(116 days)
Not Found
Yes
The device description explicitly states, "The Rapid ICH module is an AI/ML module." and the intended use section mentions it uses an "artificial intelligence algorithm".
No
The device is a radiological computer-aided triage and notification software intended to assist in workflow triage and communication of suspected positive findings by flagging cases for radiologists. It does not directly treat or diagnose a disease or condition, which is characteristic of a therapeutic device.
No
The "Intended Use / Indications for Use" section explicitly states, "The device does not alter the original medical image and is not is a a diagnostic device." It further clarifies that "Notifications include compressed preview images, which are meant for informational purposes only and not intended for diagnostic use beyond notification." The device is intended to assist with triage and prioritization by flagging suspected positive findings, not for making a definitive diagnosis.
Yes
The device description explicitly states "Rapid ICH is a radiological computer-assisted triage and notification software device." and describes it as an "AI/ML module" operating within a platform, with its output being a "priority notification". There is no mention of any hardware component being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is a "radiological computer aided triage and notification software" and is "intended to assist hospital networks and trained radiologists in workflow triage". It also clearly states that the device "does not alter the original medical image and is not is a a diagnostic device."
- Nature of the Device: The device analyzes medical images (CT scans) to flag potential findings for prioritization. It does not perform tests on biological samples (blood, urine, tissue, etc.), which is the defining characteristic of an IVD.
- Output: The output is a notification and compressed preview images for informational purposes, not a diagnostic result derived from a biological sample.
IVDs are devices used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device operates on medical images, not biological specimens.
No
The document does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
Rapid ICH is a radiological computer aded triage and notification software 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, for IPH, IVH, SAH, and SDH Intracranial Hemorrhages (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, which 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 is a a diagnostic device.
The results of Rapid ICH are intended to be used in conjunction and based on professional judgment, to assist with trage /prioritization of medical images. Notified radiologists are responsible for viewing full images per the standard of care.
Product codes
QAS
Device Description
Rapid ICH is a radiological computer-assisted triage and notification software device. The Rapid ICH module is a non-enhanced CT (NCCT) processing module which operates within the integrated Rapid Platform to provide triage and notification of suspected intracranial hemorrhage. The Rapid ICH module is an AI/ML module. The output of the module is a priority notification to clinicians indicating the suspicion of ICH based on positive findings. The Rapid ICH module uses the basic services supplied by the Rapid Platform including DICOM processing, job management, imaging module execution and imaging output including the notification and compressed image.
Mentions image processing
Rapid ICH is a radiological computer-assisted triage and notification software device. The Rapid ICH module is a non-enhanced CT (NCCT) processing module which operates within the integrated Rapid Platform to provide triage and notification of suspected intracranial hemorrhage.
Mentions AI, DNN, or ML
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 Rapid ICH module is an AI/ML module.
Input Imaging Modality
non-enhanced head CT images.
NCCT
Anatomical Site
head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital networks and trained radiologists
clinicians
Description of the training set, sample size, data source, and annotation protocol
The minor change causing this filing, is the use of additional data for training and validation; there are no further differences.
Description of the test set, sample size, data source, and annotation protocol
The minor change causing this filing, is the use of additional data for training and validation; there are no further differences.
Summary of Performance Studies
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 NCCT head images containing intracranial hemorrhage (ICH) findings in 314 (ICH Pos:148, Neg:166) cases.
Sensitivity and specificity exceeded the 80% performance goal. Specifically, sensitivity was observed to be 96.8% (95% CI: 92.6% - 98.6%) and specificity was observed to be 100% (95% CI: 97.7% - 100%) overall.
AUC is 0.98632 when using Rapid estimated Volume as the predictor of Suspected ICH:
In addition, a secondary endpoint measure was Rapid ICH's potential clinical benefit of worklist prioritization for true positive ICH cases. For that purpose, iSchemaView is using the predefined process timeline as defined in the predicate.
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 PACS/Workstation, email and mobile. The standard of care time-to-open-exam consisted of the time from the initial scan of the patient to when the radiologist first opened the exam for review.
Rapid ICH time-to-notification has been documented for all 314 cases. One hundred four-nine (149) cases have been identified as true positive (i.e., identified as positive by Rapid ICH and the ground truth) and the time-to-exam-open is referenced from the predicate.
As shown in the table below, the predicate analysis demonstrated that standard of care time-toexam-open (72.6 minutes: 95% CI 45.0-100.2) is significantly longer than the parallel time-tonotification of the Rapid ICH software (0.65 minutes: 95% CI 0.63 - 0.67).
Key Metrics
Sensitivity: 96.8% (95% CI: 92.6% - 98.6%)
Specificity: 100% (95% CI: 97.7% - 100%)
AUC: 0.98632
Mean Time to open in standard of care (Minutes): 72.58 (95% CI: 45.02 - 100.14)
Mean Time to notification of Rapid ICH (Minute): 0.65 (95% CI: 0.63 - 0.67)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is the Department of Health & Human Services logo. The right side of the logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
iSchemaView Inc. % James Rosa SVP Regulatory and Quality 1120 Washington Ave., Ste 200 GOLDEN CO 80401
Re: K221456
September 12, 2022
Trade/Device Name: Rapid ICH Regulation Number: 21 CFR 892.2080 Regulation Name: Radiological computer aided triage and notification software Regulatory Class: Class II Product Code: QAS Dated: August 15, 2022 Received: August 17, 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/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 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,
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221456
Device Name Rapid ICH
Indications for Use (Describe)
Rapid ICH is a radiological computer aded triage and notification software 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, for IPH, IVH, SAH, and SDH Intracranial Hemorrhages (CH).
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, which 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 is a a diagnostic device.
The results of Rapid ICH are intended to be used in conjunction and based on professional judgment, to assist with trage /prioritization of medical images. Notified radiologists are responsible for viewing full images per the standard of care.
Type of Use (Select one or both. as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Section 5: 510(k) Summary
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: | 1120 Washington Ave., Ste. 200 |
| Golden, CO 80401 | |
| Official Contact: | Jim Rosa |
| Phone: (303) 704-3374 | |
| Email: rosa@ischemaview.com |
Summary Preparation Date: August 17, 2022
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:
iSchemaView's Rapid ICH device is claimed to be substantially equivalent to the following legally marketed predicate device: iSchemaView's Rapid ICH (K193087).
Device Description:
Rapid ICH is a radiological computer-assisted triage and notification software device. The Rapid ICH module is a non-enhanced CT (NCCT) processing module which operates within the integrated Rapid Platform to provide triage and notification of suspected intracranial hemorrhage. The Rapid ICH module is an AI/ML module. The output of the module is a priority notification to clinicians indicating the suspicion of ICH based on positive findings. The Rapid ICH module uses the basic services supplied by the Rapid Platform including DICOM processing, job management, imaging module execution and imaging output including the notification and compressed image.
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.
4
Section 5: 510(k) Summary
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, for IPH, IVH, SAH, and SDH Intracranial Hemorrhages (ICH).
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 radiologists are responsible for viewing full images per the standard of care.
Comparison of Technological Characteristics:
Rapid ICH does not raise new questions of safety or effectiveness compared to the previously cleared Rapid ICH (K193087). Both devices are radiological computer-aided triage and notification software applications for use with non-contrast CT input. The minor change causing this filing, is the use of additional data for training and validation; there are no further differences. Thus, the Rapid ICH software is substantially equivalent.
The following table summarizes and compares data on the Rapid ICH (K193087) to the subject device of this Traditional 510(k) submission. A table comparing the key features of the subject and predicate devices is provided below.
| Substantial Equivalence Table | ||
|---|---|---|
| Comparison Feature | Rapid ICH (K193087) | Rapid ICH – Subject Device |
| 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 standalone | 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, for IPH, IVH, SAH, and SDH Intracranial Hemorrhages (ICH).
Rapid ICH uses an artificial intelligence algorithm to analyze |
| | 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. | 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, which 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
radiologists 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
Implementati
on | AI/ML/Neural Network | AI/ML/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. | 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. | The device operates in parallel with
the standard of care, which remains. |
| Primary
User(s) | Clinician | Radiologist |
| Alteration of
original
image data | No | No |
| Alters
Standard of
Care
Workflow | In parallel to | In parallel to |
| Notification/
Prioritization | Yes - PACS, Workstation, email,
mobile | Yes - PACS, Workstation, email,
mobile |
5
Section 5: 510(k) Summary
6
Section 5: 510(k) Summary
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 NCCT head images containing intracranial hemorrhage (ICH) findings in 314 (ICH Pos:148, Neg:166) cases.
Sensitivity and specificity exceeded the 80% performance goal. Specifically, sensitivity was observed to be 96.8% (95% CI: 92.6% - 98.6%) and specificity was observed to be 100% (95% CI: 97.7% - 100%) overall.
AUC is 0.98632 when using Rapid estimated Volume as the predictor of Suspected ICH:
7
Section 5: 510(k) Summary
Image /page/7/Figure/2 description: This image shows a Receiver Operating Characteristic curve. The x-axis is labeled '1-Specificity False Positive' and ranges from 0 to 1.00. The y-axis is labeled 'Sensitivity True Positive' and ranges from 0 to 1.00. The AUC is 0.98632.
In addition, a secondary endpoint measure was Rapid ICH's potential clinical benefit of worklist prioritization for true positive ICH cases. For that purpose, iSchemaView is using the predefined process timeline as defined in the predicate.
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 PACS/Workstation, email and mobile. The standard of care time-to-open-exam consisted of the time from the initial scan of the patient to when the radiologist first opened the exam for review.
Rapid ICH time-to-notification has been documented for all 314 cases. One hundred four-nine (149) cases have been identified as true positive (i.e., identified as positive by Rapid ICH and the ground truth) and the time-to-exam-open is referenced from the predicate.
As shown in the table below, the predicate analysis demonstrated that standard of care time-toexam-open (72.6 minutes: 95% CI 45.0-100.2) is significantly longer than the parallel time-tonotification of the Rapid ICH software (0.65 minutes: 95% CI 0.63 - 0.67).
| Parameter | Mean | 95% CI
Lower | 95% CI
Upper |
|-----------------------------------------------|-------|-----------------|-----------------|
| Time to open in standard of
care (Minutes) | 72.58 | 45.02 | 100.14 |
| Time to notification of Rapid
ICH (Minute) | 0.65 | 0.63 | 0.67 |
| Difference (Minutes) | 71.93 | NA | NA |
8
Section 5: 510(k) Summary
Performance across subtype differentiation shows:
| Performance Metrics by Gender | |||||
|---|---|---|---|---|---|
| Gender | Measure | N | Estimate | Lower 95% | |
| CI | Upper 95% | ||||
| CI | |||||
| Female | Sensitivity | 63 | 1.000 | 0.943 | 1.000 |
| Female | Specificity | 64 | 1.000 | 0.943 | 1.000 |
| Male | Sensitivity | 72 | 0.932 | 0.849 | 0.970 |
| Male | Specificity | 97 | 1.000 | 0.962 | 1.000 |
Performance Metrics by Age Groups
| Age Group | Measure | N | Estimate | Lower 95%
CI | Upper 95%
CI |
|---------------|-------------|----|----------|-----------------|-----------------|
| Age ≤ 50 | Sensitivity | 27 | 0.926 | 0.766 | 0.979 |
| | Specificity | 26 | 1.000 | 0.871 | 1.000 |
| 50