Rapid (6.0)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. iSchemaView, Inc. Jim Rosa SVP Regulatory and Quality 1120 Washington Ave. Suite 200 Golden, CO 80401 January 16, 2024 # Re: K233512 Trade/Device Name: Rapid (6.0) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management and Processing System Regulatory Class: Class II Product Code: QIH, LLZ Dated: December 26, 2023 Received: January 12, 2024 Dear Jim 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. 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). {1}------------------------------------------------ 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. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 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. 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 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 Assistant Director Imaging Software Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use Submission Number (if known) K233512 Device Name Rapid (6.0) Indications for Use (Describe) Rapid is an image processing software package to be used by trained professionals,including but not limited to physicians and medical technicians. The software runs ona 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 provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT Perfusion (CTP). CT Angiography (CTA), and MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast-enhanced imaging data for MRI and CT). The CT analysis includes NCCT maps showing areas of hypodense and hyperdense tissue. The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion weighted MRI data. The Dynamic Analysis Module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. Rapid CT-Perfusion and Rapid MR-Perfusion can be used by physicians to aid in the selection of acute stroke patients (with known occlusion of the intracranial internal carotid artery or proximal middle cerebral artery)Instructions for the use of contrast agents for this indication can be found in Appendix A of the User's Manual. Additional information for safe and effective drug use is available inthe product-specific iodinated CT and gadolinium-based MR contrast drug labeling. In addition to the Rapid imaging criteria, patients must meet the clinical requirements for thrombectomy, as assessed by the physician, and have none of the following contraindications or exclusions: - · Bolus Quality: absent or inadequate bolus. - · Patient Motion: excessive motion leading to artifacts that make the scan technically inadequate - Presence of hemorrhage 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. {3}------------------------------------------------ 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." {4}------------------------------------------------ ## 510(k) Summary ## iSchemaView, Inc.'s Rapid This document contains the 510(k) summary for the iSchemaView Rapid Platform. The content of this summary is based on the requirements of 21 CFR Section 807.92(c). #### Applicant Name and Address: | Name: | iSchemaView, Inc. | |-------------------|------------------------------------------------------------------| | Address: | 1120 Washington St., Suite 200<br>Golden, CO 80401 | | Official Contact: | Jim Rosa<br>Phone: (303) 704-3374<br>Email: rosa@ischemaview.com | #### Summary Preparation Date: January 12, 2024 ## Device Name and Classification: | Trade Name: | iSchemaView Rapid Platform | |--------------------------|---------------------------------------------------| | Common Name: | PACS – Picture Archiving Communications<br>System | | Classification: | II | | Product Code: | Primary: QIH, Secondary: LLZ | | Regulation No: | 21 C.F.R. §892.2050 | | Classification<br>Panel: | Radiology Devices | #### Predicate Devices: The iSchemaView Rapid is claimed to be substantially equivalent to the following legally marketed predicate devices: Primary: iSchemaView Rapid (K213165) # Previous Related FDA Submission: iSchemaView Rapid (K121447) - Initial Rapid Clearance #### Device Description: Rapid is a software package that provides for the visualization and study of changes in tissue using digital images captured by diagnostic imaging systems including CT (Computed Tomography) and MRI (Magnetic Image Resonance), as an aid to physician diagnosis. Rapid can be installed on a customer's Server or it can be accessed online as a virtual system. It provides viewing, quantification, analysis and reporting capabilities. Rapid works with the following types of (DICOM compliant) medical image data: {5}------------------------------------------------ - CT (Computed Tomography) ● - MRI(Magnetic Image Resonance) ● Rapid acquires (DICOM compliant) medical image data from the following sources: - . DICOM file - DICOM CD-R - Network using DICOM protocol. Rapid provides tools for performing the following types of analysis: - selection of acute stroke patients for endovascular thrombectomy - . volumetry of thresholded maps - time intensity plots for dynamic time courses ● - . measurement of mismatch between labeled volumes on co-registered image volumes - large vessel density ● Rapid is a Software as a Medical Device (SaMD) consisting of one or more Rapid Servers (dedicated or virtual) in on-premises or hybrid (on-premises/cloud) configurations. The Rapid Server is an image processing engine that connects to a hospital LAN, or inside the Hospital Firewall in the on-premises configuration or in conjunction with a secure link to the cloud in the hybrid configuration. It can be a dedicated Rapid Server or a VM Rapid appliance, which is a virtualized Rapid Server that runs on a dedicated server. Rapid is designed to streamline medical image processing tasks that are time consuming and fatiguing in routine patient workup. Once Rapid is installed it operates with minimal user interaction. Once the CT (NCCT, CT, CTA) or MR (MR, MRA) data are acquired, the CT or MRI console operator selects Rapid as the target for the DICOM images, and then the operator selects which study/series data to be sent to Rapid. Based on the type of incoming DICOM data. Rapid will identify the data set scanning modality and determine the suitable processing module. The Rapid platform is a central control unit which coordinates the execution image processing modules which support various analysis methods used in clinical practice today: - Rapid CTP/MRP, DWI, Dynamic Analysis (Original: K121447, Updated with K172477; . and K182130) - Rapid CTA (K172477) ● - Rapid ASPECTS(K190395) - Rapid ICH (K193087, K221436) - Rapid LVO (K200941, K221248) - Rapid PETN (K220499) - Rapid RVLV (K223396 - Rapid NCCT Stroke (K222884) - . Rapid ANRT (K230074) - Rapid SDH (K232436) ● {6}------------------------------------------------ The iSchemaView Server is a dedicated server that provides a central repository for Rapid data. All iSchemaView Server data is stored on encrypted hard drives within the hospital infrastructure. It also provides a user interface for accessing Rapid data. It connects to a firewalled Data Center Network and has its own firewall for additional cyber/data security. The iSchemaView Server connects to one or more Rapid Servers via WAN. Available types of connection include VPN (Virtual Private Network - RFC2401 and RFC4301 Standards) Tunnel and SSH (Secure Shell). # Indications for Use: Rapid is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. 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 provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT Perfusion (CTP), CT Angiography (CTA), and MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast-enhanced imaging data for MRI and CT). The CT analysis includes NCCT maps showing areas of hypodense and hyperdense tissue. The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion - weighted MRI data. The Dynamic Analysis Module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. Rapid CT-Perfusion and Rapid MR-Perfusion can be used by physicians to aid in the selection of acute stroke patients (with known occlusion of the intracranial internal carotid artery or proximal middle cerebral artery) Instructions for the use of contrast agents for this indication can be found in Appendix A of the User's Manual. Additional information for safe and effective drug use is available in the product-specific iodinated CT and gadolinium-based MR contrast drug labeline. In addition to the Rapid imaging criteria, patients must meet the clinical requirements for thrombectomy, as assessed by the physician, and have none of the following contraindications or exclusions: - . Bolus Quality: absent or inadequate bolus. - Patient Motion: excessive motion leading to artifacts that make the scan technically . inadequate - Presence of hemorrhage ● {7}------------------------------------------------ # Technological Characteristics: Rapid performs the following functions: - . processes DICOM images from multiple sources to provide visualization of changes of tissue perfusion, diffusion and change. - . receives DICOM images from external DICOM image providers (modalities (CT/MRI Scanners), PACS and Workstations) and sends DICOM images to external image consumers. - . processes requests, statuses and results, and references therein, which are stored in a searchable database. - processing status is available through a web browser using HTTP, HTML and PHP. - can send summary results to the user over email. For this, Rapid generally connects to ● the infrastructure of the medical partner (e.g., the hospital). Rapid uses a SMTP protocol with security extensions to provide secure communications. Rapid is available in the following configurations: - Standard Rapid, which is installed directly on a customer's Linux-based server and . integrated with medical image processing software such as commercial PACS. - . Virtual Rapid, wherein the user accesses Rapid online and uses it to process DICOM images otherwise available on his/her computer. Rapid is a DICOM-compliant PACS software that provides comprehensive functionality to transfer, process, and display modality specific imaging data. Rapid runs on standard "offthe- shelf' computer and networking hardware. Rapid is entirely independent from CT, MRI, or independent PACS platforms. It supports secure VPN (Virtual Private Network) networking or encapsulated Secure Shell (SSH), and seamlessly integrates into an existing radiological data network. # Clinical Characteristics: The primary users of Rapid software are medical imaging professionals who analyze tissue using CT or MRI images. The images generated by Rapid provide additional diagnostic information, which is derived from the temporal/diffusion/density features of the native CT or MRI images. Rapid CT Perfusion and Rapid MRI can be used by physicians to select acute stroke patients for endovascular thrombectomy. The recommended selection criteria are listed in the table below. Patients must meet the clinical requirements for thrombectomy as assessed by the physician. # Performance Standards: Rapid has been developed in conformance with the following standards, as applicable: | EN ISO 14971:2019 | Application of Risk Management to Medical Devices | |-------------------|---------------------------------------------------------| | IEC 62304:2016 | Medical device software – Software lifecycle processes | | IEC 62366:2015 | Application of Usability Engineering to Medical Devices | {8}------------------------------------------------ NEMA PS 3.1 - 3.20 Digital Imaging and Communications in Medicine (DICOM) # 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. Additionally, iSchemaView conducted extensive performance validation testing and software verification and validation testing of the Rapid system. This performance validation testing demonstrated that the Rapid system provides accurate representation of key processing parameters under a range of clinically relevant parameters and perturbations associated with the intended use of the software. Software performance, validation and verification testing demonstrated that the Rapid system met all design requirements and specifications. # Prescriptive Statement: Caution: Federal law restricts this device to sale by or on the order of a physician. # Safety & Effectiveness: Rapid has been designed, verified and validated in compliance with 21 CFR, Part 820.30 requirements. The device has been designed to meet the requirements associated with EN ISO 14971:2019 (risk management). The Rapid System performance has been validated with phantom and case data. # Substantial Equivalence: Rapid is as safe and effective as the previously cleared Rapid (K213165) with an extension of installation in a hybrid configuration (on-premises and hybrid). Rapid has the same intended use and similar indications, technological characteristics and principles of operation as its predicate devices. Rapid raises no new issues of safety or effectiveness compared to Rapid (K2131650), as demonstrated by the testing conducted with Rapid. Thus, Rapid Platform v6.0 software is substantially equivalent. | Parameter | Rapid Platform v6 | Rapid (K213165) Primary Predicate | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | LLZ, QIH | LLZ, QIH | | Regulation | 21 CFR §892.2050 | 21 CFR §892.2050 | | Intended Use/<br>Indications for<br>Use | iSchemaView's Rapid is an image<br>processing software package to be used<br>by trained professionals, including but<br>not limited to physicians and medical<br>technicians. The software runs on a<br>standard off-the-shelf computer or a<br>virtual platform, such as VMware, and<br>can be used to perform image viewing,<br>processing and analysis of images. Data<br>and images are acquired through<br>DICOM compliant imaging devices.<br>The iSchemaView Rapid provides both | iSchemaView's Rapid is an image<br>processing software package to be used<br>by trained professionals, including but<br>not limited to physicians and medical<br>technicians. The software runs on a<br>standard off-the-shelf computer or a<br>virtual platform, such as VMware, and<br>can be used to perform image viewing,<br>processing and analysis of images. Data<br>and images are acquired through<br>DICOM compliant imaging devices.<br>The iSchemaView Rapid provides both | | viewing and analysis capabilities for<br>functional and dynamic imaging<br>datasets acquired with CT/CBCT<br>Perfusion (CTP/CBCTP), CT<br>Angiography (CTA), and MRI<br>including a Diffusion Weighted MRI<br>(DWI) Module and a Dynamic Analysis<br>Module (dynamic contrast-enhanced<br>imaging data for MRI and CT). | viewing and analysis capabilities for<br>functional and dynamic imaging<br>datasets acquired with CT/CBCT<br>Perfusion (CTP/CBCTP), CT<br>Angiography (CTA), and MRI<br>including a Diffusion Weighted MRI<br>(DWI) Module and a Dynamic Analysis<br>Module (dynamic contrast-enhanced<br>imaging data for MRI and CT). | | | The CT analysis includes NCCT maps<br>showing areas of hypodense and<br>hyperdense tissue. | The CT analysis includes NCCT maps<br>showing areas of hypodense and<br>hyperdense tissue. | | | The DWI Module is used to visualize<br>local water diffusion properties from the<br>analysis of diffusion - weighted MRI<br>data. | The DWI Module is used to visualize<br>local water diffusion properties from the<br>analysis of diffusion - weighted MRI<br>data. | | | The Dynamic Analysis Module is used<br>for visualization and analysis of<br>dynamic imaging data, showing<br>properties of changes in contrast over<br>time. This functionality includes<br>calculation of parameters related to<br>tissue flow (perfusion) and tissue blood<br>volume. | The Dynamic Analysis Module is used<br>for visualization and analysis of<br>dynamic imaging data, showing<br>properties of changes in contrast over<br>time. This functionality includes<br>calculation of parameters related to<br>tissue flow (perfusion) and tissue blood<br>volume. | | | Rapid CT-Perfusion and Rapid MR-<br>Perfusion can be used by physicians to aid<br>in the selection of acute stroke patients<br>(with known occlusion of the intracranial<br>internal carotid artery or proximal middle<br>cerebral artery) | Rapid CT-Perfusion and Rapid MR-<br>Perfusion can be used by physicians to aid<br>in the selection of acute stroke patients<br>(with known occlusion of the intracranial<br>internal carotid artery or proximal middle<br>cerebral artery) | | | Instructions for the use of contrast agents<br>for this indication can be found in<br>Appendix A of the User's Manual.<br>Additional information for safe and<br>effective drug use is available in the<br>product-specific iodinated CT and<br>gadolinium-based MR contrast drug<br>labeling. | Instructions for the use of contrast agents<br>for this indication can be found in<br>Appendix A of the User's Manual.<br>Additional information for safe and<br>effective drug use is available in the<br>product-specific iodinated CT and<br>gadolinium-based MR contrast drug<br>labeling. | | | In addition to the Rapid imaging criteria,<br>patients must meet the clinical<br>requirements for thrombectomy, as<br>assessed by the physician, and have none of<br>the following contraindications or<br>exclusions. | In addition to the Rapid imaging criteria,<br>patients must meet the clinical<br>requirements for thrombectomy, as<br>assessed by the physician, and have none of<br>the following contraindications or<br>exclusions. | | | Contraindications/Exclusions: | Contraindications/Exclusions: | | | | Bolus Quality: absent or inadequate bolus. Patient Motion: excessive motion leading to artifacts that make the scan technically inadequate. Presence of hemorrhage | Bolus Quality: absent or inadequate bolus. Patient Motion: excessive motion leading to artifacts that make the scan technically inadequate. Presence of hemorrhage | | Basic PACS<br>Functions | Software package which interfaces to a<br>PACS or allows viewing within the<br>application | Same | | Computer<br>Platform | Standard off-the-shelf Hardware: On-<br>Premises | Standard off-the-shelf Hardware: Hybrid (on-<br>premises/cloud) | | Software | Traditional Coding for platform | Traditional Coding for platform | | DICOM<br>Compliance | Yes | Yes | | Functional<br>Overview | Rapid is a software package that<br>provides for the visualization and study<br>of changes of tissue in digital images<br>captured by CT and MRI. Rapid<br>provides viewing and quantification.<br>The base Platform provides common<br>services to the imaging modules | Same | | Data/Image<br>Types | Computed Tomography (CT) via<br>DICOM Format | Same | | | Magnetic Image Resonance (MRI) via<br>DICOM Format | Same | {9}------------------------------------------------ {10}------------------------------------------------ # Conclusion: In conclusion, the iSchemaView Rapid is substantially equivalent in intended use, technological characteristics, safety, and performance characteristics to the legally marketed predicate devices, Rapid (K213165).