(192 days)
No
The summary describes image processing and analysis based on established parameters and thresholds (e.g., ADC threshold volume, Tmax threshold volume, Mismatch Ratio, DEFUSE3 criteria). There is no mention of learning from data or adaptive algorithms, which are characteristic of AI/ML. The "Virtual Expert" module performs automatic delineation based on these defined thresholds, not through learned patterns.
No
This device is image processing software for decision support and does not directly provide therapy. It is explicitly stated that it is "intended to be used as decision support software only and the clinician continues to provide all treatment decisions."
Yes
The device processes and analyzes medical images to provide information about tissue perfusion and blood volume, calculate parameters related to stroke assessment (e.g., ADC threshold volume, Tmax threshold volume, Mismatch Ratio), and generate hemodynamic markers for disease management, all of which are used by professionals for clinical decision support.
Yes
The device description explicitly states "Cercare Medical Neurosuite is a software-only device".
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.
- Device Function: The Cercare Medical Neurosuite and its modules are image processing software packages that analyze medical images (MRI) acquired directly from the patient's body. They do not perform tests on samples taken from the body.
- Intended Use: The intended use is for image viewing, processing, and analysis of functional and dynamic imaging datasets acquired with MRI. This is focused on interpreting images of the body, not analyzing biological samples.
Therefore, while it is a medical device used for diagnostic purposes, it falls under the category of medical imaging software rather than an In Vitro Diagnostic device.
N/A
Intended Use / 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.
The Virtual Expert module allows the calculation of mirrored regions of interest and the visual inspection of time attenuation curves. One clinical application is to visualize the apparent blood perfusion and to calculate Hypoperfused Area and Mismatch Ratio in the brain tissue affected by acute stroke.
Areas of decreased perfusion appear as areas of changed signal intensity:
- Lower signal intensity for CBF and CBV
- Higher signal intensity for TTP, TTD, MTT, and Tmax
Product codes
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. CMN works 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.
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.
CMN Virtual Expert
Virtual Expert, when activated in the installed CMN Capillary Function, provides further functionalities for reading, writing, visualizing, and studying medical images.
Virtual Expert provides automatic delineation of regions of interest (ROI) relevant for stroke patient assessment based on perfusion and diffusion image output generated by the Capillary Function module. Specifically, diffusion MRI images are used to generate threshold masks of perceived core lesions, whereas perfusion MRI images are used to generate threshold masks of perceived perfusion restriction. Virtual Expert thus works with MRI technology.
The generated masks can be combined into a mismatch region of interest.
Volumetric calculations and ratios can be calculated from the computed regions of interest.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI
Anatomical Site
Brain tissue
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
Comparative performance testing was performed for the Subject Device with respect to the Predicate Device and Reference Device through bench testing including simulated digital phantoms and retrospective clinical data.
For the Capillary Function module, the retrospective clinical data was primarily used for visual inspection due to the relative nature of most perfusion image biomarkers, while 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-tonoise ratios, and diffusion gradient schemes. Following the process undertaken with FDA on the Predicate Device (K202793), only human-like phantom testing and analyses were conducted since this approach allows for more realistic experimental settings (motion correction, noise, etc) 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.
For the Virtual Expert module, comparison testing of retrospective patient MR perfusion and diffusion imaging consisted of primary analyses of volumetric and spatial agreement per-patient and per-lesion. Secondary clinical application assessments (high-level context of the devices not associated with clinical claims) were then conducted in terms of image-driven decision to treat analysis through the so-called DEFUSE3 criteria. The Virtual Expert comparison testing was modeled by the comparison testing conducted for the Predicate Device (K202213) and in the associated published technical comparison study (Bathla et al, J. Neurointerventional Surg., 12:1028-1032 (2020)).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
CMN Capillary Function with Virtual Expert 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 with Virtual Expert. 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 and Reference Device through bench testing including simulated digital phantoms and retrospective clinical data.
For the Capillary Function module, the retrospective clinical data was primarily used for visual inspection due to the relative nature of most perfusion image biomarkers, while 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-tonoise ratios, and diffusion gradient schemes. Following the process undertaken with FDA on the Predicate Device (K202793), only human-like phantom testing and analyses were conducted since this approach allows for more realistic experimental settings (motion correction, noise, etc) 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.
For the Virtual Expert module, comparison testing of retrospective patient MR perfusion and diffusion imaging consisted of primary analyses of volumetric and spatial agreement per-patient and per-lesion. Secondary clinical application assessments (high-level context of the devices not associated with clinical claims) were then conducted in terms of image-driven decision to treat analysis through the so-called DEFUSE3 criteria. The Virtual Expert comparison testing was modeled by the comparison testing conducted for the Predicate Device (K202213) and in the associated published technical comparison study (Bathla et al, J. Neurointerventional Surg., 12:1028-1032 (2020)).
Together with software verification and validation, the performance validation demonstrated that CMN Capillary Function with Virtual Expert satisfies all design requirements and device specifications and is substantially equivalent to the Predicate Device and Reference Device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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Cercare Medical A/S % Jennifer Willner President JW Regulatory Consulting LLC 406 Wacouta Street, Suite 417 SAINT PAUL MN 55101
July 14, 2023
Re: K230016
Trade/Device Name: Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: June 6, 2023 Received: June 14, 2023
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 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,
1
including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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 (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 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,
Jessica Lamb
Jessica S. 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K230016
Device Name
Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert
Indications for Use (Describe)
Cercare Medical Neurosute 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.
The Virtual Expert module allows the calculation of regions of interest and the visual inspection of time attenuation curves. One clinical application is to visualize the apparent blood perfusion and to calculate ADC threshold volume, Tmax threshold volume, and Mismatch Ratio in the brain tissue affected by acute stroke.
Areas of decreased perfusion appear as areas of changed signal intensity:
- · Lower signal intensity for CBF and CBV
· Higher signal intensity for TTP, MTT, and Tmax
| 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
| 510(k) Number: | K230016 |
|---|---|
| Date Prepared: | July 12, 2023 |
Table 1: Submitter Information
| Manufacturer: Cercare Medical A/S | Manufacturer's Contact Person: |
|---|---|
| Inge Lehmanns Gade 10 | Mikkel Bo Hansen |
| DK-8000 Aarhus | Chief Scientific Officer |
| Denmark | Phone: +45 22890125 |
| US FDA ERN: 3019844085 | Email: mbh@cercare-medical.com |
Table 2: Device Information
| Trade Name | Cercare Medical Neurosuite (CMN) Capillary Function
with Virtual Expert for MRI |
|----------------------------|------------------------------------------------------------------------------------|
| Common Name | CMN Capillary Function with Virtual Expert |
| Classification Name | System, Image Processing, Radiological |
| Regulation | 21 CFR 892.2050 |
| Product Code | LLZ |
| Regulatory Classification: | Class II |
| Device Panel: | Radiology |
CMN Capillary Function with Virtual Expert MRI is substantially equivalent to the CMN Capillary Function Predicate Device (Table 3) and its modifications are similar to those provided in the iSchemaView RAPID Reference Device (Table 4). Neither of these have been subject to a design-related recall.
Table 3: Predicate Device
| Predicate Device | Manufacturer | FDA 510(k) |
|---|---|---|
| CMN Capillary Function | Cercare Medical A/S | K202793 |
Table 4: Reference Device
| Predicate Device | Manufacturer | FDA 510(k) |
|---|---|---|
| RAPID | iSchemaView | K182130 |
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
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Image /page/4/Picture/1 description: The image contains 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 a turquoise sans-serif font. The text is positioned to the right of the circle cluster.
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. CMN works 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.
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.
CMN Virtual Expert
Virtual Expert, when activated in the installed CMN Capillary Function, provides further functionalities for reading, writing, visualizing, and studying medical images.
Virtual Expert provides automatic delineation of regions of interest (ROI) relevant for stroke patient assessment based on perfusion and diffusion image output generated by the Capillary Function module. Specifically, diffusion MRI images are used to generate threshold masks of perceived core lesions, whereas perfusion MRI images are used to generate threshold masks of perceived perfusion restriction. Virtual Expert thus works with MRI technology.
The generated masks can be combined into a mismatch region of interest.
Volumetric calculations and ratios can be calculated from the computed regions of interest.
Indications for Use
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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 teal circles with one larger red circle at the top left, followed by the text "Cercare Medical" in teal. The text is in a clean, sans-serif font and is aligned horizontally with the circle cluster.
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.
The Virtual Expert module allows the calculation of mirrored regions of interest and the visual inspection of time attenuation curves. One clinical application is to visualize the apparent blood perfusion and to calculate Hypoperfused Area and Mismatch Ratio in the brain tissue affected by acute stroke.
Areas of decreased perfusion appear as areas of changed signal intensity:
- Lower signal intensity for CBF and CBV
- Higher signal intensity for TTP, TTD, MTT, and Tmax ●
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 Capillary Function with Virtual Expert 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 CT, MRI or PACS platforms. It supports secure VPN networking or
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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 CT or 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 Capillary Function with Virtual Expert is identical to the Predicate CMN Capillary Function (K202793) with the exception of the following features:
- . Output from the so-called SVD algorithm for computing perfusion derived markers has been exposed to the end-user and entails the common perfusion markers CBF, CBV, MTT, and Tmax, which to clearly distinguish these from the similarly named markers of the predicate device are called, respectively, CBF-basic, CBV-basic, MTT-basic, and Tmax-basic.
- Image thresholding features have been implemented via the Virtual Expert module, which provide thresholding of images and subsequent volumetric calculations relevant to ischemic stroke patient assessment.
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. These differences do not impact the intended use or raise new questions with the safety and performance of the device.
Performance Standards
CMN Capillary Function with Virtual Expert 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 14971:2019, Medical devices Application of risk management to medical ● devices
- IEC 62304:2006/Amd 1:2015, 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
- ISO 15223-1:2021, Medical devices – Symbols to be used with medical device labels, labeling and information to be supplied
- ISO 20417:2021, Medical devices Information to be supplied by the manufacturer ●
- NEMA PS 3.1-3.20:2022 Digital Imaging and Communications in Medicine (DICOM) ●
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- . 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
Performance Data
CMN Capillary Function with Virtual Expert 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 with Virtual Expert. 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 and Reference Device through bench testing including simulated digital phantoms and retrospective clinical data.
For the Capillary Function module, the retrospective clinical data was primarily used for visual inspection due to the relative nature of most perfusion image biomarkers, while 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-tonoise ratios, and diffusion gradient schemes. Following the process undertaken with FDA on the Predicate Device (K202793), only human-like phantom testing and analyses were conducted since this approach allows for more realistic experimental settings (motion correction, noise, etc) 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.
For the Virtual Expert module, comparison testing of retrospective patient MR perfusion and diffusion imaging consisted of primary analyses of volumetric and spatial agreement per-patient and per-lesion. Secondary clinical application assessments (high-level context of the devices not associated with clinical claims) were then conducted in terms of image-driven decision to treat analysis through the so-called DEFUSE3 criteria. The Virtual Expert comparison testing was modeled by the comparison testing conducted for the Predicate Device (K202213) and in the associated published technical comparison study (Bathla et al, J. Neurointerventional Surg., 12:1028-1032 (2020)).
Together with software verification and validation, the performance validation demonstrated that CMN Capillary Function with Virtual Expert satisfies all design requirements and device specifications and is substantially equivalent to the Predicate Device and Reference Device.
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Substantial Equivalence
In comparison with the Predicate CMN Capillary Function device (K202793) and Reference RAPID device (K182130), CMN Capillary Function with Virtual Expert has the same intended use and similar indications, technological characteristics, and principles of operation as described in the comparison table below.
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Image /page/9/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 logo is simple and modern, with a focus on the company name.
| Description | Subject Device | Predicate Device CMN
Capillary Function (K202793) | Reference Device IschemaView
Rapid (K182130) |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product
Name | CMN Capillary Function with Virtual
Expert | CMN Capillary Function | IschemaView Rapid |
| Product Code
/ Regulation | LLZ / 21CFR/892.2050 | 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 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 | 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 including
a Diffusion Weighted MRI (DWI)
Module and a Dynamic Analysis | 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 a 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). |
| Description | Subject Device | Predicate Device CMN
Capillary Function (K202793) | Reference Device IschemaView
Rapid (K182130) |
| | 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 Virtual Expert module allows the
calculation of mirrored regions of interest
and the visual inspection of time
attenuation curves. One clinical application
is to visualize the apparent blood perfusion
and to calculate Hypoperfused Area and
Mismatch Ratio in the brain tissue affected
by acute stroke.
Areas of decreased perfusion appear as
areas of changed signal intensity:
Lower signal intensity for CBF and CBV Higher signal intensity for TTP, TTD, MTT, and TMax | 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. | The DWI Module 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.
RAPID CT-Perfusion and RAPID
MR-Perfusion can be used by
physicians to aid in the selection of
acute stroke patients (with known
occlusion of the intracranial internal
carotid artery or proximal middle
cerebral artery) for endovascular
thrombectomy.
Instructions for use of contrast agents
for this indication can be found in
Appendix A of the User's Manual.
Additional information for safe and
effective drug use is available in
product specific iodinated CT and
gadolinium-based MR contrast drug
labeling. |
| Description | Subject Device | Predicate Device CMN Capillary Function (K202793) | Reference Device IschemaView Rapid (K182130) |
| Basic PACS Functions | View, process and analyze medical images. Communication of results through service class user protocols. | Yes | In addition to the RAPID imaging criteria, patients must meet the clinical requirements for thrombectomy, as assessed by the physician, and have none of the following contraindications or exclusions.
Contraindications/Exclusions:
Bolus Quality: absent or inadequate bolus. Patient Motion: excessive motion leading to artifacts that make the scan technically inadequate. Presence of Hemorrhage. |
| PACS Functionality | | | |
| Computer Platform | Standard off-the-shelf PC workstation / server
Virtual platform such as VMware | Yes | Yes |
| DICOM Compliance | Yes | 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 | Same |
| Description | Subject Device | Predicate Device CMN Capillary Function (K202793) | Reference Device IschemaView Rapid (K182130) |
| Data Acquisition | Acquires medical image data from DICOM compliant imaging devices and modalities | Same | Same |
| Data / Image Types | MRI via DICOM format | Same | Same |
| Acquisition and Modalities Features | | | |
| MRI | Diffusion Weighted Image (DWI) | Yes | Yes |
| | Dynamic Analysis tissue flow (perfusion) and tissue blood volume | Yes | Yes |
| Computed Parameter Maps | | | |
| Diffusion MRI | Isotropic DWI (isoDWI) | Yes | Yes |
| | ADC | Yes | Yes |
| | Zero-gradient image (B=0 image) | Yes | Yes |
| Perfusion MRI | Relative cerebral blood flow (rCBF) | Yes | No |
| | Relative cerebral blood volume (rCBV) | Yes | No |
| | Mean transit time (MTT) | Yes | No |
| | Delay | Yes | No |
| | Capillary transit time heterogeneity (CTH) | Yes | No |
| | Coefficient of variation (COV) | Yes | No |
| | Model-based oxygen extraction fraction (OEF (model-based)) | Yes | No |
| | Model-based relative cerebral metabolic rate of oxygen (rCMRO2 (model-based)) | Yes | No |
| | Relative extravasation correction (rLeakage) | Yes | No |
| Description | Subject Device | Predicate Device CMN
Capillary Function (K202793) | Reference Device IschemaView
Rapid (K182130) |
| | rCBF-basic | No | Yes
Denoted rCBF but likely based on the
same (or similar) algorithm (SVD) |
| | rCBV-basic | No | Yes
Denoted rCBV but likely based on the
same (or similar) algorithm (SVD) |
| | MTT-basic | No | Yes
Denoted MTT but likely based on the
same (or similar) algorithm (SVD) |
| | Tmax-basic | No | Yes
Denoted Tmax but likely based on the
same (or similar) algorithm (SVD) |
| Measurement Tools | | | |
| | Arterial input function (AIF) | Yes | Yes |
| | Time-course | Yes | Yes |
| MRI Tools | Brain mask | Yes | Yes |
| | Region of interest (ROI) and Volumetry | No | Yes |
| | Volumetric comparison between 2 ROIs | No | Yes |
| | Motion correction | Yes | Yes |
| | Export parameter maps PACS and DICOM
file systems | Yes | Yes |
| | Acquire, transmit, process, and store
medical images | Yes | Yes |
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Conclusions
The CMN Capillary Function with Virtual Expert 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 Capillary Function with Virtual Expert performs as intended in the specified use conditions. CMN Capillary Function with Virtual Expert is substantially equivalent in intended use, technological characteristics, safety, and performance characteristics to the legally marketed Predicate device, CMN Capillary Function (K202793).