(185 days)
No
The summary describes image processing and analysis software for CT Perfusion data, but does not mention AI, ML, or related terms like deep learning or neural networks. The focus is on calculating and visualizing perfusion parameters.
No
The device is image processing software for diagnosis, not a therapeutic device.
Yes
This device is designed to provide "viewing, quantification, analysis, and reporting, as an aid to physician diagnosis" and performs "characterization of perfusion parameters" which are key functions of a diagnostic device.
Yes
The device is described as a software package that runs on standard off-the-shelf computers or virtual platforms and processes images acquired from DICOM compliant imaging devices. There is no mention of proprietary hardware included with the device.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Brainomix 360 e-CTP's Function: The description clearly states that Brainomix 360 e-CTP is an image processing software package that analyzes CT Perfusion images acquired from a patient. It processes and visualizes data related to blood flow and volume within the brain.
- No Specimen Analysis: The software does not analyze any biological specimens taken from the patient. It works directly with medical images.
Therefore, while it's a medical device used in diagnosis, it falls under the category of medical image processing software rather than an In Vitro Diagnostic.
N/A
Intended Use / 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.
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.
Product codes
LLZ
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:
- 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT Perfusion
Anatomical Site
Brain (implied by "brain CT Perfusion datasets" and "Cerebral blood flow", "Cerebral blood volume")
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained professionals, including but not limited to physicians and medical technicians.
Clinical/Hospital environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Extensive performance validation testing and 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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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.
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.
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 Limited
First Floor, Seacourt Tower
West Way
Oxford OX2 7HN
United Kingdom |
|------------------------|--------------------------------------------------------------------------------------------------|
| Contact: | Thais Sala
Regulatory Affairs Manager
+44 (0) 1865 582730 |
| Prepared by: | MCRA, LLC
803 7th St., NW, 3rd Floor
Washington, DC 20001
Office: 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: II
Primary Product Code: LLZ
Regulation No.: 21 § CFR 892.2050 |
| Classification Panel: | Radiology |
| Predicate Device: | Primary: RAPID (K121447) |
| Reference Device: | Viz CTP (K180161) |
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:
-
- 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.
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.
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 for | ||
| Use | iSchemaView's RAPID is an image processing | |
| software package to be used by trained | ||
| professionals, including but not limited to | ||
| physicians and medical technicians. | ||
| The software runs on a standard "off-the- | ||
| shelf" computer or a virtual platform, such | ||
| as VMware, and can be used to perform | ||
| image viewing, processing and analysis of | ||
| brain images. Data and images are acquired | ||
| through DICOM compliant imaging devices. | ||
| iSchemaView's RAPID provides both viewing | ||
| and analysis capabilities for functional and | ||
| dynamic imaging datasets acquired with CT | ||
| Perfusion and MRI including a Diffusion | ||
| Weighted MRI (DWI) Module and a Dynamic | ||
| Analysis Module (dynamic contrast | ||
| enhanced imaging data for MRI and CT). | ||
| The DWI Module is used to visualize local | ||
| water diffusion properties from the analysis | ||
| of diffusion-weighted MRI data. | ||
| The Dynamic Analysis Module is used for | ||
| visualization and analysis of dynamic | ||
| imaging data, showing properties of changes | ||
| in contrast over time. This functionality | ||
| includes calculation of parameters related to | ||
| tissue flow (perfusion) and tissue blood | ||
| volume. | Brainomix 360 e-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. | ||
| Functional | ||
| overview | The software package that provides for the | |
| visualization and study of changes of tissue | ||
| in digital images captured by CT and MRI. | ||
| The software provides viewing and | ||
| quantification. | Same but with no MRI capabilities. | |
| Environment of | ||
| use | 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 format | |
| Magnetic Resonance Image (MRI) | Same | |
| None | ||
| 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.