(60 days)
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.
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.
The provided text describes the Veuron-Brain-pAb2 device, a software for the registration, fusion, display, and analysis of medical images (MRI and PET) to aid clinicians in assessing and quantifying 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).
However, the document is a 510(k) summary and primarily focuses on demonstrating substantial equivalence to a predicate device (Veuron-Brain-pAb). While it mentions "bench testing" and that the "measurement tool performance meets its pre-defined requirements," it does not provide explicit details about specific acceptance criteria, reported device performance metrics against those criteria, or the study design (including sample size, ground truth establishment, expert qualifications, or adjudication methods) that would typically prove such acceptance.
Therefore, many of your requested details cannot be extracted from this document.
Here's a breakdown of what can and cannot be answered from the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be fully provided. 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. 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."
- This implies that there were pre-defined requirements (acceptance criteria) and that the device met them. However, the document does not list these specific acceptance criteria (e.g., accuracy thresholds for SUVR calculation, registration precision limits) or the quantitative results of the device's performance against them.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document mentions "bench testing" but does not describe the test set size, its provenance, or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be provided. The document does not describe the method for establishing ground truth for any test set or the involvement or qualifications of experts in such a process.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Cannot be provided. The document does not mention an MRMC study or any assessment of human reader improvement with AI assistance. The device is described as aiding clinicians and providing automatic analysis but not specifically as an AI assistance tool in an MRMC context within this summary.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Partially addressed, but not with specific performance metrics. The device is described as "stand-alone software to automatically calculate the 'Standardized Uptake Value Ratio (SUVR)' for quantitative analysis of amyloid PET." This indicates that the core SUVR calculation is standalone. However, the document does not present specific standalone performance metrics (e.g., sensitivity, specificity, accuracy) for this calculation. It merely states that its performance "is as safe and effective as its predicate device."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be provided. The document does not specify the type of ground truth used for performance evaluation.
8. The sample size for the training set
- Cannot be provided. The document does not mention a training set or its size.
9. How the ground truth for the training set was established
- Cannot be provided. No information about a training set or its ground truth establishment is present.
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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 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-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 theregistration, fusion, display and analysis ofmedical images from multiple modalitiesincluding MRI and PET. The software aidsclinician in the assessment and quantificationof pathologies from PET Amyloid scans ofthe human brain. It enables automatic analysisand visualization of amyloid proteinconcentration through the calculation ofstandard uptake volume ratios (SUVR) withintarget regions of interest and comparison tothose within the reference regions. Thesoftware is deployed via medical imagingworkplaces and is organized as a series ofworkflows which are specific to use with | The Veuron-Brain-pAb is a software for theregistration, fusion, display and analysis ofmedical images from multiple modalitiesincluding MRI and PET. The software aidsclinician in the assessment and quantificationof pathologies from PET Amyloid scans ofthe human brain. It enables automatic analysisand visualization of amyloid proteinconcentration through the calculation ofstandard uptake volume ratios (SUVR) withintarget regions of interest and comparison tothose within the reference regions. Thesoftware is deployed via medical imagingworkplaces and is organized as a series ofworkflows which are specific to use with | |
| radiotracer and disease combinations. | radio-tracer and disease combinations. | |
| ComparisonItem | Veuron-Brain-pAb2 | Veuron-Brain-pAb |
| Target Users | Trained Medical professionals | Trained Medical professionals |
| AnatomicalSite | Brain | Brain |
| Where Used | Hospital | Hospital |
| DesignFeatures | 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 datanetwork or USB | Export the resulting data onlythrough USB | |
| OS | Server: Ubuntu 16.04 LTS or higherClient: Windows 10, 64-bit | Windows 10, 64-bit |
| Non-clinicalPerformance | Bench testing performed to test thefunctionality of the system and | Bench testing performed to test thefunctionality of the system and |
| measurement tools. | measurement tools. | |
| Standards | · ISO 14971 | · ISO 14971 |
| · IEC 62304 | · IEC 62304 | |
| · IEC 62366 | · IEC 62366 | |
| SWverificationand validation | Tested in accordance withverification and validation processesand planning. The testing results | Tested in accordance withverification and validation processesand 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. | |
| CompatibleInput DataFormat andModality | DICOM & NiFTIPET, MRI | DICOM & NiFTIPET, MRI |
| InputPatient Data | Manual through keyboard/mouse | Manual through keyboard/mouse |
| OutputPatient DataFormat | Pictures: PNGReport: .csv | Pictures: PNGReport: .csv |
| ComparisonItem | Veuron-Brain-pAb2 | Veuron-Brain-pAb |
| Study listfunctionality | 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.
§ 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).