(96 days)
Yes
The device description explicitly states that it uses "artificial intelligence algorithm" and "machine learning algorithms".
No
The device is a radiological computer-aided triage and notification software for analyzing medical images, not a device that directly treats or provides therapy.
No
The "Intended Use / Indications for Use" section explicitly states, "The device does not alter the original image, and it is not intended to be used as a primary diagnostic device." It is described as a "radiological computer aided triage and notification software" to "assist hospital networks and trained clinicians in workflow triage by flagging and communicating suspected positive findings."
Yes
The device is explicitly described as a "software package" and a "stand-alone software device" that runs on off-the-shelf server hardware. It processes existing medical images and provides notifications, without including or requiring proprietary hardware.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: In Vitro Diagnostics are designed to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- This device analyzes medical images: The Brainomix 360 Triage Stroke analyzes non-contrast head CT (NCCT) images, which are medical images, not biological samples.
- The intended use is image analysis and workflow triage: The primary purpose of this device is to analyze medical images to identify potential findings and assist in prioritizing workflow for trained clinicians. It does not perform tests on biological specimens.
Therefore, while it is a medical device that uses AI for analysis, it falls under the category of medical imaging software rather than an In Vitro Diagnostic.
No
The letter does not state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The provided text indicates "Not found" for "Control Plan Authorized (PCCP) and relevant text".
Intended Use / Indications for Use
Brainomix 360 Triage Stroke is a radiological computer aided triage and notification software indicated for use in the analysis of non-contrast head CT (NCCT) images to assist hospital networks and trained clinicians in workflow triage by flagging and communicating suspected positive findings of head NCCT images for large vessel occlusion (LVO) of the intracranial ICA and M1 and intracranial hemorrhage (ICH). Specifically, the device is intended to be used for the triage of images acquired from adult patients in the acute setting, within 24 hours of the acute symptoms, or where this is unclear, since last known well (LKW) time. It is not intended to detect isolated subarachnoid hemorrhage and symmetrical bilateral MCA occlusions.
Brainomix 360 Triage Stroke uses an artificial intelligence algorithm to analyze images and highlight cases with detected NCCT LVO or ICH on the Brainomix server on premise or in the cloud in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected LVO or ICH findings via a web user interface or mobile applications include compressed preview images that are meant for informational purposes only and are not intended for diagnostic use beyond notification.
The device does not alter the original mage, and it is not intended to be used as a primary diagnostic device. The results of Brainomix 360 Triage Stroke are intended to be used in conjunction with other patient information and based on professional judgment to assist with triage/prioritization of medical images. Notified clinicians are ultimately responsible for reviewing full images per the standard of care.
Product codes
QAS
Device Description
Brainomix 360 Triage Stroke is a radiological computer aided triage and notification software package compliant with the DICOM standard and running on an off-the-shelf physical or virtual server.
The Triage Stroke module is a non-contrast CT processing module which operates within the integrated Brainomix 360 Platform to provide triage and notification of suspected large vessel occlusion (LVO) and intracranial hemorrhage (ICH). Brainomix 360 Triage Stroke is a stand-alone software device which uses machine learning algorithms that uses advanced non adaptive imaging artificial intelligence, and large data analytics to automatically identify suspected LVO and ICH on non-contrast CT (NCCT) imaging acquired from adult patients in the acute setting, within 24 hours of the acute symptoms, or where this is unclear, since last known well (LKW) time. The output of the module is a priority notification to clinicians indicating the suspicion of LVO or ICH based on positive findings. Specifically, Brainomix 360 Triage Stroke's ICH analysis is optimized to identify findings of hyperdense volume in the parenchyma typically associated with acute intracranial hemorrhage; and the NCCT LVO suspicion uses the combined analysis of the ASPECTS and hyperdense vessel sign (HDVS) algorithms. It is not intended to detect isolated subarachnoid hemorrhage and symmetrical bilateral MCA occlusions. The Triage Stroke module uses the basic services supplied by the Brainomix 360 Platform including DICOM processing, job management, imaging module execution and imaging output including the notification and compressed image.
Brainomix 360 Triage Stroke notification capabilities enable clinicians to review images via mobile app notification. Alternatively, intended users can also access the notification (a "Suspected LVO" or "Suspected hemorrhage" flag) and straightened images via the Brainomix 360 web user interface. Images that are previewed via mobile app are compressed, are for preview informational purposes only, and not intended for diagnostic use beyond notification.
The device is intended for use as an additional tool for assisting study triage within existing pathways. It does not replace any part of the current standard of care. It is designed to assist in prioritization of studies for reading within a worklist, in addition to any other pre-existing formal methods of study prioritization in place. Specifically, it does not remove cases from a reading queue and operates in parallel to the standard of care. This device is not intended to replace the usual methods of communication and transfer of information in the current standard of care.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
non-contrast head CT (NCCT) images
Anatomical Site
Head
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Hospital networks and trained clinicians, in the acute setting.
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 retrospective study was conducted with the primary endpoint of assessing the performance of Brainomix 360 Triage Stroke in identifying NCCT head images containing intracranial hemorrhage (ICH) or large vessel occlusion (LVO) findings in 267 cases (ICH positive: 40 cases; LVO positive: 112 cases; Negative for ICH or LVO: 115; excluded: 3 cases due to technical inadequacy). ICH positive cases were previously truthed using NCCT imaging with additional clinical information as described in the standalone study for our previously cleared device, Brainomix 360 Triage ICH (K231195). The LVO positive and negative cases were truthed using acute CTA imaging and additional clinical information by consensus of three experienced US board certified neuroradiologists.
Summary of Performance Studies
Study type: Retrospective study
Sample size: 267 cases (ICH positive: 40 cases; LVO positive: 112 cases; Negative for ICH or LVO: 115; excluded: 3 cases due to technical inadequacy).
Key results:
ICH performance: 92.5% sensitivity (95% Cl: 80.97-98.36%) and 87.22% specificity (Cl: 82.39-91.18%).
NCCT LVO performance: 68.75% sensitivity (C: 59.71-76.90%) and 89.57% specificity (Cl: 82.92-94.36%).
A reader study was conducted where Triage Stroke passed both conditions (expert non-inferiority and non-expert superiority), with a sensitivity for all readers (experts and non-experts) of 47.94% (Cl: 37.91-57.97%). The difference between the device's sensitivity and that of all readers was 20.52% (Cl: 8.26-32.78%). The general radiologists (nonexperts) performed with a sensitivity of 47.18% (C: 33.62-60.75%). The difference between the device and nonexpert sensitivity was 21.28% (CI: 5.84-36.72%).
Time-to-notification analysis: minimum expected time-to-notification of 62 seconds, and a maximum of 134 seconds, which met the acceptability criterion of under 3.5 minutes.
Performance across subgroups (age, gender, slice thickness, scanner manufacturer) was also analyzed and reported.
Key Metrics
Sensitivity and Specificity for ICH: 92.5% sensitivity (95% Cl: 80.97-98.36%) and 87.22% specificity (Cl: 82.39-91.18%).
Sensitivity and Specificity for NCCT LVO: 68.75% sensitivity (C: 59.71-76.90%) and 89.57% specificity (Cl: 82.92-94.36%).
Sensitivity for all readers in reader study: 47.94% (Cl: 37.91-57.97%).
Sensitivity for general radiologists (nonexperts): 47.18% (C: 33.62-60.75%).
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2080 Radiological computer aided triage and notification software.
(a)
Identification. Radiological computer aided triage and notification software is an image processing prescription device intended to aid in prioritization and triage of radiological medical images. The device notifies a designated list of clinicians of the availability of time sensitive radiological medical images for review based on computer aided image analysis of those images performed by the device. The device does not mark, highlight, or direct users' attention to a specific location in the original image. The device does not remove cases from a reading queue. The device operates in parallel with the standard of care, which remains the default option for all cases.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include:
(i) A detailed description of the notification and triage algorithms and all underlying image analysis algorithms including, but not limited to, a detailed description of the algorithm inputs and outputs, each major component or block, how the algorithm affects or relates to clinical practice or patient care, and any algorithm limitations.
(ii) A detailed description of pre-specified performance testing protocols and dataset(s) used to assess whether the device will provide effective triage (
e.g., improved time to review of prioritized images for pre-specified clinicians).(iii) Results from performance testing that demonstrate that the device will provide effective triage. The performance assessment must be based on an appropriate measure to estimate the clinical effectiveness. The test dataset must contain sufficient numbers of cases from important cohorts (
e.g., subsets defined by clinically relevant confounders, effect modifiers, associated diseases, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals for these individual subsets can be characterized with the device for the intended use population and imaging equipment.(iv) Stand-alone performance testing protocols and results of the device.
(v) Appropriate software documentation (
e.g., device hazard analysis; software requirements specification document; software design specification document; traceability analysis; description of verification and validation activities including system level test protocol, pass/fail criteria, and results).(2) Labeling must include the following:
(i) A detailed description of the patient population for which the device is indicated for use;
(ii) A detailed description of the intended user and user training that addresses appropriate use protocols for the device;
(iii) Discussion of warnings, precautions, and limitations must include situations in which the device may fail or may not operate at its expected performance level (
e.g., poor image quality for certain subpopulations), as applicable;(iv) A detailed description of compatible imaging hardware, imaging protocols, and requirements for input images;
(v) Device operating instructions; and
(vi) A detailed summary of the performance testing, including: test methods, dataset characteristics, triage effectiveness (
e.g., improved time to review of prioritized images for pre-specified clinicians), diagnostic accuracy of algorithms informing triage decision, and results with associated statistical uncertainty (e.g., confidence intervals), including a summary of subanalyses on case distributions stratified by relevant confounders, such as lesion and organ characteristics, disease stages, and imaging equipment.
0
Image /page/0/Picture/0 description: The image shows the logo for 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 a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Brainomix Limited % Zsolt Szrnka Regulatory Affairs Manager First Floor Seacourt Tower West Way Oxford. OX2 0JJ United Kingdom
November 21, 2023
Re: K232496 Trade/Device Name: Brainomix 360 Triage Stroke Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological computer aided triage and notification software Regulatory Class: Class II Product Code: QAS Dated: November 6, 2023 Received: November 6, 2023
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/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.
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).
1
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.
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 medical devices and radiation-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 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
2
Indications for Use
510(k) Number (if known) K232496
Device Name Brainomix 360 Triage Stroke
Indications for Use (Describe)
Brainomix 360 Triage Stroke is a radiological computer aided triage and notification software indicated for use in the analysis of non-contrast head CT (NCCT) images to assist hospital networks and trained clinicians in workflow triage by flagging and communicating suspected positive findings of head NCCT images for large vessel occlusion (LVO) of the intracranial ICA and M1 and intracranial hemorrhage (ICH). Specifically, the device is intended to be used for the trage of images acquired from adult patients in the acute setting, within 24 hours of the acute symptoms, or where this is unclear, since last known well (LKW) time. It is not intended to detect isolated subarachnoid hemorrhage and symmetrical bilateral MCA occlusions.
Brainomix 360 Triage Stroke uses an artificial intelligence algorithm to analyze images and highlight cases with detected NCCT LVO or ICH on the Brainomix server on premise or in the cloud in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected LVO or ICH findings via a web user interface or mobile applications include compressed preview images that are meant for informational purposes only and are not intended for diagnostic use beyond notification.
The device does not alter the original mage, and it is not intended to be used as a primary diagnostic device. The results of Brainomix 360 Triage Stroke are intended to be used in conjunction with other patient information and based on professional judgment to assist with triage/prioritization of medical images. Notified clinicians are ultimately responsible for reviewing full images per the standard of care.
Cautions:
· All patients should get adequate care for their symptoms, including angiography and/or other appropriate care per the standard clinical practice, irrespective of the output of Brainomix 360 Triage Stroke.
· Brainomix 360 Triage Stroke is not intended to be a rule-out device and for cases that have been processed by the device without notification for "Suspected L VO" should not be viewed as indicating that LVO is excluded. All cases should undergo angiography, per the standard stroke workup.
Limitations:
• Brainomix 360 Triage Stroke is not intended for mobile diagnostic use. Images viewed on a mobile platform are compressed preview images and not for diagnostic interpretation.
· Brainomix 360 Triage Stroke does not replace the need for CT A in ischemic stroke workflow prioritization and notification only.
- Brainomix 360 Triage Stroke has been validated and is intended to be used on Siemens, GE and Philips scanners.
· Brainomix 360 Triage Stroke is not intended to be used on patients with recent (within 6 weeks) neurosurgery or endovascular neurointervention or recent (within 4 weeks) previous diagnosis of stroke.
· Brainomix 360 Triage Stroke is not intended to detect isolated subarachnoid hemorrhage and symmetrical bilateral MCA occlusions.
Contraindications: Brainomix 360 Triage Stroke is not suitable for use with scan data containing image features associated with:
· tumors or abscesses
· coils, shunts, embolization or movement artifacts
3
Brainomix 360 Triage Stroke is not intended to be used for analyzing CT images in intracranial vascular pathologies such as arterial aneurysms, arteriovenous malformations or venous thrombosis.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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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 teal, while the word "BRAINOMIX" is mostly gray, with the "AI" portion in teal.
K232496
510(K) Summary Brainomix 360 Triage Stroke
| Date Prepared: | 16Aug2023 |
|---|---|
| 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 Trade Name: | Brainomix 360 Triage Stroke |
| Device Common Name: | Radiological Computer-Assisted Triage and Notification Software |
| Regulatory Class: | Class II |
| Product Code: | QAS |
| Regulation No: | 21 C.F.R. §892.2080 |
| Classification Panel: | Radiology Devices |
Predicate Device
The Brainomix 360 Triage Stroke device is claimed to be substantially equivalent to the following legally marketed predicate device: iSchemaView's Rapid NCCT Stroke (K222884).
Indications for Use
Brainomix 360 Triage Stroke is a radiological computer aided triage and notification software indicated for use in the analysis of non-contrast head CT (NCCT) images to assist hospital networks and trained clinicians in workflow triage by flagging and communicating suspected positive findings of head NCCT images for large vessel occlusion (LVO) of the intracranial ICA and M1 and intracranial hemorrhage (ICH). Specifically, the device is intended to be used for the triage of images acquired from adult patients in the acute setting, within 24 hours of the acute symptoms, or where this is unclear, since last known well (LKW) time. It is not intended to detect isolated subarachnoid hemorrhage and symmetrical bilateral MCA occlusions.
Brainomix 360 Triage Stroke uses an artificial intelligence algorithm to analyze images and highlight cases with detected NCCT LVO or ICH on the Brainomix server on premise or in the cloud in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected LVO or ICH findings via a web user interface or mobile applications include compressed preview images that are meant for informational purposes only and are not intended for diagnostic use beyond notification.
The device does not alter the original medical image, and it is not intended to be used as a primary diagnostic device. The results of Brainomix 360 Triage Stroke are intended to be used in conjunction with other patient information and based on professional judgment to assist with triage/prioritization of medical images. Notified clinicians are ultimately responsible for reviewing full images per the standard of care.
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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 gradient of teal and blue, while the letters "AI" in "BRAINOMIX" are also in the same gradient, providing a visual connection between the brain icon and the artificial intelligence aspect implied by the letters.
Cautions:
- All patients should get adequate care for their symptoms, including angiography and/or other appropriate care per the standard clinical practice, irrespective of the output of Brainomix 360 Triage Stroke.
- . Brainomix 360 Triage Stroke is not intended to be a rule-out device and for cases that have been processed by the device without notification for "Suspected LVO" should not be viewed as indicating that LVO is excluded. All cases should undergo angiography, per the standard stroke workup.
Limitations:
- Brainomix 360 Triage Stroke is not intended for mobile diagnostic use. Images viewed on a mobile platform are compressed preview images and not for diagnostic interpretation.
- . Brainomix 360 Triage Stroke does not replace the need for CTA in ischemic stroke workup - it provides workflow prioritization and notification only.
- . Brainomix 360 Triage Stroke has been validated and is intended to be used on Siemens, GE and Philips scanners.
- Brainomix 360 Triage Stroke is not intended to be used on patients with recent (within 6 weeks) neurosurgery or endovascular neurointervention or recent (within 4 weeks) previous diagnosis of stroke.
- Brainomix 360 Triage Stroke is not intended to detect isolated subarachnoid hemorrhage and symmetrical bilateral MCA occlusions.
Contraindications:
Brainomix 360 Triage Stroke is not suitable for use with scan data containing image features associated with:
- tumors or abscesses
- coils, shunts, embolization or movement artifacts
Brainomix 360 Triage Stroke is not intended to be used for analyzing CT images in intracranial vascular pathologies such as arterial aneurysms, arteriovenous malformations or venous thrombosis.
Device Description
Brainomix 360 Triage Stroke is a radiological computer aided triage and notification software package compliant with the DICOM standard and running on an off-the-shelf physical or virtual server.
The Triage Stroke module is a non-contrast CT processing module which operates within the integrated Brainomix 360 Platform to provide triage and notification of suspected large vessel occlusion (LVO) and intracranial hemorrhage (ICH). Brainomix 360 Triage Stroke is a stand-alone software device which uses machine learning algorithms that uses advanced non adaptive imaging artificial intelligence, and large data analytics to automatically identify suspected LVO and ICH on non-contrast CT (NCCT) imaging acquired from adult patients in the acute setting, within 24 hours of the acute symptoms, or where this is unclear, since last known well (LKW) time. The output of the module is a priority notification to clinicians indicating the suspicion of LVO or ICH based on positive findings. Specifically, Brainomix 360 Triage Stroke's ICH analysis is optimized to identify findings of hyperdense volume in the parenchyma typically associated with acute intracranial hemorrhage; and the NCCT LVO suspicion uses the combined analysis of the ASPECTS and hyperdense vessel sign (HDVS) algorithms. It is not intended to detect isolated subarachnoid hemorrhage and symmetrical bilateral MCA occlusions. The Triage Stroke module uses the basic services supplied by the Brainomix 360 Platform including DICOM processing, job management, imaging module execution and imaging output including the notification and compressed image.
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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 letters "AI" in the word "BRAINOMIX" are colored in a gradient of blue and green, while the rest of the letters are black.
Brainomix 360 Triage Stroke notification capabilities enable clinicians to review images via mobile app notification. Alternatively, intended users can also access the notification (a "Suspected LVO" or "Suspected hemorrhage" flag) and straightened images via the Brainomix 360 web user interface. Images that are previewed via mobile app are compressed, are for preview informational purposes only, and not intended for diagnostic use beyond notification.
The device is intended for use as an additional tool for assisting study triage within existing pathways. It does not replace any part of the current standard of care. It is designed to assist in prioritization of studies for reading within a worklist, in addition to any other pre-existing formal methods of study prioritization in place. Specifically, it does not remove cases from a reading queue and operates in parallel to the standard of care. This device is not intended to replace the usual methods of communication and transfer of information in the current standard of care.
Comparison of Technological Characteristics
Both subject and predicate device use automatic data identification and transfer to send images from the local hospital network to a remote server for image processing and analysis, i.e., via a DICOM router that automatically identifies relevant images on a local IT Network and transfers them to a Backend Server using a DICOM compliant communication protocol. The Backend Server software for each device has the same additional software functionality that interacts with the image management architecture, including a notifier module.
Both subject and predicate device provide triage and notification of suspected ICH and LVO. In case of both devices, the ICH analysis is optimized to identify findings of hyperdense volume in the parenchyma typically associated with acute ICH; and the NCCT LVO suspicion uses the combined analysis of the ASPECTS and hyperdense vessel sign (HDVS) algorithms. The algorithms do not externalize any internal segmentation, analysis, or intermediate outputs used in determining if an ICH or LVO is present in the NCCT, nor does either algorithm mark the analyzed NCCT image. Both devices support a mobile application that allows a user to receive push notifications, preview related images, and view patient details associated with a series. The mobile application of both devices is subject to nondiagnostic viewing limitations and have a non-diagnostic warning on the image viewing screen.
Where subject device differs from the predicate is that Brainomix 360 Triage Stroke may also notify the user of a suspected LVO or ICH via a web user interface, as an additional output. The unprocessed images are subjected to rotation and resampling (pre-processing and registration) which do not alter the original imaging in relation to aid for diagnostic. Identically to the predicate, the 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. Therefore, the technical differences in how the notification may be sent to the user between the proposed and predicate devices do not raise different questions of safety and effectiveness. The predicate device offers two additional channels of notification via email and PACS, which the subject device does not, and therefore, the risks associated with these are not applicable to the subject device.
The below table summarizes and compares data on the Brainomix 360 Triage Stroke device, the subject of this filing, with the Rapid NCCT Stroke device (K222884).
| Characteristic/Parameter | Brainomix 360 Triage Stroke
Subject Device (K232496) | iSchemaView Rapid NCCT Stroke
Predicate Device (K222884) |
|--------------------------|---------------------------------------------------------|-------------------------------------------------------------|
| Product Code | QAS | QAS |
| Regulation | 21 C.F.R. §892.2080 | 21 C.F.R. §892.2080 |
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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 brain icon is split into two halves, with a gradient of blue and teal. The letters "AI" in "BRAINOMIX" are also in the same blue and teal gradient, while the rest of the letters are in a dark gray color.
Indications for Use
Brainomix 360 Triage Stroke is a radiological computer aided triage and notification software indicated for use in the analysis of non-contrast head CT (NCCT) images to assist hospital networks and trained clinicians in workflow triage by flagging and communicating suspected positive findings of head NCCT images for large vessel occlusion (LVO) of the intracranial ICA and M1 and intracranial hemorrhage (ICH). Specifically, the device is intended to be used for the triage of images acquired from adult patients in the acute setting, within 24 hours of the onset of the acute symptoms, or where this is unclear, since last known well (LKW) time. It is not intended to detect isolated subarachnoid hemorrhage and symmetrical bilateral MCA occlusions.
Brainomix 360 Triage Stroke uses an artificial intelligence algorithm to analyze images and highlight cases with detected NCCT LVO or ICH on the Brainomix server on premise or in the cloud in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected LVO or ICH findings via a web user interface or mobile application. Notifications include compressed preview images that are meant for informational purposes only and are not intended for diagnostic use beyond notification.
The device does not alter the original medical image, and it is not intended to be used as a primary diagnostic device. The results of Brainomix 360 Triage Stroke are intended to be used in conjunction with other patient information and based on professional judgment to assist with triage/prioritization of medical images. Notified clinicians are ultimately responsible for reviewing full images per the standard of care.
Cautions:
- All patients should get adequate care for their symptoms, including angiography and/or other appropriate care per the standard clinical practice, irrespective of the output of Brainomix 360 Triage Stroke.
- Brainomix 360 Triage Stroke is not intended to be a rule-out device and for cases that have been processed by the device without notification for "Suspected LVO" should not be viewed as indicating that LVO is excluded. All cases should undergo
Rapid NCCT Stroke is a radiological computer aided triage and notification software indicated for use in the analysis of (1) nonenhanced head CT (NCCT) images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communicating suspected positive findings of (1) head CT images for Intracranial Hemorrhage (ICH) and (2) NCCT large vessel occlusion (LVO) of the ICA and MCA-M1.
Rapid NCCT Stroke uses an artificial intelligence algorithm to analyze images and highlight cases with detected (1) ICH or (2) NCCT LVO on the Rapid server on premise or in the cloud in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected ICH or LVO findings via PACS, email or mobile device. Notifications include compressed preview images that are meant for informational purposes only, and are not intended for diagnostic use beyond notification.
The device does not alter the original medical image, and it is not intended to be used as a primary diagnostic device. The results of Rapid NCCT Stroke are intended to be used in conjunction with other patient information and based on professional judgment to assist with triage/prioritization of medical images. Notified clinicians are ultimately responsible for reviewing full images per the standard of care. Rapid NCCT Stroke is for Adults only.
Cautions:
- All patients should get adequate care for their symptoms including CTA or MRA and/or other appropriate care per the standard clinical practice, irrespective of the device output.
- The device is not intended to be a ruleout device and for cases that have been processed by the device without notification for "Suspected LVO" should not be viewed as indicating that LVO is excluded. All cases should undergo CTA or MRA, per the standard stroke workup.
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Image /page/8/Picture/0 description: The image contains the word "BRAINOMIX" in a stylized font. The letters are a dark gray color, except for the "AI" which is a gradient of light blue to dark blue. To the left of the word is a graphic of a brain in the same gradient of light blue to dark blue.
initial assessment not meant for diagnostic
purposes.
| Environment of use | Clinical/Hospital environment | Clinical/Hospital environment |
|---|---|---|
| User | Clinician | Clinician |
| Anatomical Region | Head | Head |
| Input Data | NCCT (ICH and LVO) | NCCT (ICH and LVO) |
| Technical Implementation | AI/ML/Neural Network | AI/ML/Neural Network |
| Diagnostic application | Notification-only | Notification-only |
| Results of image analysis | Internal, no image marking | Internal, no image marking |
| Segmentation of ROI | The device does not highlight or direct user's attention to a specific location in the image file | The device does not highlight or direct user's attention to a specific location in the image file |
| Notification Display | PACS, email and mobile device | Web user interface and mobile device |
| Limitations: | Brainomix 360 Triage Stroke is not intended for mobile diagnostic use. Images viewed on a mobile platform are compressed preview images and not for diagnostic interpretation. Brainomix 360 Triage Stroke does not replace the need for CTA in ischemic stroke workup - it provides workflow prioritization and notification only. Brainomix 360 Triage Stroke has been validated and is intended to be used on Siemens, GE and Philips scanners. Brainomix 360 Triage Stroke is not intended to be used on patients with recent (within 6 weeks) neurosurgery or endovascular neurointervention or recent (within 4 weeks) previous diagnosis of stroke. Brainomix 360 Triage Stroke is not intended to detect isolated subarachnoid hemorrhage and symmetrical bilateral MCA occlusions. Contraindications: Brainomix 360 Triage Stroke is not suitable for use with scan data containing image features associated with: tumors or abscesses coils, shunts, embolization or movement artifacts Brainomix 360 Triage Stroke is not intended to be used for analyzing CT images in intracranial vascular pathologies such as arterial aneurysms, arteriovenous malformations or venous thrombosis. | Rapid NCCT Stroke does not replace the need for CTA in ischemic stroke workup, it provides workflow prioritization and notification only. Rapid ICH has been shown to reliably identify hemorrhages of ≥ 0.4ml. Contraindications/Exclusions/Cautions: Patient Motion: excessive motion leading to artifacts that make the scan technically inadequate. Hemorrhagic Transformation, Hematoma Very thin or no Ventricles |
| The device operates in parallel with the | ||
| standard of care. | The device operates in parallel with the | |
| standard of care. | ||
| Annotation / Localization | Device does not mark, highlight, or direct | |
| users' attention to a specific location in the | ||
| original image | Device does not mark, highlight, or direct | |
| users' attention to a specific location in the | ||
| original image | ||
| Results of Image Analysis | Internal, no image marking | Internal, no image marking |
| Prioritization Notification | Yes | Yes |
| Clinical SoC Workflow | In parallel to | In parallel to |
| Technical Pipeline | Two cascaded functions (ICH then LVO) using | |
| three integrated algorithms | Two cascaded functions (ICH then LVO) using | |
| three integrated algorithms | ||
| Removal of Cases from | ||
| SoC review | No | No |
initial assessment not meant for diagnostic
purposes.
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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 teal, and the letters of the word "BRAINOMIX" are a gradient of teal to gray.
Performance Data
A retrospective study was conducted with the primary endpoint of assessing the performance of Brainomix 360 Triage Stroke in identifying NCCT head images containing intracranial hemorrhage (ICH) or large vessel occlusion (LVO) findings in 267 cases (ICH positive: 40 cases; LVO positive: 112 cases; Negative for ICH or LVO: 115; excluded: 3 cases due to technical inadequacy). ICH positive cases were previously truthed using NCCT imaging with additional clinical information as described in the standalone study for our previously cleared device, Brainomix 360 Triage ICH (K231195). The LVO positive and negative cases were truthed using acute CTA imaging and additional clinical information by consensus of three experienced US board certified neuroradiologists.
Sensitivity and specificity exceeded the pre-specified performance goals for ICH and NCCT LVO. Specifically, ICH performance was observed at 92.5% sensitivity (95% Cl: 80.97-98.36%) and 87.22% specificity (Cl: 82.39-91.18%). These results were consistent with the Triage ICH standalone module performance (K231195). NCCT LVO performance was observed at 68.75% sensitivity (C: 59.71-76.90%) and 89.57% specificity (Cl: 82.92-94.36%).
In addition, a reader study was conducted to compare NCCT LVO sensitivity of the device to that of radiologists. Secondary endpoints of expert non-inferiority and non-expert superiority were used. Triage Stroke passed both conditions, with a sensitivity for all readers (experts and non-experts) of 47.94% (Cl: 37.91-57.97%). The difference between the device's sensitivity and that of all readers was 20.52% (Cl: 8.26-32.78%). The general radiologists (nonexperts) performed with a sensitivity of 47.18% (C: 33.62-60.75%). The difference between the device and nonexpert sensitivity was 21.28% (CI: 5.84-36.72%).
The Triage Stroke time-to-notification analysis includes three steps: (1) the time taken to transfer the image for DICOM transfer, (2) the device processing time, and (3) the time taken to deliver a notification after processing. The combined time-to-notification was compared to an acceptability criterion of 3.5 minutes. The minimum and maximum estimates for each of the three steps was assessed and combined to create a range of expected values for the total time-to-notification. The results were a minimum expected time-to-notification of 62 seconds, and a maximum of 134 seconds. This met the acceptability criterion of time-to-notification of under 3.5 minutes.
Performance across subgroups
Subgroup analyses were conducted for the LVO indication (the ICH algorithm is the same as the device cleared under K231195). The analyses assessed performance across age, gender, slice thickness and scanner manufacturer subgroups.
| Metrics | 21