Cercare Medical Neurosuited modules, including the Capillary Function module, is an image processing software package to be used by trained professionals, including physicians and medical technicians.

The software package runs on standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, and analysis of images. Data and images are acquired through DICOM (Digital Imaging and Communications in Medicine) compliant MR imaging devices.

Cercare Medical Neurosuite provides viewing capabilities, whereas the Capillary Function module provides analysis capabilities for functional and dynamic imaging datasets acquired with MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast-enhanced imaging data for MRI).

The Capillary Function module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. In addition, the Capillary Function module's DWI technology is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data.

Device Description

Cercare Medical Neurosuite is a software-only device designed to streamline medical image processing by providing for the visualization and study of medical images. CMN can be installed on a customer PC or it can be accessed remotely using remote desktop technologies. CMN provides viewing, quantification, analysis and reporting capabilities. CMN is not intended as a dedicated PACS system for long term persistent storage of patient data.

CMN is software that is intended for use by trained professionals, including physicians and medical technicians. The software provides cerebral image processing capabilities. CMN is intended to be used as decision support software only and the clinician continues to provide all treatment decisions.

The software is intended to visualize and study neuroimaging by image viewing and registration of medical images obtained with MRI (Magnetic Resonance Image) technology.

CMN accepts and produces data sets in the DICOM format. DICOM is a standard format for storing and transmitting medical image data in vendor neutral format and is managed by the DICOM Standards Committee.

CMN is a platform that allows for the addition of certain modules for further analysis. One of these modules included in this submission is Capillary Function.

Capillary Function, when activated in the installed Cercare Medical Neurosuite, provides further functionalities for reading, writing, visualizing and studying medical images.

Capillary Function provides perfusion post-processing technologies, where dynamically acquired perfusion MRI series can be processed to yield information relevant for assessment of the hemodynamic status of a patient.

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

The generated output maps can be viewed by standard DICOM image viewers. In addition, Capillary Function includes the possibility for post-processing diffusion-weighted imaging (DWI) MRI data. Post-processing of DWI data results in maps reflective of local water diffusion properties. The post-processed DWI-derived maps can be viewed in standard DICOM image viewers. Capillary Function thus works with MRI technology.

AI/ML Overview

The provided text is a 510(k) summary for the Cercare Medical Neurosuite (CMN) with Capillary Function. It details the device's characteristics, indications for use, and a comparison to a predicate device (iSchemaView's RAPID). While it states that acceptance criteria were met, it does not provide specific numerical acceptance criteria or detailed results of the performance studies.

However, I can extract the information that is present and highlight what is missing based on your request.

Device: Cercare Medical Neurosuite (CMN) with Capillary Function

Indications for Use: Image processing software package for trained professionals (physicians, medical technicians) to perform image viewing, processing, and analysis of functional and dynamic MRI datasets (DWI and dynamic contrast-enhanced imaging data). Specifically, the Capillary Function module is used for visualization and analysis of dynamic imaging data to calculate parameters related to tissue flow (perfusion) and tissue blood volume, and to visualize local water diffusion properties from DWI data.

Here's the breakdown of your requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes that "The established acceptance criteria were reached in all tests conducted" but does not explicitly define these criteria or provide specific numerical results of the device performance against them. It generally states:

Criterion Type	Acceptance Criteria (Not Explicitly Defined in Document)	Reported Device Performance (Summary)
Accuracy (Phantom Data)	Implicit: High correlation, low absolute bias, high multi-scale structural similarity index.	"The established acceptance criteria were reached in all tests conducted." (Bench testing with digital phantoms showed accurate representation of key processing parameters.)
Software Functionality	Implicit: Met all design requirements and specifications.	"Software performance, validation and verification testing demonstrated that the CMN system met all design requirements and specifications."
DICOM Compliance	Implicit: Full compliance with NEMA PS 3.1-3.20.	"CMN with Capillary Function complies with DICOM (Digital Imaging and Communications in Medicine)."
Safety	Implicit: No unacceptable risks.	"The CMN with Capillary Function performs as intended and presents no unacceptable risks to the intended patient population."
Substantial Equivalence	Implicit: Similar intended use, indications, technological characteristics, and principles of operation to predicate device.	"The non-clinical bench data support the safety of the device and demonstrate that CMN performs as intended in the specified use conditions. CMN is substantially equivalent in intended use, technological characteristics, safety, and performance characteristics to the legally marketed Predicate device, RAPID (K172477)."

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

Test Set Description: The document refers to "bench testing including simulated digital phantoms and retrospective clinical data."
Sample Size: Not specified. The exact number of digital phantoms or retrospective clinical cases used in the test set is not mentioned.
Data Provenance:
- Country of Origin: Not specified for the retrospective clinical data.
- Retrospective/Prospective: Retrospective clinical data was used. Digital phantoms are simulated data.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The document mentions the retrospective clinical data was "primarily used for visual inspection," implying human expert review, but does not detail the nature or number of these experts. For digital phantoms, the "true parameter combinations were known," meaning the ground truth was inherent to the simulation design, not established by human experts.

4. Adjudication Method for the Test Set:

Method: Not specified. For the retrospective clinical data, it states "primarily used for visual inspection," which generally implies a qualitative review, but no formal adjudication process (like 2+1 or 3+1 consensus) is described. For phantom data, ground truth was inherent to the simulation.

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

MRMC Study: No, it does not appear that a formal MRMC study was done to compare human readers with and without AI assistance. The performance testing was comparative against a predicate device using bench testing (digital phantoms) and retrospective clinical data primarily for visual inspection, not assessing the impact on human reader performance.
Effect Size: Not applicable, as no MRMC study was described.

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

Standalone Performance: Yes, the performance data described ("bench testing including simulated digital phantoms and retrospective clinical data") appears to primarily evaluate the algorithm's performance in generating the output maps and parameters independently. The phrase "the CMN system provides accurate representation of key processing parameters" and "rigorous testing was conducted through digital phantoms where the true parameter combinations were known" suggests a standalone evaluation of the algorithm's output.

7. The Type of Ground Truth Used:

For digital phantoms: The ground truth was known parameter combinations inherent to the simulated data. This is considered a form of "synthetic ground truth."
For retrospective clinical data: The ground truth method is not explicitly defined for quantitative comparison, as this data was "primarily used for visual inspection due to the relative nature of most perfusion image biomarkers." This implies a qualitative assessment against an unspecified clinical or expert consensus. It does not mention pathology or outcomes data as ground truth.

8. The Sample Size for the Training Set:

Not specified. The document focuses on the validation of the device and does not provide details about its development process, including the training set size.

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

Not specified. As the training set size is not provided, neither is how its ground truth was established.

Summary

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May 17, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

Cercare Medical ApS % Jennifer Willner President JW Regulatory Consulting LLC 406 Wacouta Street, Suite 417 SAINT PAUL MN 55101

Re: K202793

Trade/Device Name: Cercare Medical Neurosuite (CMN) with Capillary Function Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management and Processing System Regulatory Class: Class II Product Code: LLZ Dated: September 18, 2020 Received: September 22, 2020

Dear Jennifer Willner:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, PhD Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202793

Device Name

Cercare Medical Neurosuite (CMN) with Capillary Function

Indications for Use (Describe)

Type of Use ( Select one or both, as applicable )
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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5.0 510(K) SUMMARY

510(k) Number:	K202793
Date Prepared:	May 14, 2021

Table 1: Submitter Information

Manufacturer:	Manufacturer's Contact Person:
Cercare Medical ApSInge Lehmanns Gade 10DK-8000 Aarhus CDenmarkUS FDA ERN: Pending	Mikkel Bo HansenChief Scientific OfficerPhone: +45 22890125Email: mbh@cercare-medical.com

Table 2: Device Information

Trade Name	Cercare Medical Neurosuite (CMN) with Capillary Function
Common Name	CMN
Classification Name	Medical image management and processing system
Regulation	21 CFR 892.2050
Product Code	LLZ
Regulatory Classification:	Class II
Device Panel:	Radiology

Cercare Medical Neurosuite is substantially equivalent to iSchemaView's RAPID medical device (Table 3). Neither of these have been subject to a design-related recall.

Table 3: Predicate Devices

Predicate Device	Manufacturer	FDA 510(k)
RAPID	iSchemaView	K172477

5.1 Device Description

The software is intended to visualize and study neuroimaging by image viewing and registration of medical images obtained with MRI (Magnetic Resonance Image) technology.

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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.

5.2 Indications for Use

Cercare Medical Neurosuite and associated modules, including the Capillary Function module, is an image processing software package to be used by trained professionals, including physicians and medical technicians.

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5.3 Technological Characteristics

CMN with Capillary Function provides the following functions:

. processes DICOM images from multiple sources to provide visualization of changes of tissue perfusion, diffusion and change
receives DICOM images from external DICOM image providers (modalities (MRI ● Scanners), PACS and Workstations) and sends DICOM images to external image consumers
storage of status and results, and references therein, in a searchable database ●

CMN with Capillary Function is a DICOM-compliant PACS software that provides comprehensive functionality to transfer, process and display modality specific imaging data. CMN runs on standard off-the-shelf computer and networking hardware and is entirely independent from MRI or PACS platforms. It supports secure VPN networking or encapsulated Secure Shell (SSH), and seamlessly integrates into an existing radiological data network.

The primary users of CMN software are medical imaging professionals who analyze tissue using MRI images. The images generated by CMN provide additional diagnostic information, which is derived from the temporal/diffusion/density features of the native MRI image.

Differences in Technical Characteristics/Performance with Respect to the Predicate Device

CMN with Capillary Function is identical to the Predicate RAPID (K172477) with the exception of limited functionality regarding diffusion tensor analysis, venous output function (VOF) detection, and the ability to issue PACS queries. The Subject and Predicate devices are based on the same technological elements of viewing, processing and analyzing DICOM image data to assist the clinician during diagnostic procedures.

The following technological difference exists between the subject and predicate devices:

The UI component of the Predicate Device is thin client-based running in web-browsers . dissociated from the backend server. CMN also provides the ability to run a headless backend server for data management and processing. CMN does not however make its GUI available via a webserver, instead the CMN application can also act as a frontend, attaching to a remote CMN backend.
The computation of perfusion markers rCBF, rCBV, MTT, and Tmax (delay) is believed ● to be implemented through a different algorithm than the predicate device.
CMN provides additional perfusion markers (CTH, OEF (model-based), rCMRO2 . (model-based), rLeakage, and COV) not currently available in the Predicate Device. These markers originate from the same principles, namely the residue function part of the perfusion post-processing step.

These differences do not impact the intended use or raise new questions with the safety and performance of the device.

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5.4 Performance Standards

CMN Capillary Function has been developed in conformance with the following standards and FDA guidance, as applicable:

ISO 13485:2016, Quality management systems Requirements for regulatory purposes ●
ISO 14971:2012, Medical devices Application of risk management to medical ● devices
IEC 62304:2015, Medical device software Software lifecycle processes ●
IEC 82304-1:2016, Health Software Part 1: General Requirements for Product Safety ●
IEC 62366-1:2015, Medical devices Part 1: Application of usability engineering to ● medical devices
. NEMA PS 3.1-3.20:2016, Digital Imaging and Communications in Medicine (DICOM)
. Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, October 2018
Computer-Assisted Detection Devices Applied to Radiology Images and Radiology . Device Data - Premarket Notification [510(k)] Submissions, July 2012

5.5 Performance Data

CMN with Capillary Function complies with DICOM (Digital Imaging and Communications in Medicine), developed by the American College of Radiology and the National Electrical Manufacturers Association - NEMA PS 3.1-3.20.

Cercare conducted extensive performance validation testing and software verification and validation testing of the CMN Capillary Function. This performance validation testing demonstrated that the CMN system provides accurate representation of key processing parameters under a range of clinically relevant parameters associated with the intended use of the software. Software performance, validation and verification testing demonstrated that the CMN system met all design requirements and specifications.

Comparative performance testing was performed for the Subject Device with respect to the Predicate Device through bench testing including simulated digital phantoms and retrospective clinical data. Whereas the latter was primarily used for visual inspection due to the relative nature of most perfusion image biomarkers, rigorous testing was conducted through digital phantoms where the true parameter combinations were known. The simulated phantom data included variations of hemodynamic parameter combinations, while simultaneously simulating various experimental conditions such as patient motion, signal-to-noise ratios, and diffusion gradient schemes. Both so-called structured digital phantoms and more human-like phantom testing and analyses were conducted and performance quantified through comparison of absolute bias, correlation coefficients, and multi-scale structural similarity index obtained for both devices. The established acceptance criteria were reached in all tests conducted.

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Together with software verification and validation, the performance validation demonstrated that CMN with Capillary Function satisfies all design requirements and device specifications and is substantially equivalent to the Predicate device.

5.6 Substantial Equivalence

In comparison with the Predicate RAPID device (K172477), CMN with Capillary Function has the same intended use and similar indications, technological characteristics and principles of operation as described in the comparison table below.

Description	Subject Device	Predicate Device iSchemaViewRAPID (K172477)
Product Name	CMN Capillary Function	RAPID
Product Code /Regulation	LLZ / 21CFR/892.2050	LLZ / 21CFR/892.2050
Indications forUse	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 MRIperfusion including a DiffusionWeighted MRI (DWI) Module and aDynamic Analysis Module (dynamiccontrast-enhanced imaging data forMRI).The Capillary Function module isused for visualization and analysis ofdynamic imaging data, showing	iSchemaView RAPID is an imageprocessing software package to beused by trained professionals,including but not limited to, physiciansand medical technicians.The software runs on standard off-the-shelf computer or a virtual platform,such as VMware, and can be used toperform image viewing, processingand analysis of images. Data andimages are acquired through DICOMcompliant imaging devicesThe 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).The DWI Module is used to visualizelocal water diffusion properties fromthe analysis of diffusion-weighted MRIdata.
Description	Subject Device	Predicate Device iSchemaViewRAPID (K172477)
	properties of changes in contrastover time. This functionalityincludes calculation of parametersrelated to tissue flow (perfusion) andtissue blood volume. In addition, theCapillary Function module's DWItechnology is used to visualize localwater diffusion properties from theanalysis of diffusion-weighted MRIdata.	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.
PACS Functionality
Basic PACSFunctions	View, process and analyze medicalimages. Communication of resultsthrough service class user protocols.	Yes
ComputerPlatform	Standard off-the-shelf PCworkstation / serverVirtual platform such as VMware	Yes
DICOMCompliance	Yes	Yes
FunctionalOverview	CMN is software package thatprovides for the visualization andstudy of changes of tissue in digitalimages captured by MRI. CMNprovides viewing and quantification.	Same
Data Acquisition	Acquires medical image data fromDICOM compliant imaging devicesand modalities	Same
Data / ImageTypes	MRI via DICOM format	Same
Acquisition and Modalities Features
MRI	Diffusion Weighted Image (DWI)Dynamic Analysis tissue flow(perfusion) and tissue blood volume	Yes
Computed Parameter Maps
Diffusion MRI	Isotropic DWI (isoDWI)ADCZero=gradient image (B=0 image)	Yes
Perfusion MRI	Relative cerebral blood flow (rCBF)	Yes
Description	Subject Device	Predicate Device iSchemaViewRAPID (K172477)
	Relative cerebral blood volume(rCBV)	Yes
	Mean transit time (MTT)	Yes
	Delay	YesDenoted Tmax in the predicate
	Capillary transit time heterogeneity(CTH)	NoDerived from the impulse responsefunction similar to MTT and CBF
	Coefficient of variation (COV)	NoDerived from the impulse responsefunction similar to MTT and CBF.Also denoted relative transit timeheterogeneity (RTH) in the literature.
	Model-based oxygen extractionfraction (OEF (model-based))	NoDerived from the impulse responsefunction similar to MTT and CBF inconjunction with a substanceextraction model
	Model-based relative cerebralmetabolic rate of oxygen (rCMRO2(model-based))	NoDerived from the impulse responsefunction similar to MTT and CBF inconjunction with a substanceextraction model
	Relative extravasation correction(rLeakage)	NoPossibility to correct for extravasationof contrast agent from the vasculature
	Measurement Tools
MRI Tools	Arterial input function (AIF)	Yes
		Time-course
		Brain mask
		Region of interest (ROI) andVolumetry
		Volumetric comparison between 2ROIs
		Motion correction
		Export parameter maps PACS andDICOM file systems
Description	Subject Device	Predicate Device iSchemaViewRAPID (K172477)
	Acquire, transmit, process, and storemedical images	Yes

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5.7 Conclusions

The CMN with Capillary Function performs as intended and presents no unacceptable risks to the intended patient population. The non-clinical bench data support the safety of the device and demonstrate that CMN performs as intended in the specified use conditions. CMN is substantially equivalent in intended use, technological characteristics, safety, and performance characteristics to the legally marketed Predicate device, RAPID (K172477).

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).