(133 days)
Yes
The document explicitly mentions "NCCT Motion Artifact AI/ML Module Performance" and provides performance metrics (AUC, Sensitivity, Specificity) specifically for this AI/ML module.
No.
The device is an image processing software package that aids in diagnosis and patient selection, rather than directly providing therapy.
Yes
The "Intended Use / Indications for Use" section states: "Rapid is an image processing software package to be used by trained professionals... The software... can be used to perform image viewing, processing and analysis of images." It also explicitly mentions that it is "to aid in the selection of acute patients" and in the "Device Description" it's described as "an aid to physician diagnosis," indicating its role in identifying or interpreting medical conditions.
Yes
The device is described as a "software package" and "Software as a Medical Device (SaMD)". While it interacts with hardware (standard off-the-shelf computers, servers, virtual systems, DICOM compliant imaging devices), the device itself is the software component that performs the image processing and analysis. The description focuses on the software's functionality and installation methods (on a server or as a virtual system), not on any proprietary hardware included as part of the device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: In Vitro Diagnostics are designed to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- This device analyzes medical images: The description clearly states that Rapid is an image processing software package that analyzes images acquired from medical imaging devices like CT and MRI. It does not interact with or analyze biological samples.
Therefore, while this device is a medical device used in diagnosis, it falls under the category of medical imaging software rather than an In Vitro Diagnostic.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device. The section "Control Plan Authorized (PCCP) and relevant text" is marked "Not Found".
Intended Use / 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 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 ●
Product codes
QIH, 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 a 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 as a Medical Device (SaMD) consisting of one or more Rapid Servers (dedicated or virtual). The Rapid Server is an image processing engine that connects to a hospital LAN, or 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 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);
- Rapid LVO (K200941);
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
Yes
Input Imaging Modality
CT, CT Perfusion (CTP), CT Angiography (CTA), MRI, Diffusion Weighted MRI (DWI)
Anatomical Site
Intracranial internal carotid artery or proximal middle cerebral artery
Indicated Patient Age Range
32-88 years (for motion artifact study)
Intended User / Care Setting
Trained professionals, including but not limited to physicians and medical technicians.
Description of the training set, sample size, data source, and annotation protocol
Training was performed on 23066 (Pos:1021, Neg:12877) axial image slices from multiple sites. Samples were obtained from Siemens, GE, Toshiba, Philips, and Neurologica.
Description of the test set, sample size, data source, and annotation protocol
A test set of 3262 (pos:2914, neg:348) images was used. For final independent validation, an N=619 was used with ground truth established by 3 experienced truthers. Testing was performed independent of the development group to avoid bias. The cases were split Male:55%, Female 45%. The samples were primarily from Siemens with GE mixed.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: NCCT Motion Artifact AI/ML Module Performance.
Sample Size:
Training: 23066 axial image slices (Pos:1021, Neg:12877)
Training validation: 5906 (pos: 422.neg: 5484)
Test Set: 3262 (pos:2914, neg:348) images
Independent Validation: N=619
AUC: Optimal performance for final engineering solution: AUC = 0.95. For final independent validation: AUC = 0.96 (0.94, 0.97).
Standalone Performance/Key Results:
Optimal performance for the final engineering solution: Sensitivity=0.95, Specificity=0.96.
For final independent validation, the primary endpoint was passed (weak artifact = 0) with Sensitivity = 0.91 (0.83, 0.95) and Specificity = 0.86 (0.83, 0.89).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Optimal performance for the final engineering solution: Sensitivity=0.95, Specificity=0.96.
For final independent validation: Sensitivity = 0.91(0.83,0.95) and Specificity = 0.86(0.83,0/89).
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
qER-Quant (K211222), iSchemaView Rapid (K182130)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
iSchemaView Rapid (K121447), iSchemaView Rapid (K172477), iSchemaView Rapid (K182130)
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
March 15, 2022
Image /page/0/Picture/1 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
iSchemaView Inc. James Rosa SVP Regulatory and Quality 433 Park Point Drive, Suite 220 Golden, Colorado 80401
Re: K213165
Trade/Device Name: Rapid Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH, LLZ
Dear James Rosa:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated 02/08/2022. Specifically, FDA is updating this SE Letter to change the company name from "ischema View Inc." to "iSchemaView Inc." as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact CAPT Patrick Hintz, MSIH, CIH, USPHS, OHT7: Office of In Vitro Diagnostics and Radiological Health, 301-796-6927, Patrick.Hintz(@fda.hhs.gov.
Sincerely,
Michael D. O'Hara
For
CAPT Patrick Hintz, MSIH, CIH, USPHS Chief Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
iSchema View Inc. % James Rosa SVP Regulatory and Quality 433 Park Point Drive, Suite 220 GOLDEN CO 80401
Re: K213165
February 8, 2022
Trade/Device Name: Rapid Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH, LLZ Dated: January 4, 2022 Received: January 5, 2022
Dear James Rosa:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
2
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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, Ph.D. Assistant Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known)
K213165
Device Name Rapid
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 on a standard off-the-shelf computer or 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, 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 patients (with known ocuusion of the intracranial internal carotid artery or proximal middle cerebral artery)
Instructions for the use of contrast agents for this 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 labeling.
In addition to the Rapid imaging criteria, patients must 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) |
|---|---|
| ---------------------------------------------- | --------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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4
iSchemaView - Traditional 510(k) Rapid 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: | 1120 Washington St., Suite 200 |
| Golden, CO 80401 | |
| Official Contact: | Jim Rosa |
| Phone: (303) 704-3374 | |
| Email: rosa@ischemaview.com |
Summary Preparation Date: `September 24, 2021
Device Name and Classification:
| Trade Name: | iSchemaView Rapid |
|---|---|
| Common Name: | PACS – Picture Archiving Communications System |
| Classification: | II |
| Product Code: | Primary: QIH, Secondary: 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 devices:
Primary: qER-Quant (K211222) Secondary: iSchemaView Rapid (K182130)
Previous Related FDA Submission:
iSchemaView Rapid (K121447) iSchemaView Rapid (K172477) iSchemaView Rapid (K182130)
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
5
510(k) Summary
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:
- 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). The Rapid Server is an image processing engine that connects to a hospital LAN, or 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 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);
- . Rapid LVO (K200941);
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
6
510(k) Summarv
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 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 ●
7
510(k) Summary
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. ●
- . for NCCT images, a motion filter (AI/ML) is employed which provides a textual overlay on an image suspected of having motion artifacts, without distorting the original image
- 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 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.
NCCT Motion Artifact AI/ML Module Performance:
Training was performed on 23066 (Pos:1021, Neg:12877) axial image slices from multiple sites, training validation included 5906 (pos: 422.neg: 5484) with a test set of 3262 (pos:2914, neg:348) images. Slice thickness ranged from 1.2-6.0 mm; The optimal performance for the final engineering solution showing an optimal AUC = 0.95, Sensitivity=0.95, Specificity=0.96. Samples were obtained from Siemens, GE, Toshiba, Philips, and Neurologica.
For final independent validation, an N=619 was used with ground truth established by 3 experienced truthers. Testing was performed indevendent of the development group to avoid bias. The primary endpoint was passed (weak artifact = 0) with Sensitivity = 0.91(0.83,0.95) and Specificity = 0.86(0.83,0/89) with AUC = 0.96(0.94,0.97). The cases were split Male:55%, Female 45% with an age range or 32-88 years. The samples were primarily from Siemens with GE mixed.
8
510(k) Summary
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 |
| 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 through the use of phantoms and case data.
Substantial Equivalence:
Rapid is as safe and effective as the previously cleared Rapid (K182130) with an extension of two parameters similar to the hyperdensity defined in qER-Quant (K211222). 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 qER-Quant (K211222) or Rapid (K182130), as demonstrated by the testing
9
510(k) Summary
conducted with Rapid that confirms the software reliably processes and supports analysis of CT and MRI medical images for tissue evaluation. Thus, the Rapid software is substantially equivalent. The claims have been expanded to include the use of Rapid to show areas of hypodensity and hyperdensity and NCCT Motion Suspicion (AI/ML).
10
510(k) Summary
Substantial Equivalence Discussion:
| Parameter | Rapid (K182130) – Secondary | qER-Quant (K211222) - Primary | Rapid |
|---|---|---|---|
| Product Code | LLZ | QIH | QIH, LLZ |
| Regulation | 21 CFR §892.2050 | 21 CFR §892.2050 | 21 CFR §892.2050 |
| 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
Angiography, 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. | The qER-Quant device is intended
for automatic labeling, visualization
and quantification of segmentable
brain structures from a set of Non-
Contrast head CT (NCCT) images.
The software is intended to automate
the current manual process of
identifying, labeling and quantifying
the volume of segmentable brain
structures identified on NCCT
images.
qER-Quant provides volumes from
NCCT images acquired at a single
time point and provides a table with
comparative analysis for two or more
images that were acquired on the
same scanner with the same image
acquisition protocol for the same
individual at multiple time points.
The qER-Quant software is indicated
for use in the analysis of the
following structures: Intracranial
Hyperdensities, Lateral Ventricles
and Midline Shift. | 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, 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 |
| | | | |
| | 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
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 | | 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
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 |
| | PACS Functionality | | |
| Basic PACS Functions | Software package which interfaces to a
PACS or allows viewing within the
application | Viewing through user PACS | Same |
| Computer Platform | Standard off-the-shelf Hardware: On-
Premise | Standard off-the-shelf Hardware: On-
Premise and Secure Cloud | Standard off-the-shelf Hardware: On-
Premise |
| Software | Traditional Coding | AI/ML | Mixed Traditional and AI/ML(NCCT
Motion Filter) |
| DICOM Compliance | Yes | Yes | Yes |
| Functional Overview | Rapid is a software package that
provides for the visualization and
study of changes of tissue in digital
images captured by CT and MRI.
Rapid provides viewing and
quantification. | Same | Same |
| Data/Image Types | Computed Tomography (CT) via
DICOM Format | Same | Same |
| | Magnetic Image Resonance (MRI) via
DICOM Format | Not supported | Supported |
| | Acquisition and Modalities Features | | |
| MRI | Diffusion Weighted Image (DWI) | Not supported | Supported |
| | Dynamic Analysis tissue flow
(perfusion) and tissue blood volume | Not supported | Supported |
| CT | CT Perfusion (CTP) | Not supported | Supported |
| | CTA-large vessel density analysis | Not Supported | Supported |
| | Computed Parameter Maps | | |
| Diffusion MRI | Isotropic DWI (isoDWI) | Not supported | Supported |
| | ADC | Not supported | Supported |
| | Trace of diffusion tensor (Trace) | Not supported | Supported |
| | Fractional Anisotropy (FA) and color
FA | Not supported | Supported |
| Perfusion MRI and
Perfusion CT | Cerebral blood flow (CBF) | Not supported | Supported |
| | Cerebral blood volume (CBV) | Not supported | Supported |
| | Mean transit time (MTT) | Not supported | Supported |
| | Tissue residue function time to peak
(Tmax) | Not supported | Supported |
| | Measurement Tools | | |
| MRI and CT Tools | Arterial input function (AIF)Venous
output function
(VOF) | Not supported | Supported |
| | Time-course | Not supported | Supported |
| | Mask | Not supported | Supported |
| | Region of interest (ROI) and
Volumetry | Not supported | Supported |
| | Volumetric comparison between 2
ROIs | Not supported | Supported |
| | Motion correction | Not supported | Supported |
| | Export perfusion and diffusion files to
RACS and DICOM file systems | Not supported | Supported |
| | Acquire, transmit, process, and store
medical images | Not supported | Supported |
| Thrombectomy | Selection of Patients meeting criteria
for Thrombectomy | Supported | Supported |
| NCCT | Hyperdensity (Not included) | Supported | Supported |
| | Hypodensity (Not included) | Not supported | Supported |
| | Motion Artifact Filter (Not included) | Not supported | Supported |
11
510(k) Summary
12
510(k) Summary
13
510(k) Summary
14
510(k) Summary
Conclusion:
In conclusion, the iSchemaView Rapid is substantially equivalent in intended use, technological characteristics, safety, and performance characteristics to the legally marketed predicate devices, qER-Quant (K211222) and Rapid (K182130).