Rapid Aneurysm Triage and Notification

K230074 · Ischemaview, Inc. · QFM · Jul 27, 2023 · Radiology

Device Facts

• Record ID: K230074
• Device Name: Rapid Aneurysm Triage and Notification
• Applicant: Ischemaview, Inc.
• Product Code: QFM · Radiology
• Decision Date: Jul 27, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2080
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

Rapid Aneurysm Triage and Notification (ANRTN) is a radiological computer-assisted triage and notification software device for analysis of CT images of the head. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and prioritizing studies with suspected saccular aneurysms during routine patient care. Rapid ANRTN uses an artificial intelligence algorithm to analyze images and highlight studies with suspected saccular aneurysms in a standalone application for study list prioritization or triage in parallel to ongoing standard of care. The device generates compressed preview images that are meant for informational purposes only and not intended for diagnostic use. The device does not alter the original medical image and is not intended to be used as a diagnostic device. Analyzed images are available for review through the PACS, email and mobile application. When viewed the images are for informational purposes only and not for diagnostic use. The results of Rapid ANRTN, in conjunction with other clinical information and professional judgment, are to be used to assist with triage/prioritization of saccular aneurysm cases. Radiologists who read the original medical images are responsible for the diagnostic decision. Rapid ANRTN 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.

Device Story

Rapid ANRTN is an AI/ML-based radiological software module integrated into the Rapid Platform; analyzes head CTA DICOM images to detect saccular aneurysms >= 4mm. Operates as a triage tool in hospital networks; flags studies for prioritization in parallel to standard of care. Outputs include notifications and non-diagnostic compressed preview images accessible via PACS, email, or mobile app. Used by radiologists and clinicians to assist in workflow triage; does not replace diagnostic evaluation. Benefits include faster identification of potential aneurysm cases, enabling timely clinical review and decision-making.

Clinical Evidence

Bench testing only. Performance validated on 266 CTA cases (151 positive, 115 negative) with ground truth established by 3 experts. Primary endpoint AUC > 0.95. Overall sensitivity 0.933, specificity 0.868. Sub-analysis provided for scanner manufacturers (GE, Philips, Siemens, Toshiba), gender, aneurysm size ([4, 5) to [10, 25) mm), and anatomical location (ACA, ACOM, Basilar/PCA, ICA, MCA, VA/PICA).

Technological Characteristics

Software-only device; AI/ML image processing module. Operates on DICOM CTA datasets. Complies with DICOM (NEMA PS 3.1-3.20), ISO 14971 (risk management), IEC 62304 (software lifecycle), and IEC 62366 (usability). Connectivity via PACS, email, and mobile application. Input requirements: headfirst supine, axial slices, Z FOV >= 90mm, pixel spacing 0.2-1.0mm, X/Y FOV 160-400mm, Z slice spacing 0.2-1.25mm, 80-140kVp.

Indications for Use

Indicated for adults with suspected saccular aneurysms >= 4mm in diameter. Analyzes head CTA images to flag/prioritize studies for triage. Excludes cases with significant motion/artifacts. Requires headfirst supine positioning, axial slices, specific FOV/spacing/kVp parameters, and continuous data series.

Regulatory Classification

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.

Special Controls

Radiological computer aided triage and notification software must comply with the following special controls: 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. Standalone 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. 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.

*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.

Predicate Devices

• Viz.AI's Aneurysm Software (K213319)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The logo is simple and professional, and it is easily recognizable.

iSchemaView Inc. James Rosa SVP Regulatory and Quality 1120 Washington Ave., Ste 200 GOLDEN, COLORADO 80401

July 27, 2023

## Re: K230074

Trade/Device Name: Rapid Aneurysm Triage and Notification Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological Computer Aided Triage And Notification Software Regulatory Class: Class II Product Code: QFM Dated: July 10, 2023 Received: July 11, 2023

#### Dear James Rosa:

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

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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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Jessica Lamb

Jessica Lamb. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K230074

#### Device Name Rapid Aneurysm Triage and Notification

#### Indications for Use (Describe)

Rapid Aneurysm Triage and Notification (ANRTN) is a radiological computer-assisted triage and notification software device for analysis of CT images of the head. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and prioritizing studies with suspected saccular aneurysms during routine patient care. Rapid ANRTN uses an artificial intelligence algorithm to analyze images and highlight studies with suspected saccular aneurysms in a standalone application for study list prioritization or triage in parallel to ongoing standard of care. The device generates compressed preview images that are meant for informational purposes only and not intended for diagnostic use. The device does not alter the original medical image and is not intended to be used as a diagnostic device. Analyzed images are available for review through the PACS, email and mobile application. When viewed the images are for informational purposes only and not for diagnostic use. The results of Rapid ANRTN, in conjunction with other clinical information and professional judgment, are to be used to assist with triage/prioritization of saccular aneurysm cases. Radiologists who read the original medical images are responsible for the diagnostic decision. Rapid ANRTN 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.

Rapid ANRT is limited to detecting saccular aneurysms at least 4mm in diameter in adults. Inclusion Criteria:

The module shall detect unruptured saccular brain aneurysms greater than or equal to 4 mm in size within the following anatomical region:

- · Internal Carotid Artery (ICA): ophthalmic segment to ICA terminus
- · Middle Cerebral Artery (MCA): M1 segment through M1/M2 bifurcation
- · Anterior Cerebral Artery (ACA): A1 and A2 segments
- · Anterior Communicating Artery (ACOM)
- · Posterior Communicating Artery (PCOM)
- · Posterior Cerebral Artery (PCA): P1 segment
- · Vertebral Artery (VA): intracranial portion of the VA through the vertebrobasilar (VB) junction
- · Basilar Artery (BA)
- Contraindications/Exclusions/Cautions:
- · The module shall process only CTA datasets with a patient position of 'headfirst supine'.
- · The module shall process only a series within CTA datasets comprised only of axial slices.

· The module shall process only CTA datasets with Z FOV (cranio-caudal transverse anatomical coverage) greater than or equal to 90 mm

- · The module shall process only CTA datasets with in-plane pixel spacing (X & Y resolution): 0.2 1.0 mm
- · The module shall process only CTA datasets with in-plane X FOV: 160-400mm.
- · The module shall process only CTA datasets with in-plane Y FOV: 160-400 mm
- · The module shall process only CTA datasets with Z slice spacing of 0.2 1.25 mm

· The module shall process only CTA data acquired at x-ray tube voltage 80kVp-140kVp, as reported in the input data DICOM header

- · The module shall process only CTA datasets consisting of continuous order without gaps.
- · The module shall process only CTA datasets where the images belong to a single series (i.e., identical SeriesInstanceUID DICOM tag value for all images).
- · The module shall not process CTA datasets where the DICOM tags "ImagePositionPatient" (IPP),

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- · The module shall only process a single series per study, being the largest available that passes the above requirements.
- · The module shall accept input files within a parent folder named by a unique identifier for the case.
- · The module shall accept axial-oblique CTA datasets with an oblique plane of < 35 degrees.
- · Cases with significant motion and/or imaging artifacts.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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## K230074 510(k) Summary

# iSchemaView, Inc.'s Rapid Aneurysm Triage and Notification

This document contains the 510(k) summary for the iSchemaView Rapid Aneurysm Triage and Notification Device (ANRTN). The content of this summary is based on the requirements of 21 CFR Section 807.92(c).

# Applicant Name and Address:

| Name: | iSchemaView, Inc. |
|-------------------|------------------------------------------------------------------|
| Address: | 1120 Washington St., Suite 200<br>Golden, CO 80401 |
| Official Contact: | Jim Rosa<br>Phone: [phone]<br>Email: [e-mail] |

#### July 25, 2023 Summary Preparation Date:

## Device Name and Classification:

| Trade Name: | Rapid Aneurysm Triage and Notification |
|--------------------------|-----------------------------------------------------------------|
| Classification<br>Name: | Radiological computer aided triage and<br>notification software |
| Classification: | II |
| Product Code: | QFM |
| Regulation No: | 21 C.F.R. §892.2080 |
| Classification<br>Panel: | Radiology Devices |

## Predicate Devices:

The iSchemaView Rapid ANRTN device is claimed to be substantially equivalent to the following legally marketed predicate devices:

Viz.AI's Aneurysm Software (K213319)

## Device Description:

Rapid ANRTN software device is a radiological computer-assisted image processing software device. The Rapid ANRTN device is a CTA processing module which operates within the integrated Rapid Platform to determine the suspicion of head saccular aneurysm(s). The ANRTN software analyzes input CTA images that are provided in DICOM format and provides notification of suspected saccular aneurysm(s) and a non-diagnostic, compressed image for preview. Rapid ANRTN is an AI/ML image processing module which integrates within the Rapid Platform.

## Indications for Use:

Rapid Aneurysm Triage and Notification (ANRTN) is a radiological computer-assisted triage and notification software device for analysis of CT images of the head. The device is

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# K230074 510(k) Summary

intended to assist hospital networks and trained radiologists in workflow triage by flagging and prioritizing studies with suspected saccular aneurysms during routine patient care.

Rapid ANRTN uses an artificial intelligence algorithm to analyze images and highlight studies with suspected saccular aneurysms in a standalone application for study list prioritization or triage in parallel to ongoing standard of care. The device generates compressed preview images that are meant for informational purposes only and not intended for diagnostic use. The device does not alter the original medical image and is not intended to be used as a diagnostic device.

Analyzed images are available for review through the PACS, email and mobile application. When viewed the images are for informational purposes only and not for diagnostic use. The results of Rapid ANRTN, in conjunction with other clinical information and professional judgment, are to be used to assist with triage/prioritization of saccular aneurysm cases. Radiologists who read the original medical images are responsible for the diagnostic decision. Rapid ANRTN is limited to analysis of imaging data and should not be used inlieu of full patient evaluation or relied upon to make or confirm diagnosis.

Rapid ANRT is limited to detecting saccular aneurysms at least 4mm in diameter in adults.

# Inclusion Criteria:

The module shall detect unruptured saccular brain aneurysms greater than or equal to 4 mm in size within the following anatomical region:

- Internal Carotid Artery (ICA): ophthalmic segment to ICA terminus .
- . Middle Cerebral Artery (MCA): M1 segment through M1/M2 bifurcation
- Anterior Cerebral Artery (ACA): A1 and A2 segments .
- Anterior Communicating Artery (ACOM) .
- Posterior Communicating Artery (PCOM) .
- Posterior Cerebral Artery (PCA): P1 segment .
- Vertebral Artery (VA): intracranial portion of the VA through the vertebrobasilar (VB) . junction
- Basilar Artery (BA) .

# Contraindications/Exclusions/Cautions:

- . The module shall process only CTA datasets with a patient position of 'headfirst supine'.
- The module shall process only a series within CTA datasets comprised only of axial slices.
- . The module shall process only CTA datasets with Z FOV (cranio-caudal transverse anatomical coverage) greater than or equal to 90 mm
- . The module shall process only CTA datasets with in-plane pixel spacing (X & Y resolution): 0.2 – 1.0 mm
- The module shall process only CTA datasets with in-plane X FOV: 160-400mm.
- . The module shall process only CTA datasets with in-plane Y FOV: 160-400 mm
- . The module shall process only CTA datasets with Z slice spacing of 0.2 – 1.25 mm
- . The module shall process only CTA datasets with data acquired at x-ray tube voltage 80kVp-140kVp, as reported in the input data DICOM header
- . The module shall process only CTA datasets consisting of input slices of continuous order without gaps.
- . The module shall process only CTA datasets where the images belong to a single series (i.e., identical SeriesInstanceUID DICOM tag value for all images).

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## K230074 510(k) Summary

- The module shall not process CTA datasets where the DICOM tags "ImagePositionPatient" ● (IPP), "ImageOrientationPatient" (IOP), or "PixelSpacing" are missing
- The module shall only process a single series per study, being the largest available that passes the • above requirements.
- The module shall accept input files within a parent folder named by a unique identifier for the case.
- The module shall accept axial-oblique CTA datasets with an oblique plane of ≤ 35 degrees. •
- Cases with significant motion and/or imaging artifacts.

# Technological Characteristics and Substantial Equivalence:

Rapid ANRTN does not raise new questions of safety or effectiveness compared to the previously cleared Viz.AI ANX Software (K213319). There are minor differences in technical characteristics with the predicate device; with the minor changes the clinical use for Rapid ANRTN device is the same with no additional risks. Thus, the Rapid ANRTN device is substantially equivalent.

The following table summarizes and compares data on the Viz.AI ANX Software (K213319) to the Rapid ANRTN device that is the subject of this Traditional 510(k) submission.

| Parameter | Rapid ANRTN (Subject Device) | Viz Aneurysm (Predicate Device) |
|---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | QFM | QFM |
| Regulation | 21 CFR §892.2080 | 21 CFR §892.2080 |
| Intended Use/<br>Indications for<br>Use | Rapid Aneurysm Triage and<br>Notification (ANRTN) is a<br>radiological computer-assisted<br>triage and notification software<br>device for analysis of CT images<br>of the head. The device is<br>intended to assist hospital<br>networks and trained radiologists<br>in workflow triage by flagging and<br>prioritizing studies with suspected<br>saccular aneurysms during routine<br>patient care.<br><br>Rapid ANRTN uses an artificial<br>intelligence algorithm to analyze<br>images and highlight studies with<br>suspected saccular aneurysms in a<br>standalone application for study<br>list prioritization or triage in<br>parallel to ongoing standard of<br>care. The device generates<br>compressed preview images that<br>are meant for informational<br>purposes only and not intended for | Viz ANEURYSM (Viz ANX)<br>is a radiological computer-<br>assisted triage and notification<br>software device for analysis of<br>CT images of the head. The<br>device is intended to assist<br>hospital networks and trained<br>radiologists in workflow triage<br>by flagging and prioritizing<br>studies with suspected<br>aneurysms during routine<br>patient care.<br><br>Viz ANEURYSM uses an<br>artificial intelligence algorithm<br>to analyze images and highlight<br>studies with suspected<br>aneurysms in a standalone<br>application for study list<br>prioritization or triage in<br>parallel to ongoing standard of<br>care. The device generates<br>compressed preview images<br>that are meant for informational |
| Parameter | Rapid ANRTN (Subject Device) | Viz Aneurysm (Predicate Device) |
| | diagnostic use. The device does<br>not alter the original medical<br>image and is not intended to be<br>used as a diagnostic device.<br>Analyzed images are available for<br>review through the PACS, email<br>and mobile application. When<br>viewed the images are for<br>informational purposes only and<br>not for diagnostic use. The results<br>of Rapid ANRTN, in conjunction<br>with other clinical information and<br>professional judgment, are to be<br>used to assist with<br>triage/prioritization of saccular<br>aneurysm cases. Radiologists who<br>read the original medical images<br>are responsible for the diagnostic<br>decision. Rapid ANRT is limited<br>to analysis of imaging data and<br>should not be used in-lieu of full<br>patient evaluation or relied upon to<br>make or confirm diagnosis.<br>Rapid ANRT is limited to<br>detecting saccular aneurysms at<br>least 4mm in diameter in adults.<br><inclusions and="" limitations<br="">provided above&gt;</inclusions> | purposes only and not intended<br>for diagnostic use. The device<br>does not alter the original<br>medical image and is not<br>intended to be used as a<br>diagnostic device. Analyzed<br>images are available for review<br>through the standalone<br>application. When viewed<br>through the standalone<br>application the images are for<br>informational purposes only<br>and not for diagnostic use. The<br>results of Viz ANEURYSM, in<br>conjunction with other clinical<br>information and professional<br>judgment, are to be used to<br>assist with triage/prioritization<br>of medical images.<br>Radiologists who read the<br>original medical images are<br>responsible for the diagnostic<br>decision. Viz ANEURYSM is<br>limited to analysis of imaging<br>data and should not be used in-<br>lieu of full patient evaluation or<br>relied upon to make or confirm<br>diagnosis.<br>Viz ANEURYSM is limited to<br>detecting aneurysms at least<br>4mm in diameter. |
| Anatomical<br>Region | Head | Head |
| Independent<br>Standard of Care | Yes | Yes |
| Notification/<br>Prioritization | Yes | Yes |
| Identify patients<br>with pre-specified<br>clinical condition | Yes | Yes |
| Clinical Condition | Aneurysm | Aneurysm |
| Intended User | Radiologist | Radiologist |
| Parameter | Rapid ANRTN (Subject Device) | Viz Aneurysm (Predicate Device) |
| DICOM | Yes | Yes |
| Imaging Modality | CTA | CTA |
| Alteration of Image | No | No |
| Preview Images | Non-diagnostic | Non-diagnostic |

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K230074 510(k) Summary

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K230074 510(k) Summary

# AI/ML Module Development:

Algorithm development was performed using 698 (633training, 65 validation) CTA cases from multiple sites. Cases selected covered a wide range of suspected saccular aneurysms. Cases were obtained from Siemens, GE, Toshiba, and Philips scanners.

# Clinical Characteristics:

The primary users of Rapid ANRTN software are medical professionals including radiologists, neuroradiologists, emergency physicians, neurologists, neurosurgeons, etc., who may review CTA scans of the head for indication of aneurysm.

# Performance Standards:

Rapid ANRTN has been developed in conformance with the following standards, as applicable:

| EN ISO 14971:2019 (R2021) | Application of Risk Management to Medical Devices |
|---------------------------|---------------------------------------------------------|
| IEC 62304:2006 (R2015) | Medical device software – Software lifecycle processes |
| IEC 62366:2015 (R2020) | Application of Usability Engineering to Medical Devices |
| NEMA PS 3.1 - 3.20 | Digital Imaging and Communications in Medicine (DICOM) |

# Performance Data:

Rapid ANRTN complies with DICOM (Digital Imaging and Communications in Medicine) -Developed by the American College of Radiology and the National Electrical Manufacturers Association. NEMA PS 3.1 - 3.20.

iSchemaView conducted extensive performance validation testing and software verification and validation testing of the Rapid ANRTN device. Final device validation included standalone performance validation. This performance validation testing demonstrated the Rapid ANRTN device provides accurate representation of key processing parameters under a range of clinically relevant perturbations associated with the intended use of the software. Software performance, validation and verification testing demonstrated that the Rapid ANRTN device met all design requirements and specifications. Final performance validation included 266 (151 pos, 115 neg) CTA cases with ground truth established by 3 experts. The primary endpoint passed with AUC > 0.95 for high performance per the OFM product code definition. Additionally, Sensitivity (0.933) and Specificity(0.868) supported the finding. Age range evaluated was 21-99 with mean 64. Sub-segmented performance by scanners have different performance levels which are affected by sample sizes as seen in the confidence interval spread.

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iSchemaView - Traditional 510(k) Rapid Aneurysm Triage and Notification K230074 510(k) Summary

Image /page/9/Figure/1 description: This image is a plot of sensitivity versus 1-specificity. The y-axis is labeled "Sensitivity True Positive" and ranges from 0 to 1.00 in increments of 0.10. The x-axis is labeled "1-Specificity False Positive" and ranges from 0 to 1.00 in increments of 0.10. A black curve is plotted on the graph, and a yellow line is plotted from approximately (0, 0.8) to (0.2, 1.0).

The following performance is seen across the indicated sub analysis:

| Manufacturer | Measure | N | Estimate | Lower 95% CI | Upper 95% CI |
|--------------|-------------|----|----------|--------------|--------------|
| GE | Sensitivity | 37 | 0.973 | 0.862 | 0.995 |
| | Specificity | 32 | 0.875 | 0.719 | 0.950 |
| PHILIPS | Sensitivity | 19 | 0.842 | 0.624 | 0.945 |
| | Specificity | 21 | 0.857 | 0.654 | 0.950 |
| SIEMENS | Sensitivity | 36 | 0.889 | 0.747 | 0.956 |
| | Specificity | 33 | 0.818 | 0.656 | 0.914 |
| TOSHIBA | Sensitivity | 42 | 0.976 | 0.877 | 0.996 |
| | Specificity | 28 | 0.929 | 0.774 | 0.980 |
| Gender | Measure | N | Estimate | Lower 95% CI | Upper 95% CI |
| Female | Sensitivity | 96 | 0.958 | 0.898 | 0.984 |
| | Specificity | 53 | 0.868 | 0.752 | 0.935 |
| Male | Sensitivity | 36 | 0.861 | 0.713 | 0.939 |
| | Specificity | 51 | 0.902 | 0.790 | 0.957 |
| ANR Size | Measure | N | Estimate | Lower 95% CI | Upper 95% CI |
| [4, 5) | Sensitivity | 41 | 0.927 | 0.806 | 0.975 |
| [5, 7) | Sensitivity | 54 | 0.944 | 0.849 | 0.981 |
| [7, 10) | Sensitivity | 28 | 0.893 | 0.728 | 0.963 |
| [10, 25) | Sensitivity | 11 | 1.000 | 0.741 | 1.000 |
| ANR Location | Measure | N | Estimate | Lower 95% CI | Upper 95% CI |
| ACA | Sensitivity | 8 | 1.000 | 0.676 | 1.000 |
| ACOM | Sensitivity | 29 | 0.931 | 0.780 | 0.981 |
| Basilar/PCA | Sensitivity | 18 | 0.944 | 0.742 | 0.990 |
| ICA | Sensitivity | 40 | 0.900 | 0.769 | 0.960 |
| MCA | Sensitivity | 33 | 0.939 | 0.804 | 0.983 |
| VA/PICA | Sensitivity | 6 | 1.000 | 0.610 | 1.000 |

{10}------------------------------------------------

K230074 510(k) Summary

# Prescriptive Statement:

Caution: Federal law restricts this device to sale by or on the order of a physician.

# Safety & Effectiveness:

Rapid ANRTN has been designed, verified and validated in compliance with 21 CFR, Part 820.30 requirements. The device has been designed to meet the requirements associated with EN ISO 14971:2019 (risk management). The Rapid ANRTN performance has been validated with case data.

Rapid ANRTN has been developed using the cybersecurity framework defined within the FDA Draft Guidance: Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions

# Conclusion:

In conclusion, the iSchemaView Rapid ANRTN software device is substantially equivalent in intended use, technological characteristics, safety and performance characteristics to the legally marketed predicate device, Viz.AI ANX Software (K213319).