(143 days)
No
The document describes image processing and analysis software but does not mention AI, ML, or related terms like deep learning or neural networks. The validation is described as using phantoms and retrospective clinical data evaluation, not training or testing on large datasets typically associated with AI/ML development.
No
Explanation: The device is an image processing software that aids physicians in the selection of acute stroke patients for endovascular thrombectomy; it does not directly treat or cure a disease or condition.
Yes
The device is explicitly described as an "aid to physician diagnosis" and is used to "aid in the selection of acute stroke patients." These phrases indicate its role in assisting in the identification or determination of a medical condition or patient suitability for a procedure, which falls under the definition of a diagnostic device.
Yes
The device description explicitly states "RAPID is a software-only device consisting of one or more RAPID Servers (dedicated or virtual and an iSchemaView Server)." and "RAPID is a software-only device designed to streamline medical image processing tasks". While it interacts with hardware (standard computers, virtual platforms, DICOM imaging devices, servers), the device itself, as described, is solely the software package.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that RAPID is used to "aid in the selection of acute stroke patients... for endovascular thrombectomy." This is a diagnostic purpose, helping physicians make decisions about patient treatment based on the analysis of medical images.
- Analysis of Biological Data: While the input is medical imaging data (CT and MRI), the software analyzes this data to derive parameters related to "tissue flow (perfusion) and tissue blood volume." These are biological properties of the patient's tissue, which are being analyzed to aid in diagnosis and treatment selection.
- Aid to Physician Diagnosis: The device description states that RAPID is used "as an aid to physician diagnosis." This directly aligns with the definition of an IVD, which is used to provide information for diagnostic purposes.
- Processing of Medical Images for Tissue Evaluation: The document repeatedly mentions that RAPID processes and supports the analysis of CT and MRI medical images for "tissue evaluation." This evaluation of tissue characteristics is a key aspect of diagnosis.
While the device processes imaging data rather than directly analyzing biological samples like blood or urine, the analysis of tissue properties derived from these images for diagnostic purposes falls under the scope of IVDs in many regulatory frameworks. The focus is on providing information about the patient's condition to aid in diagnosis and treatment decisions.
N/A
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 images. Data and images are acquired through DICOM compliant imaging devices.
The iSchemaView RAPID provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT Perfusion (CT-P), 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 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) for endovascular thrombectomy.
Instructions for 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 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.
Contraindications/Exclusions:
- · Bolus Quality: absent or inadequate bolus.
- · Patient Motion: excessive motion leading to artifacts that make the scan technically inadequate.
- · Presence of Hemorrhage
Product codes
LLZ
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 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 .
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-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 VM RAPID 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.
RAPID is a software-only device designed to streamline medical image processing tasks that are time consuming and fatiguing in routine patient workup. RAPID is typically installed on a server running within a hospital's network and operates with minimal user interaction. Once the CT or MR 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 as CT or MRI data, and determine the suitable processing module. RAPID is a toolbox of modules which support various analysis methods used in clinical practice today:
- . RAPID CTA: used to visualize large cerebral vessels and analyze hemispheric difference via contralateral comparison.
- RAPID MR DWI Module: used to visualize local water diffusion properties of tissue . from the analysis of diffusion-weighted MRI data.
- RAPID Dynamic Analysis Module: 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.
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 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).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT Perfusion (CT-P), 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).
Anatomical Site
Intracranial internal carotid artery or proximal middle cerebral artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained professionals, including but not limited to physicians and medical technicians. Hospital LAN, inside the Hospital Firewall.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 description: The image contains 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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
iSchemaView, Inc. Jim Rosa VP Quality Assurance and Regulatory Affairs 433 Park Point Drive. Suite 220 GOLDEN. CO 80401
Re: K182130
Trade/Device Name: iSchemaView RAPID Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: LLZ Dated: November 28, 2018 Received: December 3, 2018
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 (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
December 27, 2018
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
For
Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182130
Device Name iSchemaView RAPID
Indications for Use (Describe)
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 images. Data and images are acquired through DICOM compliant imaging devices.
The iSchemaView RAPID provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT Perfusion (CT-P), 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 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) for endovascular thrombectomy.
Instructions for 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 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.
Contraindications/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.
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."
3
iSchemaView - Traditional 510(k) RAPID Section 5: 510(k) Summary
510(k) Summary
iSchemaView, Inc.'s RAPID
This document contains the 510(k) summary for the iSchemaView RAPID. 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: | 433 Park Point Drive, Suite 220 |
| Golden, CO 80401 | |
| Official Contact: | Jim Rosa |
| Phone: (303) 704-3374 | |
| Email: rosa@ischemaview.com |
| Summary Preparation Date: | November 28, 2018 |
|---|---|
| --------------------------- | ------------------- |
Device Name and Classification:
| Trade Name: | iSchemaView RAPID | ||
|---|---|---|---|
| Common Name: | PACS – Picture Archiving Communications | ||
| System | |||
| Classification: | II | ||
| Product Code: | LLZ | ||
| Regulation No: | 21 C.F.R. §892.2050 | ||
| Classification Panel: | Radiology Devices |
Predicate Devices:
The iSchemaView RAPID is claimed to be substantially equivalent to the following legally marketed predicate device:
iSchemaView RAPID (K172477)
Previous FDA Submission:
iSchemaView RAPID (K121447) iSchemaView RAPID (K172477) iSchemaView Q-Submission Q172046-S001
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 virtual system. It provides viewing, quantification, analysis and reporting capabilities.
4
Section 5: 510(k) Summary
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 .
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-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 VM RAPID 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.
RAPID is a software-only device designed to streamline medical image processing tasks that are time consuming and fatiguing in routine patient workup. RAPID is typically installed on a server running within a hospital's network and operates with minimal user interaction. Once the CT or MR 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 as CT or MRI data, and determine the suitable processing module. RAPID is a toolbox of modules which support various analysis methods used in clinical practice today:
- . RAPID CTA: used to visualize large cerebral vessels and analyze hemispheric difference via contralateral comparison.
- RAPID MR DWI Module: used to visualize local water diffusion properties of tissue . from the analysis of diffusion-weighted MRI data.
- RAPID Dynamic Analysis Module: 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.
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
5
Section 5: 510(k) Summary
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:
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 images. Data and images are acquired through DICOM compliant imaging devices.
The iSchemaView RAPID provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT Perfusion (CT-P), 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 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) for endovascular thrombectomy.
Instructions for 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 productspecific 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.
Contraindications/Exclusions:
- Bolus Quality: absent or inadequate bolus.
- Patient Motion: excessive motion leading to artifacts that make the scan technically inadequate.
- · Presence of Hemorrhage.
Technological Characteristics:
RAPID performs the following functions:
- processes DICOM images from multiple sources to provide visualization of changes ● of tissue perfusion, diffusion and change.
6
Section 5: 510(k) Summary
- 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). 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 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 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 PACS 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 and have no contraindications or exclusions:
7
Section 5: 510(k) Summary
| Known
Neurologic
Baseline
(KNB)(Hrs) | Modality | RAPID Map | Lesion
Volume | DBF/DWI
Threshold
(rCBF/ADC) | Volume
(ml) | Tmax
Threshold
(sec) | Mismatch
Ratio* |
|------------------------------------------------|----------|--------------|------------------|------------------------------------|----------------|----------------------------|--------------------|
| MISMATCH BASED INDICATIONS | | | | | | | |
| KNB ≤ 6 | CTP | Mismatch | CBF/Tmax | 6 | ≥ 1.2 CBF |
| | MRI | Mismatch | DWI/Tmax | 6 | ≥ 1.8 DWI |
| 6 6 | ≥ 1.8 CBF |
| | MRI | Mismatch | DWI/Tmax | 6 | ≥ 1.8 DWI |
| ISCHEMIC CORE RELATED INDICATIONS | | | | | | | |
| Patient ≥ 80 yrs AND NIHSS ≥ 10 | | | | | | | |
| 6 ≤ KNB ≤ 24 | CTP | Mismatch | CBF |