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

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.

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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Capillary Function Module (Perfusion Biomarkers)
Digital phantoms: Absolute bias	Reached in all tests conducted
Digital phantoms: Correlation coefficients	Reached in all tests conducted
Digital phantoms: Multi-scale structural similarity index	Reached in all tests conducted
Virtual Expert Module (Volumetric and Spatial Agreement)
Per-patient volumetric agreement	Not explicitly quantified, but comparison testing was performed and modeled after the predicate device, implying acceptable performance.
Per-lesion volumetric agreement	Not explicitly quantified, but comparison testing was performed and modeled after the predicate device, implying acceptable performance.
Per-patient spatial agreement	Not explicitly quantified, but comparison testing was performed and modeled after the predicate device, implying acceptable performance.
Per-lesion spatial agreement	Not explicitly quantified, but comparison testing was performed and modeled after the predicate device, implying acceptable performance.
Overall Software Performance
Meets all design requirements and specifications	Demonstrated through software performance, validation, and verification testing.
Provides accurate representation of key processing parameters under a range of clinically relevant parameters	Demonstrated through extensive performance validation testing.

2. Sample Size Used for the Test Set and Data Provenance:

Capillary Function Module:
- Test Set: Predominantly digital phantoms. The text mentions "human-like phantom testing."
- Data Provenance: Not explicitly stated for retrospective clinical data, but the phantoms are simulated.
- Note: Retrospective clinical data was primarily used for visual inspection, not rigorous quantitative testing in this module's validation.
Virtual Expert Module:
- Test Set: Retrospective patient MR perfusion and diffusion imaging.
- Data Provenance: Not explicitly stated (e.g., country of origin). The data is described as "retrospective clinical data."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document does not explicitly state the number of experts used or their specific qualifications for establishing ground truth for either module's test sets.
For the Virtual Expert module, it mentions "comparison testing...in the associated published technical comparison study (Bathla et al, J. Neurointerventional Surg., 12:1028-1032 (2020))." This external publication might contain more details on expert involvement, but it's not present in this document.

4. Adjudication Method for the Test Set:

The document does not explicitly state the adjudication method used for either module's test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size:

No, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was not explicitly described in this document. The performance testing focused on the device's accuracy and agreement with ground truth or a predicate device, not on human reader improvement.
The Virtual Expert module's secondary application assessment mentioned "image-driven decision to treat analysis through the so-called DEFUSE3 criteria," which hints at clinical relevance, but it's not a formal MRMC study of human performance improvement.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, standalone performance testing was conducted. The entire performance data section describes the testing of the CMN Capillary Function with Virtual Expert as a software-only device. The device was compared against known parameters (digital phantoms) and retrospective clinical data (yielding volumetric and spatial agreement) without explicit mention of human-in-the-loop performance during these validation steps.

7. The Type of Ground Truth Used:

Capillary Function Module:
- Digital Phantoms: "True parameter combinations were known." This means the ground truth was synthetically generated and precisely defined.
Virtual Expert Module:
- Retrospective Clinical Data: Ground truth implies a reference standard or consensus derived from the clinical images themselves for volumetric and spatial agreement. The comparison was modeled after a published technical study, which may provide insight into how ground truth was typically established in such contexts (likely expert consensus or a validated reference method).

8. The Sample Size for the Training Set:

The document does not explicitly state the sample size used for the training set.

9. How the Ground Truth for the Training Set Was Established:

The document does not explicitly state how the ground truth for the training set was established. In fact, it doesn't mention training data at all. The description focuses on validation and verification rather than model development.

Summary

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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,

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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

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Indications for Use

510(k) Number (if known) K230016

Device Name

Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert

Indications for Use (Describe)

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 Functionwith 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

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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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 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 generates hemodynamic markers, which can be used for management of diseases with possibly compromised hemodynamic function, such as ischemic stroke and tumors.

CMN Virtual Expert

Virtual Expert, when activated in the installed CMN Capillary Function, provides further functionalities for reading, writing, visualizing, and studying medical images.

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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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 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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Description	Subject Device	Predicate Device CMNCapillary Function (K202793)	Reference Device IschemaViewRapid (K182130)
ProductName	CMN Capillary Function with VirtualExpert	CMN Capillary Function	IschemaView Rapid
Product Code/ Regulation	LLZ / 21CFR/892.2050	LLZ / 21CFR/892.2050	LLZ / 21CFR/892.2050
Indicationsfor Use	CMN and associated modules, includingthe Capillary Function module, is an imageprocessing software package to be used bytrained professionals, including physiciansand medical technicians.The software package runs on standard off-the-shelf computer or a virtual platform,such as VMware, and can be used toperform image viewing, processing andanalysis of images. Data and images areacquired through DICOM compliantimaging devices.CMN provides viewing capabilities,whereas the Capillary Function moduleprovides analysis capabilities forfunctional and dynamic imaging datasetsacquired with MRI including a DiffusionWeighted MRI (DWI) Module and aDynamic Analysis Module (dynamiccontrast-enhanced imaging data for MRI).The Capillary Function module is used forvisualization and analysis of dynamicimaging data, showing properties of	CMN and associated modules,including the Capillary Functionmodule, is an image processingsoftware package to be used bytrained professionals, includingphysicians and medical technicians.The software package runs onstandard off-the-shelf computer or avirtual platform, such as VMware,and can be used to perform imageviewing, processing and analysis ofimages. Data and images areacquired through DICOM compliantimaging devices.CMN provides viewing capabilities,whereas the Capillary Functionmodule provides analysis capabilitiesfor functional and dynamic imagingdatasets acquired with MRI includinga Diffusion Weighted MRI (DWI)Module and a Dynamic Analysis	iSchemaView RAPID is an imageprocessing software package to beused by trained professionals,including but not limited to physiciansand medical technicians.The software runs on a standard off-the-shelf computer or a virtualplatform, such as VMware, and can beused to perform image viewing,processing and analysis of images.Data and images are acquired throughDICOM compliant imaging devices.The iSchemaView RAPID providesboth viewing and analysis capabilitiesfor functional and dynamic imagingdatasets acquired with CT Perfusion(CT-P), CT Angiography (CTA), andMRI including a Diffusion WeightedMRI (DWI) Module and a DynamicAnalysis Module (dynamic contrast- enhanced imaging data for MRI andCT).
Description	Subject Device	Predicate Device CMNCapillary Function (K202793)	Reference Device IschemaViewRapid (K182130)
	changes in contrast over time. Thisfunctionality includes calculation ofparameters related to tissue flow(perfusion) and tissue blood volume. Inaddition, the Capillary Function module'sDWI technology is used to visualize localwater diffusion properties from theanalysis of diffusion-weighted MRI data.The Virtual Expert module allows thecalculation of mirrored regions of interestand the visual inspection of timeattenuation curves. One clinical applicationis to visualize the apparent blood perfusionand to calculate Hypoperfused Area andMismatch Ratio in the brain tissue affectedby acute stroke.Areas of decreased perfusion appear asareas of changed signal intensity:Lower signal intensity for CBF and CBV Higher signal intensity for TTP, TTD, MTT, and TMax	Module (dynamic contrast-enhancedimaging data for MRI).The Capillary Function module isused for visualization and analysis ofdynamic imaging data, showingproperties of changes in contrast overtime. This functionality includescalculation of parameters related totissue flow (perfusion) and tissueblood volume. In addition, theCapillary Function module's DWItechnology is used to visualize localwater diffusion properties from theanalysis of diffusion-weighted MRIdata.	The DWI Module is used to visualizelocal water diffusion properties fromthe analysis of diffusion - weightedMRI data.The Dynamic Analysis Module is usedfor visualization and analysis ofdynamic imaging data, showingproperties of changes in contrast overtime. This functionality includescalculation of parameters related totissue flow (perfusion) and tissueblood volume.RAPID CT-Perfusion and RAPIDMR-Perfusion can be used byphysicians to aid in the selection ofacute stroke patients (with knownocclusion of the intracranial internalcarotid artery or proximal middlecerebral artery) for endovascularthrombectomy.Instructions for use of contrast agentsfor this indication can be found inAppendix A of the User's Manual.Additional information for safe andeffective drug use is available inproduct specific iodinated CT andgadolinium-based MR contrast druglabeling.
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 / serverVirtual 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 CMNCapillary Function (K202793)	Reference Device IschemaViewRapid (K182130)
	rCBF-basic	No	YesDenoted rCBF but likely based on thesame (or similar) algorithm (SVD)
	rCBV-basic	No	YesDenoted rCBV but likely based on thesame (or similar) algorithm (SVD)
	MTT-basic	No	YesDenoted MTT but likely based on thesame (or similar) algorithm (SVD)
	Tmax-basic	No	YesDenoted Tmax but likely based on thesame (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 DICOMfile systems	Yes	Yes
	Acquire, transmit, process, and storemedical images	Yes	Yes

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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 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.

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Image /page/11/Picture/0 description: The image shows the logo for Cercare Medical. The logo consists of a teal-colored icon on the left and the words "Cercare Medical" on the right. The icon is a cluster of teal-colored circles with one red circle in the upper left corner. The text is also teal-colored.

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Image /page/12/Picture/0 description: The image shows the logo for Cercare Medical. The logo consists of a teal-colored icon on the left and the words "Cercare Medical" on the right. The icon is made up of several teal-colored circles of varying sizes, with one red circle among them.

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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 blue circles with one red circle at the top left, followed by the text "Cercare Medical" in a light blue sans-serif font. The text is aligned 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 larger red circle at the top left, followed by the text "Cercare Medical" in turquoise. The text is in a sans-serif font and is aligned to the right of the circle cluster.

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).

Regulation Number and Section

§ 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).