The Veuron-Brain-pAb is a software for the registration, fusion, display and analysis of medical images from multiple modalities including MRI and PET. The software aids clinician in the assessment and quantification of pathologies from PET Amyloid scans of the human brain. It enables automatic analysis and visualization of amyloid protein concentration through the calculation of standard uptake volume ratios (SUVR) within target regions of interest and comparison to those within the reference regions. The software is deployed via medical imaging workplaces and is organized as a series of workflows which are specific to use with radio-tracer and disease combinations.

Device Description

The Veuron-Brain-pAb is stand-alone software to automatically calculate the "Standardized Uptake Value Ratio (SUVR)" for quantitative analysis of amyloid PET. The calculated result supports the accuracy of the diagnosis of patients' dementia for the medical professional. It also helps with accurate visual interpretation through visualization functions. Various amyloid PET images can be processed by providing a variety of options for users to choose in the image process.

AI/ML Overview

The provided Presubmission document does not contain the detailed acceptance criteria and study results for the Veuron-Brain-pAb device's performance in the quantitative analysis of amyloid PET scans. The document primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, design features, and general technological characteristics.

However, based on the information provided, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document states "Bench testing is done to show that the system is suitable for its intended use and that the measurement tool performance meets its pre-defined requirements," and that "This did not reveal any issues with the system, demonstrating that the performance of Veuron-Brain-pAb is as safe and effective as its predicate devices." However, specific quantitative acceptance criteria (e.g., accuracy, precision, correlation with ground truth for SUVR values) and the actual numerical performance results against these criteria are not reported.

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

This information is not provided in the document. The document mentions "non-clinical study performance" and "bench testing" but does not specify the sample size of the test set used or the provenance (country of origin, retrospective/prospective) of the data.

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

This information is not provided in the document. The document does not describe how ground truth was established for any performance testing.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This information is not provided in the document. There is no mention of expert adjudication for ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

This information is not provided in the document. The document focuses on standalone device performance and substantial equivalence to predicate devices, not on comparative effectiveness with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the document implies that standalone performance testing was conducted. It states, "The Veuron-Brain-pAb is stand-alone software to automatically calculate the 'Standardized Uptake Value Ratio (SUVR)' for quantitative analysis of amyloid PET." The "non-clinical study performance" and "bench testing" described would likely refer to the evaluation of this standalone performance. However, specific results beyond the general statement of "no issues" are not presented.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

This information is not provided in the document. Given the device calculates SUVR for amyloid PET, the ground truth would typically involve either:

Standardized quantitative methods using a reference region for SUVR calculation (which the device aims to automate).
Correlation with definitive histopathological findings (e.g., brain biopsy/autopsy) or clinical outcomes for amyloid burden.
Concordance with expert readings or a consensus panel on amyloid positivity/negativity.
The document does not specify which, if any, of these were used as ground truth for testing.

8. The Sample Size for the Training Set

This information is not provided in the document. The document does not discuss the development or training of the algorithm.

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

This information is not provided in the document, as the training set and its ground truth establishment are not discussed.

Summary

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January 15, 2021

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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Heuron Co., Ltd. % Mr. Edward Park CEO LightenBridge LLC 4408 Tortuga Lane MCKINNEY TX 75070

Re: K203142

Trade/Device Name: Veuron-Brain-pAb Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: October 20, 2020 Received: October 20, 2020

Dear Mr. Park:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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, Ph.D. 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)

K2O3142

Device Name Veuron-Brain-pAb

Indications for Use (Describe)

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 K203142

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

Submitter Information

Submitter Name:	HEURON CO., LTD.
Address:	10th Floor, 7, Mirae-ro, Namdong-gu, Incheon, 21558 Republic ofKorea
Phone/Fax	Tel. 82-32-429-8508 / Fax. 82-32-429-8507
Contact Person:	Edward Park, official correspondent of Heuron Co., Ltd.
Date of submission:	Sep 01, 2020
Device Information
Proprietary Name(s):	Veuron-Brain-pAb
Common Name:	Image Processing Software
Classification Name:	Picture Archiving and Communication System per 21 CFR 892.2050
Product Code:	LLZ
Classification Panel:	Radiology
Device Class:	II

Device Description

Predicate Device

< Primary predicate device >

Scenium 2.0 (Siemens Medical Solutions USA, Inc. K121074, 06/08/2012) ●
< Secondary device >
. MIM 4.0 (NEURO) (MlMvista Corp. K060816, 05/16/2006)

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Intended Use

The Veuron-Brain-pAb is a display and analysis software to aid the Clinician in the assessment and quantification of pathologies taken from amyloid PET scans. The software is deployed via medical imaging workplaces and is organized as a series of workflows which are specific to use with particular drug and disease combinations. The software aids in the assessment of human brain scans enabling automated analysis through quantitative analysis of amyloid PET. It facilitates comparison with those different regions and calculation of standard uptake value ratios between regions of interest on the medical image.

Comparison of Indications for Use Statements

The following table compares Indications for Use Statements between the Veuron-Brain-pAb and the two predicate devices. i.e. Scenium 2.0 and MIM 4.0 (NEURO). Similar to the other predicate devices, the Veuron-Brain-pAb is used for managing patient and case base data, collection, analysis, fusion, and display of the medical images. The device assists the clinician with the visual evaluation, assessment and quantification of pathologies derived from brain sans.

Veuron-Brain-pAb	Simens Scenium 2.0	MIMvista Corp. MIM 4.0(NEURO)
Proposed device	Primary predicate device(K121074)	Secondary predicate device(K060816)
The Veuron-Brain-pAb is asoftware for the registration,fusion, display and analysisof medical images frommultiple modalitiesincluding MRI and PET.The software aids clinicianin the assessment andquantification of pathologiesfrom PET Amyloid scans ofthe human brain. It enablesautomatic analysis andvisualization of amyloidprotein concentrationthrough the calculation ofstandard uptake volumeratios (SUVR) within targetregions of interest andcomparison to those withinthe reference regions. The	The Scenium display andanalysis software has beendeveloped to aid the Clinicianin the assessment andquantification of pathologiestaken from PET and SPECTscans.The software is deployed viamedical imaging workplacesand is organized as a series ofworkflows which are specificto use with particular drugand disease combinations.The software aids in theassessment of human brainscans enabling automatedanalysis throughquantification of mean pixelvalues located withinstandard regions of interest. It	MIM 4.0 (NEURO) is asoftware package thatprovides the physician withthemeans to display, register andfuse medical images frommultiple modalities.Additionally, it evaluatescardiac left ventricularfunction and perfusionincluding left ventricular end-diastolic volume, end-systolicvolume, and ejection fraction.The Region of Interest (ROI)feature reduces the timenecessary for the physician todefine objects in medicalimage volumes by providingan initial definition of objectcontours. The objects include
software is deployed via	facilitates comparison with

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Veuron-Brain-pAb	Siemens Scenium 2.0	MIMvista Corp. MIM 4.0(NEURO)
Proposed device	Primary predicate device(K121074)	Secondary predicate device(K060816)
medical imaging workplacesand is organized as a seriesof workflows which arespecific to use with radio-tracer and diseasecombinations.	existing scans derived fromFDG-PET, amyloid-PET, andSPECT studies andcalculation of uptake ratiosbetween regions of interest.	but are not limited to tumorsand organs.MIM 4.0 (NEURO) also aidsthe physician in theassessment of PET/SPECTbrainscans. It provides automatedquantitative and statisticalanalysis by automaticallyregistering PET/SPECT brainscans to a standard templateand comparing intensityvalues to a reference databaseor to other PET/SPECT scanson a voxel by voxel basis,within stereotactic surfaceprojections, or withinstandardizedregions of interest.

Summary of the technological characteristics compared to the predicate device new device

The software is similar in uses and applications to the predicate devices. As stated in the comparison table provided below, both the device and predicates are used to assist the Clinician with the visual evaluation, assessment and quantification of pathologies derived from brain scans.

ComparisonItem	Veuron-Brain-pAb	SimensScenium 2.0(Primary predicate)	MIMvista Corp.MIM4.0 (NEURO)(2nd predicate)
Target Users	Trained Medicalprofessionals	Trained Medicalprofessionals	Trained Medicalprofessionals
AnatomicalSite	Brain	Brain	Brain
Where Used	Hospital	Hospital	Hospital
DesignFeatures	Import DICOM dataPerform automatic post-processing	Import DICOM dataPerform automatic post-processing	Import DICOM dataPerform automatic post-processing
Comparison Item	Veuron-Brain-pAb	Simens Scenium 2.0 (Primary predicate)	MIMvista Corp. MIM4.0 (NEURO) (2nd predicate)
	Provide the user confirmationExport the resulting data only through USB	Provide the user confirmationExport the resulting data through data network	Provide the user confirmationExport the resulting data only through data network
OS	Windows 10, 64-bit	Windows 7, 64-bit	Windows 2000/XP
Non-clinical Performance	Bench testing performed to test the functionality of the system and measurement tools.	Bench testing performed to test the functionality of the system and measurement tools.	Bench testing performed to test the functionality of the system and measurement tools.
Standards	• ISO 14971• IEC 62304• IEC 62366	• ISO 14971• IEC 62304	• ISO 14971• IEC 62304
SW verification and validation	Tested in accordance with verification and validation processes and planning. The testing results support that all the system requirements have met their acceptance criteria and are adequate for its intended use.	Tested in accordance with verification and validation processes and planning. The testing results support that all the system requirements have met their acceptance criteria and are adequate for its intended use.	Tested in accordance with verification and validation processes and planning. The testing results support that all the system requirements have met their acceptance criteria and are adequate for its intended use.
Compatible Input Data Format and Modality	DICOM & NiFTIPET, MRI	DICOMPET, SPECT, MRI, CT	DICOMPET, SPECT, MRI, CT
Input Patient Data	Manual through keyboard/mouse	Manual through keyboard/mouse	Manual through keyboard/mouse
Output Patient Data Format	Pictures: PNGReport: .csv	Pictures: JPEGReport: DICOM
Study list functionality	Search, Importing, Exporting	Search, Importing, Exporting, Deleting	Search, Importing, Exporting

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Non-Clinical Study performance

Bench testing is done to show that the system is suitable for its intended use and that the measurement tool performance meets its pre-defined requirements. This did not reveal any

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Heuron Co., Ltd. 10th Floor, 7, Mirae-ro, Namdong-gu Incheon, 21558 Republic of Korea Tel. +82-32-429-8508 / Fax. +82-32-429-8507

issues with the system, demonstrating that the performance of Veuron-Brain-pAb is as safe and effective as its predicate devices.

Conclusion

By virtue of its intended use, design features, and technological characteristics, Veuron-BrainpAb is substantially equivalent to a device that has been approved for marketing in the United States. The non-clinical performance data shows that Veuron-Brain-pAb is as safe and effective as the predicate devices without raising any new safety and/or effectiveness concerns.

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).