(94 days)
Not Found
Yes
The "Intended Use / Indications for Use" section explicitly states that the device synthesizes imaging features using an "artificial intelligence algorithm".
No
This device is a diagnostic software that assists clinicians in assessing brain tissue abnormalities from CT images. It does not directly provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section states that Rapid ASPECTS is "used to assist the clinician in the assessment and characterization of brain tissue abnormalities using CT image data." It also indicates it's used for "evaluation of patients presenting for diagnostic imaging workup" and "provides information that may be useful in the characterization of early ischemic brain tissue injury during image interpretation." These phrases clearly indicate its role in diagnosis.
Yes
The device is described as a "computer-aided diagnosis (CADx) software device" and its description focuses entirely on software processes (registration, segmentation, analysis, AI algorithm, user interface). 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 ASPECTS Function: Rapid ASPECTS analyzes CT image data of the brain. It does not process biological samples taken from the patient.
- Intended Use: The intended use is to assist clinicians in assessing brain tissue abnormalities using imaging data, not to perform a diagnostic test on a biological sample.
Therefore, Rapid ASPECTS falls under the category of a medical device that processes medical images, not an in vitro diagnostic device.
No
The provided text states "Control Plan Authorized (PCCP) and relevant text: Not Found", meaning there is no information supporting that the FDA has reviewed or cleared a PCCP for this device.
Intended Use / Indications for Use
Rapid ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities using CT image data. The Software automatically registers images and segments and analyzes ASPECTS Regions of Interest (ROIs). Rapid ASPECTS extracts image data for the ROI(s) to provide analysis and computer analytics based on morphological characteristics. The imaging features are then synthesized by an artificial intelligence algorithm into a single ASPECT (Alberta Stroke Program Early CT) Score.
Rapid ASPECTS is indicated for evaluation of patients presenting for diagnostic imaging workup with known MCA or ICA occlusion, for evaluation of extent of disease. Extent of disease refers to the number of ASPECTS regions affected which is reflected in the total score.
This device provides information that may be useful in the characterization of early ischemic brain tissue injury during image interpretation (within 6 hours). Rapid ASPECTS provides a comparative analysis to the ASPECTS standard of care radiologist assessment using the ASPECTS atlas definitions and atlas display including highlighted ROIs and numerical scoring.
Limitations:
-
- Rapid ASPECTS is not intended for primary interpretation of CT images. it is used to assist physician evaluation.
-
- Rapid ASPECTS has been validated in patients with known MCA or ICA Occlusion prior to ASPECT scoring.
-
- Use of the Rapid ASPECTS Module in clinical settings other than early brain ischemia (within 6 hours) caused by known ICA or MCA occlusions has not been tested.
-
- Rapid ASPECTS has been validated and is intended to be used on GE Lightspeed VCT Scanners.
Product codes
POK
Device Description
Rapid ASPECTS provides an automatic ASPECT score based on the case input file for the physician. The score includes which ASPECT regions are identified based on regional imaging features derived from non-contrast computed tomography (NCCT) brain image data. The results are generated based on the Alberta Stroke Program Early CT Score (ASPECTS) guidelines and provided to the clinician for review and verification. At the discretion of the clinician, the scores may be adjusted based on other clinical factors the clinician may integrate though the Rapid Platform User Interface.
The ASPECTS software module processing pipeline performs four major tasks:
- Orientation and spatial normalization of the input imaging data (rigid ● registration/alignment with anatomical template);
- Delineation of pre-defined regions of interest on the normalized input data . and computing numerical values characterizing underlying voxel values within those regions;
- . Identification and highlighting previous/old stroke areas along with areas of early ischemic change; and
- Labeling of these delineated regions and providing a summary score reflecting ● the number of regions with early ischemic change as per ASPECTS guidelines.
Subsequently, the system notifies the physician of the ASPECT score which then requires the confirmation by the physician that a Large Vessel Occlusion (LVO) is detected. The ASPECTS information is then available for the physician to review and edit prior to pushing the data to a PACS or Workstation. The final summary score together with the regions selected and underlying voxel values are then sent to the Picture Archiving and Communication System (PACS) to become a part of the permanent patient medical record.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
CT, NCCT
Anatomical Site
Brain/Head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinician (physician, neuroradiologist) in hospitals and primary stroke centers.
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
Retrospective data from case data.
Reader Study: 50 cases with each of 10 regions scored independently. Data truthing was performed by three experts. Eight readers were used to represent the intended use population.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance validation testing: demonstrated that the Rapid ASPECTS module 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 ASPECTS module met all design requirements and specifications.
Reader study: concurrent read, cross-over study design with 50 cases with each of 10 regions scored independently. Data truthing was performed by three experts. Eight readers were used to represent the intended use population.
Key Results: Performance was independently tested against expert neuroradiologist readers and indicated that a wide range of readers (neurologists, radiologists, emergency medicine, neurocritical care specialists) benefited from the Rapid ASPECTS and significantly increased their agreement with an expert consensus read when considering all ASPECTS regions in all patients evaluated (P
§ 892.2060 Radiological computer-assisted diagnostic software for lesions suspicious of cancer.
(a)
Identification. A radiological computer-assisted diagnostic software for lesions suspicious of cancer is an image processing prescription device intended to aid in the characterization of lesions as suspicious for cancer identified on acquired medical images such as magnetic resonance, mammography, radiography, or computed tomography. The device characterizes lesions based on features or information extracted from the images and provides information about the lesion(s) to the user. Diagnostic and patient management decisions are made by the clinical user.(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 image analysis algorithms including, but not limited to, a detailed description of the algorithm inputs and outputs, each major component or block, and algorithm limitations.
(ii) A detailed description of pre-specified performance testing protocols and dataset(s) used to assess whether the device will improve reader performance as intended.
(iii) Results from performance testing protocols that demonstrate that the device improves reader performance in the intended use population when used in accordance with the instructions for use. The performance assessment must be based on appropriate diagnostic accuracy measures (
e.g., receiver operator characteristic plot, sensitivity, specificity, predictive value, and diagnostic likelihood ratio). The test dataset must contain sufficient numbers of cases from important cohorts (e.g., subsets defined by clinically relevant confounders, effect modifiers, concomitant diseases, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals of the device for these individual subsets can be characterized for the intended use population and imaging equipment.(iv) Standalone 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; and description of verification and validation activities including system level test protocol, pass/fail criteria, results, and cybersecurity).(2) Labeling must include:
(i) A detailed description of the patient population for which the device is indicated for use.
(ii) A detailed description of the intended reading protocol.
(iii) A detailed description of the intended user and recommended user training.
(iv) A detailed description of the device inputs and outputs.
(v) A detailed description of compatible imaging hardware and imaging protocols.
(vi) Warnings, precautions, and limitations, including situations in which the device may fail or may not operate at its expected performance level (
e.g., poor image quality or for certain subpopulations), as applicable.(vii) Detailed instructions for use.
(viii) A detailed summary of the performance testing, including: Test methods, dataset characteristics, results, and a summary of sub-analyses on case distributions stratified by relevant confounders (
e.g., 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 name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
June 26, 2020
iSchemaView, Inc. % Mr. James Rosa VP Quality and Regulatory 433 Park Point Drive, Suite 220 GOLDEN CO 80401
Re: K200760
Trade/Device Name: Rapid ASPECTS Regulation Number: 21 CFR 892.2060 Regulation Name: Radiological computer-assisted diagnostic software for lesions suspicious of cancer Regulatory Class: Class II Product Code: POK Dated: May 23, 2020 Received: May 27, 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/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); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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.
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) K200760
Device Name Rapid ASPECTS
Rapid ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities using CT image automatically registers images and segments and analyzes ASPECTS Regions of Interest (ROIs). Rapid ASPECTS extracts image data for the ROI(s) to provide analysis and computer analytics based on morphological characteristics. The imaging features are then synthesized by an artificial intelligence algorithm into a single ASPECT (Alberta Stroke Program Early CT) Score. Rapid ASPECTS is indicated for evaluation of patients presenting for diagnostic imaging workup with known MCA or ICA occlusion, for evaluation of extent of disease refers to the number of ASPECTS regions affected which is reflected in the total score. This device information that may be useful in the characterization of early issue mury during mage interpretation (within 6 hours). Rapid ASPECTS provides a comparative analysis to the ASPECTS standard of care radiologist assessment using the ASPECTS atlas definitions and atlas display including highlighted ROIs and numerical scoring.
Limitations:
-
- Rapid ASPECTS is not intended for primary interpretation of CT images, it is used to assist physician evaluation.
-
- Rapid ASPECTS has been validated in patients with known MCA or ICA Occlusion prior to ASPECT scoring.
-
- Use of the Rapid ASPECTS Module in clinical settings other than early brain ischemia (within 6 hours) caused by known ICA or MCA occlusions has not been tested.
-
- Rapid ASPECTS has been validated and is intended to be used on GE Lightspeed VCT Scanners.
Contraindications/Exclusions/Cautions:
- · Patient Motion: excessive motion leading to artifacts that make the scan technically inadequate.
- · Hemorrhagic Transformation, Hematoma
- · Very thin or no Ventricles
| 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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3
Section 5: 510(k) Summary
510(k) Summary
iSchemaView, Inc.'s Rapid ASPECTS
This document contains the 510(k) summary for the iSchemaView Rapid ASPECTS. 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 |
May 23, 2020 Summary Preparation Date:
Device Name and Classification:
| Trade Name: | Rapid ASPECTS |
|---|---|
| Common Name: | CADx |
| Classification: | II |
| Product Code: | POK |
| Regulation No: | 21 C.F.R. §892.2060 |
| Classification Panel: | Radiology Devices |
Predicate Devices:
The iSchemaView Rapid is claimed to be substantially equivalent to the following legally marketed predicate device:
QuantX (DEN170022)
Device Description:
Rapid ASPECTS Module
Rapid ASPECTS provides an automatic ASPECT score based on the case input file for the physician. The score includes which ASPECT regions are identified based on regional imaging features derived from non-contrast computed tomography (NCCT) brain image data. The results are generated based on the Alberta Stroke Program Early CT Score (ASPECTS) guidelines and provided to the clinician for review and verification. At the discretion of the clinician, the scores may be adjusted based on other clinical factors the clinician may integrate though the Rapid Platform User Interface.
The ASPECTS software module processing pipeline performs four major tasks:
- Orientation and spatial normalization of the input imaging data (rigid ● registration/alignment with anatomical template);
4
Section 5: 510(k) Summary
- Delineation of pre-defined regions of interest on the normalized input data . and computing numerical values characterizing underlying voxel values within those regions;
- . Identification and highlighting previous/old stroke areas along with areas of early ischemic change; and
- Labeling of these delineated regions and providing a summary score reflecting the number of regions with early ischemic change as per ASPECTS guidelines.
Subsequently, the system notifies the physician of the ASPECT score which then requires the confirmation by the physician that a Large Vessel Occlusion (LVO) is detected. The ASPECTS information is then available for the physician to review and edit prior to pushing the data to a PACS or Workstation. The final summary score together with the regions selected and underlying voxel values are then sent to the Picture Archiving and Communication System (PACS) to become a part of the permanent patient medical record.
Clinical Characteristics
The images generated by Rapid ASPECTS provide additional diagnostic information, which is derived from the temporal/diffusion/density features of the native CT images. The following figure provides a general layout of the ASPECTS display image as provided from Rapid ASPECTS.
Image /page/4/Figure/8 description: The image shows a CT scan of a brain with ASPECTS scoring. The ASPECTS score is 7. The Hounsfield Units Mean are shown for both the right and left hemispheres, with values for C, IC, L, I, M1, M2, M3, M4, M5, and M6 regions. The image also includes text indicating that the use of Rapid ASPECTS is in a setting other than early brain ischemia and that LVO is confirmed.
Page 5-2 of 5-10
5
Section 5: 510(k) Summary
Indications for Use:
Rapid ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities using CT image data. The Software automatically registers images and segments and analyzes ASPECTS Regions of Interest (ROIs). Rapid ASPECTS extracts image data for the ROI(s) to provide analysis and computer analytics based on morphological characteristics. The imaging features are then synthesized by an artificial intelligence algorithm into a single ASPECT (Alberta Stroke Program Early CT) Score.
Rapid ASPECTS is indicated for evaluation of patients presenting for diagnostic imaging workup with known MCA or ICA occlusion, for evaluation of extent of disease. Extent of disease refers to the number of ASPECTS regions affected which is reflected in the total score.
This device provides information that may be useful in the characterization of early ischemic brain tissue injury during image interpretation (within 6 hours). Rapid ASPECTS provides a comparative analysis to the ASPECTS standard of care radiologist assessment using the ASPECTS atlas definitions and atlas display including highlighted ROIs and numerical scoring.
Limitations:
-
- Rapid ASPECTS is not intended for primary interpretation of CT images. it is used to assist physician evaluation.
-
- Rapid ASPECTS has been validated in patients with known MCA or ICA Occlusion prior to ASPECT scoring.
-
- Use of the Rapid ASPECTS Module in clinical settings other than early brain ischemia (within 6 hours) caused by known ICA or MCA occlusions has not been tested.
-
- Rapid ASPECTS has been validated and is intended to be used on GE Lightspeed VCT Scanners.
Contraindications/Exclusions/Cautions:
- · Patient Motion: excessive motion leading to artifacts that make the scan technically inadequate.
- · Hemorrhagic Transformation, Hematoma
- · Very thin or no Ventricles
Technological Characteristics:
Rapid ASPECTS is a machine learning implementation using the processing pipeline below. Rapid ASPECTS provides an automatic ASPECT score based on the case input file for the physician. The score includes which ASPECT regions are identified based on regional imaging features derived from non-contrast computed tomography (NCCT) brain image data based on the random forest machine learning technique. The results are generated based on the Alberta Stroke Program Early CT Score (ASPECTS) guidelines and provided to the clinician for review and verification. At the discretion of the clinician, the scores may be adjusted based on the clinician's judgment as well as other factors the clinician may integrate though the Rapid Platform User Interface.
The red box denotes input data (e.g. patient imaging data) which is processing through the PACS and Rapid platform, the white boxes denote the Rapid ASPECTS architecture which generates analysis data for output results (Green Boxes) for display to the user
6
Section 5: 510(k) Summary
through the Rapid platform UI. The Rapid ASPECTS software module processing pipeline performs four major tasks:
- Orientation and spatial normalization of the input imaging data (rigid ● registration/alignment with anatomical template);
- Delineation of pre-defined regions of interest on the normalized input data and computing numerical values characterizing underlying voxel values within those regions:
- Identification and highlighting previous/old stroke areas along with areas of early ischemic change; and
- Labeling of these delineated regions and providing a summary score reflecting ● the number of regions with early ischemic change as per ASPECTS guidelines.
Image /page/6/Figure/7 description: The image shows a flowchart of an image processing pipeline. The pipeline starts with an NCCT image, which is then pre-processed and data pre-conditioned. The next step is region outlining, which produces normalized images and region masks. The pipeline then moves to classification pre-processing, classification, and reporting, which produces a report and classified regions.
Rapid ASPECTS Processing Pipeline Architecture
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 ASPECTS module both as standalone software and as integrated within the Rapid Platform. This performance validation testing demonstrated that the Rapid ASPECTS module 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 ASPECTS module met all design requirements and specifications.
7
Section 5: 510(k) Summary
The reader study design was a concurrent read, cross-over study design with 50 cases with each of 10 regions scored independently. Data truthing was performed by three experts. Eight readers were used to represent the intended use population.
Performance was independently tested against expert neuroradiologist readers and indicated that a wide range of readers (neurologists, radiologists, emergency medicine, neurocritical care specialists) benefited from the Rapid ASPECTS and significantly increased their agreement with an expert consensus read when considering all ASPECTS regions in all patients evaluated (P