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

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.

AI/ML Overview

The provided document describes the acceptance criteria and the study conducted for the Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert device.

Acceptance Criteria and Device Performance Study

The acceptance criteria for the CMN Capillary Function with Virtual Expert device were established through performance validation testing, encompassing both simulated digital phantoms and retrospective clinical data. The document states that "The established acceptance criteria were reached in all tests conducted" (page 10).

1. Table of Acceptance Criteria and Reported Device Performance

For the Capillary Function module, the acceptance criteria focused on quantitative comparisons using digital phantoms, ensuring accuracy under varying hemodynamic parameters and experimental conditions. For the Virtual Expert module, the acceptance criteria involved volumetric and spatial agreement for lesion identification and secondary clinical application assessments like the DEFUSE3 criteria.

Module/Parameter	Acceptance Criteria (Implicit from Testing Method)	Reported Device Performance
Capillary Function Module	Performance quantified through comparison of absolute bias, correlation coefficients, and multi-scale structural similarity index between the device and known true parameters in digital phantoms. Expected to operate proficiently under various experimental conditions (motion, noise, diffusion gradient schemes).	"The established acceptance criteria were reached in all tests conducted." (page 10) This implicitly means the device demonstrated acceptable absolute bias, correlation coefficients, and structural similarity as per the defined thresholds for the phantoms.
Virtual Expert Module	Volumetric and spatial agreement per-patient and per-lesion in comparison testing of retrospective CT perfusion imaging. Secondary clinical application assessments based on "image-driven decision to treat analysis through the so-called DEFUSE3 criteria."	The 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))." (page 10) This implies that the device performed comparably to its predicate and the results presented in the reference study.
Overall Device	Satisfies all design requirements and device specifications and is substantially equivalent to the Predicate Device and Reference Device.	"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." (page 10-11)

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

Capillary Function Module:
- Test Set: Included simulated digital phantoms with variations of hemodynamic parameter combinations, as well as retrospective clinical data primarily for visual inspection (page 10). No specific numbers for the retrospective clinical data sample size are provided, and no country of origin is explicitly stated, though it's typically global or multi-center for such studies. The data from digital phantoms is synthetic.
- Provenance: "retrospective clinical data" and "simulated digital phantoms" (page 10).
Virtual Expert Module:
- Test Set: "retrospective patient CT perfusion imaging" (page 10). The specific sample size is not stated in the provided text.
- Provenance: "retrospective patient CT perfusion imaging" (page 10). The associated published technical comparison study (Bathla et al, J. Neurointerventional Surg., 12:1028-1032 (2020)) might contain details on data provenance, but it's not present in this document.

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

The document does not explicitly state the number or qualifications of experts used to establish ground truth for the test set. However, for the Virtual Expert module, it references a published study (Bathla et al, J. Neurointerventional Surg., 12:1028-1032 (2020)) which would typically involve expert consensus for ground truth. For the Capillary Function module, ground truth for the simulated phantoms is "known" (inherent to the phantom design), and clinical data was used for "visual inspection" which implies expert review.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1). For quantitative phantom testing, adjudication is not typically needed as the ground truth is predefined. For retrospective clinical data, particularly for "visual inspection" and comparison to a published study, it is common to have multiple readers involved, but the specific adjudication protocol is not detailed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The provided text does not indicate that an MRMC comparative effectiveness study was performed to evaluate human reader improvement with AI assistance versus without. The studies described are performance validation tests of the device itself (standalone or comparative to predicate/reference), not human-in-the-loop clinical utility studies.

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

Yes, the performance validation testing described for both the Capillary Function module (using digital phantoms and visual inspection of clinical data) and the Virtual Expert module (volumetric and spatial agreement, DEFUSE3 criteria) appears to be focused on standalone algorithm performance. The comparative testing against a predicate and reference device also implies standalone performance evaluation.

7. The Type of Ground Truth Used

Capillary Function Module: For simulated digital phantoms, the "true parameter combinations were known" (page 10), indicating a simulation-based (synthetic) ground truth. For retrospective clinical data, it was primarily used for "visual inspection," implying a clinical expert-derived visual ground truth.
Virtual Expert Module: For retrospective patient CT perfusion imaging, the ground truth for volumetric and spatial agreement would likely be expert consensus or highly delineated clinical ground truth based on expert review of the images. The reference to the DEFUSE3 criteria also points to clinically relevant ground truth.

8. The Sample Size for the Training Set

The document does not specify the sample size used for the training set. It focuses on the performance validation testing.

9. How the Ground Truth for the Training Set was Established

The document does not specify how the ground truth for the training set was established, as it does not elaborate on the training process or data.

Summary

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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"

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(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

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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

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Indications for Use

Submission Number (if known)

K241989

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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

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510(K) SUMMARY

510(k) Number: K241989

Date Prepared: December 5, 2024

Table 1: Submitter Information

Manufacturer:	Manufacturer's Contact Person:
Cercare Medical A/SInge Lehmanns Gade 10DK-8000 Aarhus CDenmarkUS FDA ERN: 3019844085	Mikkel Bo HansenChief Scientific OfficerPhone: +45 22890125Email: 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

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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.

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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.

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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. 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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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)).

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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
ProductName	CMN Capillary Function withVirtual Expert MRI & CT	CMN Capillary Function withVirtual 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
Indicationsfor Use	Cercare Medical Neurosuite(CMN) and associatedmodules is an imageprocessing software packageto be used by trainedprofessionals, includingphysicians and medicaltechnicians.The CMN software packageruns on standard off-the-shelfcomputer or a virtualplatform, such as VMware,and can be used to performimage viewing, processing,and analysis of images. Dataand images are acquiredthrough DICOM (DigitalImaging andCommunications inMedicine) compliant imagingdevices. CMN providesviewing capabilities ofdatasets acquired with CT andMRI.	CMN and associated modules,including the Capillary Functionmodule, is an image processingsoftware package to be used bytrained professionals, includingphysicians and medicaltechnicians.The software package runs onstandard off-the-shelf computer ora virtual platform, such asVMware, and can be used toperform image viewing,processing and analysis of images.Data and images are acquiredthrough DICOM compliantimaging devices.CMN provides viewingcapabilities, whereas the CapillaryFunction module provides analysiscapabilities for functional anddynamic imaging datasetsacquired with MRI including aDiffusion Weighted MRI (DWI)Module and a Dynamic Analysis	iSchemaView RAPID is animage processing softwarepackage to be used by trainedprofessionals, including butnot limited to physicians andmedical technicians.The software runs on astandard off-the-shelfcomputer or a virtualplatform, such as VMware,and can be used to performimage viewing, processingand analysis of images. Dataand images are acquiredthrough DICOM compliantimaging devices.The iSchemaView RAPIDprovides both viewing andanalysis capabilities forfunctional and dynamicimaging datasets acquiredwith CT Perfusion (CT-P),CT Angiography (CTA), andMRI including a Diffusion	Similar; SubjectDevice MRcapability identical toPredicate Device andCT capability similarto Reference Device.No new questions ofsafety oreffectiveness.
Description	Subject Device	Predicate Device (K230016)	Reference Device (K182130)	Conclusion
	The Capillary Functionmodule provides analysiscapabilities for functional anddynamic imaging datasetsacquired with MRI includinga Diffusion Weighted MRI(DWI) Module and aDynamic Analysis Module(dynamic contrast-enhancedimaging data for MRI andCT). The Capillary Functionmodule is used forvisualization and analysis ofdynamic imaging data,showing properties ofchanges in contrast over time.This functionality includescalculation of parametersrelated to tissue flow(perfusion) and tissue bloodvolume. In addition, theCapillary Function module'sDWI technology is used tovisualize local water diffusionproperties from the analysisof diffusion-weighted MRIdata.The Virtual Expert moduleallows the calculation ofregions of interest and thevisual inspection of timeattenuation curves. For MRI,one clinical application is to	Module (dynamic contrast-enhanced imaging data for MRI).The Capillary Function module isused for visualization and analysisof dynamic imaging data, showingproperties of changes in contrastover time. This functionalityincludes calculation of parametersrelated to tissue flow (perfusion)and tissue blood volume. Inaddition, the Capillary Functionmodule's DWI technology is usedto visualize local water diffusionproperties from the analysis ofdiffusion-weighted MRI data.The Virtual Expert module allowsthe calculation of mirrored regionsof interest and the visualinspection of time attenuationcurves. One clinical application isto visualize the apparent bloodperfusion and to calculateHypoperfused Area and MismatchRatio in the brain tissue affectedby acute stroke.Areas of decreased perfusionappear as areas of changed signalintensity:• Lower signal intensity forCBF and CBV• Higher signal intensity forTTP, TTD, MTT, and TMax	Weighted MRI (DWI)Module and a DynamicAnalysis Module (dynamiccontrast-enhanced imagingdata for MRI and CT).The DWI Module is used tovisualize local water diffusionproperties from the analysisof diffusion - weighted MRIdata.The Dynamic AnalysisModule is used forvisualization and analysis ofdynamic imaging data,showing properties ofchanges in contrast over time.This functionality includescalculation of parametersrelated to tissue flow(perfusion) and tissue bloodvolume.
Description	Subject Device	Predicate Device (K230016)	Reference Device (K182130)	Conclusion
	visualize the apparent bloodperfusion and diffusion and tocalculate ADC thresholdvolume, Tmax thresholdvolume, and Mismatch Ratioin the brain tissue affected byacute stroke.
	For CT, one clinicalapplication is to visualize theapparent blood perfusion andto calculate rCBF thresholdvolume, Tmax thresholdvolume, and Mismatch Ratioin the brain tissue affected byacute stroke.Areas of decreased perfusionappear as areas of changedsignal intensity:
	• Lower signal intensityfor CBF and CBVHigher signal intensity forTTP, MTT, and Tmax
PACS Functionality
Basic PACSFunctions	View, process and analyzemedical images.Communication of resultsthrough service class userprotocols.	Yes	Yes	Same
ComputerPlatform	Standard off-the-shelf PCworkstation / server	Yes	Yes	Same
Description	Subject Device	Predicate Device (K230016)	Reference Device (K182130)	Conclusion
	Virtual platform such asVMware	Yes	Yes	Same
DICOMCompliance	Yes	Yes	Yes	Same
FunctionalOverview	CMN is software packagethat provides for thevisualization and study ofchanges of tissue in digitalimages captured by CT andMRI. CMN provides viewingand quantification.	CMN is software package thatprovides for the visualization andstudy of changes of tissue indigital images captured by MRI.CMN provides viewing andquantification.	Same	Same; SubjectDevice MRcapability identical toPredicate Device andCT capability similarto Reference Device.No new questions ofsafety oreffectiveness.
DataAcquisition	Acquires medical image datafrom DICOM compliantimaging devices andmodalities	Same	Same	Same
Data / ImageTypes	CT via DICOM format	N/A	Same	Same as ReferenceDevice
	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 bloodvolume	Yes	Yes	Same
Description	Subject Device	Predicate Device (K230016)	Reference Device (K182130)	Conclusion
CT	Dynamic Analysis tissue flow(perfusion) and tissue bloodvolume	No	Yes	Same as ReferenceDevice
Computed Parameter Maps
DiffusionMRI	Isotropic DWI (isoDWI)	Yes	Yes	Same
	ADC	Yes	Yes	Same
	Zero=gradient image (B=0image)	Yes	Yes	Same
	Relative cerebral blood flow(rCBF)	Yes	No
	Relative cerebral bloodvolume (rCBV)	Yes	No
	Mean transit time (MTT)	Yes	No
	Delay	Yes	No
	Capillary transit timeheterogeneity (CTH)	Yes	No
PerfusionMRI	Coefficient of variation(COV)	Yes	No	Same as PredicateDevice
	Model-based oxygenextraction fraction (OEF(model-based))	Yes	No
	Model-based relative cerebralmetabolic rate of oxygen(rCMRO2 (model-based))	Yes	No
	Relative extravasationcorrection (rLeakage)	Yes	No
Description	Subject Device	Predicate Device (K230016)	Reference Device (K182130)	Conclusion
	rCBF-basic	No	YesDenoted rCBF in thereference device but likelybased on the same (or similar)algorithm (SVD)
	rCBV-basic	No	YesDenoted rCBV in thereference device but likelybased on the same (or similar)algorithm (SVD)	Similar to ReferenceDevice; minor designdifferences do notraise new questionsof safety oreffectiveness
	MTT-basic	No	YesDenoted MTT in thereference device but likelybased on the same (or similar)algorithm (SVD)
	Tmax-basic	No	YesDenoted Tmax in thereference device but likelybased on the same (or similar)algorithm (SVD)
Perfusion CT	rCBF-basic	No	YesDenoted rCBF in thereference device but likelybased on the same (or similar)algorithm (SVD)	Similar to ReferenceDevice; minor designdifferences do notraise new questionsof safety oreffectiveness
	rCBV-basic	No	YesDenoted rCBV in thereference device but likelybased on the same (or similar)algorithm (SVD)
Description	Subject Device	Predicate Device (K230016)	Reference Device (K182130)	Conclusion
	MTT-basic	No	YesDenoted MTT in thereference device but likelybased on the same (or similar)algorithm (SVD)
	Tmax-basic	No	YesDenoted Tmax in thereference device but likelybased on the same (or similar)algorithm (SVD)
Measurement Tools
MR/CT Tools	Arterial input function (AIF)	Yes - MRI only	Yes	Same; SubjectDevice MRcapability identical toPredicate Device andCT capability similarto Reference Device.Minor designdifferences do notraise new questionsof safety oreffectiveness.
	Time-course	Yes - MRI only	Yes
	Brain mask	Yes - MRI only	Yes
	Region of interest (ROI) andVolumetry	Yes - MRI only	Yes
	Volumetric comparisonbetween 2 ROIs	Yes - MRI only	Yes
	Motion correction	Yes - MRI only	Yes
	Export parameter maps PACSand 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).

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).