(60 days)
Not Found
No
The summary describes image processing and quantitative analysis using standard methods (SUVR calculation) but does not mention AI, ML, or related terms.
No
The device aids clinicians in assessment and quantification, and its results are for reference supporting diagnosis, not directly providing therapy.
Yes
The device aids clinicians in the assessment and quantification of pathologies and calculates results that are used as a reference supporting the accuracy of the diagnosis of patients' dementia.
Yes
The device description explicitly states it is "stand-alone software" and the intended use describes it as "software for the registration, fusion, display and analysis of medical images". There is no mention of accompanying hardware components.
Based on the provided information, it is unlikely that this device is an IVD (In Vitro Diagnostic). Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Veuron-Brain-pAb2's Function: The Veuron-Brain-pAb2 software processes medical images (MRI and PET) of the brain. These images are generated from procedures performed on the patient's body, not from specimens taken from the body.
- Intended Use: The intended use is to aid clinicians in the assessment and quantification of pathologies from PET Amyloid scans of the human brain by analyzing the images. This is image analysis, not laboratory testing of biological samples.
While the software provides quantitative analysis (SUVR calculation) and supports diagnosis, the source of the data it processes is medical imaging, not in vitro testing of biological specimens.
Therefore, based on the typical definition of an IVD, the Veuron-Brain-pAb2 software does not fit that category. It is a medical image analysis software.
N/A
Intended Use / Indications for Use
The Veuron-Brain-pAb2 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 radiotracer and disease combinations.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The Veuron-Brain-pAb2 is stand-alone software to automatically calculate the "Standardized Uptake Value Ratio (SUVR)" for quantitative analysis of amyloid PET. The calculated result is just used as a reference supporting 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
MRI and PET
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-pAb2 is as safe and effective as its predicate device.
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.
Veuron-Brain-pAb (Heuron Co., Ltd. K203142, 01/15/2021)
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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Image /page/0/Picture/0 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
February 4, 2022
Heuron Co., Ltd. % Edward Park CEO LightenBridge LLC 4408 Tortuga Ln McKinney, TX 75070
Re: K213801
Trade/Device Name: Veuron-Brain-pAb2 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: December 6, 2021 Received: December 6, 2021
Dear Edward 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
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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
Device Name Veuron-Brain-pAb2
Indications for Use (Describe)
The Veuron-Brain-pAb2 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 radiotracer 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 and the word "heuron" on the right. The symbol is made up of four circles connected by lines, with one of the circles being a different color than the others. The word "heuron" is written in a sans-serif font, with the "h" being a different color than the rest of the letters.
510(k) Summary
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-pAb2 |
| Common Name: | Image Processing Software |
| Classification Name: | Medical Image Management and Processing System per 21 CFR 892.205 |
| Product Code: | LLZ |
| Classification Panel: | Radiology |
| Device Class: | II |
Device Description
The Veuron-Brain-pAb2 is stand-alone software to automatically calculate the "Standardized Uptake Value Ratio (SUVR)" for quantitative analysis of amyloid PET. The calculated result is just used as a reference supporting 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
- Veuron-Brain-pAb (Heuron Co., Ltd. K203142, 01/15/2021) ●
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Image /page/4/Picture/0 description: The image shows the logo for Heuron. The logo consists of a stylized icon on the left and the word "heuron" on the right. The icon is made up of interconnected circles, with one circle in a light blue color and the rest in gray. The word "heuron" is written in a rounded sans-serif font, with the "h" in light blue and the rest of the letters in gray.
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
Intended Use
Veuron-Brain-pAb2 is software for brain image analysis. Veuron-Brain-pAb2 is stand-alone software that provides the medical professional with the means to process and display medical images from modalities such as MR and PET. Additionally it calculates deposition of ß amyloid protein in the cerebral cortex. The calculate feature improve the accuracy necessary for the medical professional. It provides automated quantitative and statistical analysis by automatically registering PET/MRI brain scans to a standard template and comparing intensity values to a reference database or to other PET/MRI scans on a voxel basis, within stereotactic surface projections, or within standardized regions of interest.
Comparison of Indications for Use Statements
The following table compares Indications for Use Statements between the Veuron-Brain-oAb2 and the predicate device. Veuron-Brain-pAb. identical to the predicate device. the Veuron-Brain-pAb2 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-pAb2 | Veuron-Brain-pAb | |
|---|---|---|
| Proposed device | Proposed device | |
| The Veuron-Brain-pAb2 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 | 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 | ||
| radiotracer and disease combinations. | radio-tracer and disease combinations. | |
| Comparison | ||
| Item | Veuron-Brain-pAb2 | Veuron-Brain-pAb |
| Target Users | Trained Medical professionals | Trained Medical professionals |
| Anatomical | ||
| Site | Brain | Brain |
| Where Used | Hospital | Hospital |
| Design | ||
| Features | Import DICOM data | Import DICOM data |
| Perform automatic post-processing | Perform automatic post-processing | |
| Provide the user confirmation | Provide the user confirmation | |
| Export the resulting data through data | ||
| network or USB | Export the resulting data only | |
| through USB | ||
| OS | Server: Ubuntu 16.04 LTS or higher | |
| Client: Windows 10, 64-bit | Windows 10, 64-bit | |
| Non-clinical | ||
| Performance | Bench testing performed to test the | |
| functionality of the system and | Bench testing performed to test the | |
| functionality of the system and | ||
| measurement tools. | measurement tools. | |
| Standards | · ISO 14971 | · ISO 14971 |
| · IEC 62304 | · IEC 62304 | |
| · IEC 62366 | · IEC 62366 | |
| SW | ||
| verification | ||
| and validation | Tested in accordance with | |
| verification and validation processes | ||
| and planning. The testing results | Tested in accordance with | |
| verification and validation processes | ||
| and planning. The testing results | ||
| support that all the system | support that all the system | |
| requirements have met their | requirements have met their | |
| acceptance criteria and are adequate | acceptance criteria and are adequate | |
| for its intended use. | for its intended use. | |
| Compatible | ||
| Input Data | ||
| Format and | ||
| Modality | DICOM & NiFTI | |
| PET, MRI | DICOM & NiFTI | |
| PET, MRI | ||
| Input | ||
| Patient Data | Manual through keyboard/mouse | Manual through keyboard/mouse |
| Output | ||
| Patient Data | ||
| Format | Pictures: PNG | |
| Report: .csv | Pictures: PNG | |
| Report: .csv | ||
| Comparison | ||
| Item | Veuron-Brain-pAb2 | Veuron-Brain-pAb |
| Study list | ||
| functionality | Search, Importing, Exporting | Search, Importing, Exporting |
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Image /page/5/Picture/0 description: The image shows the logo for Heuron. The logo consists of a stylized graphic of interconnected nodes, with one node colored in blue, followed by the word "heuron" in a rounded, sans-serif font. The "h" is blue, while the rest of the letters are gray.
Summary of the technological characteristics compared to the predicate device new device
The software is similar in uses and applications to the predicate device. As stated in the comparison table provided below, both the proposed and the predicate devices are used to assist the Clinician with the visual evaluation, assessment and quantification of pathologies derived from brain scans.
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Image /page/6/Picture/0 description: The image shows the Neuron logo. The logo consists of a stylized neuron symbol on the left and the word "neuron" on the right. The neuron symbol is made up of interconnected circles, with one circle in a different color. The word "neuron" is written in a rounded, sans-serif font, with the "h" in a different color 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 issues with the system, demonstrating that the performance of Veuron-Brain-pAb2 is as safe and effective as its predicate device.
Conclusion
By virtue of its intended use, design features, and technological characteristics, Veuron-BrainpAb2 is substantially equivalent to the predicate device. The non-clinical performance data shows that Veuron-Brain-pAb2 is as safe and effective as the predicate device without raising any new safety and/or effectiveness concerns.