(151 days)
No
The document describes image processing and analysis software with modules for specific calculations and delineations, but it does not mention AI, ML, deep learning, or any related terms. The "Virtual Expert" module performs automatic delineation based on thresholds, which is a rule-based approach, not necessarily AI/ML.
No.
The device is described as image processing software for viewing, processing, and analyzing medical images to inform diagnostic and treatment decisions, not to directly treat a condition. It is explicitly stated as "decision support software only" and that the "clinician continues to provide all treatment decisions."
Yes
Explanation: The device processes medical images (CT and MRI) to provide analysis capabilities, calculate parameters related to tissue flow and blood volume, visualize local water diffusion properties, and calculate thresholds and ratios for stroke assessment. These functions directly contribute to the diagnosis of medical conditions, such as ischemic stroke and tumors, by providing information relevant for assessment of hemodynamic status and lesion identification. The statement "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 and CT)" and "The Virtual Expert module allows the calculation of regions of interest and the visual inspection of time attenuation curves" are key indicators of its diagnostic nature. While it states it's "decision support software only," the information it provides (e.g., perfusion, diffusion, lesion volumes) is inherently diagnostic.
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 hardware imaging devices (CT and MRI).
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 (CMN) is an image processing software package that analyzes medical images (CT and MRI) acquired from imaging devices. It does not perform tests on biological samples.
- Intended Use: The intended use is for image viewing, processing, and analysis of images acquired through DICOM compliant imaging devices, specifically for visualizing and analyzing brain tissue in the context of acute stroke. This is image-based analysis, not in vitro testing.
- Device Description: The description clearly states it's a "software-only device designed to streamline medical image processing."
Therefore, while it's a medical device used in diagnosis and treatment planning, 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 (CMN) and associated modules is an image processing software package to be used by trained professionals, including physicians and medical technicians.
The CMN 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. CMN provides viewing capabilities of datasets acquired with CT and MRI.
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 and CT). 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. For MRI, one clinical application is to visualize the apparent blood perfusion and diffusion and to calculate ADC threshold volume, Tmax threshold volume, and Mismatch Ratio in the brain tissue affected by acute stroke.
For CT, one clinical application is to visualize the apparent blood perfusion and to calculate rCBF 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
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 inage 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) and CT (computed tomography) technologies.
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 or perfusion CT 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 and CT technologies.
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 MRI or CT perfusion images are used to generate threshold masks of perceived perfusion restriction. For CT perfusion, derived perfusion images are used to generate threshold masks of perceived core lesions. Virtual Expert thus works with MRI and CT technologies.
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
CT, MRI
Anatomical Site
Brain (implied by "brain tissue affected by acute stroke")
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 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-to-noise ratios, and diffusion gradient schemes. Following the process undertaken with FDA on the Predicate Device (K230016), 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 CT perfusion 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 (K230016) 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)
Study Type: Performance validation testing, software verification and validation testing, comparative performance testing (bench testing including simulated digital phantoms and retrospective clinical data).
Sample Size: Not explicitly stated for retrospective clinical data, but simulated digital phantoms were used for rigorous testing.
AUC: Not Found
MRMC: Not Found
Standalone performance: Software performance, validation and verification testing demonstrated that the CMN system met all design requirements and specifications.
Key Results: The established acceptance criteria were reached in all tests conducted for the Capillary Function module using simulated phantom data. For the Virtual Expert module, comparison testing of retrospective patient CT perfusion imaging involved analyses of volumetric and spatial agreement per-patient and per-lesion, and secondary clinical application assessments were conducted in terms of image-driven decision to treat analysis through the DEFUSE3 criteria. Overall, the performance validation demonstrated that CMN Capillary Function with Virtual Expert satisfies all design requirements and device specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Absolute bias, correlation coefficients, multi-scale structural similarity index (for Capillary Function module). Volumetric and spatial agreement per-patient and per-lesion (for Virtual Expert module).
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.
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
December 6, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Cercare Medical A/S % Jennifer Willner Official Correspondent JW Regulatory Consulting LLC 406 Wacouta St, Unit 417 Saint Paul. Minnesota 55101
Re: K241989
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: July 5, 2024 Received: November 4, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert
Indications for Use (Describe)
Cercare Medical Neurosuite (CMN) and associated modules is an image processing software package to be used by trained professionals, including physicians and medical technicians.
The CMN 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. CMN provides viewing capabilities of datasets acquired with CT and MRI.
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 and CT). 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 diffusionweighted MRI data.
The Virtual Expert module allows the calculation of regions of interest and the visual inspection of time attenuation curves. For MRI, one clinical application is to visualize the apparent blood perfusion and diffusion and to calculate ADC threshold volume, Tmax threshold volume, and Mismatch Ratio in the brain tissue affected by acute stroke.
For CT, one clinical application is to visualize the apparent blood perfusion and to calculate rCBF 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)
The-Counter Use (21 CFR 801 Subpart C)
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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 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 positioned to the right of the circle cluster.
510(K) SUMMARY
510(k) Number: K241989
Date Prepared: December 5, 2024
Table 1: Submitter Information
| Manufacturer: | Manufacturer's Contact Person: |
|---|---|
| Cercare Medical A/S | |
| Inge Lehmanns Gade 10 | |
| DK-8000 Aarhus C | |
| Denmark | |
| US FDA ERN: 3019844085 | Mikkel Bo Hansen |
| Chief Scientific Officer | |
| Phone: +45 22890125 | |
| Email: mbh@cercare-medical.com |
Table 2: Device Information
| Trade Name | Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert |
|---|---|
| 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 for MRI and CT 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 Devices
| Predicate Device | Manufacturer | FDA 510(k) |
|---|---|---|
| CMN Capillary Function with Virtual Expert for MRI | Cercare Medical A/S | K230016 |
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 inage 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.
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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 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 text is positioned to the right of the circle cluster. The overall design is clean and modern.
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) and CT (computed tomography) technologies.
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 or perfusion CT 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 and CT technologies.
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 MRI or CT perfusion images are used to generate threshold masks of perceived perfusion restriction. For CT perfusion, derived perfusion images are used to generate threshold masks of perceived core lesions. Virtual Expert thus works with MRI and CT technologies.
7
Image /page/7/Picture/0 description: The image shows the logo for Cercare Medical. The logo consists of a cluster of 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.
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
Cercare Medical Neurosuite (CMN) and associated modules is an image processing software package to be used by trained professionals, including physicians and medical technicians.
The CMN 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. CMN provides viewing capabilities of datasets acquired with CT and MRI.
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 and CT). 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. For MRI, one clinical application is to visualize the apparent blood perfusion and diffusion and to calculate ADC threshold volume, Tmax threshold volume, and Mismatch Ratio in the brain tissue affected by acute stroke.
For CT, one clinical application is to visualize the apparent blood perfusion and to calculate rCBF 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 ●
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
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Image /page/8/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 text is aligned to the right of the circle cluster.
- . 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 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 (K230016) with the exception of the following features:
- CT perfusion post-processing ●
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 62366-1:2015, Medical devices - Part 1: Application of usability engineering 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 ●
- ISO 15223-1:2021, Medical devices — Symbols to be used with information to be supplied by the manufacturer -- Part 1: General requirements
- ISO 20417:2021, Medical devices Information to be supplied by the manufacturer .
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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 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.
- 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, September 2022
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 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 (K230016), 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 CT perfusion 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 (K230016) and in the associated published technical comparison study (Bathla et al, J. Neurointerventional Surg., 12:1028-1032 (2020)).
10
Image /page/10/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 text is positioned to the right of the circle cluster.
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.
Substantial Equivalence
In comparison with the Predicate CMN Capillary Function with Virtual Expert for MRI device (K230016) and Reference RAPID device (K182130), CMN Capillary Function with Virtual Expert (MRI & CT) 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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| Description | Subject Device | Predicate Device (K230016) | Reference Device (K182130) | Conclusion |
|---|---|---|---|---|
| Product | ||||
| Name | CMN Capillary Function with | |||
| Virtual Expert MRI & CT | CMN Capillary Function with | |||
| Virtual Expert MRI | Rapid | |||
| Manufacturer | Cercare Medical A/S | Cercare Medical A/S | ISchemaView | |
| Product Code | ||||
| / Regulation | LLZ / 21CFR 892.2050 | LLZ / 21CFR 892.2050 | LLZ / 21CFR 892.2050 | Same |
| Indications | ||||
| for Use | Cercare Medical Neurosuite | |||
| (CMN) and associated | ||||
| modules is an image | ||||
| processing software package | ||||
| to be used by trained | ||||
| professionals, including | ||||
| physicians and medical | ||||
| technicians. | ||||
| The CMN 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. CMN provides | ||||
| viewing capabilities of | ||||
| datasets acquired with CT and | ||||
| MRI. | 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 | Similar; Subject | |||
| Device MR | ||||
| capability identical to | ||||
| Predicate Device and | ||||
| CT capability similar | ||||
| to Reference Device. | ||||
| No new questions of | ||||
| safety or | ||||
| effectiveness. | ||||
| Description | Subject Device | Predicate Device (K230016) | Reference Device (K182130) | Conclusion |
| 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 and | ||||
| CT). 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. For MRI, | ||||
| one clinical application is to | 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 | 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. | ||||
| 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. | ||||
| Description | Subject Device | Predicate Device (K230016) | Reference Device (K182130) | Conclusion |
| visualize the apparent blood | ||||
| perfusion and diffusion and to | ||||
| calculate ADC threshold | ||||
| volume, Tmax threshold | ||||
| volume, and Mismatch Ratio | ||||
| in the brain tissue affected by | ||||
| acute stroke. | ||||
| For CT, one clinical | ||||
| application is to visualize the | ||||
| apparent blood perfusion and | ||||
| to calculate rCBF 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 | ||||
| PACS Functionality | ||||
| Basic PACS | ||||
| Functions | View, process and analyze | |||
| medical images. | ||||
| Communication of results | ||||
| through service class user | ||||
| protocols. | Yes | Yes | Same | |
| Computer | ||||
| Platform | Standard off-the-shelf PC | |||
| workstation / server | Yes | Yes | Same | |
| Description | Subject Device | Predicate Device (K230016) | Reference Device (K182130) | Conclusion |
| Virtual platform such as | ||||
| VMware | Yes | Yes | Same | |
| DICOM | ||||
| Compliance | Yes | Yes | Yes | Same |
| Functional | ||||
| Overview | CMN is software package | |||
| that provides for the | ||||
| visualization and study of | ||||
| changes of tissue in digital | ||||
| images captured by CT and | ||||
| MRI. CMN provides viewing | ||||
| and quantification. | 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; Subject | ||
| Device MR | ||||
| capability identical to | ||||
| Predicate Device and | ||||
| CT capability similar | ||||
| to Reference Device. | ||||
| No new questions of | ||||
| safety or | ||||
| effectiveness. | ||||
| Data | ||||
| Acquisition | Acquires medical image data | |||
| from DICOM compliant | ||||
| imaging devices and | ||||
| modalities | Same | Same | Same | |
| Data / Image | ||||
| Types | CT via DICOM format | N/A | Same | Same as Reference |
| Device | ||||
| MRI via DICOM format | Same | Same | Same | |
| Acquisition and Modalities Features | ||||
| MRI | Diffusion Weighted Image | |||
| (DWI) | Yes | Yes | Same | |
| Dynamic Analysis tissue flow | ||||
| (perfusion) and tissue blood | ||||
| volume | Yes | Yes | Same | |
| Description | Subject Device | Predicate Device (K230016) | Reference Device (K182130) | Conclusion |
| CT | Dynamic Analysis tissue flow | |||
| (perfusion) and tissue blood | ||||
| volume | No | Yes | Same as Reference | |
| Device | ||||
| Computed Parameter Maps | ||||
| Diffusion | ||||
| MRI | Isotropic DWI (isoDWI) | Yes | Yes | Same |
| ADC | Yes | Yes | Same | |
| Zero=gradient image (B=0 | ||||
| image) | Yes | Yes | Same | |
| 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 | ||
| Perfusion | ||||
| MRI | Coefficient of variation | |||
| (COV) | Yes | No | Same as Predicate | |
| Device | ||||
| 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 (K230016) | Reference Device (K182130) | Conclusion |
| rCBF-basic | No | Yes | ||
| Denoted rCBF in the | ||||
| reference device but likely | ||||
| based on the same (or similar) | ||||
| algorithm (SVD) | ||||
| rCBV-basic | No | Yes | ||
| Denoted rCBV in the | ||||
| reference device but likely | ||||
| based on the same (or similar) | ||||
| algorithm (SVD) | Similar to Reference | |||
| Device; minor design | ||||
| differences do not | ||||
| raise new questions | ||||
| of safety or | ||||
| effectiveness | ||||
| MTT-basic | No | Yes | ||
| Denoted MTT in the | ||||
| reference device but likely | ||||
| based on the same (or similar) | ||||
| algorithm (SVD) | ||||
| Tmax-basic | No | Yes | ||
| Denoted Tmax in the | ||||
| reference device but likely | ||||
| based on the same (or similar) | ||||
| algorithm (SVD) | ||||
| Perfusion CT | rCBF-basic | No | Yes | |
| Denoted rCBF in the | ||||
| reference device but likely | ||||
| based on the same (or similar) | ||||
| algorithm (SVD) | Similar to Reference | |||
| Device; minor design | ||||
| differences do not | ||||
| raise new questions | ||||
| of safety or | ||||
| effectiveness | ||||
| rCBV-basic | No | Yes | ||
| Denoted rCBV in the | ||||
| reference device but likely | ||||
| based on the same (or similar) | ||||
| algorithm (SVD) | ||||
| Description | Subject Device | Predicate Device (K230016) | Reference Device (K182130) | Conclusion |
| MTT-basic | No | Yes | ||
| Denoted MTT in the | ||||
| reference device but likely | ||||
| based on the same (or similar) | ||||
| algorithm (SVD) | ||||
| Tmax-basic | No | Yes | ||
| Denoted Tmax in the | ||||
| reference device but likely | ||||
| based on the same (or similar) | ||||
| algorithm (SVD) | ||||
| Measurement Tools | ||||
| MR/CT Tools | Arterial input function (AIF) | Yes - MRI only | Yes | Same; Subject |
| Device MR | ||||
| capability identical to | ||||
| Predicate Device and | ||||
| CT capability similar | ||||
| to Reference Device. | ||||
| Minor design | ||||
| differences do not | ||||
| raise new questions | ||||
| of safety or | ||||
| effectiveness. | ||||
| Time-course | Yes - MRI only | Yes | ||
| Brain mask | Yes - MRI only | Yes | ||
| Region of interest (ROI) and | ||||
| Volumetry | Yes - MRI only | Yes | ||
| Volumetric comparison | ||||
| between 2 ROIs | Yes - MRI only | Yes | ||
| Motion correction | Yes - MRI only | Yes | ||
| Export parameter maps PACS | ||||
| and DICOM file systems | Yes - MRI only | Yes | ||
| Acquire, transmit, process, | ||||
| and store medical images | Yes - MRI only | Yes |
Table 5: Substantial Equivalence Comparison Table
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Image /page/12/Picture/0 description: The image shows the logo for Cercare Medical. The logo consists of a cluster of small turquoise circles with one 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 to the right of the circle cluster.
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Image /page/13/Picture/0 description: The image shows the logo for Cercare Medical. The logo consists of a cluster of small turquoise circles with one 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 to the right of the circle cluster.
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Image /page/14/Picture/0 description: The image shows the logo for Cercare Medical. The logo consists of a cluster of small turquoise circles with one 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 to the right of the circle cluster.
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Image /page/15/Picture/0 description: The image shows the logo for Cercare Medical. The logo consists of a cluster of small turquoise circles with one 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 to the right of the circle cluster.
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Image /page/16/Picture/0 description: The image shows the logo for Cercare Medical. The logo consists of a cluster of small turquoise circles with one red circle at the top left, followed by the text "Cercare Medical" in turquoise. The text is in a sans-serif font and is slightly larger than the cluster of circles.
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Image /page/17/Picture/0 description: The image shows the logo for Cercare Medical. The logo consists of a cluster of small turquoise circles with one 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 to the right of the circle cluster.
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Image /page/18/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, followed by the text "Cercare Medical" in a turquoise sans-serif font. The logo is simple and modern, with a focus on the company name.
Conclusions
The CMN Capillary Function with Virtual Expert (MRI & CT) device 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 the CMN Capillary Function with Virtual Expert (MRI & CT) device performs as intended. The CMN Capillary Function with Virtual Expert (MRI & CT) is substantially equivalent in intended use, technological characteristics, safety, and performance characteristics to the legally marketed Predicate Device (K230016) with comparable characteristics to the Reference Device (K182130).