Predicate Devices

Reference Devices

K121447, K172477, K182130, K233512, K200760, K232156, K193087, K221456, K200941, K221248, K222884, K223396, K220499, K230074, K232436

AI/ML (Artificial Intelligence / Machine Learning)

Yes
The text explicitly states "Mixed Traditional and AI/ML" under the Software section of the Substantial Equivalence Comparison table.

Therapeutic

No
The device is image processing software, an aid to diagnosis, and does not provide direct treatment.

Diagnostic

Yes

The device, "Rapid," is explicitly described as aiding "physician diagnosis" and providing "viewing, quantification, analysis and reporting capabilities" for medical images. It is also indicated for use by physicians in "selection of acute stroke patients." These functions clearly align with the purpose of a diagnostic device.

SaMD (Software as a Medical Device)

Yes

The device is described as a "software package" and "Software as a Medical Device (SaMD)" that runs on standard off-the-shelf computers or virtual platforms, processing images acquired from separate DICOM compliant imaging devices. While it interacts with hardware (imaging devices, servers), the device itself is the software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs analyze biological samples: IVDs 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 Rapid software processes and analyzes medical images acquired from imaging devices like CT and MRI. It does not interact with or analyze biological samples.
The intended use is image processing and analysis: The description clearly states the software is for "image viewing, processing, and analysis of images" and "visualization and study of changes in tissue using digital images."

Therefore, while it is a medical device used for diagnosis, it falls under the category of medical imaging software, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

No
The letter does not 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 blank, indicating no such information is present.

Overview

Intended Use / Indications for Use

Rapid is an image processing software package to be used by trained professionals, including but not limited to physicians (medical analysis and decision making) and medical technicians (administrative case processing). The software runs on a standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, and analysis of images. Data and images are acquired through DICOM compliant imaging devices. Rapid is indicated for use in Adults only.

Rapid provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT, CT Perfusion (CTP), CT Angiography (CTA), C-arm CT Perfusion and MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast-enhanced imaging data for MRI, CT, and C-arm CT).

Rapid C-arm CT Perfusion can be used to qualitatively assess cerebral hemodynamics in the angiography suite.

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.
C-Arm CTP is not to be used in the Rapid Thrombectomy indication for patient selection criteria, other modalities should be consulted.

Caution:

. C-Arm CTP provides qualitative data only, review other modalities prior to diagnosis. CBV and CBT are not absolute and CBT, CBV, MTT and Tmax are supported for qualitative interpretation of the perfusion maps only.

Product codes

LLZ, QIH

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, C-arm CT(CBCT)] 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 unit which coordinates the execution image processing modules which support various analysis methods used in clinical practice today:
Rapid CTP/MRP/C-arm CTP, DWI, Dynamic Analysis (Original: K121447, Updated ● with K172477, K182130, K213165, K233512 and K233582)
Rapid CTA (K172477) ●
Rapid ASPECTS (K200760, K232156)
Rapid ICH (K193087, K221456)
Rapid LVO (K200941, K221248)
Rapid NCCT Stroke (K222884)
. Rapid RV/LV (K223396)
Rapid PETN (K220499)
Rapid ANRTN (K230074) ●
Rapid SDH (K232436) ●
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

Mixed Traditional and AI/ML

Input Imaging Modality

CT, CT Perfusion (CTP), CT Angiography (CTA), C-arm CT Perfusion, MRI, Diffusion Weighted MRI (DWI), dynamic contrast-enhanced imaging data for MRI, CT, and C-arm CT, NCCT, C-Arm CT (CBCT), MRA

Anatomical Site

Cerebral (implicit from stroke and brain imaging)

Indicated Patient Age Range

Adults only

Intended User / Care Setting

Trained professionals, including but not limited to physicians (medical analysis and decision making) and medical technicians (administrative case processing). Angiography suite (for C-arm CT Perfusion). Hospital LAN or 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)

iSchemaView conducted extensive phantom validation testing of the Rapid System for characterizing the perfusion imaging performance of conventional CT and C-arm CT scanners. The 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.

Additionally, iSchemaView conducted software verification and validation testing of the Rapid system. Software performance, validation and verification testing demonstrated that the Rapid system met all design requirements and specifications.

Phantom validation results between conventional CT and C-arm CT scanners for the perfusion indication of Rapid Core are comparable with small biases in MTT (mean transit time) and Tmax (time to the maximum of the residue function) which were expected due to the temporal resolution difference in conventional and C-arm CT scanners.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

iSchemaView Rapid (K213165)

Reference Device(s)

iSchemaView Rapid (K121447), iSchemaView Rapid (K172477), iSchemaView Rapid (K182130), iSchemaView Rapid (K233512), Rapid ASPECTS (K200760), Rapid ASPECTS (K232156), Rapid ICH (K193087), Rapid ICH (K221456), Rapid LVO (K200941), Rapid LVO (K221248), Rapid NCCT Stroke (K222884), Rapid RV/LV (K223396), Rapid PETN (K220499), Rapid ANRTN (K230074), Rapid SDH (K232436)

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

iSchemaView Inc. Jim Rosa SVP Quality and Regulatory 1120 Washington Ave., Ste 200 Golden. Colorado 80401

Re: K233582

April 22, 2024

Trade/Device Name: Rapid Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ, QIH Dated: March 18, 2024 Received: March 19, 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 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

Jessica Lamb Assistant Director 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

510(k) Number (if known) K233582

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 (medical analysis and decision making) and medical technicians (administrative case processing). The software runs on a standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, and analysis of images are acquired through DICOM compliant imaging devices. Rapid is indicated for use in Adults only.

Rapid provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT, CT Perfusion (CTP), CT Angiography (CTA), C-arm CT Perfusion and MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast-enhanced imaging data for MRI, CT, and C-arm CT).

Rapid C-arm CT Perfusion can be used to qualitatively assess cerebral hemodynamics in the angiography suite.

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.

· C-Arm CTP is not to be used in the Rapid Thrombectomy indication criteria, other modalities should be consulted.

Cautions:

· C-Arm CTP provides qualitative data only, review other modalities prior to diagnosis. CBV and CBT are not absolute and CBT, CBV, MTT and Tmax are supported for qualitative interpretation of the perfusion maps only.

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

iSchemaView - Traditional 510(k) Rapid Section 11: 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

Device Name and Classification:

Trade Name:	Rapid
Common Name:	MIMPS – Medical image management and processing system.
Classification:	II
Product Code:	Primary: LLZ, Secondary: QIH
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: iSchemaView Rapid (K213165).

Previous Related FDA Submission:

iSchemaView Rapid (K121447) iSchemaView Rapid (K172477) iSchemaView Rapid (K182130) iSchemaView Rapid (K213165) iSchemaView Rapid (K233512)

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.

5

Section 11: 510(k) Summary

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, C-arm CT(CBCT)] 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 unit which coordinates the execution image processing modules which support various analysis methods used in clinical practice today:

Rapid CTP/MRP/C-arm CTP, DWI, Dynamic Analysis (Original: K121447, Updated ● with K172477, K182130, K213165, K233512 and K233582)
Rapid CTA (K172477) ●
Rapid ASPECTS (K200760, K232156)
Rapid ICH (K193087, K221456)
Rapid LVO (K200941, K221248)
Rapid NCCT Stroke (K222884)
. Rapid RV/LV (K223396)
Rapid PETN (K220499)
Rapid ANRTN (K230074) ●
Rapid SDH (K232436) ●

6

Section 11: 510(k) Summary

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).