(87 days)
Not Found
No
The summary describes image processing and quantitative analysis using standard methods (SUVR calculation) and does not mention AI, ML, or related concepts.
No
The device is a software for image analysis that aids in diagnosis, but it does not directly treat or prevent any condition.
Yes
The software "aids clinician in the assessment and quantification of pathologies" and "helps with accurate visual interpretation" of amyloid protein concentration, supporting the diagnosis of patients' dementia.
Yes
The device description explicitly states it is "stand-alone software" and the intended use and device description focus solely on software functionalities for image processing and analysis. There is no mention of accompanying hardware components.
Based on the provided information, the Veuron-Brain-pAb is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). The Veuron-Brain-pAb analyzes images of the human brain, which are generated by medical imaging equipment (PET and MRI). It doesn't directly interact with or analyze biological samples.
- The intended use is image processing and analysis. The software registers, fuses, displays, and analyzes medical images to aid in the assessment and quantification of pathologies. This is a function of medical imaging software, not an IVD.
- The output is quantitative analysis of image data (SUVR). While this analysis supports the diagnosis, it's based on image data, not the direct measurement of substances in a biological sample.
The Veuron-Brain-pAb falls under the category of medical imaging software or medical image analysis software. Its function is to process and interpret image data to provide information to the clinician, rather than performing a test on a biological sample.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
PET, MRI
Anatomical Site
Brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained Medical Professionals / Hospital
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 issues with the system, demonstrating that the performance of Veuron-Brain-pAb is as safe and effective as its predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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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
1
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)
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.
| 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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Image /page/3/Picture/0 description: The image shows the logo for "Heuron". The logo consists of a symbol on the left that resembles a network of interconnected nodes, possibly representing neurons or connections. To the right of the symbol is the word "heuron" in a stylized, sans-serif font. The color of both the symbol and the text is a muted gray.
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 of |
| Korea | |
| 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
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.
Predicate Device
-
Scenium 2.0 (Siemens Medical Solutions USA, Inc. K121074, 06/08/2012) ●
-
. MIM 4.0 (NEURO) (MlMvista Corp. K060816, 05/16/2006)
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Image /page/4/Picture/0 description: The image contains the logo for Heuron. The logo consists of a stylized graphic to the left of the word "heuron". The graphic is made up of a grid of circles connected by lines, resembling a neural network. The word "heuron" is written in a rounded, sans-serif font.
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 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 | The Scenium display and
analysis software has been
developed to aid the Clinician
in the assessment and
quantification of pathologies
taken from PET and SPECT
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
quantification of mean pixel
values located within
standard regions of interest. It | MIM 4.0 (NEURO) is a
software package that
provides the physician with
the
means to display, register and
fuse medical images from
multiple modalities.
Additionally, it evaluates
cardiac left ventricular
function and perfusion
including left ventricular end-
diastolic volume, end-systolic
volume, and ejection fraction.
The Region of Interest (ROI)
feature reduces the time
necessary for the physician to
define objects in medical
image volumes by providing
an initial definition of object
contours. The objects include |
| software is deployed via | facilitates comparison with | |
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Image /page/5/Picture/0 description: The image shows the logo for Heuron. The logo consists of a stylized graphic to the left of the word "Heuron". The graphic is made up of a series of interconnected circles, resembling a neural network. The word "Heuron" is written in a rounded, sans-serif font.
| 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 workplaces
and is organized as a series
of workflows which are
specific to use with radio-
tracer and disease
combinations. | existing scans derived from
FDG-PET, amyloid-PET, and
SPECT studies and
calculation of uptake ratios
between regions of interest. | but are not limited to tumors
and organs.
MIM 4.0 (NEURO) also aids
the physician in the
assessment of PET/SPECT
brain
scans. It provides automated
quantitative and statistical
analysis by automatically
registering PET/SPECT brain
scans to a standard template
and comparing intensity
values to a reference database
or to other PET/SPECT scans
on a voxel by voxel basis,
within stereotactic surface
projections, or within
standardized
regions 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.
| Comparison
Item | Veuron-Brain-pAb | Simens
Scenium 2.0
(Primary predicate) | MIMvista Corp.
MIM4.0 (NEURO)
(2nd predicate) |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Target Users | Trained Medical
professionals | Trained Medical
professionals | Trained Medical
professionals |
| Anatomical
Site | Brain | Brain | Brain |
| Where Used | Hospital | Hospital | Hospital |
| Design
Features | Import DICOM data
Perform automatic post-
processing | Import DICOM data
Perform automatic post-
processing | Import DICOM data
Perform automatic post-
processing |
| Comparison Item | Veuron-Brain-pAb | Simens Scenium 2.0 (Primary predicate) | MIMvista Corp. MIM4.0 (NEURO) (2nd predicate) |
| | Provide the user confirmation
Export the resulting data only through USB | Provide the user confirmation
Export the resulting data through data network | Provide the user confirmation
Export 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 & NiFTI
PET, MRI | DICOM
PET, SPECT, MRI, CT | DICOM
PET, SPECT, MRI, CT |
| Input Patient Data | Manual through keyboard/mouse | Manual through keyboard/mouse | Manual through keyboard/mouse |
| Output Patient Data Format | Pictures: PNG
Report: .csv | Pictures: JPEG
Report: DICOM | |
| Study list functionality | Search, Importing, Exporting | Search, Importing, Exporting, Deleting | Search, Importing, Exporting |
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Image /page/6/Picture/0 description: The image shows the logo for Heuron. The logo consists of two parts: a symbol on the left and the word "heuron" on the right. The symbol is made up of interconnected circles, resembling a network or a neural connection. The word "heuron" is written in a rounded, sans-serif font, with the "h" in a lighter shade of gray than the rest of the letters.
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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Image /page/7/Picture/0 description: The image shows the word "Heuron" in a stylized font, with a logo to the left of the word. The logo consists of a network of interconnected circles, resembling a neural network or a cluster of neurons. The word "Heuron" is written in lowercase letters, with a rounded and modern typeface.
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.