ISCHEMA VIEW RAPID

{0}------------------------------------------------ ## 510(k) SUMMARY iSchemaView, Inc.'s RAPID | Applicant's name: | iSchemaView, Inc.<br>323 Olmsted Road<br>Stanford, CA 94305 | |-------------------|-------------------------------------------------------------------------------------------------------------------| | Contact Person: | John J. Smith, M.D., J.D.<br>Partner<br>Hogan Lovells US LLP<br>555 Thirteenth Street, NW<br>Washington, DC 20004 | **OCT 04 2013** Date Prepared: September 13, 2013 Name of Device: RAPID PACS - Picture Archiving Communications System Common or Usual Name: Classification: Product Code: LLZ Regulation No: 21 C.F.R. §892.2050 Class: Il Classification Panel: Radiology Devices Tel. (202) 637-3638 Fax (202) 637-5910 #### Predicate Devices OLEA MEDICAL's Olea Sphere (K120196) ### Device Description RAPID is a software package that provides for the visualization and study of changes of tissue perfusion and diffusion in digital images captured by CT (Computed Tomography) and MRI (Magnetic Image Resonance). RAPID can be installed on a customer PC or it can be accessed online as virtual system. It provides viewing, quantification, analysis and reporting capabilities. RAPID works with the following types of (DICOM compliant) medical image data: - · 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 {1}------------------------------------------------ RAPID provides tools for performing the following types of analysis: - · volumetry of threshold maps - · time intensity plots for dynamic time courses - measurement of mismatch between labeled volumes on co-registered image volumes RAPID is a software-only device consisting of one or more RAPID Servers (dedicated or virtual and an iSchemaView Server). The RAPID Server is an image processing engine that connects to a hospital LAN, inside the Hospital Firewall. It can be a dedicated RAPID Server or a vmRAPID appliance, which is a virtualized RAPID Server that runs on a dedicated hospital server. Where available, the RAPID Server is placed logically in the demilitarized zone (DMZ) of the hospital's network to facilitate bidirectional secure connection between the (local) RAPID Server and the centralized iSchemaView Server. The RAPID Server is configured to connect to applicable DICOM devices (PACS, Imaging Modalities, Research Workstations) via the hospital LAN and to receive diffusion and perfusion (DICOM) data directly and automatically from imaging modalities as they become available. It processes acquired data and delivers postprocessed images directly back to imaging modalities, local PACS and/or workstations, again using DICOM communication. It also transmits data to the iSchemaView Server for storage, retrieval and viewing. The iSchemaView Server is a dedicated server that provides a central repository for RAPID data. All iSchemaView Server data is stored on encrypted hard disks. 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 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). ## Intended Use / Indications for Use iSchemaView's 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 brain images. Data and images are acquired through DICOM compliant imaging devices. iSchemaView's RAPID provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT Perfusion and MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast enhanced imaging data for MRI and CT). The DWI Module is used to visualize local water diffusion properties from the analysis of diffusionweighted 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. {2}------------------------------------------------ ## Technological Characteristics RAPID performs the following functions: - processes DICOM images from multiple sources to provide visualization of changes of . tissue perfusion and diffusion - 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 . queryable 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). In particular, RAPID uses a SMTP protocol with security extensions to provide secure emailing. RAPID is available in the following configurations: - Standard RAPID, which is installed directly on a customer's Linux-based PC 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 diffusion-weighted MRI (DWI) and dynamically acquired CT and MR imaging data (following the administration of a bolus of contrast media). RAPID runs on standard "off-theshelf" computer and networking hardware. RAPID is entirely independent from CT, MRI, or PACS platforms. It supports secure VPN (Virtual Private Network) networking or encapsulated Secure Shell (SSH), and seamlessly integrates into an existing radiological data network. The primary users of RAPID PACS software are medical imaging professionals who analyze diffusion MRI and/or dynamic CT or MRI images. The images generated by RAPID provide additional diagnostic information, which is derived from the temporal/diffusion features of the native CT or MRI images. ### 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 (2011). 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 diffusion and perfusion processing parameters under a range of clinically relevant parameters and perturbations associated with the intended use of the software. Software validation and verification testing demonstrated that the RAPID system met all design requirements and specifications. {3}------------------------------------------------ ## Substantial Equivalence RAPID is as safe and effective as the Olea Sphere. RAPID has the same intended use and similar indications, technological characteristics and principles of operation as its predicate device. The minor technological differences between the RAPID and its predicate raise no new issues of safety or effectiveness as demonstrated by the testing conducted with RAPID that confirms that the software reliably processes CT diffusion and MRI diffusion and perfusion medical images. Thus, the RAPID software is substantially equivalent. {4}------------------------------------------------ | Parameter | RAPID | Olea Sphere (K120196) | |--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | LLZ | LLZ | | Regulation | 21 CFR §892.2050 | 21 CFR §892.2050 | | Intended Use/ Indications for use | iSchemaView's RAPID is an image processing<br>software package to be used by trained<br>professionals, including but not limited to physicians<br>and medical technicians. The software runs on a<br>standard "off-the-shelf" computer or a virtual<br>platform, such as VMware, and can be used to<br>perform image viewing, processing and analysis of<br>brain images. Data and images are acquired<br>through DICOM compliant imaging devices. | Olea Sphere is an image processing software package to be used by<br>trained professionals including but not limited to physicians and<br>medical technicians. The software runs on a standard "off-the-shelf"<br>workstation and can be used to perform image viewing, processing<br>and analysis of medical images. Data and images are acquired<br>through DICOM compliant imaging devices and modalities. | | | The iSchemaView RAPID provides both viewing and<br>analysis capabilities for functional and dynamic<br>imaging datasets acquired with CT Perfusion and<br>MRI including a Diffusion Weighted MRI (DWI)<br>Module and a Dynamic Analysis Module (dynamic<br>contrast-enhanced imaging data for MRI and CT). | Olea Sphere provides both viewing and analysis capabilities of<br>functional and dynamic imaging datasets acquired with MRI or other<br>relevant modalities, including a Diffusion Weighted MRI (DWI) / Fiber<br>Tracking Module and a Dynamic Analysis Module (dynamic contrast<br>enhanced imaging data for MRI and CT). | | | The DWI Module is used to visualize local water<br>diffusion properties from the analysis of diffusion-<br>weighted MRI data. | The DWI Module is used to visualize local water diffusion properties<br>from the analysis of diffusion-weighted MRI data. The Fiber Tracking<br>feature utilizes the directional dependency of the diffusion to display<br>the white matter Structure in the brain or more generally the central<br>nervous system. | | | The Dynamic Analysis Module is used for<br>visualization and analysis of dynamic imaging data,<br>showing properties of changes in contrast over time.<br>This functionality includes calculation of parameters<br>related to tissue flow (perfusion) and tissue blood<br>volume. | The Dynamic Analysis Module is used for visualization and analysis<br>of dynamic imaging data, showing properties of changes in contrast<br>over time where such techniques are useful or necessary. This<br>functionality is referred to as:<br>Perfusion Module - the calculation of parameters related to<br>tissue flow (perfusion) and tissue blood volume.<br>Permeability Module - the calculation of parameters related<br>to leakage of injected contrast material from intravascular to<br>extracellular space. | | PACS Functionality<br>Basic PACS Functions | View, process and analyze medical images.<br>Performs standard PACS functions with respect to<br>querying and listing. | Same | | Computer Platform | Standard "off-the-shelf" PC workstation | Same | | DICOM Compliance | | Yes | | Funcional Overview | RAPID is a software package that provides for the<br>visualization and study of changes of tissue<br>perfusion and diffusion in digital images captured by<br>CT and MRI. RAPID provides viewing and<br>quantification. | Same | | Data Acquisition | Acquires medical image data from DICOM compliant<br>imaging devices and modalities | Same | | Data/Image Types | Computed Tomography (CT)<br>Magnetic Image Resonance (MRI) | Same | | Acquisition and Modalities Features | | | | MRI | Diffusion Weighted Image (DWI)<br>Perfusion Weighted Image (PWI) | Yes | | CT | CT Perfusion (CTP) | Yes | | Computed Parameter Maps | Isotropic DWI (isoDWI) | Yes | | | Exponential apparent diffusion coefficient (eADC) | Yes | | | ADC | Yes | | Diffusion MRI | Trace of diffusion tensor (Trace) | Yes | | | Fractional Anisotropy (FA) and color FA | Yes | | | Eigenvector | Yes | | | Eigenvalue | Yes | | Perfusion MRI and Perfusion<br>CT | Cerebral blood flow (CBF) | Yes | | | Cerebral blood volume (CBV) | Yes | | | Mean transit time (MTT) | Yes | | | Tissue residue function time to peak (Tmax) | Yes | | Measurements/Tools | Arterial input function (AIF)/Venous output function<br>(VOF) | Yes | | | Time-course | Yes | | | Brain mask | Yes | | MRI and CT Tools | Region of interest (ROI) and Volumetry | Yes | | | Volumetric comparison between 2 ROIs | Yes | | | Motion correction | Yes | | | Export perfusion and diffusion files to PACS and<br>DICOM file systems | Yes | | | Acquire, transmit, process, and store medical<br>images | Yes | Substantial Equivalence Note: RAPID also may be used with a virtual platform such as VMware - NDC - 038926/00001 - 4886242 v2 {5}------------------------------------------------ NDC: 03892600001-4886242 V2 K121442 page 6 of 6 0137 {6}------------------------------------------------ Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-0609 Silver Spring, MD 20993-0002 October 4, 2013 iSchemaView, Inc. % John J. Smith, M.D., J.D. Pariner Hogan Lovells US L.LP Columbia Square 555 Thirtcenth Street. NW WASHINGTON DC 20004 Re: K121447 Trade/Device Name: RAPID Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ. Dated: September 16, 2013 Received: September 16, 2013 Dear Dr. Smith: 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 for too May 28, 1976. the enactment date of the Medical Device Amendments, or 10 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). and Cosmetic North the device, subject to the general controls provisions of the Act. The rou may, merely provisions of the Act include requirements for annual registration. Ilisting 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. ff your device is classified (see above) into cither 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 mat I DA has made a devel regulations administered by other Federal agencies. You must or any roothall the Act s requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {7}------------------------------------------------ Page 2-Dr. Smith forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.hum for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, for Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ # Indications for Use 510(k) Number (if known): K121447 Device Name: iSchemaView's RAPID Indications for Use: iSchemaView's 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 brain images. Data and images are acquired through DICOM compliant imaging devices. iSchemaView's RAPID provides both viewing and analysis capabilities for functional and dynamic Imaging datasets acquired with CT Perfusion and MRI including a Diffusion Weighted MRI (DVM) Module and a Dynamic Analysis Module (dynamic contrast enhanced imaging data for MRI and CT). The DWI Module is used to visualize local water diffusion properties from the analysis of diffusionweighted 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. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) \$\sin(7)\$ (Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health > 长121447 510(k) Page 1 of 1