Rapid Neuro3D

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. iSchemaView, Inc. Patricia Setti-Laperch Sr. Directory of Regulatory Affairs 1120 Washington Ave. Ste 200 Rm 108 Golden, Colorado 80401 January 22, 2025 Re: K243350 Trade/Device Name: Rapid Neuro3D Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: OIH Dated: December 17, 2024 Received: December 17, 2024 Dear Patricia Setti-Laperch: 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). 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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. {1}------------------------------------------------ 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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. 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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. 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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-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 {2}------------------------------------------------ the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Jessica Lamb Jessica Lamb, PhD 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 {3}------------------------------------------------ # Indications for Use Submission Number (if known) K243350 Device Name Rapid Neuro3D ### Indications for Use (Describe) Rapid Neuro3D (RN3D) is an image analysis software for imaging datasets acquired with conventional CT Angiography (CTA) from the aortic arch to the vertex of the head. The module removes bone, tissue, and venous vessels, providing a 3D and 2D visualization of the neurovasculature supplying arterial blood to the brain. Outputs of the device include 3D rotational maximum intensity projections (MIPS), volume renders (VR), along with the curved planar reformation (CPR) of the isolated left and right internal carotid and vertebral arteries. Rapid Neuro3D is designed to support the physician in confirming the presence or absence of physician-identified lesions and evaluation, documentation, and follow-up of any such lesion and treatment planning. Its results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment. RN3D is indicated for adults. Precautions/Exclusions: o Series containing excessive patient motion or metal implants may impact module output quality. o The RN3D module will not process series that meet the following module exclusion criteria: • Series containing inadequate contrast agent (<0.3 mL of right-hemisphere intracranial arterial - contrast media or <0.3 mL of left-hemisphere intracranial arterial contrast media, above 120 HU) - · Series acquired w/cone-beam CT scanners (c-arm CT) - · Series that are non-axial - · Series with a non-supine patient position - · Series containing missing or improperly ordered slices (e.g., as a result of manual correction by an imaging technician) - CTA datasets with: - 1) in-plane X and Y FOV < 160mm or > 400mm. - 2) Z FOV (cranio-caudal transverse anatomical coverage) < 90 mm. - 3) in-plane pixel spacing (X & Y resolution) < 0.2 mm or > 1.0 mm. - 4) Z slice spacing of < 0.2 mm or > 1.25 mm. - 5) slice thickness > 1.5mm. - 6) data acquired at x-ray tube voltage < 70kVp or > 150kVp. 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. {4}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {5}------------------------------------------------ ### 510(k) Summary ### iSchemaView, Inc.'s Rapid Neuro3D This document contains the 510(k) summary for the iSchemaView Rapid Neuro3D. 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<br>Suite 200<br>Golden, CO 80401 | | Official Contact: | Patricia Setti-LaPerch<br>Phone: 650-388-9767<br>Email: settilaperch@ischemaview.com | | Summary Preparation Date: | October 25, 2024 | | Device Name and Classification: | | | Trade Name: | Rapid Neuro3D | | Common Name: | Automated Radiological Image Processing<br>Software | | Classification: | II | | Product Code: | QIH | | Regulation No: | 21 C.F.R. §892.2050 | | Classification | Radiology Devices | ### Predicate Devices: Panel: iSchemaView's Rapid Neuro3D is claimed to be substantially equivalent to the following legally marketed predicate device: Rapid (K233582). #### Device Description: Rapid Neuro 3D (RN3D) is a Software as a Medical Device (SaMD) image processing module and is part of the Rapid Platform. It allows for visualization of arterial vessels of the head and neck and identifies and segments arteries of interest in patient CTA exams. The Rapid Platform provides common functions and services to support image processing modules such as DICOM filtering and job and interface management. The Rapid Platform can be installed on-premises within customer's infrastructure behind their firewall or in a hybrid on- {6}------------------------------------------------ 510(k) Summary premises/cloud configuration. The software can be installed on dedicated hardware or a virtual machine. The Rapid Platform accepts DICOM images and, upon processing, returns the processed DICOM images to the source imaging modality or PACS. The RN3D image processing module is based on pre-trained artificial intelligence / machinelearning models and facilitates a 3D visualization of the neurovasculature supplying arterial blood to the brain. The module analyzes input CTA images in DICOM format and provides a corresponding DICOM series output that can be used by a DICOM viewer, clinical workstations. and PACS systems. # Intended Use/Indications for Use Statement: Rapid Neuro3D (RN3D) is an image analysis software for imaging datasets acquired with conventional CT Angiography (CTA) from the aortic arch to the vertex of the head. The module removes bone, tissue, and venous vessels, providing a 3D and 2D visualization of the neurovasculature supplying arterial blood to the brain. Outputs of the device include 3D rotational maximum intensity projections (MIPS), volume renders (VR), along with the curved planar reformation (CPR) of the isolated left and right internal carotid and vertebral arteries. Rapid Neuro3D is designed to support the physician in confirming the presence or absence of physician-identified lesions and evaluation, documentation, and follow-up of any such lesion and treatment planning. Its results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment. RN3D is indicated for adults. ## Precautions/Exclusions: - Series containing excessive patient motion or metal implants may impact module output O quality. - The RN3D module will not process series that meet the following module exclusion criteria: O - . Series containing inadequate contrast agent (<0.3 mL of right-hemisphere intracranial arterial contrast media or <0.3 mL of left-hemisphere intracranial arterial contrast media, above 120 HU) - Series acquired w/cone-beam CT scanners (c-arm CT) ● - Series that are non-axial - Series with a non-supine patient position ● - Series containing missing or improperly ordered slices (e.g., as a result of manual correction by an imaging technician) - . CTA datasets with: - 1) in-plane X and Y FOV < 160mm or > 400mm. {7}------------------------------------------------ 510(k) Summary - 2) Z FOV (cranio-caudal transverse anatomical coverage) < 90 mm. - 3) in-plane pixel spacing (X & Y resolution) < 0.2 mm or > 1.0 mm. - 4) Z slice spacing of < 0.2 mm or > 1.25 mm. - 5) slice thickness > 1.5mm. - 6) data acquired at x-ray tube voltage < 70kVp or > 150kVp. # Comparison of Technological Characteristics with the Predicate Device: Rapid Neuro3D's predicate device is Rapid (K233582), under regulation 21 CFR §892.2050. Both are SaMD and share the same intended use as Automated Radiological Image Processing Software utilized when reviewing neurological images. Rapid Neuro3D is substantially equivalent to the previously cleared Rapid (K233582) device and contains analogous CTA software outputs (e.g. 2D/3D vessel visualization and MIPS) facilitated by the automated segmentation and removal of obstructive bones and/or vessels. Rapid Neuro3D has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate. Rapid Neuro3D raises no new issues of safety or effectiveness when compared with Rapid (K233582). Verification and validation testing confirms the software reliably processes and supports analysis of CTA medical images for visualization of the neurovasculature supplying arterial blood to the brain. Thus, Rapid Neuro3D software is substantially equivalent. | Product Name | Rapid Neuro3D (Subject Device) | Rapid (including Rapid CTA) (K233582) | |---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulation | 21 CFR 892.2050; Medical image management and processing system | 21 CFR 892.2050; Medical image management and processing system | | Product Code | QIH | LLZ, QIH | | Intended Use/<br>Indications for Use<br>Statement | Rapid Neuro3D (RN3D) is an image analysis software for imaging datasets acquired with conventional CT Angiography (CTA) from the aortic arch to the vertex of the head). The module removes bone, tissue, and venous vessels, providing a 3D and 2D visualization of the neurovasculature supplying arterial blood to the brain.<br><br>Outputs of the device include 3D rotational maximum intensity projections (MIPS), volume renders (VR), along with the curved planar reformation (CPR) of the isolated left and right internal carotid and vertebral arteries.<br><br>Rapid Neuro3D is designed to support the physician in confirming the presence | Rapid is an image processing software package to be used by trained professionals, including but not limited to physicians (medical analysis and decision making) and medical technicians (administrative case processing). The software runs on a standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, and analysis of images. Data and images are acquired through DICOM compliant imaging devices. Rapid is indicated for Adults only.<br><br>Rapid provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT, CT Perfusion (CTP), CT Angiography (CTA), C-arm CT Perfusion and MRI including a Diffusion | | Product Name | Rapid Neuro3D (Subject Device) | Rapid (including Rapid CTA) (K233582) | | | or absence of physician-identified lesions<br>and evaluation, documentation, and<br>follow-up of any such lesion and<br>treatment planning. | Weighted MRI (DWI) Module and a Dynamic<br>Analysis Module (dynamic contrast-enhanced<br>imaging data for MRI, CT, and C-arm CT). | | | Its results are not intended to be used on<br>a stand-alone basis for clinical decision-<br>making or otherwise preclude clinical<br>assessment. | Rapid C-arm CT Perfusion can be used to<br>qualitatively assess cerebral hemodynamics in<br>the angiography suite.<br>The CT analysis includes NCCT maps showing<br>areas of hypodense and hyperdense tissue. | | | RN3D is indicated for adults. | | | | Precautions/Exclusions: | The DWI Module is used to visualize local<br>water | | | Series containing excessive patient<br>motion or metal implants may impact<br>module output quality. | diffusion properties from the analysis of<br>diffusion -weighted MRI data. | | | The RN3D module will not process series<br>that meet the following module exclusion<br>criteria:<br>• Series containing inadequate contrast<br>agent (<0.3 mL of right-hemisphere<br>intracranial arterial contrast media or | The Dynamic Analysis Module is used for<br>visualization and analysis of dynamic imaging<br>data, showing properties of changes in<br>contrast over time. This functionality includes<br>calculation of parameters related to tissue<br>flow (perfusion) and tissue blood volume. | | | <0.3 mL of left-hemisphere<br>intracranial arterial contrast media,<br>above 120 HU)<br>• Series acquired w/cone-beam CT<br>scanners (c-arm CT)<br>• Series that are non-axial<br>• Series with a non-supine patient | Rapid CT Perfusion and Rapid MR Perfusion<br>can be used by physicians to aid in the<br>selection of acute stroke patients (with<br>known occlusion of the intracranial internal<br>carotid artery or proximal middle cerebral<br>artery). | | | position<br>• Series containing missing or<br>improperly ordered slices (e.g., as a<br>result of manual correction by an<br>imaging technician)<br>• CTA datasets with:<br>1) in-plane X and Y FOV < 160mm or<br>> 400mm.<br>2) Z FOV (cranio-caudal transverse<br>anatomical coverage) < 90 mm.<br>3) in-plane pixel spacing (X & Y<br>resolution) < 0.2 mm or > 1.0 mm.<br>4) Z slice spacing of < 0.2 mm or > | Instructions for the use of contrast agents for<br>this indication can be found in Appendix A of<br>the User's Manual. Additional information for<br>safe and effective drug use is available in the<br>product-specific iodinated CT and gadolinium-<br>based MR contrast drug labeling.<br>In addition to the Rapid imaging criteria,<br>patients must meet the clinical requirements<br>for thrombectomy, as assessed by the<br>physician, and have none of the following<br>contraindications or exclusions: | | | 1.25 mm.<br>5) slice thickness > 1.5mm.<br>6) data acquired at x-ray tube voltage | • Bolus Quality: absent or inadequate bolus.<br>• Patient Motion: excessive motion leading to<br>artifacts that make the scan technically<br>inadequate. | | | < 70kVp or > 150kVp. | | | Product Name | Rapid Neuro3D (Subject Device) | Rapid (including Rapid CTA) (K233582) | | | | • Presence of hemorrhage.<br>• C-Arm CTP is not used in the Rapid<br>Thrombectomy<br>indication for patient selection criteria, other<br>modalities should be consulted. | | | | <b>Caution</b><br>CBV and CBT are not absolute and CBT, CBV,<br>MTT and Tmax are supported for qualitative<br>interpretation of the perfusion maps only. | | Intended<br>Users | Radiologists, neurovascular and<br>neurosurgical specialists, such as<br>vascular neurosurgeons, neuro-<br>interventional specialists, ED physicians,<br>or users with similar training. | Medical imaging professionals who analyze<br>tissue using CT or MRI images | | | Technological Characteristics | | | Functionality | Software package (SaMD) which<br>interfaces to a PACS/Viewer or allows<br>viewing within the application. | Software package (SaMD) which interfaces to<br>a PACS/Viewer or allows viewing within the<br>application. | | Computer<br>Platform | Standard off-the-shelf Hardware: On-<br>Premises or Cloud Hybrid | Standard off-the-shelf Hardware: On-<br>Premises or Cloud<br>Hybrid | | Technical<br>Implementation | AI/ML | Mixed - Traditional Coding and AI/ML | | Input DICOM<br>Imaging<br>Modality | CTA | CT, CTP, CTA, C-arm CT, MRI, NCCT | | Imaging Type | Neurological (aortic arch to the vertex<br>of the head) | Neurological | | Software<br>Outputs | • 2D/3D vessel visualization (Thins, MIPS,<br>VR, CPR)<br>• Automated segmentation and removal<br>of obstructive bones and/or vessels | • Digital image processing, visualization, and<br>analysis tools (various detailed in IFU above,<br>including tissue flow (perfusion), tissue blood<br>volume, etc.)<br>Specifically for Rapid CTA:<br>• 2D/3D vessel visualization (MIPS, colored<br>overlay indicating reduction of vessel density)<br>• Automated segmentation and removal of<br>obstructive bones and/or vessels | {8}------------------------------------------------ # 510(k) Summary {9}------------------------------------------------ # 510(k) Summary {10}------------------------------------------------ 510(k) Summary # Performance Standards: Rapid has been developed in conformance with the following standards, as applicable: | ISO 14971:2019 | Application of Risk Management to Medical Devices | |------------------------------|------------------------------------------------------------------------| | IEC 62304:2015 | Medical Device software – Software lifecycle processes | | IEC 62366-1:2015<br>+A1:2020 | Application of Usability Engineering to Medical Devices | | NEMA PS 3.1 - 3.20 | Digital Imaging and Communications in Medicine (DICOM) | | ISO 15223-1:2021 | Symbols to be Used with Information to be Supplied by the Manufacturer | Rapid has been designed to meet the cybersecurity requirements using design Vulnerability Assessments, SBOM's, and PEN Testing. # Performance Data: Rapid 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 performance validation testing and software verification and validation testing of the Rapid Neuro3D device. Software performance testing demonstrated that the device met all design requirements and specifications. Final device validation included standalone performance validation (segmentation quality and segmentation accuracy). All major CT scanner manufacturers (incl. Siemens, GE, Toshiba/Canon, and Philips) were represented in the data. Patient demographics included representative age/gender distribution and incorporated data to assess the influence of potential confounders (abnormalities/anomalies/ anatomical variants) on performance. The test dataset was independent from the data used during model training per internal data quality control processes. The segmentation quality study used 120 CTA cases (104 US, 16 OUS) from 115 patients (65 female; 50 male; aged from 27 to 90+) to compare the Rapid Neuro3D segmentation outputs against source DICOM images. All four output image types were evaluated: 3D rotational maximum intensity projection (MIP) images, 3D volume rendering (VR) images, a source seriesequivalent (SSE) with all tissue/bone/vein removed, and 2D curved planar reformation (CPR) images. MIP, VR, and SSE images were assessed for a total of 1,920 segments; CPR images included 480 segments. The primary endpoint, clinical accuracy, as determined by the consensus of up to three clinical experts against the source DICOM images, passed for all RN3D outputs with 99.8% agreement for MIP images, 98.6% agreement for VR images, 100.0% agreement for SSE images, and 100.0% agreement for CPR. The secondary endpoint, labeling, passed with 100% of the anatomical labels applied found to be accurate for the vessels visualized. {11}------------------------------------------------ ## 510(k) Summary The segmentation accuracy study used 50 CTA cases (43 US, 7 OUS) from 48 patients (24 female; 24 male; aged from 27 to 90+) to quantitatively assess the Rapid Neuro3D segmentation outputs against ground truth. The assessment for 3D visualizations was divided by anatomical region: extracranial and intracranial. For the extracranial region, the primary endpoint, segmentation accuracy, was met with an average Dice Coefficient of 0.89 and an average Hausdorff Distance of 0.44 mm between the module and ground truth. For the intracranial region, the primary endpoint. substantial equivalence, was met with an average Dice Coefficient of 0.97 and an average Hausdorff Distance of 0.44mm between the module and the predicate device. The secondary endpoint, reproducibility (of ground truths), showed a within case variance of 1%, demonstrating strong reproducibility of ground truth segmentations. For the CPR visualizations, the primary endpoint, centerline accuracy, was met with an average Hausdorff Distance of 0.31 mm between the module and ground truth. ### Prescriptive Statement: Caution: Federal law restricts this device to sale by or on the order of a physician. ### Safety & Effectiveness: Rapid Neuro3D 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 IEC 62304:2015. Software performance, validation and verification testing demonstrated that the Rapid Neuro3D system met all design requirements. ## Conclusion: Based on the shared technological characteristics and intended use, iSchemaView's Rapid Neuro3D is substantially equivalent to the legally marketed predicate device, Rapid (K233582). The results of performance validation and software verification/validation testing support the safety and performance of Rapid Neuro3D.