(92 days)
Not Found
Yes
The summary explicitly states that the predicate device uses an "artificial intelligence algorithm" and the device description mentions a "software algorithm" for analysis.
No
Explanation: The device is intended to assist in workflow triage and notification of suspected findings, not to treat or cure a disease.
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."
Yes
The device description explicitly states that Rapid LVO is a "clinical module which operates within the integrated Rapid Platform" and that the Rapid Platform is a "software package". It describes the device's function as analyzing images using a "software algorithm" and providing notifications. There is no mention of any accompanying hardware components being part of the device itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological specimens: In Vitro Diagnostics are designed to examine samples 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 LVO analyzes CTA head images. This is a form of medical imaging, not the analysis of biological specimens.
- Intended Use focuses on workflow triage: The intended use is to assist in workflow triage by flagging and communicating suspected findings in images, not to perform a diagnostic test on a biological sample.
- Explicitly states "not intended to be used as a diagnostic device": The description explicitly states that the device is not intended for diagnostic use beyond notification and is not intended to be used as a diagnostic device.
Therefore, Rapid LVO falls under the category of medical imaging software or computer-aided detection/triage software, not 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 provided text only contains "Control Plan Authorized (PCCP) and relevant text: Not Found".
Intended Use / Indications for Use
Rapid LVO is a radiological computer aided triage and notification software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive Large Vessel Occlusion (LVO) findings in head CTA images.
Rapid LVO uses a software algorithm to analyze images and highlight cases with suspected LVO 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 LVO 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 LVO 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
QAS
Device Description
Rapid LVO 1.0 is a clinical module which operates within the integrated Rapid Platform to provide triage and notification of suspected Large Vessel Occlusion (LVO). The Rapid LVO module consists of the core Rapid Platform software which provides the administration and services for the Rapid image processing modules; and the Rapid LVO module which functions as one of many image processing modules hosted by the platform.
Rapid LVO acquires (DICOM compliant) medical image data from CTA scanners through the Rapid Platform interface:
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, XA and MRI (Magnetic Image Resonance), as an aid to physician diagnosis. Rapid can be installed on a customer's Server or it can be accessed online as virtual system. It provides viewing, quantification, analysis and reporting capabilities. The Rapid platform has multiple modules a clinician may elect to run and provide analysis for decision making. The basic architecture supports the general functionality to support the Rapid LVO imaging module such as DICOM interfaces, job management, data base functions and communications. The Rapid Platform and base functions are not under review for this submission.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
CTA head images
CT, CTA, XA and MRI (Magnetic Image Resonance) - for the Rapid platform, not specifically for Rapid LVO.
CT Angiography
Anatomical Site
head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital networks and trained radiologists
Clinician
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 performed standalone performance in accordance with the 892.2080 special controls to show acceptance of the clinical performance of the Rapid LVO module. The Standalone Performance exceeded the 80% Goal using the lower bound of the 95% Confidence Interval for Sensitivity (Se) and Specificity (Sp). The observed results are Se: Sensitivity (Se) of 0.970 (95% CI: 0.933.0.987) and Specificity (Sp) 0.956 (95% CI: 0.919, 0.977) with a ROC AUC of 0.99 (95% CI:0.972, 0.995). Additionally, at a prevalence of 45%, PPV = 0.95 (95% CI: 0.90, 0.97) and NPV = 0.98 (95% CI 0.94, 0.99)
In addition, an analysis on time to notification using Rapid LVO to notify of suspicion/nonsuspicion as 2.86 min (95% CI: 2.79. 2.92) was achieved meeting the goal of
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym and name on the right. The seal features an eagle with outstretched wings, and the FDA part includes the acronym in a blue square and the full name "U.S. Food & Drug Administration" in blue text.
July 9, 2020
iSchemaView, Inc. % Mr. James Rosa VP Quality and Regulatory 433 Park Point Drive, Suite 220 GOLDEN CO 80401
Re: K200941
Trade/Device Name: Rapid LVO 1.0 Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological computer aided triage and notification software Regulatory Class: Class II Product Code: QAS Dated: June 8, 2020 Received: June 9, 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 and Part 809); 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
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Indications for Use
510(k) Number (if known) K200941
Device Name Rapid LVO 1.0
Indications for Use (Describe)
Rapid LVO is a radiological computer aided triage and notification software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive Large Vessel Occlusion (LVO) findings in head CTA images.
Rapid LVO uses a software algorithm to analyze images and highlight cases with suspected LVO 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 LVO 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 LVO 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 LVO is one input to physician diagnosis for patients undergoing screening for acute ischemic stroke.
· Excessive patient motion may lead to artifacts that make the scan technically inadequate.
• 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.
| 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) |
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510(k) Summary
iSchemaView, Inc.'s Rapid LVO 1.0
This document contains the 510(k) summary for the iSchemaView Rapid LVO. 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: June 29, 2020
Device Name and Classification:
| Trade Name: | iSchemaView Rapid LVO 1.0 |
|---|---|
| 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 LVO is claimed to be substantially equivalent to the following legally marketed predicate device:
iSchemaView Rapid ICH (K193087)
Device Description:
Rapid LVO 1.0 is a clinical module which operates within the integrated Rapid Platform to provide triage and notification of suspected Large Vessel Occlusion (LVO). The Rapid LVO module consists of the core Rapid Platform software which provides the administration and services for the Rapid image processing modules; and the Rapid LVO module which functions as one of many image processing modules hosted by the platform.
Rapid LVO acquires (DICOM compliant) medical image data from CTA scanners through the Rapid Platform interface:
4
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, XA and MRI (Magnetic Image Resonance), as an aid to physician diagnosis. Rapid can be installed on a customer's Server or it can be accessed online as virtual system. It provides viewing, quantification, analysis and reporting capabilities. The Rapid platform has multiple modules a clinician may elect to run and provide analysis for decision making. The basic architecture supports the general functionality to support the Rapid LVO imaging module such as DICOM interfaces, job management, data base functions and communications. The Rapid Platform and base functions are not under review for this submission.
Indications for Use:
Rapid LVO is a radiological computer aided triage and notification software indicated for use in the analysis of CTA head images. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and communication of suspected positive Large Vessel Occlusion (LVO) findings in head CTA images.
Rapid LVO uses a software algorithm to analyze images and highlight cases with suspected LVO 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 LVO 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 LVO 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 LVO is one input to physician diagnosis for patients undergoing screening for acute ischemic stroke.
- Excessive patient motion may lead to artifacts that make the scan technically inadequate.
- . 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.
Technological Characteristics:
Rapid Platform performs the following functions in support of Rapid LVO:
- processes DICOM images from multiple sources to provide visualization of changes . of tissue perfusion, diffusion and change.
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- . receives DICOM images from external DICOM image providers (modalities (CT/MRI Scanners), PACS and Workstations) and sends DICOM images to external image consumers.
- . processes requests, statuses and results, and references therein, which are stored in a searchable database
- processing status is available through a web browser using HTTP. HTML and PHP. ●
- . can send summary results to the user over email and mobile application. For this, Rapid generally connects to the infrastructure of the medical partner (e.g., the hospital). In particular, Rapid uses a SMTP protocol with security extensions to provide secure emailing.
Rapid is available in the following configurations:
- Standard Rapid, which is installed directly on a customer's Linux-based server and . integrated with medical image processing software such as commercial PACS.
- . Virtual Rapid, wherein the user accesses Rapid online and uses it to process DICOM images otherwise available on his/her computer.
Rapid Platform is a DICOM-compliant PACS software that provides comprehensive functionality to transfer, process, and display modality specific imaging data. Rapid runs on standard "off-the- shelf" computer and networking hardware. Rapid is entirely independent from CT, XA, MRI, or PACS platforms. It supports secure VPN (Virtual Private Network) networking or encapsulated Secure Shell (SSH), and seamlessly integrates into an existing radiological data network.
The primary users of Rapid PACS software are medical imaging professionals who analyze tissue using CT or MRI images.
Performance Standards:
Rapid has been developed in conformance with the following standards, as applicable:
| ISO 14971:2019 | Application of Risk Management to Medical Devices |
|---|---|
| IEC 62304:2015 | 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.
6
iSchemaView performed standalone performance in accordance with the 892.2080 special controls to show acceptance of the clinical performance of the Rapid LVO module. The Standalone Performance exceeded the 80% Goal using the lower bound of the 95% Confidence Interval for Sensitivity (Se) and Specificity (Sp). The observed results are Se: Sensitivity (Se) of 0.970 (95% CI: 0.933.0.987) and Specificity (Sp) 0.956 (95% CI: 0.919, 0.977) with a ROC AUC of 0.99 (95% CI:0.972, 0.995). Additionally, at a prevalence of 45%, PPV = 0.95 (95% CI: 0.90, 0.97) and NPV = 0.98 (95% CI 0.94, 0.99)
In addition, an analysis on time to notification using Rapid LVO to notify of suspicion/nonsuspicion as 2.86 min (95% CI: 2.79. 2.92) was achieved meeting the goal of