(613 days)
Not Found
No
The summary explicitly states, "The software algorithms are not based on machine learning."
No.
The device is described as post-processing software for image enhancement and visualization to aid diagnosis, not for direct treatment or therapy.
Yes
The device "may aid the qualified radiologist with diagnosis by providing enhanced visualization of tissue structures," directly linking its function to assisting in the diagnostic process, even if it doesn't provide a diagnosis on its own.
Yes
The device description explicitly states it is "post-processing software" and its function is to provide "visualization, manipulation and reconstruction capabilities" of existing MR images. There is no mention of any associated hardware component being part of the device itself.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Veuron-Brain-mN1's function: Veuron-Brain-mN1 is a software that performs post-acquisition image enhancement of existing MR images of the brain. It processes images that have already been acquired from the patient's body.
- No sample analysis: The device does not analyze any biological samples taken from the patient. Its input is image data, not biological material.
Therefore, Veuron-Brain-mN1 falls under the category of medical image processing software rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Veuron-Brain-mN1 is intended for use in the post-acquisition image enhancement of 3T MR images of the brain acquired through a 3D gradient-echo sequence. When used in combination with other clinical information, the Veuron-Brain-mN1 application may aid the qualified radiologist with diagnosis by providing enhanced visualization of tissue structures with magnetic susceptibility contrasts in brain 3T MR images.
Product codes
LNH, LLZ
Device Description
Veuron-Brain mN1 is a post-processing software intended to provide visualization, manipulation and reconstruction capabilities, including susceptibility map-weighted images, of 3D gradient multi echo brain 3T MR images. The Veuron-Brain-mN1 aids in the clinical analysis of brain structures from MR images.
- 3D gradient multi echo images are acquired at a specific orientation through the anatomy of interest.
SMWI Algorithm
- Susceptibility map-weighted imaging (SMWI) are reconstructed from the magnitude and Quantitative Susceptibility Mapping (QSM) images of each echo.
- Algorithm output is a 3D SMWI image. ·
- . The software algorithms are not based on machine learning.
Mentions image processing
Veuron-Brain-mN1 is intended for use in the post-acquisition image enhancement of 3T MR images of the brain acquired through a 3D gradient-echo sequence.
Mentions AI, DNN, or ML
The software algorithms are not based on machine learning.
Input Imaging Modality
3T MR images acquired through a 3D gradient-echo sequence.
MRI (Siemens Healthcare, Philips, 3.0T)
DICOM
Anatomical Site
Brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified radiologist
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. In order to evaluate the safety of the product, unit tests and integration tests were performed, and all results met the acceptance criteria. The device performance was evaluated using phantom testing representing the range of susceptibility values in the brain tissue. Additionally, the device performance was also evaluated on clinical images using CNR/SNR metrics. The scanner models used for the testing were Siemens Healthcare's and Philips's and field strength was 3T. The predefined acceptance criteria were met to demonstrate substantial equivalence to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
CNR/SNR metrics
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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Image /page/0/Picture/0 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 and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 12, 2022
Heuron Co., Ltd. % John J. Smith, M.D., J.D. Partner Hogan Lovells US LLP 555 Thirteenth St. NW WASHINGTON DC 20004
Re: K203279
Trade/Device Name: Veuron-Brain-mN1 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LLZ Dated: June 10, 2022 Received: June 10, 2022
Dear Dr. Smith:
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
1
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 medical devices and radiation-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
Michael D. O'Hara, Ph.D. Deputy Director DHT 8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203279
Device Name Veuron-Brain-mN1
Indications for Use (Describe)
Veuron-Brain-mN1 is intended for use in the post-acquisition image enhancement of 3T MR images of the brain acquired through a 3D gradient-echo sequence. When used in combination with other clinical information, the Veuron-Brain-mN1 application may aid the qualified radiologist with diagnosis by providing enhanced visualization of tissue structures with magnetic susceptibility contrasts in brain 3T MR images.
| 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 Neuron logo, which is a combination of a stylized brain-like symbol and the word "neuron" in a combination of blue and gray. Below the logo, the text "510(k) summary" is present. To the right of the logo and text, the number "K203279" is displayed.
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: +82-32-429-8508 / +82-32-429-8507 Correspondent Contact: Hogan Lovells US LLP (John J. Smith M.D., J.D., john.smith(@hoganlovells.com), +1-202-637-3638, 555 Thirteenth Street, NW, 20004 USA on behalf of Heuron Co., Ltd. Date of preparation: May 05, 2022
Device information Proprietary name(s): Veuron-Brain-mN1 Common name: Image Processing Software Classification name: System, Nuclear Magnetic Resonance Imaging per 21 CFR 892.1000 Product code: LNH, LLZ Classification panel: Radiology Device class: II
Device description
Veuron-Brain mN1 is a post-processing software intended to provide visualization, manipulation and reconstruction capabilities, including susceptibility map-weighted images, of 3D gradient multi echo brain 3T MR images. The Veuron-Brain-mN1 aids in the clinical analysis of brain structures from MR images.
- 3D gradient multi echo images are acquired at a specific orientation through the anatomy of interest.
SMWI Algorithm
- Susceptibility map-weighted imaging (SMWI) are reconstructed from the magnitude and Quantitative Susceptibility Mapping (QSM) images of each echo.
- Algorithm output is a 3D SMWI image. ·
- . The software algorithms are not based on machine learning.
Predicate device
SPIN-SWI application software (SpinTech, Inc. K173224, Feb 23, 2018)
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Image /page/4/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, with one circle colored in blue and the rest in gray. The word "heuron" is written in a rounded, sans-serif font, with the "h" in blue and the rest of the letters in gray.
Indications for Use
Veuron-Brain-mN1 is intended for use in the post-acquisition image enhancement of 3T MR images of the brain acquired through a 3D gradient-echo sequence. When used in combination with other clinical information, the Veuron-Brain-mN1 application may aid the qualified radiologist with diagnosis by providing enhanced visualization of tissue structures with magnetic susceptibility contrasts in brain 3T MR images.
Comparison of indications for use statement
The following table compares indications for use statements between the Veuron-Brain-mN1 and the predicate device (i.e. SPIN-SWI application software). Similar to the predicate device, the Veuron-Brain-mN1 is used for managing patient and case base data, collection, analysis and display of the medical images. The device assists the clinician with the visual evaluation, manipulation, and assessment of pathologies derived from brain scans.
| Veuron-Brain-mN1 | SPIN-SWI |
|---|---|
| Subject device (K203279) | Predicate device (K173224) |
| Veuron-Brain-mN1 is intended for use in the | The SpinTech, Inc. SPIN- SWI application is |
| post-acquisition image enhancement of 3T MR | intended for use in the post-acquisition image |
| images of the brain acquired through a 3D | enhancement of MRI acquired 3D gradient- |
| gradient-echo sequence. When used in | echo images of the brain. When used in |
| combination with other clinical information, | combination with other clinical information, |
| the Veuron-Brain-mN1 application may aid the | the SPIN-SWI application may aid the |
| qualified radiologist with diagnosis by | qualified radiologist with diagnosis by |
| providing enhanced visualization of tissue | providing enhanced visualization of structures |
| structures with magnetic susceptibility | containing venous blood such as cerebral |
| contrasts in brain 3T MR images. | venous vasculature. |
Summary of the technological characteristics compared to the predicate device and new device.
The software is similar in uses and application to the predicate device. As stated in the comparison table provided below, both the device and predicates are used to assist the clinician with the visual evaluation, manipulation, and assessment of pathologies derived from brain scans.
| Comparison item | Veuorn-Brian-mN1
Subject device (K203279) | SpinTech, Inc.
SPIN-SWI application software
Predicate device (K173224) |
|-----------------|----------------------------------------------|-------------------------------------------------------------------------------|
| Target user | Qualified radiologist | Qualified radiologist and
technologist |
| Anatomical site | Brain | Brain |
| Where used | Hospital | Hospital |
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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
Image /page/5/Picture/1 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 colored in blue. The word "neuron" is written in a rounded sans-serif font, with the "h" in blue and the rest of the letters in gray.
| 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 only | |||
| through USB | • Export the resulting data through | ||
| data network | |||
| Non-clinical | |||
| performance | • Bench testing performed to the | ||
| test functionality of the system. | • Bench testing performed to the test | ||
| functionality of the system. | |||
| Standards | • ISO 14971 | • ISO 14971 | |
| • ISO 62304 | • ISO 62304 | ||
| • IEC 62366 | |||
| SW verification and | |||
| validation | Tested in accordance with | ||
| verification and validation process | |||
| 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 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 | • DICOM | |
| • MRI (Siemens Healthcare, Philips, | |||
| 3.0T) | • MRI | ||
| Input patient data | Manual through keyboard / mouse | ||
| Output patient data | |||
| format | DICOM | • Unknown | |
| Study list functionality | Search, Importing and Exporting | Search, Importing and Exporting |
Non-clinical study performance
Bench testing is done to show that the system is suitable for its intended use. In order to evaluate the safety of the product, unit tests and integration tests were performed, and all results met the acceptance criteria. The device performance was evaluated using phantom testing representing the range of susceptibility values in the brain tissue. Additionally, the device performance was also evaluated on clinical images using CNR/SNR metrics. The scanner models used for the testing were Siemens Healthcare's and Philips's and field strength was 3T. The predefined acceptance criteria were met to demonstrate substantial equivalence to the predicate.
Conclusion
By virtue of its intended use, design features, and technological characteristics, Veuron-BrainmN1 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-mN1 is as safe and effective as the predicate device without raising any new safety and/or effectiveness concerns.