Rapid NCCT Stroke

K222884 · Ischemaview, Inc. · QAS · Mar 2, 2023 · Radiology

Device Facts

• Record ID: K222884
• Device Name: Rapid NCCT Stroke
• Applicant: Ischemaview, Inc.
• Product Code: QAS · Radiology
• Decision Date: Mar 2, 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 NCCT Stroke is a radiological computer aided triage and notification software indicated for use in the analysis of (1) nonenhanced head CT (NCCT) images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communicating suspected positive findings of (1) head CT images for Intracranial Hemorrhage (ICH) and (2) NCCT large vessel occlusion (LVO) of the ICA and MCA-M1. Rapid NCCT Stroke uses an artificial intelligence algorithm to analyze images and highlight cases with detected (1) ICH or (2) NCCT LVO on the Rapid server on premise or in the cloud in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected ICH or LVO findings via PACS, email or mobile device. Notifications include compressed preview images that are meant for informational purposes only, and are not intended for diagnostic use beyond notification. The device does not alter the original medical image, and it is not intended to be used as a primary diagnostic device. The results of Rapid NCCT Stroke are intended to be used in conjunction with other patient information and based on professional judgment to assist with triage/prioritization of medical images. Notified clinicians are ultimately responsible for reviewing full images per the standard of care. Rapid NCCT Stroke is for Adults only.

Device Story

Rapid NCCT Stroke is an AI/ML-based radiological triage software. It processes non-enhanced head CT (NCCT) images on-premise or in the cloud. The device runs in parallel to standard-of-care interpretation, analyzing images for suspected Intracranial Hemorrhage (ICH) and Large Vessel Occlusion (LVO) of the ICA and MCA-M1. It outputs notifications to clinicians via PACS, email, or mobile device, including compressed preview images. The device does not alter original images or serve as a primary diagnostic tool; it assists in workflow prioritization. Clinicians use these notifications to expedite review of suspected positive cases. The device benefits patients by significantly reducing time-to-notification compared to standard-of-care, potentially accelerating stroke treatment workflows.

Clinical Evidence

Retrospective, blinded, multicenter, multinational study (N=254). Primary endpoint: performance in identifying ICH and LVO. ICH performance: Se 0.962, Sp 0.974. LVO performance: Se 0.635 (95% CI: 0.544-0.717), Sp 0.951 (95% CI: 0.891-0.979). Secondary endpoints: expert non-inferiority and non-expert superiority achieved. Mean time-to-notification (2.5 min) significantly faster than standard-of-care time-to-exam-open (58.72 min).

Technological Characteristics

AI/ML SaMD; operates on Rapid Platform (DICOM processing, job management). Uses cascaded algorithms (ICH module + ASPECTS and Hyperdense Vessel Sign algorithms for LVO). Connectivity: PACS, email, mobile. Standards: ISO 14971:2012, IEC 62304:2015, DICOM (NEMA PS 3.1-3.20).

Indications for Use

Indicated for adult patients undergoing nonenhanced head CT (NCCT) scans to assist clinicians in triaging suspected Intracranial Hemorrhage (ICH) and Large Vessel Occlusion (LVO) of the ICA and MCA-M1. Contraindicated for scans with excessive motion artifacts, hemorrhagic transformation, hematoma, or very thin/absent ventricles.

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

• Avicenna's CINA device (K200855)

Reference Devices

• Rapid ICH (K221456)
• DEN170073

Submission Summary (Full Text)

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

March 2, 2023

Re: K222884 Trade/Device Name: Rapid NCCT Stroke Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological computer aided triage and notification software Regulatory Class: Class II Product Code: QAS Dated: February 9, 2023 Received: February 10, 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 ([e-mail]) or phone [phone] 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

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# Indications for Use

510(k) Number (if known) K222884

Device Name Rapid NCCT Stroke

#### Indications for Use (Describe)

Rapid NCCT Stroke is a radiological computer aided triage and notification software indicated for use in the analysis of (1) nonenhanced head CT (NCCT) images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communicating suspected positive findings of (1) head CT images for Intracranial Hemorrhage (ICH) and (2) NCCT large vessel occlusion (LVO) of the ICA and MCA-M1.

Rapid NCCT Stroke uses an artificial intelligence algorithm to analyze images and highlight cases with detected (1) ICH or (2) NCCT LVO on the Rapid server on premise or in the cloud in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected ICH or LVO findings via PACS, email or mobile device. Notifications include compressed preview images that are meant for informational purposes only, and are not intended for diagnostic use beyond notification.

The device does not alter the original medical image, and it is not intended to be used as a primary diagnostic device. The results of Rapid NCCT Stroke are intended to be used in conjunction with other patient information and based on professional judgment to assist with triage/prioritization of medical images. Notified clinicians are ultimately responsible for reviewing full images per the standard of care. Rapid NCCT Stroke is for Adults only.

Cautions:

· All patients should get adequate care for their symptoms including CTA and/or other appropriate care per the standard clinical practice, irrespective of the device output.

· The device is not intended to be a rule-out device and for cases that have been processed by the device without notification for "Suspected LVO" should not be viewed as indicating that LVO is excluded. All cases should undergo CTA, per the standard stroke workup.

Limitations:

· Rapid NCCT Stroke does not replace the need for CTA or MRA in ischemic stroke workflow prioritization and notification only.

· Rapid ICH has been shown to reliably identify hemorrhages of ≥ 0.4ml.

#### Contraindications/Exclusions

· Patient Motion: excessive motion leading to artifacts that make the scan technically inadequate.

- · Hemorrhagic Transformation, Hematoma
· Very thin or no Ventricles

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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# K222884

# 510(k) Summary

# iSchemaView, Inc.'s Rapid NCCT Stroke

This document contains the 510(k) summary for the iSchemaView Rapid NCCT Stroke. 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 Ave., Ste. 200<br>Golden, CO 80401 |
| Official Contact: | Jim Rosa<br>Phone: [phone]<br>Email: [e-mail] |

# Summary Preparation Date: February 28, 2023

# Device Name and Classification:

| Trade Name: | Rapid NCCT Stroke | |
|-----------------------|--------------------------------------------------------------|--|
| Common Name: | Radiological computer aided triage and notification software | |
| Classification: | II | |
| Product Code: | QAS | |
| Regulation No: | 21 C.F.R. §892.2080 | |
| Classification Panel: | Radiology Devices | |

# Predicate Devices:

The Rapid NCCT Stroke device is claimed to be substantially equivalent to the following legally marketed predicate device: Avicenna's CINA device (K200855).

# Device Description:

Rapid NCCT Stroke (RNS) is a radiological computer-assisted triage and notification software device. RNS is a non-enhanced CT (NCCT) processing module which operates within the integrated Rapid Platform to provide triage and notification of suspected intracranial hemorrhage (ICH) and NCCT Large Vessel Occlusion (LVO) of the ICA and MCA-M1. The RNS is an AI/ML SaMD. The output of the module is a priority notification to clinicians indicating the suspicion of ICH or NCCT LVO. ICH analysis uses the ICH Algorithm to identify findings within the ICH algorithm; and the NCCT LVO suspicion uses the combined analysis of the ASPECTS and Hyperdense Vessel Sign (HVS) algorithms. The RNS module uses the basic services supplied by the Rapid Platform including DICOM processing, job management, imaging module execution and imaging output including the notification and compressed image.

# Indications for Use:

Rapid NCCT Stroke is a radiological computer aided triage and notification software indicated for use in the analysis of (1) nonenhanced head CT (NCCT) images. The device is intended to assist hospital networks and trained clinicians in workflow triage by flagging and communicating

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# 510(k) Summary

suspected positive findings of (1) head CT images for Intracranial Hemorrhage (ICH) and (2) NCCT large vessel occlusion (LVO) of the ICA and MCA-M1.

Rapid NCCT Stroke uses an artificial intelligence algorithm to analyze images and highlight cases with detected (1) ICH or (2) NCCT LVO on the Rapid server on premise or in the cloud in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected ICH or LVO findings via PACS, email or mobile device. Notifications include compressed preview images that are meant for informational purposes only, and are not intended for diagnostic use beyond notification.

The device does not alter the original medical image, and it is not intended to be used as a primary diagnostic device. The results of Rapid NCCT Stroke are intended to be used in conjunction with other patient information and based on professional judgment to assist with triage/prioritization of medical images. Notified clinicians are ultimately responsible for reviewing full images per the standard of care. Rapid NCCT Stroke is for Adults only.

# Cautions:

- All patients should get adequate care for their symptoms including CTA or MRA and/or other . appropriate care per the standard clinical practice, irrespective of the device output.
- The device is not intended to be a rule-out device and for cases that have been processed by the device o without notification for "Suspected LVO" should not be viewed as indicating that LVO is excluded. All cases should undergo CTA or MRA, per the standard stroke workup.

## Limitations:

- Rapid NCCT Stroke does not replace the need for CTA in ischemic stroke workup, it provides . workflow prioritization and notification only.
- Rapid ICH has been shown to reliably identify hemorrhages of > 0.4ml. .

## Contraindications/Exclusions/Cautions:

- Patient Motion: excessive motion leading to artifacts that make the scan technically inadequate. .
- Very thin or no Ventricles .

# Comparison of Technological Characteristics:

Rapid NCCT Stroke does not raise new questions of safety or effectiveness compared to the previously cleared CINA device (K200855). Both devices are radiological computer-aided triage and notification software applications for determining suspicion of ICH and LVO. The Avicenna device uses both NCCT for ICH and CTA imaging for LVO, while the Rapid device uses the NCCT Scan for both indications. A significant difference between these devices is that the subject device operates on NCCT images to provide a suspected LVO notification instead of CTA. The benefits include the shorter time to a suspected LVO notification by assessing non-contrast imaging immediately, then CTA follow-up per standard of care for stroke workup. The risks stem from the lower sensitivity of the subject device, which is an inherent limitation of the modality. See SE discussion for assessment of these benefits and risks. A caution has been added to notify the user that CTA should still be considered per standard of care in stroke workup as a reinforcement AHA/ASA guidelines. Thus, the Rapid NCCT Stroke software is substantially equivalent.

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# 510(k) Summary

The following table summarizes and compares data on the Rapid NCCT Stroke device, the subject of this filing, with the Avicenna CINA device (K200855). A table comparing the key features of the subject and predicate devices is provided below.

| Substantial Equivalence Table | | |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison<br>Feature | Avicenna CINA (K200855) | Rapid NCCT Stroke – Subject<br>Device |
| Indications<br>for Use | CINA is a radiological computer<br>aided triage and notification<br>software indicated for use in the<br>analysis of (1) non-enhanced head<br>CT images and (2) CT<br>angiographies of the head. The<br>device is intended to assist hospital<br>networks and trained radiologists in<br>workflow triage by flagging and<br>communicating suspected positive<br>findings of (1) head CT images for<br>Intracranial Hemorrhage (ICH) and<br>(2) CT angiographies of the head<br>for large vessel occlusion (LVO). | Rapid NCCT Stroke is a<br>radiological computer aided triage<br>and notification software indicated<br>for use in the analysis of (1)<br>nonenhanced head CT (NCCT)<br>images. The device is intended to<br>assist hospital networks and trained<br>clinicians in workflow triage by<br>flagging and communicating<br>suspected positive findings of (1)<br>head CT images for Intracranial<br>Hemorrhage (ICH) and (2) NCCT<br>large vessel occlusion (LVO) of the<br>ICA and MCA-M1. |
| | CINA uses an artificial intelligence<br>algorithm to analyze images and<br>highlight cases with detected (1)<br>ICH or (2) LVO on a standalone<br>Web application in parallel to the<br>ongoing standard of care image<br>interpretation. The user is<br>presented with notifications for<br>cases with suspected ICH or LVO<br>findings. Notifications include<br>compressed preview images that<br>are meant for informational<br>purposes only, and are not intended<br>for diagnostic use beyond<br>notification. The device does not<br>alter the original medical image,<br>and it is not intended to be used as a<br>diagnostic device.<br>The results of CINA are intended to<br>be used in conjunction with other<br>patient information and based on<br>professional judgment to assist with<br>triage/prioritization of medical<br>images. Notified clinicians are<br>ultimately responsible for | Rapid NCCT Stroke uses an<br>artificial intelligence algorithm to<br>analyze images and highlight cases<br>with detected (1) ICH or (2) NCCT<br>LVO on the Rapid server on<br>premise or in the cloud in parallel<br>to the ongoing standard of care<br>image interpretation. The user is<br>presented with notifications for<br>cases with suspected ICH or LVO<br>findings via PACS, email or mobile<br>device. Notifications include<br>compressed preview images that<br>are meant for informational<br>purposes only, and are not intended<br>for diagnostic use beyond<br>notification.<br>The device does not alter the<br>original medical image, and it is not<br>intended to be used as a primary<br>diagnostic device. The results of<br>Rapid NCCT Stroke are intended to<br>be used in conjunction with other<br>patient information and based on<br>professional judgment to assist with<br>triage/prioritization of medical |
| | reviewing full images per the<br>standard of care. | images. Notified clinicians are<br>ultimately responsible for<br>reviewing full images per the<br>standard of care. Rapid NCCT<br>Stroke is for Adults only. |
| | | <b>Cautions:</b><br>• All patients should get adequate<br>care for their symptoms including<br>CTA or MRA and/or other<br>appropriate care per the standard<br>clinical practice, irrespective of the<br>device output.<br>• The device is not intended to be a<br>rule-out device and for cases that<br>have been processed by the device<br>without notification for "Suspected<br>LVO" should not be viewed as<br>indicating that LVO is excluded.<br>All cases should undergo CTA or<br>MRA, per the standard stroke<br>workup. |
| | | <b>Limitations:</b> |
| | | • Rapid NCCT Stroke does not<br>replace the need for CTA in<br>ischemic stroke workup, it<br>provides workflow prioritization<br>and notification only.<br>• Rapid ICH has been shown to<br>reliably identify hemorrhages of ≥<br>0.4ml. |
| | | <b>Contraindications/Exclusions/Cautions:</b> |
| | | • Patient Motion: excessive motion<br>leading to artifacts that make the<br>scan technically inadequate.<br>• Hemorrhagic Transformation,<br>Hematoma<br>• Very thin or no Ventricles |
| User | Radiologist | Clinician |
| Anatomy | Head | Head |
| Input Data | NCCT (ICH) and CTA(LVO) | NCCT (ICH and LVO) |
| Technology | AI/ML/Neural Network | AI/ML/Neural Network |
| Segmentation<br>of ROI | The device does not highlight or<br>direct a user's attention to a specific<br>location in the image file. | The device does not highlight or<br>direct a user's attention to a specific<br>location in the image file. |
| Preview<br>Images | Presentation of a preview of the<br>study for initial assessment not<br>meant for diagnostic purposes. | Presentation of a preview of the<br>study for initial assessment not<br>meant for diagnostic purposes. |
| | The device operates in parallel with<br>the standard of care. | The device operates in parallel with<br>the standard of care. |
| Annotation /<br>Localization | Device does not mark, highlight, or<br>direct users' attention to a specific<br>location in the original image | Device does not mark, highlight, or<br>direct users' attention to a specific<br>location in the original image |
| Prioritization<br>Notification | Yes | Yes |
| Clinical SoC<br>Workflow | In parallel to | In parallel to |
| Technical<br>Pipeline | Two independent Algorithms | Two cascaded functions (ICH then<br>LVO) using three integrated<br>algorithms |
| Removal of<br>Cases from<br>SoC review | No | No |

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# 510(k) Summary

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# 510(k) Summary

# Performance Standards:

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

| EN ISO 14971:2012 | Application of Risk Management to Medical Devices |
|--------------------|--------------------------------------------------------|
| IEC 62304:2015 | Medical device software – Software lifecycle processes |
| NEMA PS 3.1 - 3.20 | Digital Imaging and Communications in Medicine (DICOM) |

# Performance Data:

iSchemaView conducted a retrospective, blinded, multicenter, multinational study with the Rapid NCCT Stroke device with the primary endpoint to evaluate the software's performance in identifying NCCT head images containing intracranial hemorrhage (ICH) and large vessel occlusion (LVO) findings in 254 (ICH Pos:26, LVO Pos: 115, Neg to ICH, LVO:103, Excluded: 10 for age and technical inadequacy) cases.

Sensitivity and specificity exceeded the pre-specified performance goals for ICH and NCCT LVO. Specifically, ICH performance was observed at Se:0.962, Sp:0.974, consistent with the ICH standalone module performance (K221456); and LVO was observed at Se:0.635 (95% CI: 0.544 - 0.717) and Sp: 0.951 (95% CI: 0.891 - 0.979).

In addition, secondary clinical endpoints were used to show expert non-inferiority and nonexpert superiority. Rapid NCCT Stroke passed both conditions with a Se for all readers (experts and non-experts) of 0.436, with difference in Se between NCCT Stroke and all readers of 0.199(95%C1: 0.055-0.34); Se for general radiologists of 0.409, with difference in Se of 0.226(95%CI: 0.071-0.381).

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# 510(k) Summary

The Rapid NCCT time-to-notification analysis includes the time to get the DICOM exam, deidentify it (if required), analyze and send a notification back to the PACS/Workstation, email and mobile. The standard of care time-to-open-exam consisted of the time from the initial scan of the patient to when the radiologist first opened the exam for review.

Rapid NCCT Stroke time-to-notification has been documented for all 254 cases with results shown in the following table. The time time-to-exam-open is referenced from DEN170073 which was for LVO only and did not take into account the time from initial CT to CTA; however, the time indicates from image complete to notification which is similar to the subject device in referencing SoC time. The predicate does not reference combined timelines, only individual time for each portion of the device:

The standard of care time-to-exam-open (58.72 minutes: 95% CI 51.5,71.23 is significantly longer than the parallel time-to-notification of the Rapid NCCT Stroke software.

| Parameter | Mean | 95% CI Lower | 95% CI Upper |
|-----------------------------------------------------|-------|--------------|--------------|
| Time to open in standard of care (Minutes) | 58.72 | 51.50 | 71.23 |
| Time to notification of Rapid NCCT Stroke (Minutes) | 2.5 | 2.4 | 2.6 |
| Difference (Minutes) | 70.08 | NA | NA |

Performance across subgroups:

Subgroup analyses were conducted for the LVO indication. The ICH algorithm is the same as the device cleared under K221456.

| Gender | Measure | N | Estimate | Lower 95% CI | Upper 95% CI |
|--------|-------------|----|----------|--------------|--------------|
| Female | Sensitivity | 57 | 0.579 | 0.450 | 0.698 |
| | Specificity | 54 | 0.981 | 0.902 | 0.997 |
| Male | Sensitivity | 58 | 0.690 | 0.562 | 0.794 |
| | Specificity | 45 | 0.933 | 0.821 | 0.977 |

Performance Metrics by Gender

## Performance Metrics by Age Groups

| Age | Measure | N | Estimate | Lower 95% CI | Upper 95% CI |
|----------------------------------------------|-------------|----|----------|--------------|--------------|
| < 50 | Sensitivity | 12 | 0.583 | 0.320 | 0.807 |
| | Specificity | 21 | 0.905 | 0.711 | 0.973 |
| 50 - 70 | Sensitivity | 41 | 0.610 | 0.457 | 0.743 |
| | Specificity | 42 | 0.976 | 0.877 | 0.996 |
| >70 | Sensitivity | 62 | 0.661 | 0.537 | 0.767 |
| | Specificity | 35 | 0.971 | 0.855 | 0.995 |
| Performance Metrics by Slice Thickness (LVO) | | | | | |

| Slice Thickness | Measure | N | Estimate | Lower 95% CI | Upper 95% CI |
|-----------------|-------------|----|----------|--------------|--------------|
| < 4.0 | Sensitivity | 29 | 0.724 | 0.543 | 0.853 |
| | Specificity | 55 | 0.964 | 0.877 | 0.990 |

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# 510(k) Summary

| Slice Thickness | Measure | N | Estimate | Lower 95% CI | Upper 95% CI |
|-------------------------------------------|-------------|----|----------|--------------|--------------|
| ≥ 4.0 | Sensitivity | 86 | 0.605 | 0.499 | 0.701 |
| | Specificity | 48 | 0.938 | 0.832 | 0.979 |
| Performance Metrics by Manufacturer (LVO) | | | | | |
| Manufacturer | Measure | N | Estimate | Lower 95% CI | Upper 95% CI |
| GE | Sensitivity | 37 | 0.730 | 0.570 | 0.846 |
| | Specificity | 11 | 1.000 | 0.741 | 1.000 |
| PHILIPS | Sensitivity | 11 | 0.545 | 0.280 | 0.787 |
| | Specificity | 22 | 1.000 | 0.851 | 1.000 |
| SIEMENS | Sensitivity | 32 | 0.500 | 0.336 | 0.664 |
| | Specificity | 59 | 0.915 | 0.816 | 0.963 |
| TOSHIBA | Sensitivity | 35 | 0.686 | 0.520 | 0.814 |
| | Specificity | 11 | 1.000 | 0.741 | 1.000 |

In summary, performance validation data, combined with real-world evidence, establish the achievement of effective triage by the Rapid NCCT Stroke device as well as effective notification functionality of the application, as compared to the standard of care for improved time-to-exam-open of a notified case. Due to the lower estimates of performance on Philips and Siemens scanners, additional analysis was performed across subgroups including sites to further assess performance. The assessment of performance on these subgroups of scanners did not reveal any systematic errors related to the device design.

# Prescriptive Statement:

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

# Safety & Effectiveness:

Rapid NCCT Stroke 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) and the software development process conforms to ISO 62304:2015. The Rapid NCCT Stroke performance has been validated through retrospective case data based on expert reader truthing of the data and reader testing.

# Substantial Equivalence Discussion:

The subject device has the same intended use as the predicate device to provide triage and prioritization of time-sensitive suspected findings on radiological medical images. The subject device has a new indication compared to the predicate of flagging and triaging suspected LVO of the ICA and MCA-M1 on NCCT. This is expected to result in faster overall notification since NCCT is generally performed first in suspected stroke patient imaging workup. This benefit may be significant for local practices that defer ordering CTA for suspected stroke patients in their workflow.

The lower sensitivity of the device could lead to a greater risk of mis-prioritization of patients under circumstances where delay of additional imaging or treatment could reasonably be expected to worsen outcomes; it may also limit the effectiveness of the device. The risk of mis-

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# 510(k) Summary

prioritization is mitigated by inclusion of specific language in the notification for cases not suspected of LVO, by the device on NCCT, to clearly indicate that LVO cannot be excluded without CTA or MRA. The risk mitigation also includes additional performance testing to demonstrate that the device is superior to the general radiologists and non-inferior to overall readers, including both neuroradiologists and general radiologists, when triaging the LVO based on NCCT. These mitigations in combination with the significant time-sensitive nature of LVO detection and treatment lead to comparable benefit-risk profile to the predicate, and the device being substantially equivalent for the labeled intended use.

# Conclusion:

In conclusion, iSchemaView's Rapid NCCT Stroke is substantially equivalent in technological characteristics, safety, and performance characteristics to the legally marketed predicate device, Avicenna CINA (K200855).