image /page/4/Picture/1 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 letters "AI" in "BRAINOMIX" are also in the same gradient of blue and green, while the rest of the letters are in dark gray.
Head office First Floor, Seacourt Tower, West Way Oxford OX2 0JJ, United Kingdom
510(K) Summary Brainomix Limited – Brainomix 360 e-CTA
| Date Prepared: | 26Nov2024 |
|---|---|
| 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 | |
| regulatory@brainomix.com | |
| Device Proprietary Name: | Brainomix 360 e-CTA |
| Device Common Name: | Medical Image Management And Processing System |
| Regulatory Class: | Class II |
| Product Code: | Primary: LLZ, Secondary: QIH |
| Regulation: | 21 C.F.R. §892.2050 |
1. Predicate Devices
Brainomix 360 e-CTA is Substantially Equivalent to the following Legally Marketed devices:
Trade Name: Brainomix 360 e-CTA (Primary Predicate) Manufacturer: Brainomix Ltd. Regulation Number: 21 C.F.R. §892.2050 Regulatory Class: Class II Regulation Name: Medical Image Management And Processing System Product Code: LLZ Submission Number: K192692
Trade Name: Rapid (Secondary Predicate) Manufacturer: iSchemaView Regulation Number: 21 C.F.R. §892.2050 Regulatory Class: Class II Regulation Name: Medical Image Management And Processing System Product Code: LLZ, QIH Submission Number: K233582
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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, with the word "BRAINOMIX" in capital letters to the right of the icon. The brain icon is a gradient of blue and teal, while the letters "BRA, I" are in a similar gradient, and the letters "NOMIX" are in a dark gray color.
2. 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 processes the images using Al/ML algorithms where the input channels will help the software distinguish bone from vessels and reduce image grain.
Brainomix 360 e-CTA automatically provides a colored overlay to provide a visual reference of the MCA hemisphere of the brain with lower vessel density, and corresponding contrast intensity measurements and estimated phase.
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 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 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.
3. Intended Use / 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 "off the-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).
6
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 "AI" in the word "BRAINOMIX" is in a gradient of blue and green, while the rest of the letters are in a dark gray color.
Brainomix 360 e-CTA is not intended for mobile diagnostic use.
Brainomix 360 e-CTA vessel density asymmetry ratio applies only to the MCA region.
4. Performance Data
Summary of Digital Phantom Validation 4.1
Digital phantom evaluation was performed to validate the "vessel density ratio value" output as calculated by Brainomix 360 e-CTA.
The tests have passed and demonstrate that Brainomix 360 e-CTA performs following its requirements and that the algorithm as implemented in Brainomix 360 e-CTA performs by the required performance criteria, which is summarized below in Table 1.
| Metric Name | Value | Criteria | Pass/Fail |
|---|---|---|---|
| Left-MAE | 6.444 | 0 | 0.611 > 0 |
Table 2. Comparison of performance metrics between predicate device and proposed device
The proposed device shows a reduction in the Mean Absolute Error (MAE) for both hemispheres (4.333% left; 0.611% on the right).
These results corroborate that the algorithm approach of the proposed device is safe, effective and does not raise different questions of safety and effectiveness to Brainomix 360 e-CTA while slightly improving its performance.
4.3 Summary of Standalone Performance Study
A retrospective study has been carried out to assess the standalone performance of the processing step of vessel delineation in Brainomix 360 e-CTA in comparison to the predicate (Brainomix 360 e-CTA, K192692).
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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 capital letters. The brain icon is a gradient of light blue to dark blue. The letters "AI" in "BRAINOMIX" are also in a similar blue gradient, while the rest of the letters are in a dark gray color.
A sample size of 308 Computed Tomography (CTA) brain scans (studies) were obtained from clinical sites in the U.S. The majority of studies came from Boston Medical Centre (BMC), or from referring hospitals in the Massachusetts area (N=179). The remaining studies came from Mayo Clinic Rochester (MCR; N=129). The patient cohort was enriched to ensure the distribution of clinical and demographic variables (e.g., age, gender, race) allows generalizability to the patient population for whom use is intended.
The imaging was collected on a variety of different scanner models and manufacturers (Table 8). The dataset included 133 cases from SIEMENS scanners, 96 from GE scanners, 76 from Philips scanners and 4 from Canon/Toshiba scanners.
The slice thickness distribution was median 0.75mm [IQR: 0.625 – 0.8] with a minimum of 0.5mm (n=2) and a maximum of 1mm (n=42). In-plane (axial) resolution showed a range of 0.381mm to 0.72mm with a median of 0.49mm. Four different tube voltage (KvP, peak kilovoltage) values were encountered in the dataset (90KvP n=6, 100KvP, n=64; 120KvP n=137 and 140KvP, n=99). Tube current was median of 526mA [IQR: 445mA - 645mA]. With respect to contrast phase during acquisition, 62 studies were Early Arterial (EA), 130 Peak Arterial (PA), 110 in Equilibrium phase (EQ), 3 in Peak Venous (PV), and 3 in Late Venous (LV). All the images used a standard or a soft (low-pass filter) convolution kernel for reconstruction (e.g., STANDARD in GE MEDICAL SYSTEMS).
The cases (n=308) were all successfully processed with the algorithm. The global results are shown below in Table 3, the Dice Similarity Score is 0.955 reaching for the vessel delineation and 0.999 for the parenchyma mask as the desired requirement.
Table 3. Summary performance metrics from full sample of 308 patients, with 95% confidence intervals where approgriate.
| Metrics | All Cases (N=308) |
|---|---|
| Vessels DSC | 0.955 (0.953, 0.957) |
| Parenchyma DSC | 0.999 (0.999, 1.000) |
In order to assess the generalization of the performance in different patient subgroups, further stratifications were derived from the complete dataset by age (Table 4), by gender (Table 5), by race (Table 6), by clinical site (Table 7), by scanner manufacturer (Table 8), by the presence of stenosis (Table 9).
Table 4. Summary performance metrics from patients sub-categorized by age, with 95% confidence intervals where appropriate.
| Metrics | Age 22-50 | Age 50-70 | Age 70+ |
|---|---|---|---|
| Total N | 57 | 132 | 119 |
| Vessels DSC | 0.958 (0.953, 0.962) | 0.959 (0.957, 0.962) | 0.949 (0.946, 0.953) |
| Parenchyma DSC | 0.999 (0.999, 1.000) | 0.999 (0.999, 1.000) | 0.999 (0.999, 1.000) |
Table 5. Summary performance metrics from patients sub-categorized by gender, with 95% confidence intervals where appropriate.
| Metrics | Male | Female |
|---|---|---|
| Total N | 140 | 168 |
| Vessels DSC | 0.952 (0.949, 0.955) | 0.958 (0.955, 0.960) |
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Image /page/8/Picture/0 description: The image shows the logo for BRAINOMIX. The logo consists of a stylized brain image on the left, followed by the word "BRAINOMIX" in a sans-serif font. The brain image is a gradient of light blue to white. The letters "B", "R", "O", "M", "X" are dark gray, while the letters "A", "I", "N" are a gradient of dark gray to light blue.
Parenchyma DSC 0.999 (0.999, 1.000) 0.999 (0.999, 1.000)
Table 6. Summary performance metrics from patients sub-categorized by race/ethnicity, with 95% confidence intervals where appropriate. * CI could not be calculated due to lack of evidence (low N).
| Metrics | White | Black/African
American | Hispanic/
Latino | Asian/Asian
American | Unknown/
Refused |
|-------------------|-------------------------|---------------------------|-------------------------|-------------------------|-------------------------|
| Total N | 148 | 85 | 27 | 7 | 40 |
| Vessels DSC | 0.954 (0.951,
0.956) | 0.957 (0.953,
0.961) | 0.957 (0.949,
0.964) | 0.958 (0.948,
0.967) | 0.955 (0.951,
0.959) |
| Parenchyma
DSC | 0.999 (0.999,
1.000) | 0.999 (0.999,
1.000) | 0.999 (0.999,
1.000) | 0.999 (0.999,
1.000) | 0.999 (0.999,
1.000) |
Table 7. Summary performance metrics from patients sub-categorized by clinical site, with 95% confidence intervals where appropriate. MCR = Mayo Clinic Rochester, BMC = Boston Medical Center.
| Metrics | MCR | BMC |
|---|---|---|
| Total N | 129 | 179 |
| Vessels DSC | 0.952 (0.949, 0.956) | 0.957 (0.955, 0.959) |
| Parenchyma DSC | 0.999 (0.999, 1.000) | 0.999 (0.999, 1.000) |
Table 8. Summary performance metrics from patients sub-categorized by scanner manufacturer, with 95% confidence intervals where appropriate.
| Metrics | SIEMENS | GE Medical | Philips | Canon/ Toshiba |
|---|---|---|---|---|
| Systems | ||||
| Total N | 133 | 96 | 75 | 4 |
| Vessels DSC | 0.953 (0.95, 0.956) | 0.954 (0.95, 0.957) | 0.961 (0.958, | |
| 0.964) | 0.964 (0.947, 0.981) | |||
| Parenchyma | ||||
| DSC | 0.999 (0.999, 1.000) | 0.999 (0.999, 1.000) | 0.999 (0.999, | |
| 1.000) | 0.999 (0.999, 1.000) |
Table 9. Summary performance metrics from patients with or without stenosis as noted by the truthers, with 95% confidence intervals where appropriate.
| Metrics | With Stenosis | Without Stenosis |
|---|---|---|
| Total N | 30 | 278 |
| Vessels DSC | 0.957 (0.952, 0.962) | 0.955 (0.953, 0.957) |
| Parenchyma DSC | 0.999 (0.999, 1.000) | 0.999 (0.999, 1.000) |
The standalone performance testing demonstrated that the proposed device provides accurate vessel and parenchyma delineation masks against the predicate device (head-to-head comparison) under a range of clinically relevant variables associated with the intended use of the software. These results corroborate that the algorithm approach of the proposed device adds no risks to Brainomix 360 e-CTA while slightly improving its performance.
5. Prescriptive Statement
Caution: Federal law restricts this device to sale by or on the order of a physician.
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Image /page/9/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 teal, while the letters "A" and "I" in "BRAINOMIX" are also in the same gradient, providing a visual connection between the icon and the text.
6. Safety and Effectiveness
Brainomix 360 e-CTA has been designed, verified and validated in compliance with 21 CFR, Part 820.30 requirements. The device has been designed to meet the requirements associated with ISO 14971:2019 (risk management).
7. Cybersecurity
Brainomix 360 e-CTA has been designed and validated to the FDA Cybersecurity Guidance and IEC 81001-5-1.
8. Summary of Technological Characteristics
Brainomix 360 e-CTA includes similar CTA processing features and technological characteristics as compared to the predicate devices. Where the proposed device differs from the predicate devices, is that it provides three new claims listed below:
-
- Algorithm: The proposed device introduces an Al/ML algorithm which was not present in the primary predicate (Brainomix e-CTA). The input channels are intended to help the software distinguish bone from vessels which leads to improved image quality (less grain) as well as improved vessel detection, which has been extensively validated through digital phantom testing. In summary, the phantom validation results show a reduction in the Mean Absolute Error (MAE) for both hemispheres (4.333% left; 0.611% on the right), which corroborates that the proposed device is safe and effective and does not raise different questions of safety and effectiveness. Furthermore, the use of Al/ML algorithms is similar to the technological characteristics of the secondary predicate (Rapid).
-
- Accessible MIP views: The proposed device introduces posterior views to be accessed through Brainomix 360 e-CTA which was not present in the primary predicate (Brainomix 360 e-CTA). The current MIP views of the primary predicate device (Brainomix 360 e-CTA) already display posterior vessels where this new added view just enables focused visualization of posterior large vessels. Furthermore, there are no separate density analysis performed on the posterior MIPs and therefore this change does not raise different questions of safety and effectiveness.
-
- 3D-colored overlay: The proposed device introduces a 3-dimensional opacity graded overlay to the primary predicate device (Brainomix 360 e-CTA) that helps to visualize the asymmetry in blood vessel density between MCA hemispheres which is calculated via contralateral comparison. This colored overlay is a similar technological characteristic when compared to the secondary predicate device's (Rapid) 2D-colored overlay. The proposed 3D-colored overlay compares to the secondary predicate in that:
- Both the outputs 3D-colored overlay in the subject device and the 2D-colored overlay of a. the secondary predicate device are similar as they are a mathematical quantification of image outputs displayed in percentage that provides a reference for the clinician. Furthermore, the intended user is responsible to follow the standard of care and to engage in appropriate patient evaluation based on relevant clinical background before making care-related decisions when using both the proposed device and secondary predicate
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Image /page/10/Picture/0 description: The image shows the word "BRAINOMIX" in a sans-serif font. The first letter, "B", is in dark gray, while the "A" is in a gradient of blue and green. To the left of the word is a stylized image of a brain, also in a gradient of blue and green.
device. Where the features differ is that the proposed overlay (3D-colored overlay) uses a transparency scale instead of a multi-colored scale (secondary predicate device).
- b. The proposed overlay (3D-colored overlay) is defined as such given the user's ability to view it through different slices of the DICOM image. However, per slice it is presented as a 2D overlay. The presentation of the outputs of the regions of asymmetry in a transparency scale as compared to a multi-colored scale would not change how the user interacts with the device and the intended use of the overlay and therefore, does not raise new questions of safety and effectiveness.
The proposed device (Brainomix 360 e-CTA) and the secondary predicate (Rapid) include similar CTA processing features and technological characteristics as compared to the secondary 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.
9. Substantial Equivalence
| Characteristics/
Parameter | Proposed Device
Brainomix 360 e-CTA
(K242123) | Primary Predicate Device
Brainomix 360 e-CTA
(K192692) | Secondary Predicate Device
iSchemaView Rapid
(K233582) |
|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K242123 | K192692 | K233582 |
| Product Code | LLZ, QIH | LLZ | LLZ, QIH |
| Regulation
Number | 21 CFR §892.2050 | 21 CFR §892.2050 | 21 CFR §892.2050 |
| Intended
Use/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 "off
the-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 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-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). | Rapid is an image processing
software package to be used by
trained professionals, including
but not limited to physicians
(medical analysis and decision
making) and medical
technicians (administrative case
processing). 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.
Rapid is indicated for use in
Adults only. Rapid provides both
viewing and analysis capabilities
for functional and dynamic
imaging datasets acquired with
CT, CT Perfusion (CTP), CT
Angiography (CTA), C-arm CT |
| Characteristics/
Parameter | Proposed Device
Brainomix 360 e-CTA
(K242123) | Primary Predicate Device
Brainomix 360 e-CTA
(K192692) | Secondary Predicate Device
iSchemaView Rapid
(K233582) |
| | Brainomix 360 e-CTA is not
intended for mobile diagnostic
use. | Brainomix 360 e-CTA is not
intended for mobile diagnostic
use. | Perfusion and MRI including a
Diffusion Weighted MRI (DWI)
Module and a Dynamic Analysis
Module (dynamic contrast-
enhanced imaging data for MRI,
CT, and C-arm CT). Rapid C-arm
CT Perfusion can be used to
qualitatively assess cerebral
hemodynamics in the
angiography suite. The CT
analysis includes NCCT maps
showing areas of hypodense
and hyperdense tissue. 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. Rapid CT Perfusion and
Rapid MR Perfusion can be used
by physicians to aid in the
selection of acute stroke
patients (with known occlusion
of the intracranial internal
carotid artery or proximal
middle cerebral artery).
Instructions for the use of
contrast agents for this
indication can be found in
Appendix A of the User's
Manual. Additional information
for safe and effective drug use is
available in the product-specific
iodinated CT and gadolinium-
based MR contrast drug
labeling. In addition to the
Rapid imaging criteria, patients
must meet the clinical
requirements for
thrombectomy, as assessed by |
| | Brainomix 360 e-CTA vessel
density asymmetry ratio
applies only to the MCA region. | | |
| Characteristics/
Parameter | Proposed Device
Brainomix 360 e-CTA
(K242123) | Primary Predicate Device
Brainomix 360 e-CTA
(K192692) | Secondary Predicate Device
iSchemaView Rapid
(K233582) |
| | | | the following contraindications
or exclusions:
Bolus Quality: absent or
inadequate bolus. Patient Motion: excessive
|
| Environment of
use | Clinical/Hospital environment | Same | Same |
| Energy used
and/or delivered | None - software only
application. The software
application does not deliver or
depend on energy delivered to
or from patients | Same | Same |
| Primary Users | Radiologist/Clinician | Same | Same |
| Design:
Supported
Modalities for
image processing
and visualization | CTA only | CTA only | CT [NCCT, CT, CTA, C-arm
CT(CBCT)] or MR (MR, MRA) |
| MIP Views
accessible | Maximum intensity projections
(MIPs) of the vascular system
in axial, coronal, left and right
hemisphere sagittal, and
posterior views | Maximum intensity projections
(MIPs) of the vascular system
in axial, coronal and left and
right hemisphere sagittal views | Maximum intensity projections
(MIPs) of the vascular system in
axial, coronal, left and right
hemisphere sagittal. |
| Technical
Implementation | Mixed Traditional and AI/ML | Traditional | Mixed Traditional and AI/ML |
| Image Overlay | Vessel Density with visual
representation (3D-colored | No | Vessel Density with visual
representation (2D-colored
overlay) |
| Characteristics/
Parameter | Proposed Device
Brainomix 360 e-CTA
(K242123) | Primary Predicate Device
Brainomix 360 e-CTA
(K192692) | Secondary Predicate Device
iSchemaView Rapid
(K233582) |
| Design: PACS
functionality | View, process and analyze
medical images. Performs
standard PACS functions with
respect to querying and listing | Same | Same |
| Design: DICOM
compliance | Yes | Yes | Yes |
| Design: Computer
Platform | Standard off-the-shelf server or
virtual server | Same | Same |
| Design: Data
acquisition | Acquires medical image data
from DICOM compliant imaging
devices and modalities | Same | Same |
| Additional tools | Arterial input function
(AIF)Venous output function
(VOF) – CTA | Same | Same |
| Functional
overview | Brainomix 360 e-CTA is a
software package that provides
for the study of changes of
tissue in digital images
captured by CTA. Brainomix
360 e-CTA provides viewing
and quantification for CTA
images. | Same | RAPID is a software package
that provides for the
visualization and study of
changes of tissue in digital
images captured by CT and MRI.
RAPID provides viewing and
quantification. |
| Materials | N/A - Software only device | Same | Same |
| Biocompatibility | N/A - Software only device | Same | Same |
| Sterility | N/A - Software only device | Same | Same |
| Electrical Safety | N/A - Software only device | Same | Same |
| Mechanical Safety | N/A - Software only device | Same | Same |
| Chemical Safety | N/A - Software only device | Same | Same |
| Thermal Safety | N/A - Software only device | Same | Same |
| Radiation Safety | N/A - Software only device | Same | Same |
A table comparing the key features of the proposed and predicate devices is provided below.
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Image /page/11/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 letters "BRAINOMIX" are gray, except for the "AI" which is a gradient of blue.
Head office
First Floor, Seacourt Tower, West Way Oxford OX2 0JJ, United Kingdom
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Image /page/12/Picture/0 description: The image shows the logo for BRAINOMIX. To the left of the word BRAINOMIX is a graphic of a brain. The brain graphic is a gradient of light blue to dark blue. The letters 'AI' in BRAINOMIX are also a gradient of light blue to dark blue.
Head office
First Floor, Seacourt Tower, West Way Oxford OX2 0JJ, United Kingdom
13
Image /page/13/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 a lighter blue color than the rest of the letters.
First Floor, Seacourt Tower, West Way Oxford OX2 0JJ, United Kingdom
10. Conclusion
The proposed device has the same intended use as the primary predicate and similar intended use as the secondary predicate. The proposed device and predicate devices utilize similar CTA processing features. The differences in technological characteristics for the proposed device do not raise any new or unanswered questions of safety or effectiveness.
We conclude that the proposed device raises no unanswered questions with regards to safety and efficacy and demonstrates substantial equivalence to the predicates, Brainomix 360 e-CTA (K192692) and Rapid (K233582).