(91 days)
Not Found
Yes
The device description explicitly states that it uses "artificial intelligence algorithms" and "machine learning algorithms".
No
The device is a notification-only, parallel workflow tool intended for triage and communication, not for providing therapy.
No
The device description explicitly states multiple times that it is "not for diagnostic use beyond notification" and that "Images viewed on a mobile platform are preview images and not for diagnostic interpretation." It emphasizes that the device is a "notification-only" tool and "should not be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis."
Yes
The device description explicitly states that Brainomix 360 Triage ICH is a "stand-alone software device" and 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." While it interacts with hardware (CT scanners, servers, mobile devices), the device itself is described as the software component.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- It analyzes images for findings suggestive of a prespecified clinical condition: The device analyzes non-contrast CT images of the brain for findings suggestive of intracranial hemorrhage (ICH).
- It uses an artificial intelligence algorithm: The device explicitly states it uses an AI algorithm to perform this analysis.
- It is intended for use in a clinical setting: It is intended for use by hospital networks and trained clinicians in the acute setting.
- The analysis is performed on biological samples (images derived from the patient): While the device analyzes images, these images are directly derived from the patient's body (brain CT scans), which are considered biological samples in the context of IVD regulation.
While the device is described as a "notification-only, parallel workflow tool" and emphasizes that the notification is "not for diagnostic use beyond notification," the core function of the device is to analyze medical images (biological samples) using an algorithm to identify potential signs of a specific medical condition (ICH). This analysis is the basis for the notification.
The fact that the final diagnostic decision rests with a clinician viewing non-compressed images on a diagnostic viewer does not negate the fact that the initial analysis and identification of potential findings is being performed by the device on patient data.
Therefore, the device fits the definition of an IVD because it performs an analysis on a biological sample (medical image derived from a patient) to provide information related to a medical condition, even if that information is intended for triage and notification rather than a definitive diagnosis.
No
The letter does not state that the FDA has reviewed and approved or cleared a PCCP for this specific device. The input explicitly indicates "Not Found" for "Control Plan Authorized (PCCP) and relevant text".
Intended Use / Indications for Use
Brainomix 360 Triage ICH is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of specific patients to a specialist, independent of standard of care workflow.
Brainomix 360 Triage ICH uses an artificial intelligence algorithm to analyze images for findings suggestive of a prespecified clinical condition and to notify an appropriate medical specialist of these findings in parallel to standard of care image interpretation. Identification of suspected findings is not for diagnostic use beyond notification. Specifically, the device is intended to be used for the triage of non-contrast CT images of the brain 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. The device sends notifications to a neurovascular or neurosurgical specialist that a suspected intracranial hemorrhage has been identified and recommends review of those images. Images can be previewed through a mobile application.
Images that are previewed through the mobile application may be compressed and are for informational purposes only and not intended for diagnostic use beyond notification. Notified clinicians are responsible for viewing noncompressed 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. Brainomix 360 Triage to analysis of imaging data and should not be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis.
Limitations:
- . Brainomix 360 Triage ICH is not intended for mobile diagnostic use. Images viewed on a mobile platform are preview images and not for diagnostic interpretation.
- Brainomix 360 Triage ICH has been validated and is intended to be used on GE and Philips scanners.
- Brainomix 360 Triage ICH is not intended to detect isolated subarachnoid hemorrhage.
- Brainomix 360 Triage ICH 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 intracranial hemorrhage
Contraindications:
Brainomix 360 Triage ICH is not suitable for use with scan data containing image features associated with:
- tumors or abscesses
- coils, shunts, embolization or movement artefacts
Brainomix 360 Triage ICH is not intended to be used for analyzing CT images in intracranial vascular pathologies such as arterial aneurysms, arteriovenous malformations or venous thrombosis.
Product codes (comma separated list FDA assigned to the subject device)
QAS
Device Description
Brainomix 360 Triage ICH 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 ICH module is a non-contrast CT processing module which operates within the integrated Brainomix 360 Platform to provide triage and notification of suspected intracranial hemorrhage (ICH). Brainomix 360 Triage ICH is a stand-alone software device which uses machine learning algorithms that uses advanced non adaptive imaging algorithms, artificial intelligence, and large data analytics to automatically identify suspected ICH on non-contrast CT (NCCT) imaging 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. The module is a priority notification to clinicians indicating the suspicion of ICH based on positive findings. Specifically, Brainomix 360 Triage ICH is optimized to detect and evaluate hyperdense volume in the parenchyma typically associated with acute intracranial hemorrhage (ICH). The Triage ICH 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 ICH notification capabilities enable clinicians to review images via mobile app notification. Alternatively, intended users can also access the notification (a "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
Mentions AI, machine learning and artificial intelligence.
Input Imaging Modality
non-contrast CT images
Anatomical Site
Head
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Trained clinicians; hospital networks, 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 has been carried out to assess the standalone performance of the image analysis algorithm and notification functionality of Triage ICH. A sample size of 341 non-contrast Computed Tomography (NCCT) scans (studies) were obtained from 30 different hospitals and clinics in the U.S. The majority of patients were scanned at Boston Medical Centre (N=237) and the remainder came from 29 different referral hospitals in Massachusetts State. The patient co ensure an approximately equal balance of ICH positive studies and to ensure the distribution of clinical and demographic variables (e.g., age, gender, ICH subtype, traumatic etiology) allows generalizability to the patient population for whom use is intended. Ground truth was established by experienced US board certified neuroradiologists.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A retrospective study has been carried out to assess the standalone performance of the image analysis algorithm and notification functionality of Triage ICH. The study evaluated the Triage ICH image analysis algorithm in terms of sensitivity and specificity with respect to a ground truth, as established by experienced US board certified neuroradiologists, in the detection of intracranial hemorrhage (ICH) in the brain. In addition, the study reported and compared the time to notification for the Triage ICH device with respect to the time to notification for the standard of care as established by the predicate device.
A sample size of 341 non-contrast Computed Tomography (NCCT) scans (studies) were obtained. The cases (n=341) were all successed with the algorithm. The confusion matrix was as follows: True Positives (TP): 149, True Negatives (TN): 159, False Positives (FP): 15, False Negatives (FN): 18. The overall performance can also be summarized with the following metrics: sensitivity (or positive percentage agreement, defined as TP/[TP+FN]] was 89.22%, specificity (or negative percentage agreement, defined as TN/[TN+FP]) was 91.37%. The receiver operating curve (ROC) for the device is shown in Figure 1, with an operating point at sensitivity 89.2%, specificity 91.4%.
Because the lower bound of each confidence interval for sensitivity and specificity exceeded 80%, the study met the pre-specified performance goals. The device's time to notification ranged from 50-126 seconds, which was substantially lower than the average time to notification seen in the Standard of Care reported by the predicate device (38.2 minutes).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 89.22%
Specificity: 91.37%
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
§ 892.2080 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Brainomix Limited % Szrnka Zsolt Regulatory Affairs Manager First Floor Seacourt Tower West Way Oxford. OX2 0JJ UNITED KINGDOM
Re: K231195
July 27, 2023
Trade/Device Name: Brainomix 360 Triage ICH Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological computer aided triage and notification software Regulatory Class: Class II Product Code: QAS Dated: April 21, 2023 Received: June 22, 2023
Dear Szrnka Zsolt:
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 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
2
Indications for Use
510(k) Number (if known) K231195
Device Name Brainomix 360 Triage ICH
Indications for Use (Describe)
Brainomix 360 Triage ICH is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of specialist, independent of standard of care workflow.
Brainomix 360 Triage ICH uses an artificial intelligence algorithm to analyze images for findings suggestive of a prespecified clinical condition and to notify an appropriate medical specialist of these findings in parallel to standard of care interpretation. Identification of suspected findings is not for diagnostic use beyond notification. Specifically, the device is intended to be used for the triage of non-contrast CT images of the brain 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. The device sends notifications to a neurovascular specialist that a suspected intracranial hemorrhage has been identified and recommends review of those images. Images can be previewed through a mobile application.
Images that are previewed through the mobile application are compressed and are for informational purposes only and not intended for diagnostic use beyond notification. 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. Brainomix 360 Triage ICH is limited to analysis of imaging data and should not be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis.
Limitations:
· Brainomix 360 Triage ICH is not intended for mobile diagnostic use. Images viewed on a mobile platform are preview images and not for diagnostic interpretation.
- · Brainomix 360 Triage ICH has been validated and is intended to be used on GE and Philips scanners.
- · Brainomix 360 Triage ICH is not intended to detect isolated subarachnoid hemorrhage.
- · Brainomix 360 Triage ICH 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 intracranial hemorrhage.
Contraindications:
Brainomix 360 Triage ICH is not suitable for use with scan data containing image features associated with:
- · tumors or abscesses
- · coils, shunts, embolization or movement artefacts
Brainomix 360 Triage ICH 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)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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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 a teal gradient on the "AI" part of the word.
K231195
510(K) Summary Brainomix Limited's Brainomix 360 Triage ICH
| Date Prepared: | June 22, 2023 |
|---|---|
| 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 | |
| zszrnka@brainomix.com | |
| Device Proprietary Name: | Brainomix 360 Triage ICH |
| 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 |
Brainomix 360 Triage ICH is Substantially Equivalent to the following Legally Marketed device:
Predicate Device
| 510(k) Number | Trade Name | Manufacturer |
|---|---|---|
| K193658 | Viz ICH | Viz.ai, Inc. |
Intended Use / Indications for Use
Brainomix 360 Triage ICH is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of specific patients to a specialist, independent of care workflow.
Brainomix 360 Triage ICH uses an artificial intelligence algorithm to analyze images for findings suggestive of a prespecified clinical condition and to notify an appropriate medical specialist of these findings in parallel to standard of care image interpretation. Identification of suspected findings is not for diagnostic use beyond notification. Specifically, the device is intended to be used for the triage of non-contrast CT images of the brain 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. The device sends notifications to a neurovascular or neurosurgical specialist that a suspected intracranial hemorrhage has been identified and recommends review of those images. Images can be previewed through a mobile application.
5
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 light blue to dark blue. The letters in "BRAINOMIX" are black, except for the "A", which is a gradient of light blue to dark blue, matching the brain icon.
lmages that are previewed through the mobile application may be compressed and are for informational purposes only and not intended for diagnostic use beyond notification. Notified clinicians are responsible for viewing noncompressed 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. Brainomix 360 Triage to analysis of imaging data and should not be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis.
Limitations:
- . Brainomix 360 Triage ICH is not intended for mobile diagnostic use. Images viewed on a mobile platform are preview images and not for diagnostic interpretation.
- Brainomix 360 Triage ICH has been validated and is intended to be used on GE and Philips scanners.
- Brainomix 360 Triage ICH is not intended to detect isolated subarachnoid hemorrhage.
- Brainomix 360 Triage ICH 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 intracranial hemorrhage
Contraindications:
Brainomix 360 Triage ICH is not suitable for use with scan data containing image features associated with:
- tumors or abscesses
- coils, shunts, embolization or movement artefacts
Brainomix 360 Triage ICH 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 ICH 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 ICH module is a non-contrast CT processing module which operates within the integrated Brainomix 360 Platform to provide triage and notification of suspected intracranial hemorrhage (ICH). Brainomix 360 Triage ICH is a stand-alone software device which uses machine learning algorithms that uses advanced non adaptive imaging algorithms, artificial intelligence, and large data analytics to automatically identify suspected ICH on non-contrast CT (NCCT) imaging 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. The module is a priority notification to clinicians indicating the suspicion of ICH based on positive findings. Specifically, Brainomix 360 Triage ICH is optimized to detect and evaluate hyperdense volume in the parenchyma typically associated with acute intracranial hemorrhage (ICH). The Triage ICH 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 ICH notification capabilities enable clinicians to review images via mobile app notification. Alternatively, intended users can also access the notification (a "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
6
Image /page/6/Picture/0 description: The image shows the logo for BRAINOMIX. The logo consists of a stylized brain icon on the left, followed by the word "BRAINOMIX" in a sans-serif font. The brain icon is teal, and the letters in "BRAINOMIX" are a gradient of teal to gray.
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.
Summary of Technological Characteristics
Both proposed and predicate device are a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of specialist, independent of standard of care workflow. Notifications generated from both proposed and predicate devices are shared with clinicians to alert that a suspected intracranial hemorrhage has been identified and recommends review of those images.
The proposed and predicate devices are equally intended for use as an additional tool for assisting study triage within existing patient pathways. They do not replace any part of the current standard of care. Likewise, they are designed to assist in prioritization of studies for reading within a worklist, in addition to any other pre-existing formal or informal methods of study prioritization in place.
Both proposed and predicate devices are designed to be used by trained clinicians in a hospital/clinical environment.
Both proposed and predicate devices run on standard physical and/or virtual servers which are installed within a hospital network and within the protection of hospital firewalls.
The predicate device notifies the user via mobile and provides compressed original images which are used for informational purposes only. Likewise, the images which are shared on notifications by the proposed device are compressed and for informational purposes only. As the predicate, a persistent warning is displayed to alert users that the images are compressed and not intended for diagnostic purposes.
Where Brainomix 360 Triage ICH differs from the predicate is that the proposed device may also notify the user of a suspected ICH via the web user interface, as an additional channel of 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 noncompressed 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.
| Characteristic/Parameter | Brainomix 360 Triage ICH – Subject Device | Viz.ai Viz ICH - Predicate Device
(K193658) |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | QAS | QAS |
| Regulation | 21 C.F.R. §892.2080 | 21 C.F.R. §892.2080 |
| Indications for Use | Brainomix 360 Triage ICH is a notification-only,
parallel workflow tool for use by hospital
networks and trained clinicians to identify and
communicate images of specific patients to a
specialist, independent of standard of care
workflow.
Brainomix 360 Triage ICH uses an artificial
intelligence algorithm to analyze images for
findings suggestive of a prespecified clinical
condition and to notify an appropriate medical | Viz ICH is a notification-only, parallel
workflow tool for use by hospital networks
and trained clinicians to identify and
communicate images of specific patients
to a specialist, independent of standard of
care workflow.
Viz ICH uses an artificial intelligence
algorithm to analyze images for findings
suggestive of a prespecified clinical
condition and to notify an appropriate |
7
Image /page/7/Picture/0 description: The image shows the word "BRAINOMIX" in a stylized font. The first letter, "A", is a gradient of blue and green. The rest of the letters are gray. To the left of the word is a blue and green icon that looks like a brain.
specialist of these findings in parallel to standard of care image interpretation. ldentification of suspected findings is not for diagnostic use beyond notification. Specifically, the device is intended to be used for the triage of non-contrast CT images of the brain 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. The device sends notifications to a neurovascular or neurosurgical specialist that a suspected intracranial hemorrhage has been identified and recommends review of those images. Images can be previewed through a mobile application.
Images that are previewed through the mobile application may be compressed and are for informational purposes only and not intended for diagnostic use beyond notification. 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. Brainomix 360 Triage ICH is limited to analysis of imaging data and should not be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis.
Limitations:
- Brainomix 360 Triage ICH is not intended for mobile diagnostic use. lmages viewed on a mobile platform are preview images and not for diagnostic interpretation.
- Brainomix 360 Triage ICH has been validated and is intended to be used on GE and Philips scanners.
- Brainomix 360 Triage ICH is not intended to detect isolated subarachnoid hemorrhage.
- . Brainomix 360 Triage ICH 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 intracranial hemorrhage
medical specialist of these findings in parallel to standard of care image interpretation. Identification of suspected findings is not for diagnostic use beyond notification. Specifically, the device analyzes non-contrast CT images of the brain acquired in the acute setting, and sends notifications to a neurovascular or neurosurgical specialist that a suspected intracranial hemorrhage has been identified and recommends review of those images. Images can be previewed through a mobile application.
Images that are previewed through the mobile application may be compressed and are for informational purposes only and not intended for diagnostic use beyond notification. 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. Viz ICH is limited to analysis of imaging data and should not be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis.
Viz ICH is contraindicated for analyzing non-contrast CT scans that are acquired on scanners from manufacturers other than General Electric (GE) or its subsidiaries (i.e. GE Healthcare). This contraindication applies to NCCT scans that conform to all applicable Patient Inclusion Criteria, are of adequate technical image quality, and would otherwise be expected to be analyzed by the device for a suspected ICH.
Contraindications:
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Image /page/8/Picture/0 description: The image shows the logo for BRAINOMIX. The logo consists of a stylized brain icon on the left, colored in a gradient from light blue to white. To the right of the icon is the word "BRAINOMIX" in a sans-serif font, with the "AI" portion of the word in a lighter blue color than the rest of the text.
| | Brainomix 360 Triage ICH is not suitable for
use with scan data containing image features
associated with: | |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| | • tumors or abscesses | |
| | • coils, shunts, embolization or | |
| | movement artefacts | |
| | | |
| | Brainomix 360 Triage ICH is not intended to be | |
| | used for analyzing CT images in intracranial
vascular pathologies such as arterial
aneurysms, arteriovenous malformations or
venous thrombosis. | |
| 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 |
| Primary Users | Neurovascular Specialist | Neurovascular Specialist |
| Anatomical Region | Head | Head |
| Technical Implementation | Artificial intelligence algorithm with database
of images | Artificial intelligence algorithm with
database of images |
| Diagnostic application | Notification-only | Notification-only |
| Results of image analysis | Internal, no image marking | Internal, no image marking |
| Alteration of original
image | No | No |
| Preview Images | Initial assessment; non-diagnostic purposes | Initial assessment; non-diagnostic
purposes |
| Image viewing and
manipulation | Yes - window, pan, level, zoom | Yes – window, pan, level, zoom |
| Results of Image Analysis | Internal, no image marking | Internal, no image marking |
| Interference with
standard workflow | No. Cases are not removed from worklist or
deprioritized | No. Cases are not removed from worklist
or deprioritized |
| Notification | Mobile application and web user interface | Mobile |
| Design: DICOM
compliance | Yes | Yes |
| Design: Computer
Platform | Standard off-the-shelf server or virtual server | Standard off-the-shelf server or virtual
server |
| Design: Data acquisition | Acquires medical image data from DICOM
compliant imaging devices and modalities | Acquires medical image data from DICOM
compliant imaging devices and modalities |
| Materials | N/A - Software only device | N/A - Software only device |
| Biocompatibility | N/A - Software only device | N/A – Software only device |
| Sterility | N/A - Software only device | N/A - Software only device |
| Electrical Safety | N/A - Software only device | N/A - Software only device |
| Mechanical Safety | N/A - Software only device | N/A - Software only device |
| Chemical Safety | N/A - Software only device | N/A - Software only device |
| Thermal Safety | N/A - Software only device | N/A - Software only device |
Performance Data
A retrospective study has been carried out to assess the standalone performance of the image analysis algorithm and notification functionality of Triage ICH. The study evaluated the Triage ICH image analysis algorithm in terms
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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 "A" and "I" in "BRAINOMIX" are also teal, while the rest of the letters are gray.
of sensitivity and specificity with respect to a ground truth, as established by experienced US board certified neuroradiologists, in the detection of intracranial hemorrhage (ICH) in the brain. In addition, the study reported and compared the time to notification for the Triage ICH device with respect to the time to notification for the standard of care as established by the predicate device.
A sample size of 341 non-contrast Computed Tomography (NCCT) scans (studies) were obtained from 30 different hospitals and clinics in the U.S. The majority of patients were scanned at Boston Medical Centre (N=237) and the remainder came from 29 different referral hospitals in Massachusetts State. The patient co ensure an approximately equal balance of ICH positive studies and to ensure the distribution of clinical and demographic variables (e.g., age, gender, ICH subtype, traumatic etiology) allows generalizability to the patient population for whom use is intended.
The cases (n=341) were all successed with the algorithm. The confusion matrix was as follows: True Positives (TP): 149, True Negatives (TN): 159, False Positives (FP): 15, False Negatives (FN): 18. The overall performance can also be summarized with the following metrics: sensitivity (or positive percentage agreement, defined as TP/[TP+FN]] was 89.22%, specificity (or negative percentage agreement, defined as TN/[TN+FP]) was 91.37%. The receiver operating curve (ROC) for the device is shown in Figure 1.
Image /page/9/Figure/5 description: This image shows a plot of sensitivity versus specificity. The x-axis is labeled specificity and ranges from 0 to 1. The y-axis is labeled sensitivity and ranges from 0 to 1. A blue curve is plotted on the graph, and a red triangle is plotted at the point where specificity is approximately 0.9 and sensitivity is approximately 0.9.
Figure 1. Receiver Operating Curve for the operating point (sensitivity 89.2%, specificity 91.4%) shown with the red triangle.
Because the lower bound of each confidence interval for sensitivity and specificity exceeded 80%, the study met the pre-specified performance goals.
As part of a secondary analysis, the company stratified the device performance by various confounding variables: ICH subtype (Table 1); by gender (Table 3); by slice thickness (Table 4); by clinical site (Table 5); and by ICH Volume (Table 6).
| ICH Subtype | Sensitivity (95% CI) |
|---|---|
| Intraparenchymal Hemorrhage (IPH) | 96.61% (88.29-99.59) |
| Intraventricular Hemorrhage (IVH) | 100.00% (59.04-100.00) |
| Subarachnoid Hemorrhage (SAH) | 35.71% (12.76-64.86) |
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Image /page/10/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 word "BRAINOMIX" is a dark gray color, except for the "A" which is teal.
| Subdural Hemorrhage (SDH) | 66.67% (40.99-86.66) |
|---|---|
| Multiple Types | 98.55% (92.19-99.96) |
Table 1. Summary of the performance metrics for the subsets of scans stratified by ICH Subtype.
| Gender | Sensitivity (95% CI) | Specificity (95% CI) |
|---|---|---|
| Male | 93.18% (85.75-97.46) | 91.30% (83.58-96.17) |
| Female | 84.81% (74.97-91.90) | 91.46% (83.20-96.50) |
Table 2. Summary of the performance metrics for the subsets of scans stratified by gender.
| Age | Sensitivity (95% CI) | Specificity (95% CI) |
|---|---|---|
| 21 |