← Product Code [QAS](/productcode/QAS) · K261085

# Rapid Vessel Occlusion (Rapid VO) (K261085)

_iSchemaview · QAS · Jul 13, 2026 · Radiology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K261085

## Device Facts

- **Applicant:** iSchemaview
- **Product Code:** [QAS](/productcode/QAS.md)
- **Decision Date:** Jul 13, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.2080
- **Device Class:** Class 2
- **Review Panel:** Radiology
- **Attributes:** AI/ML, Software as a Medical Device, PCCP, Real-World Evidence

## Real-World Evidence

| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
| --- | --- | --- | --- | --- | --- |
| K261085 · Jul 13, 2026 | Rapid Vessel Occlusion (Rapid VO) | iSchemaview | Retrospective clinical CTA images from 33 clinical sites | Retrospective clinical data was used to conduct standalone performance validation of the AI/ML algorithm, establishing sensitivity and specificity metrics across various clinical subgroups. | Retrospective clinical data; Standalone performance validation; AI/ML algorithm; Clinical site data |

### Clinical Evidence

| Study Design | Population | Comparator | Key Endpoints |
| --- | --- | --- | --- |
| Standalone Performance Validation; Retrospective observational study; Follow-up/Duration: Not applicable | Adult patients undergoing head CTA; demographics: 52.9% female, 47.1% male; age range 24–90+ years; Sample Size: 282 evaluable cases (113 positive, 169 negative); Number of Sites: 33 | Not applicable for this study | Sensitivity and Specificity for detection of Large Vessel Occlusion (ICA, MCA-M1, BA) |

## Indications for Use

Rapid VO is a radiological computer aided triage and notification software indicated for use in the analysis of CTA adult head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive Large Vessel Occlusion findings in head CTA images including the ICA, MCA (M1-M2), and Basilar vascular segments. Rapid VO uses an AI software algorithm to analyze images and highlight cases with suspected occlusion on a server or standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected occlusion findings. Notifications include compressed preview images. These 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 is not intended to be used as a diagnostic device. The results of Rapid VO 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 responsible for viewing full images per the standard of care. Rapid VO is for use on Adults.

## Device Story

Rapid VO is a radiological computer-aided triage and notification software; operates within the Rapid Platform; analyzes DICOM-formatted head/neck CTA images. AI/ML algorithm identifies suspected Large Vessel Occlusions (ICA, MCA M1-M2, Basilar); provides notifications with compressed preview images to clinicians via server or desktop application. Used in hospital networks; operates in parallel to standard-of-care image interpretation. Does not alter original images; not for diagnostic use. Output assists clinicians in prioritizing workflow; clinicians must review full images per standard of care. Benefits include faster triage of critical neuro-vascular cases.

## Clinical Evidence

Bench testing only. Performance validated on 282 evaluable CTA cases (113 positive, 169 negative) from 33 sites. Ground truth established by consensus of three board-certified neuroradiologists. Primary endpoint: Sensitivity 0.956 (95% CI: 0.901, 0.981), Specificity 0.905 (95% CI: 0.852, 0.941). Mean time to notification: 3.3 minutes.

## Technological Characteristics

Software-only device; AI/ML algorithm. Inputs: DICOM CTA head images. Connectivity: Networked via Rapid Platform. Standards: EN ISO 14971:2019, IEC 62304:2006, IEC 62366:2015, NEMA PS 3.1-3.20 (DICOM), UL 2900-1 (Cybersecurity). Deployment: Server or standalone desktop application.

## Regulatory 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

- Rapid CTA 360 ([K251151](/device/K251151.md))

## Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

July 13, 2026

iSchemaview
James Rosa
Chief Regulatory and Compliance Officer
Contact Address

Re: K261085

Trade/Device Name: Rapid Vessel Occlusion (Rapid VO)

Regulation Number: 21 CFR 892.2080

Regulation Name: Radiological Computer Aided Triage And Notification Software

Regulatory Class: Class II

Product Code: QAS

Dated: June 15, 2026

Received: June 15, 2026

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 (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.

FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K261085 - James Rosa

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premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the device, then a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively.

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).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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K261085 - James Rosa

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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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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
Assistant Director
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  |   |   |
| --- | --- | --- |
|  Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | k261085 | ?  |
|  Please provide the device trade name(s). |   | ?  |
|  Rapid Vessel Occlusion (Rapid VO)  |   |   |
|  Please provide your Indications for Use below. |   | ?  |
|  Rapid VO is a radiological computer aided triage and notification software indicated for use in the analysis of CTA adult head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive Large Vessel Occlusion findings in head CTA images including the ICA, MCA (M1-M2), and Basilar vascular segments.  |   |   |
|  Rapid VO uses an AI software algorithm to analyze images and highlight cases with suspected occlusion on a server or standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected occlusion findings. Notifications include compressed preview images. These 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 is not intended to be used as a diagnostic device.  |   |   |
|  The results of Rapid VO 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 responsible for viewing full images per the standard of care.  |   |   |
|  Rapid VO is for use on Adults.  |   |   |
|  Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ?  |

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iSchemaView - Traditional 510(k) Rapid Vessel Occlusion (Rapid VO)
510(k) Summary

K261085

### 510(k) Summary

### iSchemaView, Inc.'s Rapid Vessel Occlusion (VO)

This document contains the 510(k) summary for the iSchemaView Rapid Vessel Occlusion (Rapid VO) device. 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 Golden, CO 80401  |
|  Official Contact: | James Rosa Phone: (303) 704-3374 Email: rosa@ischemaview.com  |

Summary Preparation Date: 10 July, 2026

### Device Name and Classification:

|  Trade Name: | Rapid Vessel Occlusion (Rapid VO)  |
| --- | --- |
|  Common Name: | Radiological Computer Aided Triage and Notification Software  |
|  Classification: | II  |
|  Product Code: | Primary: QAS  |
|  Regulation No: | 21 C.F.R. §892.2080  |
|  Classification Panel: | Radiology Devices  |

### Predicate Device:

The iSchemaView Rapid VO Triage and Notification Module is claimed to be substantially equivalent to the legally marketed predicate, iSchemaView Rapid CTA 360 (K251151).

### Device Description:

The Rapid VO device is a radiological computer-assisted Triage and Notification Software device using AI/ML. The Rapid VO processing module operates within the integrated Rapid Platform to provide triage and notification of suspected neuro-vessel occlusions. The Rapid VO software analyzes input Head and Neck CTA images that are provided in DICOM format and provides notification of suspected positive results. The device does not alter the original medical image and is not intended to be used as a diagnostic device.

### Indications for Use:

Rapid VO is a radiological computer aided triage and notification software indicated for use in the analysis of CTA adult head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive Large

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iSchemaView - Traditional 510(k) Rapid Vessel Occlusion (Rapid VO)
510(k) Summary

Vessel Occlusion findings in head CTA images including the ICA, MCA (M1-M2), and Basilar vascular segments.

Rapid VO uses an AI software algorithm to analyze images and highlight cases with suspected occlusion on a server or standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected occlusion findings. Notifications include compressed preview images. These 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 is not intended to be used as a diagnostic device.

The results of Rapid VO 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 responsible for viewing full images per the standard of care.

Rapid VO is for use on adults.

# Caution(s)/Warnings(s)/Limitation(s)/Exclusion(s)/Contraindications(s):

- Input data image series containing excessive patient motion or metal implants.
- Series containing inadequate contrast agent
- Series that are non-axial or non-axial oblique
- Series with missing slices or improperly ordered slices
- CTA datasets with:

- in-plane X and Y FOV < 160mm or > 400mm.
- Z FOV (cranio-caudal transverse anatomical coverage) < 90 mm or > 600 mm
- y-plane pixel spacing (X & Y resolution) < 0.15 mm or > 0.8 mm.
- Z slice spacing of < 0.2 mm or > 1.5 mm.
- lice thickness > 1.5 mm.
- data acquired at x-ray tube voltage < 70kVp or > 150kVp.
- data not representing human head or head/neck anatomical regions

# Technological Characteristics and Substantial Equivalence:

Rapid VO does not raise new questions of safety or effectiveness compared to the previously cleared Rapid CTA 360 Software (K251151). There are minor differences in intended use and technical characteristics with the predicate device; however, with the minor changes the clinical use for Rapid VO device is the same with no additional risks. Thus, the Rapid VO software device is substantially equivalent.

The following table summarizes and compares data on the predicate device (K251151) to the Rapid VO software device that is the subject of this Traditional 510(k) submission.

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iSchemaView - Traditional 510(k) Rapid Vessel Occlusion (Rapid VO)

510(k) Summary

|  Parameter | Rapid CTA 360 (K251151) Predicate Device | Rapid VO Subject Device  |
| --- | --- | --- |
|  Product Code | QAS | QAS  |
|  Regulation | 21 CFR §892.2080 | 21 CFR §892.2080  |
|  Intended Use/ Indications for Use | Rapid CTA 360 is a radiological computer aided triage and notification software indicated for use in the analysis of CTA adult, including adolescent B, head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive Large and Medium Vessel Occlusion findings in head CTA images including the ICA (C1-C5), MCA (M1-M3), ACA, PCA, Basilar and Vertebral vascular segments. Rapid CTA 360 uses a software algorithm to analyze images and highlight cases with suspected occlusion on a server or standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected LVO and MVO findings. Notifications include compressed preview images. These 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 is not intended to be used as a diagnostic device. The results of Rapid CTA 360 are intended to be used in conjunction with other patient information and based on professional judgment, to assist with triage/prioritization of | Rapid VO is a radiological computer aided triage and notification software indicated for use in the analysis of CTA adult head images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communication of suspected positive Large Vessel Occlusion findings in head CTA images including the ICA, MCA (M1-M2), and Basilar vascular segments. Rapid VO uses an AI software algorithm to analyze images and highlight cases with suspected occlusion on a server or standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected occlusion findings. Notifications include compressed preview images. These 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 is not intended to be used as a diagnostic device. The results of Rapid VO 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 responsible for viewing full  |

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iSchemaView - Traditional 510(k) Rapid Vessel Occlusion (Rapid VO)

510(k) Summary

|   | medical images. Notified clinicians are responsible for viewing full images per the standard of care. | images per the standard of care. Rapid VO is for use on Adults.  |
| --- | --- | --- |
|  Input Data Requirements | CTA | CTA  |
|  DICOM Compliance | Yes | Yes  |
|  User Output | Notification w/compressed images | Notification w/compressed images  |
|  SW | AI/ML | AI/ML  |
|  Segments | ICA (C1-C5), MCA (M1-M3), ACA, PCA, Basilar and Vertebral | ICA, MCA (M1-M2), Basilar  |
|  Outputs | Reports, DICOM Secondary Capture Series | Reports, DICOM Secondary Capture Series  |
|  Cybersecurity Framework | External I/Fs through Rapid Platform | External I/Fs through Rapid Platform  |
|  PCCP | No | Yes  |

### AI/ML Module Development:

Standalone performance validation was conducted on 314 collected CTA cases (282 evaluable: 113 positive including ICA, MCA-M1, and BA; 169 negative; 32 High-Grade Stenosis; 19 rejected on quality grounds) from 33 distinct clinical sites across the United States (99.0%) and one OUS site (1.0%). Development (training and internal validation) used 631 cases from multiple sites. Cases covered GE, Toshiba, Siemens, and Philips scanners across a range of acquisition protocols, slice thicknesses (0.2–1.5 mm), and kVp settings (80–140 kVp). Patient demographics in the performance test dataset: Female 52.9% (n=166), Male 47.1% (n=148); age range 24–90+ years. Confounders in the test dataset included aneurysm (n=18), hypoplasia (n=2), LVO/MeVO outside the cleared indication (n=43), moyamoya (n=8), and stent/coil (n=1), totaling 79 annotated confounder instances.

### Clinical Characteristics:

The primary users of Rapid VO are clinicians to support workflow prioritization.

### Performance Standards:

Rapid VO 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)

UL 2900-1 (2017)

Standard for Safety for Cybersecurity Network-Connected Products

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# iSchemaView - Traditional 510(k) Rapid Vessel Occlusion (Rapid VO)  
510(k) Summary

# **Training Data:**

Rapid VO development used 6264 (3256 Normal; 3002 Non-normal) cases. The non-normal cases included 2535 ICA, MCA (M1-M2) and Basilar cases; and 467 confounders. The data was from a broad range of US and international sites and split 49% Male, 51% Female.

# **Performance Data:**

Rapid VO 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; and was tested in accordance with the 820.20 Verification and Validation requirements and successfully passed.

iSchemaView conducted extensive performance validation testing and software verification and validation testing of the Rapid VO device. Final device validation included standalone performance validation. This performance validation testing demonstrated the Rapid VO device provides effective triage and notification in a range of clinically relevant conditions associated with the intended use of the software. Software performance, validation and verification testing demonstrated that the Rapid VO device met all design requirements and specifications.

The primary endpoint was evaluated on 282 cases (113 positive: ICA, MCA-M1, and BA; 169 negative) from 314 collected cases (32 HGS excluded, 19 rejected). Ground truth was established by consensus of three independent board-certified neuroradiologists using a 2-of-3 majority rule. The primary endpoint passed with Sensitivity 0.956 (95% CI: 0.901, 0.981) and Specificity 0.905 (95% CI: 0.852, 0.941).

Secondary endpoints: (1) BA-Off (ICA/MCA-M1 only): Se 0.968 (0.910–0.989), Sp 0.920 (0.873–0.951). (2) High-Grade Stenosis, BA-On: Se 0.869 (0.804–0.914). (3) Time to Notification BA-On: mean 3.3 min (160–262 s); BA-Off: 3.2 min (154–249 s). Acceptance threshold: <196 s.

# **Subgroup Performance:**

The following subgroup analyses were performed on the 282 evaluable cases (HGS excluded). Results are point estimate (95% CI). These values constitute the authorized performance baseline for all future PCCP modification non-inferiority evaluations per ISV-R-R-PCCP, Revision B.

|  Subgroup | Measure | N | Estimate | Lower 95% CI | Upper 95% CI  |
| --- | --- | --- | --- | --- | --- |
|  **Scanner Manufacturer** | GE — Se | 35 | 0.971 | 0.855 | 0.995  |
|   |  GE — Sp | 139 | 0.935 | 0.882 | 0.966  |
|   |  Philips — Se | 17 | 1.000* | 0.816 | 1.000  |
|   |  Siemens — Se | 58 | 0.948 | 0.859 | 0.982  |
|   |  Toshiba — Se | 3 | 0.667* | 0.208 | 0.939  |
|   |  Toshiba — Sp | 16 | 0.750 | 0.505 | 0.898  |
|  **Gender** | Female — Se | 50 | 0.940 | 0.838 | 0.979  |
|   |  Female — Sp | 101 | 0.911 | 0.839 | 0.952  |
|   |  Male — Se | 63 | 0.968 | 0.891 | 0.991  |

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iSchemaView - Traditional 510(k) Rapid Vessel Occlusion (Rapid VO)
510(k) Summary

|   | Male — Sp | 68 | 0.897 | 0.802 | 0.949  |
| --- | --- | --- | --- | --- | --- |
|  Age Group | <40 — Se | 3 | 1.000* | 0.439 | 1.000  |
|   | 40–59 — Se | 30 | 0.967 | 0.833 | 0.994  |
|   | ≥60 — Se | 80 | 0.950 | 0.878 | 0.980  |
|  Slice Thickness | <0.625mm — Se | 25 | 0.840 | 0.653 | 0.936  |
|   | 0.625–0.8mm — Se | 70 | 1.000 | 0.948 | 1.000  |
|   | >0.8mm — Se | 18 | 0.944 | 0.742 | 0.990  |
|  Occlusion Location (Se) | ICA | 41 | 0.976 | 0.874 | 0.996  |
|   | MCA-M1 | 30 | 1.000 | 0.886 | 1.000  |
|   | MCA-M2 | 23 | 0.957 | 0.790 | 0.992  |
|   | BA | 19 | 0.842 | 0.624 | 0.945  |

* Small n — interpret with caution. Demographics: Female 52.9%, Male 47.1%; age range 24–90+ years; 33 clinical sites; US 99.0%, OUS 1.0%.

### Reference Standard (Truthing Process):

Ground truth for all 314 collected validation cases was established by consensus of three independent US board-certified neuroradiologists. Specific adjudication rules for tandem lesions and proximal-lesion hierarchy were defined in the Validation Study Protocol and applied uniformly. All readers were blinded to each other's assessments and to device outputs.

### Training and Test Data Independence:

Training and test datasets were sourced from distinct, non-overlapping clinical sites. The performance test dataset comprised 33 distinct clinical sites (US 99.0%; OUS 1.0%); one consecutive-series site (n=45) confirmed sequential sampling. Training data spanned 74 sites.

### Predetermined Change Control Plan (PCCP):

Rapid VO has an authorized Predetermined Change Control Plan (PCCP). All modification types are restricted to the CT Angiography (CTA); no modification(s) will introduce a new imaging modality.

Approved Planned Modifications: (1) Device Input Compatibility — DICOM pre-processing and compatibility adjustments, no algorithm weight change; (2) CTA Scanner Expansion — algorithm retraining to add new CT scanner models or reconstruction methods within CT modality only; (3) Performance Improvement via Data Expansion — algorithm retraining on expanded CTA datasets triggered by >10% Se or Sp drift; (4) Processing Time Optimization — latency reduction (DICOM pipeline refactoring, inference quantization, parallelization, model pruning with confirmed output equivalence) with no change to algorithm weights or clinical outputs.

Testing Methods and Acceptance Criteria: Retraining modifications (Types 2 and 3): three-part sub-analysis (Original / New Cases / Integrated); primary endpoint aggregate Se and Sp ≥80% lower bound 95% CI; co-primary non-inferiority per subgroup (scanner manufacturer, age cohort 18–65 and >65 years, sex, occlusion location M1/M2/ICA/BA,

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iSchemaView - Traditional 510(k) Rapid Vessel Occlusion (Rapid VO)
510(k) Summary

slice thickness) with approved margins. Processing Time (Type 4): mean TTN <196 s with identical case-level classification results vs. prior authorized version.

User Notification: Software updates are deployed manually; updated labeling accompanies each update with a description of the modification, current Se/Sp and Time to Notification metrics, and a version history of all PCCP-authorized changes. Hospital installation personnel are notified at time of deployment.

# **Prescriptive Statement:**

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

# **Safety & Effectiveness:**

Rapid VO is 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 VO performance has been validated with case data.

# **Conclusion:**

In conclusion, the iSchemaView Rapid VO software device is substantially equivalent in intended use, technological characteristics, safety and performance characteristics to the legally marketed predicate device, Rapid CTA 360 (K251151).

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**Source:** [https://fda.innolitics.com/device/K261085](https://fda.innolitics.com/device/K261085)

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