(146 days)
Not Found
Yes
The "Intended Use / Indications for Use" section explicitly states that "RAPID ICH uses an artificial intelligence algorithm to analyze images".
No
This device is a diagnostic aid for workflow triage and notification of suspected intracranial hemorrhage, not a therapeutic device that treats or prevents a condition.
No.
The "Intended Use / Indications for Use" section explicitly states "The device does not alter the original medical image and is not intended to be used as a diagnostic device." Furthermore, it mentions that preview images are "for informational purposes only and not intended for diagnostic use beyond notification."
Yes
The device description explicitly states that RAPID ICH is a "software package" and a "clinical module which operates within the integrated RAPID Platform". It describes its function as analyzing digital images and providing notifications, all of which are software-based operations. There is no mention of accompanying hardware components that are part of the medical device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- RAPID ICH Function: RAPID ICH analyzes radiological images (CT scans), which are generated by imaging equipment, not samples taken from the body.
- Intended Use: The intended use clearly states it's a "radiological computer aided triage and notification software" and is "indicated for use in the analysis of nonenhanced head CT images." It's designed to assist with workflow triage and notification based on image analysis.
- Device Description: The description reinforces that it processes "digital images captured by diagnostic imaging systems including CT."
While RAPID ICH is a medical device that aids in the diagnostic process by prioritizing cases, it does not perform in vitro testing on biological samples. Therefore, it falls under the category of a radiological image analysis software, not an IVD.
No
The letter does not state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
RAPID ICH is a radiological computer aided triage and notification software indicated for use in the analysis of non-enhanced head CT images.
The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive findings of pathologies in head CT images, namely Intracranial Hemorrhage (ICH). RAPID ICH uses an artificial intelligence algorithm to analyze images and highlight cases with detected ICH on a server or standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected ICH findings. Notifications include compressed preview images, that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.
The results of RAPID ICH are intended to be used in conjunction with other patient information and based on professional judgment, to assist with triage /prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.
Product codes (comma separated list FDA assigned to the subject device)
QAS
Device Description
RAPID ICH is a clinical module which operates within the integrated RAPID Platform to provide triage and notification of suspected intra-cranial hemorrhage (ICH). The RAPID ICH module consists of the core RAPID Platform software which provides the administration and services for the RAPID; and the RAPID ICH module which functions as one of many image processing modules hosted by the platform.
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 ●
- Imaging features on non-contrast computed tomography
- . Imaging features based on density analysis for CT Angiography
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.
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 cyberdata 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).
RAPID ICH provides an automatic analysis of received NCCT scan data for the triage and notification of ischemic hemorrhage (ICH). The application is selected via DICOM encoding which is processed by the DICOM handler within the RAPID Platform. Once the DICOM server identifies the selected ICH processing modality, the Job Manager initiates image processing using the ICH Module.
Upon processing a case with suspicion of ICH, the clinical team is notified via messaging, the case has a suspicion of ICH. The notifications are sent to the PACS/Workstation, via email and to a mobile application. The notification provides the attending clinical team physician that suspicion of hemorrhage has been identified and immediate attention to the case should be given. The messaging provides notification and compressed image data of the case. The compressed preview is informational only and labeling identifies it as not to be used for diagnostic use and to review the data within the PACS/Workstation prior to making any diagnostic decisions. No additional information markings are added to the case.
The notifications are pop-up messages or email with the appropriate case information and suspicion or non-suspicion of ICH labelled. In all cases, the normal standard of care workflow is adhered to, this ensures the case is still reviewed when non-suspicion is determined.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
CT (Computed Tomography)
CTA (Computed Tomography Angiography)
MRI (Magnetic Image Resonance) - Note: not used in ASPECTS.
XA3D Multiphase
NCCT
Anatomical Site
Head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained radiologists / hospital networks.
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
iSchemaView conducted a retrospective, blinded, multicenter, multinational study with the RAPID ICH software with the primary endpoint to evaluate the software's performance in identifying noncontrast CT head images containing intracranial hemorrhage (ICH) findings in 336 cases from US (4 Sites and 1 Multisite Study) and OUS sites (1 site. 1 multisite). There were approximately an equal number of positive and negative cases (images with ICH versus without ICH) included in the analysis.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
iSchemaView conducted a retrospective, blinded, multicenter, multinational study with the RAPID ICH software with the primary endpoint to evaluate the software's performance in identifying noncontrast CT head images containing intracranial hemorrhage (ICH) findings in 336 cases from US (4 Sites and 1 Multisite Study) and OUS sites (1 site. 1 multisite). There were approximately an equal number of positive and negative cases (images with ICH versus without ICH) included in the analysis.
Sensitivity and specificity exceeded the 80% performance goal. Specifically, sensitivity was observed to be Se: 0.899 (95% CI: 0.847 - 0.935) and Sp: 0.943 (95% CI: 0.895 - 0.970).
In addition, a secondary endpoint measure was RAPID ICH's time to notification of suspicion non-suspicion as 2.28 min (95% CI: 2.24 - 2.33) was achieved.
The RAPID ICH time-to-notification includes the time to get the DICOM exam, de-identify it (if required), analyze and send a notification back to the attending physician(s) email and mobile.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 0.899 (95% CI: 0.847 - 0.935)
Specificity: 0.943 (95% CI: 0.895 - 0.970)
Time to notification of suspicion non-suspicion: 2.28 min (95% CI: 2.24 - 2.33)
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.
Aidoc's BriefCase (K180647)
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2080 Radiological computer aided triage and notification software.
(a)
Identification. Radiological computer aided triage and notification software is an image processing prescription device intended to aid in prioritization and triage of radiological medical images. The device notifies a designated list of clinicians of the availability of time sensitive radiological medical images for review based on computer aided image analysis of those images performed by the device. The device does not mark, highlight, or direct users' attention to a specific location in the original image. The device does not remove cases from a reading queue. The device operates in parallel with the standard of care, which remains the default option for all cases.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include:
(i) A detailed description of the notification and triage algorithms and all underlying image analysis algorithms including, but not limited to, a detailed description of the algorithm inputs and outputs, each major component or block, how the algorithm affects or relates to clinical practice or patient care, and any algorithm limitations.
(ii) A detailed description of pre-specified performance testing protocols and dataset(s) used to assess whether the device will provide effective triage (
e.g., improved time to review of prioritized images for pre-specified clinicians).(iii) Results from performance testing that demonstrate that the device will provide effective triage. The performance assessment must be based on an appropriate measure to estimate the clinical effectiveness. The test dataset must contain sufficient numbers of cases from important cohorts (
e.g., subsets defined by clinically relevant confounders, effect modifiers, associated diseases, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals for these individual subsets can be characterized with the device for the intended use population and imaging equipment.(iv) Stand-alone performance testing protocols and results of the device.
(v) Appropriate software documentation (
e.g., device hazard analysis; software requirements specification document; software design specification document; traceability analysis; description of verification and validation activities including system level test protocol, pass/fail criteria, and results).(2) Labeling must include the following:
(i) A detailed description of the patient population for which the device is indicated for use;
(ii) A detailed description of the intended user and user training that addresses appropriate use protocols for the device;
(iii) Discussion of warnings, precautions, and limitations must include situations in which the device may fail or may not operate at its expected performance level (
e.g., poor image quality for certain subpopulations), as applicable;(iv) A detailed description of compatible imaging hardware, imaging protocols, and requirements for input images;
(v) Device operating instructions; and
(vi) A detailed summary of the performance testing, including: test methods, dataset characteristics, triage effectiveness (
e.g., improved time to review of prioritized images for pre-specified clinicians), diagnostic accuracy of algorithms informing triage decision, and results with associated statistical uncertainty (e.g., confidence intervals), including a summary of subanalyses on case distributions stratified by relevant confounders, such as lesion and organ characteristics, disease stages, and imaging equipment.
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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 31, 2020
iSchemaView, Inc. % Mr. James Rosa VP Quality and Regulatory 433 Park Point Drive, Suite 220 GOLDEN CO 80401
Re: K193087
Trade/Device Name: RAPID ICH Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological computer-assisted triage and notification software Regulatory Class: Class II Product Code: QAS Dated: February 25, 2020 Received: March 2, 2020
Dear Mr. 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
1
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,
For
Thalia T. Mills, Ph.D. 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
2
Indications for Use
510(k) Number (if known)
K193087
Device Name RAPID ICH
Indications for Use (Describe)
RAPID ICH is a radiological computer aided triage and notification software indicated for use in the analysis of nonenhanced head CT images.
The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive findings of pathologies in head CT images, namely Intracranial Hemorrhage (ICH). RAPID ICH uses an artificial intelligence algorithm to analyze images and highlight cases with detected ICH on a server or standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected ICH findings. Notifications include compressed preview images, that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.
The results of RAPID ICH are intended to be used in conjunction with other patient information and based on professional judgment, to assist with triage /prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Section 5: 510(k) Summary (Ver. C)
510(k) Summary
iSchemaView, Inc.'s RAPID ICH
This document contains the 510(k) summary for the iSchemaView RAPID ICH. 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 |
| Ste. 220 | |
| Golden, CO 80401 | |
| Official Contact: | Jim Rosa |
| Phone: (303) 704-3374 | |
| Email: rosa@ischemaview.com |
Summary Preparation Date: February 25, 2020
Device Name and Classification:
| Trade Name: | RAPID ICH |
|---|---|
| Common Name: | Radiological computer aided triage and notification software |
| Classification: | II |
| Product Code: | QAS |
| Regulation No: | 21 C.F.R. §892.2080 |
| Classification | |
| Panel: | Radiology Devices |
Predicate Devices:
The iSchemaView RAPID ICH is claimed to be substantially equivalent to the following legally marketed predicate device: Aidoc's BriefCase (K180647).
Device Description:
RAPID ICH is a clinical module which operates within the integrated RAPID Platform to provide triage and notification of suspected intra-cranial hemorrhage (ICH). The RAPID ICH module consists of the core RAPID Platform software which provides the administration and services for the RAPID; and the RAPID ICH module which functions as one of many image processing modules hosted by the platform.
RAPID Platform
The RAPID platform 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), CTA, XA3D 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
4
Section 5: 510(k) Summary (Ver. C)
online as virtual system. It provides viewing, quantification, analysis and reporting capabilities. The RAPID platform has multiple modules a clinician may elect to run and provide analysis for decision making.
RAPID works with the following types of (DICOM compliant) medical image data:
- CT (Computed Tomography) .
- . CTA (Computed Tomography Angiography)
- MRI(Magnetic Image Resonance) Note: not used in ASPECTS. ●
- . XA3D Multiphase
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 ●
- Imaging features on non-contrast computed tomography
- . Imaging features based on density analysis for CT Angiography
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.
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 cyberdata 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).
5
RAPID System Overview
Image /page/5/Figure/2 description: The image shows a diagram of a medical imaging workflow. It starts with an MRI or CT scan, then the data is pushed to RAPID software. The data is then sent to PACS via DICOM for additional DICOM nodes. Finally, the image undergoes analysis, including motion and time correction, AIF & VOF selection, deconvolution & map generation, image thresholding, and computation of thresholded volume.
RAPID ICH Module
RAPID ICH provides an automatic analysis of received NCCT scan data for the triage and notification of ischemic hemorrhage (ICH). The application is selected via DICOM encoding which is processed by the DICOM handler within the RAPID Platform. Once the DICOM server identifies the selected ICH processing modality, the Job Manager initiates image processing using the ICH Module.
Upon processing a case with suspicion of ICH, the clinical team is notified via messaging, the case has a suspicion of ICH. The notifications are sent to the PACS/Workstation, via email and to a mobile application. The notification provides the attending clinical team physician that suspicion of hemorrhage has been identified and immediate attention to the case should be given. The messaging provides notification and compressed image data of the case. The compressed preview is informational only and labeling identifies it as not to be used for diagnostic use and to review the data within the PACS/Workstation prior to making any diagnostic decisions. No additional information markings are added to the case.
The notifications are pop-up messages or email with the appropriate case information and suspicion or non-suspicion of ICH labelled. In all cases, the normal standard of care workflow is adhered to, this ensures the case is still reviewed when non-suspicion is determined.
6
Section 5: 510(k) Summary (Ver. C)
Indications for Use:
RAPID ICH is a radiological computer aided triage and notification software indicated for use in the analysis of non-enhanced head CT images.
The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive Intracranial Hemorrhage (ICH) findings in head CT images, namely Intracranial Hemorrhage (ICH).
RAPID ICH uses an artificial intelligence algorithm to analyze images and highlight cases with suspected ICH on a server or standalone desktop application in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected ICH findings. Notifications include compressed preview images, that are meant for informational purposes only and not intended for diagnostic use beyond notification. The device does not alter the original medical image and is not intended to be used as a diagnostic device.
The results of RAPID ICH are intended to be used in conjunction with other patient information and based on professional judgment, to assist with triage /prioritization of medical images. Notified clinicians are responsible for viewing full images per the standard of care.
Contraindications/Exclusions/Cautions:
- . RAPID ICH is one input to physician diagnosis for patients undergoing screening for acute hemorrhage or acute stroke.
- . Excessive patient motion may lead to artifacts that make the scan technically inadequate.
- . Presence of subacute stroke with mild hemorrhagic transformation may not be detected as suspected ICH.
- . For use with non-contrast scans. Presence of intravenous contrast may lead to false positive indication of suspected ICH.
- . Identification of suspected findings is not for diagnostic use beyond notification. Images that are previewed through email and the mobile application are compressed and are for informational purposes only and not intended for diagnostic use beyond notification.
- . Notified clinicians are responsible for viewing non-compressed images on a diagnostic viewer and engaging in appropriate patient evaluation and relevant discussion with a treating physician before making care-related decisions or requests.
- . RAPID ICH is limited to analysis of imaging data and should not be used in-lieu of full pattent evaluation or relied upon to make or confirm diagnosis. Notified clinicians are responsible for viewing non-compressed images on a diagnostic viewer and engaging in appropriate patient evaluation and relevant discussion with a treating physician before making care-related decisions or requests.
Comparison of Technological Characteristics:
The subject and predicate devices are radiological computer-assisted triage and notification software programs. Both devices are artificial intelligence algorithms incorporated software packages for use with CT scanners, PACS, and workstations. Both devices process images intended to aid in prioritization and triage of radiological medical images. The subject and predicate device process NCCT images for ICH indication. Both devices are intended to provide
7
Section 5: 510(k) Summary (Ver. C)
notifications and preview head images of potential findings to radiologists and other clinicians for the purpose of treatment planning and follow up.
Both software devices notify a designated list of clinicians (the predicate device - a radiologist, the subject device - a clinician) of the availability of time sensitive radiological medical images for review based on computer aided image analysis performed by the device's AI algorithm. The subject and predicate device sends notifications and compressed previews to the workstations' desktop of the radiologist. Additionally, the subject device sends an email (normal processing within RAPID Platform and previously cleared and mobile notification (similar to the predicate's predicate device. Those notifications work in parallel to the standard of care. They promot the clinician to start preemptive triage of a flagged case, upon which they may decide after observing the preview, to turn to the local PACS/Workstation to perform the evaluation. If a notification is found to be non-suspicious of ICH, the case still remains in the queue to be handled per the standard of care.
The predicate and subject devices process CT images using similar techniques and a similar artificial intelligence algorithm. Specifically, the subject and predicate software utilize a deep learning algorithm trained on medical images. The deep-learning process allows for high accuracy in the detection of initial suspect locations. As a system, the RAPID ICH raises the same types of safety and effectiveness questions as the predicate; namely, accurate detection of findings within the reviewed and processed study on which a clinician can base a clinically useful triage/prioritization assessment considering all available clinical information.
It is important to note that, like the predicate, the device does not remove cases from a reading queue. Again, both devices operate in parallel with the standard of care, which remains the default option for all cases.
| Substantial Equivalence Table | ||
|---|---|---|
| Comparison | ||
| Feature | Aidoc Briefcase (K180647) | RAPID ICH |
| Indications | ||
| for Use | Aidoc Briefcase is a radiological | |
| computer aided triage and | ||
| notification software indicated for | ||
| use in the analysis of non-enhanced | ||
| head CT images. | ||
| The device is intended to assist | ||
| hospital networks and trained | ||
| radiologists in workflow triage by | ||
| flagging and communication of | ||
| suspected positive findings of | ||
| pathologies in head CT images, | ||
| namely Intracranial Hemorrhage | ||
| (ICH). | RAPID ICH is a radiological | |
| computer aided triage and | ||
| notification software indicated for | ||
| use in the analysis of non- | ||
| enhanced head CT images. The | ||
| device is intended to assist | ||
| hospital networks and trained | ||
| radiologists in workflow triage by | ||
| flagging and communication of | ||
| suspected positive findings of | ||
| pathologies in head CT images, | ||
| namely Intracranial Hemorrhage | ||
| (ICH). | ||
| Aidoc Briefcase uses an artificial | ||
| intelligence algorithm to analyze | ||
| images and highlight cases with | ||
| detected ICH on a standalone | ||
| desktop application in parallel to the | ||
| ongoing standard of care image | ||
| interpretation. The user is presented | ||
| with notifications for cases with | ||
| suspected ICH findings. | ||
| Notifications include compressed | ||
| preview images that are meant for | ||
| informational purposes only and not | ||
| intended for diagnostic use beyond | ||
| notification. The device does not | ||
| alter the original medical image and | ||
| is not intended to be used as a | ||
| diagnostic device. The results of | ||
| Aidoc Briefcase are intended to be | ||
| used in conjunction with other | ||
| patient information and based on | ||
| professional judgment, to assist with | ||
| triage/prioritization of medical | ||
| images. Notified clinicians are | ||
| responsible for viewing full images | ||
| per the standard of care. | RAPID ICH uses an artificial | |
| intelligence algorithm to analyze | ||
| images and highlight cases with | ||
| detected ICH on a standalone | ||
| desktop application in parallel to | ||
| the ongoing standard of care | ||
| image interpretation. The user is | ||
| presented with notifications for | ||
| cases with suspected ICH | ||
| findings. Notifications include | ||
| compressed preview images that | ||
| are meant for informational | ||
| purposes only and not intended | ||
| for diagnostic use beyond | ||
| notification. The device does not | ||
| alter the original medical image | ||
| and is not intended to be used as a | ||
| diagnostic device. The results of | ||
| RAPID ICH are intended to be | ||
| used in conjunction with other | ||
| patient information and based on | ||
| professional judgment, to assist | ||
| with triage/prioritization of | ||
| medical images. Notified | ||
| clinicians are responsible for | ||
| viewing full images per the | ||
| standard of care. | ||
| Stroke/Head | Stroke/Head | Stroke/Head |
| Removal of | ||
| cases from | ||
| worklist | ||
| queue | No | No |
| Primary | ||
| Imaging | ||
| Modalities | NCCT | NCCT |
| Technical | ||
| Implementation | ML/AI/Neural Network | ML/AI/Neural Network |
| Segmentation | ||
| of ROI | No, the device does not highlight or | |
| direct a user's attention to a specific | ||
| location in the image file. | No, the device does not highlight | |
| or direct a user's attention to a | ||
| specific location in the image file. | ||
| Preview | ||
| Images | Presentation of a preview of the | |
| study for initial assessment not | ||
| meant for diagnostic purposes. | ||
| The device operates in parallel with | ||
| the standard of care, which remains. | Presentation of a preview of the | |
| study for initial assessment not | ||
| meant for diagnostic purposes. | ||
| The device operates in parallel | ||
| with the standard of care, which | ||
| remains. | ||
| Primary | ||
| User(s) | Radiologist | Clinician |
| Alteration of | ||
| original | ||
| image data | ||
| base | No | No |
| Alters | ||
| Standard of | ||
| Care | ||
| Workflow | In parallel to | In parallel to |
| Notification/ | ||
| Prioritization | Yes - PACS, Workstation | Yes - PACS, Workstation, email, |
| mobile |
A table comparing the key features of the subject and predicate devices is provided below.
8
Section 5: 510(k) Summary (Ver. C)
9
Section 5: 510(k) Summary (Ver. C)
Performance Standards:
RAPID ICH has been developed in conformance with the following standards, as applicable:
| EN ISO 14971:2012 | Application of Risk Management to Medical Devices |
|---|---|
| IEC 62304:2015 | Medical device software – Software lifecycle processes |
| NEMA PS 3.1 - 3.20 | Digital Imaging and Communications in Medicine (DICOM |
Performance Data:
iSchemaView conducted a retrospective, blinded, multicenter, multinational study with the RAPID ICH software with the primary endpoint to evaluate the software's performance in identifying noncontrast CT head images containing intracranial hemorrhage (ICH) findings in 336 cases from US ( 4 Sites and 1 Multisite Study) and OUS sites (1 site. 1 multisite). There were approximately an equal number of positive and negative cases (images with ICH versus without ICH) included in the analysis.
Sensitivity and specificity exceeded the 80% performance goal. Specifically, sensitivity was observed to be Se: 0.899 (95% CI: 0.847 - 0.935) and Sp: 0.943 (95% CI: 0.895 - 0.970).
In addition, a secondary endpoint measure was RAPID ICH's time to notification of suspicion non-suspicion as 2.28 min (95% CI: 2.24 - 2.33) was achieved.
The RAPID ICH time-to-notification includes the time to get the DICOM exam, de-identify it (if required), analyze and send a notification back to the attending physician(s) email and mobile.
10
Section 5: 510(k) Summary (Ver. C)
Prescriptive Statement:
Caution: Federal law restricts this device to sale by or on the order of a physician.
Safety & Effectiveness:
RAPID ASPECTS 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 14971:2012 (risk management) and the software development process conforms to ISO 62304:2015. The RAPID ICH performance has been validated through the use of phantoms and retrospective case data and through the use of reader truthing of the data.
Conclusion:
In conclusion, iSchemaView's RAPID ICH is substantially equivalent in technological characteristics, safety, and performance characteristics to the legally marketed predicate device, BriefCase (K180647); the two devices vary slightly in the notification pathway, the subject device has a mobile interface to allow messaging.
The RAPID ICH is thus substantially equivalent to the BriefCase predicate device.