(237 days)
Not Found
No
The summary describes standard image processing and analysis techniques for calculating hemodynamic parameters and visualizing diffusion properties, without mentioning AI or ML.
No
The device is described as image processing software intended for decision support only, and the clinician makes all treatment decisions, indicating it does not provide therapy itself.
Yes
The device processes and analyzes medical images to provide information like tissue flow and blood volume, and generates hemodynamic markers for disease management, which are used to aid in diagnosis.
Yes
The device description explicitly states "Cercare Medical Neurosuite is a software-only device". It runs on standard off-the-shelf computers or virtual platforms and processes images acquired from separate MRI devices.
Based on the provided information, the Cercare Medical Neurosuited modules, including the Capillary Function module, is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description clearly states that the device processes and analyzes medical images acquired through MRI devices. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The device's function is image processing and analysis. Its purpose is to visualize and quantify information from medical images (MRI scans) to aid in clinical decision-making. This falls under the category of medical image analysis software, not IVD.
The device is a medical device, specifically a software-only medical device, but it does not meet the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Cercare Medical Neurosuite (CMN) with Capillary Function: Cercare Medical Neurosuited modules, including the Capillary Function module, is an image processing software package to be used by trained professionals, including physicians and medical technicians.
The software package runs on standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, and analysis of images. Data and images are acquired through DICOM (Digital Imaging and Communications in Medicine) compliant MR imaging devices.
Cercare Medical Neurosuite provides viewing capabilities, whereas the Capillary Function module provides analysis capabilities for functional and dynamic imaging datasets acquired with MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast-enhanced imaging data for MRI).
The Capillary Function module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. In addition, the Capillary Function module's DWI technology is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Cercare Medical Neurosuite is a software-only device designed to streamline medical image processing by providing for the visualization and study of medical images. CMN can be installed on a customer PC or it can be accessed remotely using remote desktop technologies. CMN provides viewing, quantification, analysis and reporting capabilities. CMN is not intended as a dedicated PACS system for long term persistent storage of patient data.
CMN is software that is intended for use by trained professionals, including physicians and medical technicians. The software provides cerebral image processing capabilities. CMN is intended to be used as decision support software only and the clinician continues to provide all treatment decisions.
The software is intended to visualize and study neuroimaging by image viewing and registration of medical images obtained with MRI (Magnetic Resonance Image) technology.
CMN accepts and produces data sets in the DICOM format. DICOM is a standard format for storing and transmitting medical image data in vendor neutral format and is managed by the DICOM Standards Committee.
CMN is a platform that allows for the addition of certain modules for further analysis. One of these modules included in this submission is Capillary Function.
Capillary Function, when activated in the installed Cercare Medical Neurosuite, provides further functionalities for reading, writing, visualizing and studying medical images.
Capillary Function provides perfusion post-processing technologies, where dynamically acquired perfusion MRI series can be processed to yield information relevant for assessment of the hemodynamic status of a patient.
Capillary Function generates hemodynamic markers, which can be used for management of diseases with possibly compromised hemodynamic function, such as ischemic stroke and tumors.
The generated output maps can be viewed by standard DICOM image viewers. In addition, Capillary Function includes the possibility for post-processing diffusion-weighted imaging (DWI) MRI data. Post-processing of DWI data results in maps reflective of local water diffusion properties. The post-processed DWI-derived maps can be viewed in standard DICOM image viewers. Capillary Function thus works with MRI technology.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals, including physicians and medical technicians
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)
Comparative performance testing was performed for the Subject Device with respect to the Predicate Device through bench testing including simulated digital phantoms and retrospective clinical data. Whereas the latter was primarily used for visual inspection due to the relative nature of most perfusion image biomarkers, rigorous testing was conducted through digital phantoms where the true parameter combinations were known. The simulated phantom data included variations of hemodynamic parameter combinations, while simultaneously simulating various experimental conditions such as patient motion, signal-to-noise ratios, and diffusion gradient schemes. Both so-called structured digital phantoms and more human-like phantom testing and analyses were conducted and performance quantified through comparison of absolute bias, correlation coefficients, and multi-scale structural similarity index obtained for both devices. The established acceptance criteria were reached in all tests conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
May 17, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
Cercare Medical ApS % Jennifer Willner President JW Regulatory Consulting LLC 406 Wacouta Street, Suite 417 SAINT PAUL MN 55101
Re: K202793
Trade/Device Name: Cercare Medical Neurosuite (CMN) with Capillary Function Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management and Processing System Regulatory Class: Class II Product Code: LLZ Dated: September 18, 2020 Received: September 22, 2020
Dear Jennifer Willner:
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
1
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 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 mediation-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, PhD 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) K202793
Device Name
Cercare Medical Neurosuite (CMN) with Capillary Function
Indications for Use (Describe)
Cercare Medical Neurosuited modules, including the Capillary Function module, is an image processing software package to be used by trained professionals, including physicians and medical technicians.
The software package runs on standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, and analysis of images. Data and images are acquired through DICOM (Digital Imaging and Communications in Medicine) compliant MR imaging devices.
Cercare Medical Neurosuite provides viewing capabilities, whereas the Capillary Function module provides analysis capabilities for functional and dynamic imaging datasets acquired with MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast-enhanced imaging data for MRI).
The Capillary Function module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. In addition, the Capillary Function module's DWI technology is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data.
| 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
Image /page/3/Picture/0 description: The image shows the logo for Cercare Medical. The logo consists of a cluster of small blue circles with one larger red circle, followed by the text "Cercare Medical" in a light blue sans-serif font. The logo is simple and modern, with a focus on the company name.
5.0 510(K) SUMMARY
| 510(k) Number: | K202793 |
|---|---|
| Date Prepared: | May 14, 2021 |
Table 1: Submitter Information
| Manufacturer: | Manufacturer's Contact Person: |
|---|---|
| Cercare Medical ApS | |
| Inge Lehmanns Gade 10 | |
| DK-8000 Aarhus C | |
| Denmark | |
| US FDA ERN: Pending | Mikkel Bo Hansen |
| Chief Scientific Officer | |
| Phone: +45 22890125 | |
| Email: mbh@cercare-medical.com |
Table 2: Device Information
| Trade Name | Cercare Medical Neurosuite (CMN) with Capillary Function |
|---|---|
| Common Name | CMN |
| Classification Name | Medical image management and processing system |
| Regulation | 21 CFR 892.2050 |
| Product Code | LLZ |
| Regulatory Classification: | Class II |
| Device Panel: | Radiology |
Cercare Medical Neurosuite is substantially equivalent to iSchemaView's RAPID medical device (Table 3). Neither of these have been subject to a design-related recall.
Table 3: Predicate Devices
| Predicate Device | Manufacturer | FDA 510(k) |
|---|---|---|
| RAPID | iSchemaView | K172477 |
5.1 Device Description
Cercare Medical Neurosuite is a software-only device designed to streamline medical image processing by providing for the visualization and study of medical images. CMN can be installed on a customer PC or it can be accessed remotely using remote desktop technologies. CMN provides viewing, quantification, analysis and reporting capabilities. CMN is not intended as a dedicated PACS system for long term persistent storage of patient data.
CMN is software that is intended for use by trained professionals, including physicians and medical technicians. The software provides cerebral image processing capabilities. CMN is intended to be used as decision support software only and the clinician continues to provide all treatment decisions.
The software is intended to visualize and study neuroimaging by image viewing and registration of medical images obtained with MRI (Magnetic Resonance Image) technology.
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Image /page/4/Picture/0 description: The image shows the logo for Cercare Medical. The logo consists of a cluster of small blue circles with one larger orange circle at the top left. To the right of the circles is the text "Cercare Medical" in a light blue sans-serif font.
CMN accepts and produces data sets in the DICOM format. DICOM is a standard format for storing and transmitting medical image data in vendor neutral format and is managed by the DICOM Standards Committee.
CMN is a platform that allows for the addition of certain modules for further analysis. One of these modules included in this submission is Capillary Function.
CMN Capillary Function
Capillary Function, when activated in the installed Cercare Medical Neurosuite, provides further functionalities for reading, writing, visualizing and studying medical images.
Capillary Function provides perfusion post-processing technologies, where dynamically acquired perfusion MRI series can be processed to yield information relevant for assessment of the hemodynamic status of a patient.
Capillary Function generates hemodynamic markers, which can be used for management of diseases with possibly compromised hemodynamic function, such as ischemic stroke and tumors.
The generated output maps can be viewed by standard DICOM image viewers. In addition, Capillary Function includes the possibility for post-processing diffusion-weighted imaging (DWI) MRI data. Post-processing of DWI data results in maps reflective of local water diffusion properties. The post-processed DWI-derived maps can be viewed in standard DICOM image viewers. Capillary Function thus works with MRI technology.
5.2 Indications for Use
Cercare Medical Neurosuite and associated modules, including the Capillary Function module, is an image processing software package to be used by trained professionals, including physicians and medical technicians.
The software package runs on standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, and analysis of images. Data and images are acquired through DICOM (Digital Imaging and Communications in Medicine) compliant imaging devices
Cercare Medical Neurosuite provides viewing capabilities, whereas the Capillary Function module provides analysis capabilities for functional and dynamic imaging datasets acquired with MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast-enhanced imaging data for MRI).
The Capillary Function module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. In addition, the Capillary Function module's DWI technology is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data.
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Image /page/5/Picture/0 description: The image shows the logo for Cercare Medical. The logo consists of a cluster of small blue circles with one red circle at the top left, followed by the text "Cercare Medical" in a light blue sans-serif font. The text is aligned horizontally to the right of the circle cluster.
5.3 Technological Characteristics
CMN with Capillary Function provides the following functions:
- . processes DICOM images from multiple sources to provide visualization of changes of tissue perfusion, diffusion and change
- receives DICOM images from external DICOM image providers (modalities (MRI ● Scanners), PACS and Workstations) and sends DICOM images to external image consumers
- storage of status and results, and references therein, in a searchable database ●
CMN with Capillary Function is a DICOM-compliant PACS software that provides comprehensive functionality to transfer, process and display modality specific imaging data. CMN runs on standard off-the-shelf computer and networking hardware and is entirely independent from MRI or PACS platforms. It supports secure VPN networking or encapsulated Secure Shell (SSH), and seamlessly integrates into an existing radiological data network.
The primary users of CMN software are medical imaging professionals who analyze tissue using MRI images. The images generated by CMN provide additional diagnostic information, which is derived from the temporal/diffusion/density features of the native MRI image.
Differences in Technical Characteristics/Performance with Respect to the Predicate Device
CMN with Capillary Function is identical to the Predicate RAPID (K172477) with the exception of limited functionality regarding diffusion tensor analysis, venous output function (VOF) detection, and the ability to issue PACS queries. The Subject and Predicate devices are based on the same technological elements of viewing, processing and analyzing DICOM image data to assist the clinician during diagnostic procedures.
The following technological difference exists between the subject and predicate devices:
- The UI component of the Predicate Device is thin client-based running in web-browsers . dissociated from the backend server. CMN also provides the ability to run a headless backend server for data management and processing. CMN does not however make its GUI available via a webserver, instead the CMN application can also act as a frontend, attaching to a remote CMN backend.
- The computation of perfusion markers rCBF, rCBV, MTT, and Tmax (delay) is believed ● to be implemented through a different algorithm than the predicate device.
- CMN provides additional perfusion markers (CTH, OEF (model-based), rCMRO2 . (model-based), rLeakage, and COV) not currently available in the Predicate Device. These markers originate from the same principles, namely the residue function part of the perfusion post-processing step.
These differences do not impact the intended use or raise new questions with the safety and performance of the device.
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Image /page/6/Picture/0 description: The image shows the logo for Cercare Medical. The logo consists of a cluster of small turquoise circles with one larger red circle at the top left, followed by the text "Cercare Medical" in turquoise. The text is in a sans-serif font and is aligned horizontally with the cluster of circles.
5.4 Performance Standards
CMN Capillary Function has been developed in conformance with the following standards and FDA guidance, as applicable:
- ISO 13485:2016, Quality management systems Requirements for regulatory purposes ●
- ISO 14971:2012, Medical devices Application of risk management to medical ● devices
- IEC 62304:2015, Medical device software Software lifecycle processes ●
- IEC 82304-1:2016, Health Software Part 1: General Requirements for Product Safety ●
- IEC 62366-1:2015, Medical devices Part 1: Application of usability engineering to ● medical devices
- . NEMA PS 3.1-3.20:2016, Digital Imaging and Communications in Medicine (DICOM)
- . Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, October 2018
- Computer-Assisted Detection Devices Applied to Radiology Images and Radiology . Device Data - Premarket Notification [510(k)] Submissions, July 2012
5.5 Performance Data
CMN with Capillary Function 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.
Cercare conducted extensive performance validation testing and software verification and validation testing of the CMN Capillary Function. This performance validation testing demonstrated that the CMN system provides accurate representation of key processing parameters under a range of clinically relevant parameters associated with the intended use of the software. Software performance, validation and verification testing demonstrated that the CMN system met all design requirements and specifications.
Comparative performance testing was performed for the Subject Device with respect to the Predicate Device through bench testing including simulated digital phantoms and retrospective clinical data. Whereas the latter was primarily used for visual inspection due to the relative nature of most perfusion image biomarkers, rigorous testing was conducted through digital phantoms where the true parameter combinations were known. The simulated phantom data included variations of hemodynamic parameter combinations, while simultaneously simulating various experimental conditions such as patient motion, signal-to-noise ratios, and diffusion gradient schemes. Both so-called structured digital phantoms and more human-like phantom testing and analyses were conducted and performance quantified through comparison of absolute bias, correlation coefficients, and multi-scale structural similarity index obtained for both devices. The established acceptance criteria were reached in all tests conducted.
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Image /page/7/Picture/0 description: The image shows the logo for Cercare Medical. The logo consists of a cluster of small blue circles with one larger red circle at the top left, followed by the text "Cercare Medical" in a light blue sans-serif font. The logo is simple and modern, with a focus on the company name.
Together with software verification and validation, the performance validation demonstrated that CMN with Capillary Function satisfies all design requirements and device specifications and is substantially equivalent to the Predicate device.
5.6 Substantial Equivalence
In comparison with the Predicate RAPID device (K172477), CMN with Capillary Function has the same intended use and similar indications, technological characteristics and principles of operation as described in the comparison table below.
| Description | Subject Device | Predicate Device iSchemaView
RAPID (K172477) |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | CMN Capillary Function | RAPID |
| Product Code /
Regulation | LLZ / 21CFR/892.2050 | LLZ / 21CFR/892.2050 |
| Indications for
Use | CMN and associated modules,
including the Capillary Function
module, is an image processing
software package to be used by
trained professionals, including
physicians and medical technicians.
The software package runs on
standard off-the-shelf computer or a
virtual platform, such as VMware,
and can be used to perform image
viewing, processing and analysis of
images. Data and images are
acquired through DICOM compliant
imaging devices.
CMN provides viewing capabilities,
whereas the Capillary Function
module provides analysis capabilities
for functional and dynamic imaging
datasets acquired with MRI
perfusion including a Diffusion
Weighted MRI (DWI) Module and a
Dynamic Analysis Module (dynamic
contrast-enhanced imaging data for
MRI).
The Capillary Function module is
used for visualization and analysis of
dynamic imaging data, showing | iSchemaView RAPID is an image
processing software package to be
used by trained professionals,
including but not limited to, physicians
and medical technicians.
The software runs on standard off-the-
shelf computer or a virtual platform,
such as VMware, and can be used to
perform image viewing, processing
and analysis of images. Data and
images are acquired through DICOM
compliant imaging devices
The iSchemaView RAPID provides
both viewing and analysis capabilities
for functional and dynamic imaging
datasets acquired with CT Perfusion
(CT-P), CT Angiography (CTA), and
MRI including a Diffusion Weighted
MRI (DWI) Module and a Dynamic
Analysis Module (dynamic contrast-
enhanced imaging data for MRI and
CT).
The DWI Module is used to visualize
local water diffusion properties from
the analysis of diffusion-weighted MRI
data. |
| Description | Subject Device | Predicate Device iSchemaView
RAPID (K172477) |
| | properties of changes in contrast
over time. This functionality
includes calculation of parameters
related to tissue flow (perfusion) and
tissue blood volume. In addition, the
Capillary Function module's DWI
technology is used to visualize local
water diffusion properties from the
analysis of diffusion-weighted MRI
data. | The Dynamic Analysis Module is used
for visualization and analysis of
dynamic imaging data, showing
properties of changes in contrast over
time. This functionality includes
calculation of parameters related to
tissue flow (perfusion) and tissue
blood volume. |
| PACS Functionality | | |
| Basic PACS
Functions | View, process and analyze medical
images. Communication of results
through service class user protocols. | Yes |
| Computer
Platform | Standard off-the-shelf PC
workstation / server
Virtual platform such as VMware | Yes |
| DICOM
Compliance | Yes | Yes |
| Functional
Overview | CMN is software package that
provides for the visualization and
study of changes of tissue in digital
images captured by MRI. CMN
provides viewing and quantification. | Same |
| Data Acquisition | Acquires medical image data from
DICOM compliant imaging devices
and modalities | Same |
| Data / Image
Types | MRI via DICOM format | Same |
| Acquisition and Modalities Features | | |
| MRI | Diffusion Weighted Image (DWI)
Dynamic Analysis tissue flow
(perfusion) and tissue blood volume | Yes |
| Computed Parameter Maps | | |
| Diffusion MRI | Isotropic DWI (isoDWI)
ADC
Zero=gradient image (B=0 image) | Yes |
| Perfusion MRI | Relative cerebral blood flow (rCBF) | Yes |
| Description | Subject Device | Predicate Device iSchemaView
RAPID (K172477) |
| | Relative cerebral blood volume
(rCBV) | Yes |
| | Mean transit time (MTT) | Yes |
| | Delay | Yes
Denoted Tmax in the predicate |
| | Capillary transit time heterogeneity
(CTH) | No
Derived from the impulse response
function similar to MTT and CBF |
| | Coefficient of variation (COV) | No
Derived from the impulse response
function similar to MTT and CBF.
Also denoted relative transit time
heterogeneity (RTH) in the literature. |
| | Model-based oxygen extraction
fraction (OEF (model-based)) | No
Derived from the impulse response
function similar to MTT and CBF in
conjunction with a substance
extraction model |
| | Model-based relative cerebral
metabolic rate of oxygen (rCMRO2
(model-based)) | No
Derived from the impulse response
function similar to MTT and CBF in
conjunction with a substance
extraction model |
| | Relative extravasation correction
(rLeakage) | No
Possibility to correct for extravasation
of contrast agent from the vasculature |
| | Measurement Tools | |
| MRI Tools | Arterial input function (AIF) | Yes |
| | | Time-course |
| | | Brain mask |
| | | Region of interest (ROI) and
Volumetry |
| | | Volumetric comparison between 2
ROIs |
| | | Motion correction |
| | | Export parameter maps PACS and
DICOM file systems |
| Description | Subject Device | Predicate Device iSchemaView
RAPID (K172477) |
| | Acquire, transmit, process, and store
medical images | Yes |
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5.7 Conclusions
The CMN with Capillary Function performs as intended and presents no unacceptable risks to the intended patient population. The non-clinical bench data support the safety of the device and demonstrate that CMN performs as intended in the specified use conditions. CMN is substantially equivalent in intended use, technological characteristics, safety, and performance characteristics to the legally marketed Predicate device, RAPID (K172477).