(245 days)
Not Found
No
The summary describes image processing and analysis software with functions like image registration and contralateral comparison, but it does not mention AI, ML, or any related terms like deep learning or neural networks. The performance studies section also does not describe training or testing on datasets typically associated with AI/ML model development.
No
The device is described as image processing software for viewing and analysis, aiding in clinical decision-making, but it does not directly treat or diagnose.
No
The text explicitly states "Brainomix 360° e-CTA is not intended for mobile diagnostic use" and "Images that are previewed via e-mail are compressed, are for informational purposes only, and not intended for diagnostic use beyond notification." It also mentions that clinicians are responsible for viewing "non-compressed images on a diagnostic viewer" for care-related decisions, implying this device is not the diagnostic viewer.
Yes
The device is described as a "software package" that runs on "standard 'off-the-shelf' hardware" and connects with other DICOM-compliant devices. The performance studies section explicitly states it is a "stand-alone software device" and testing is captured within "software and algorithm verification and validation," with no clinical or bench performance testing mentioned. This strongly indicates it is a software-only medical device.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Brainomix 360° e-CTA's function: This software processes and analyzes medical images (CTA scans) acquired from a patient's body. It does not perform tests on biological samples.
- Intended Use: The intended use clearly states it's for image processing and analysis of images acquired through imaging devices.
- Device Description: The description focuses on image visualization, processing, and analysis of DICOM compliant CTA images.
Therefore, Brainomix 360° e-CTA falls under the category of medical image processing software, not an in vitro diagnostic device.
N/A
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-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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CTA (CT Angiography)
Anatomical Site
Not Found
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)
Algorithm validation testing has 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
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
1
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
2
Indications for Use
510(k) Number (if known) K192692
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-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.
| 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
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.
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.
4
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 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.
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 - Predicate
Device (K172477) |
|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | LLZ | LLZ |
| Regulation | 21 CFR 892.2050 | 21 CFR 892.2050 |
| 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. | 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
images. Data and images are
acquired through DICOM
compliant imaging devices.
The iSchemaView RAPID
provides both viewing and
analysis capabilities for
functional and dynamic imaging
datasets acquired with CT
Perfusion (CT-P), CT
Angiography (CTA), and MRI
including a Diffusion Weighted
MRI (DWI) Module and a
Dynamic Analysis Module
(dynamic contrast-enhanced
imaging data for MRI and CT). |
| Characteristic/Parameter | Brainomix 360° e-CTA –
Proposed Device | iSchemaView RAPID - Predicate
Device (K172477) |
| Environment of use | Clinical/Hospital environment | Clinical/Hospital environment |
| Energy used and/or
delivered | None - software only
application. The software
application does not deliver or
depend on energy delivered to
or from patients | None - software only
application. The software
application does not deliver or
depend on energy delivered to
or from patients |
| Human Factors | Designed to be used by trained
clinicians | Designed to be used by trained
clinicians |
| Design: Supported
Modalities for image
processing and visualization | CTA | CT, MRI, CTA, CTP |
| Design: PACS functionality | View process and analyze
medical images. performs
standard PACS functions with
respect to querying and listing | same |
| Design: DICOM compliance | Yes | Yes |
| Design: Computer Platform | Standard off-the-shelf server or
virtual server | same |
| Design: Data acquisition | Acquires medical image data
from DICOM compliant imaging
devices and modalities | same |
| Acquisition and modalities
features: MRI | No | Diffusion Weighted Image (DWI)
Dynamic Analysis tissue flow
(perfusion) and tissue blood
volume |
| Acquisition and modalities
features: CTP | No | CTP cerebral blood flow and
blood volume |
| Characteristic/Parameter | Brainomix 360° e-CTA –
Proposed Device | iSchemaView RAPID - Predicate
Device (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 a
software package that provides
for the study of changes of
tissue in digital images
captured by CT. Brainomix 360°
e-CTA provides viewing and
quantification for CTA images. | 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 |
| 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.