(250 days)
VINT is a software that allows for the viewing, post-processing, and quantitative evaluation of cerebrovascular MRI data (in DICOM-compliant format).
It enables:
-
Importing DICOM-compliant MR Images.
-
Quantitative analysis of imported images.
-
Visualization and analysis of blood flow characteristics of cerebral arteries in MR images.
-
Advanced correction options such as offset correction, background phase correction, and anti-aliasing.
-
Data visualization as a graph or output as an image or numerical data.
-
Providing the right and left carotid and vertebral arteries wall signal intensity gradient (SIG), an image-based indirect marker for velocity gradient from TOF-MRA.
VINT is intended for use with adult (22 years or more) populations who can undergo MRA.
VINT is a standalone medical software device designed for processing, analyzing, viewing, and quantifying cerebral artery MR images. The software is intended to visualize and quantify MRI data imported in DICOM format. The key functions of the VINT software are 2D and 3D viewing, multiphase series support, zoom, pan, window level, rotate, ROI Markers: Ability to create preset shapes or freehand ROI for measurements or segmentations, provide heatmaps to help users understand the distribution of arterial signal intensity gradient at a glance, and show measured numbers in a table.
It can also be used to analyze multi-slice signal intensity gradient of a TOF-MRA to visualize and analyze the blood flow characteristics of cerebral arteries, without any-contrast medium for MR angiography.
Here's a breakdown of the acceptance criteria and the study information based on the provided text, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter / Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Quantitative Analysis (SIG from TOF-MRA vs. Velocity Gradient from PC-MR) | Highly significant correlation | SIG from TOF-MRA showed highly significant correlations with velocity gradient calculated from the PC-MR. |
| General Performance Metrics (Arterial Length, Volume, Viewing) | Performance similar to Predicate Device A | Subject device provides identical qualitative (2D/3D viewing) and quantitative analysis data for arterial length, and volume compared to the predicate device A. |
2. Sample Size and Data Provenance for Test Set
The document explicitly mentions:
- Human studies: Yes, for evaluating the correlation between TOF-MRA SIG and PC-MR velocity gradient.
- Tubal experiments: Yes, for evaluating the correlation between TOF-MRA SIG and PC-MR velocity gradient.
Data Provenance: The document does not specify the country of origin for the human studies or whether they were retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth
The document does not specify the number of experts used or their qualifications for establishing ground truth for the test set.
4. Adjudication Method
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The study involved a comparative validation between the subject device and a reference device for the correlation of SIG from TOF-MRA with PC-MR velocity gradient. It also performed bench testing against Predicate Device A for general performance metrics. There is no information provided about human readers improving with or without AI assistance as part of this study.
6. Standalone Performance Study (Algorithm Only)
The document describes "Bench testing" and "comparative validation between the subject device and the reference device" which evaluates the device's technical performance. This implicitly suggests a standalone evaluation of the algorithm's output against a reference. Specifically, it states: "Bench tests were performed using the subject device and the reference device (K213583) to validate TOF-MRA SIG as a reliable measure of shear rate obtained from PC-MR data."
7. Type of Ground Truth Used
- For evaluating the correlation between TOF-MRA SIG and velocity gradient: PC-MR data served as the ground truth. The document states, "The SIG from TOF-MRA showed highly significant correlations with velocity gradient calculated from the PC-MR, both in tubal experiments and human studies," implying PC-MR velocity gradient was the reference for comparison.
8. Sample Size for Training Set
The document does not provide information about the sample size used for the training set.
9. How Ground Truth for Training Set Was Established
The document does not provide information on how ground truth was established for the training set. Given that the VINT device is described as "Medical Image Management And Processing System" and focuses on viewing, post-processing, and quantitative evaluation, it's possible that traditional "training" in the machine learning sense might not be explicitly detailed if the core functionality is based on established image processing algorithms. However, no specifics are given.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
October 15, 2024
Mediimg Corporation % Miso Choi Regulatory Affairs Specialist Mediguide. Inc. #410, Mcluster Bldg., 17, Deogan-ro 104beon-gil Gwangmyeong-si, Gyeonggi-do 14353 Korea, South
Re: K240385
Trade/Device Name: VINT Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: September 5, 2024 Received: September 5, 2024
Dear Miso Choi:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
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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,
D
Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K240385
Device Name VINT
Indications for Use (Describe)
VINT is a software that allows for the viewing, post-processing, and quantitative evaluation of cerebrovascular MRI data (in DICOM-compliant format).
It enables:
-
Importing DICOM-compliant MR Images.
-
Quantitative analysis of imported images.
-
Visualization and analysis of blood flow characteristics of cerebral arteries in MR images.
-
Advanced correction options such as offset correction, background phase correction, and anti-aliasing.
-
Data visualization as a graph or output as an image or numerical data.
-
Providing the right and left carotid arteries wall signal intensity gradient (SIG), an image-based indirect marker for velocity gradient from TOF-MRA.
VINT is intended for use with adult (22 years or more) populations who can undergo MRA.
| Type of Use (Select one or both, as applicable) | Depurative Use (Part 21 CFR 201.Subpart D) Cosmetic Use (Part 21 CFR 201.Subpart D) | Depurative Use (Part 21 CFR 201.Subpart D) | Cosmetic Use (Part 21 CFR 201.Subpart D) |
|---|---|---|---|
| Depurative Use (Part 21 CFR 201.Subpart D) | Cosmetic Use (Part 21 CFR 201.Subpart D) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image shows a logo for MEDIIMG. The logo features a stylized letter "M" that is formed by two figures standing side-by-side. The figures have orange circles for heads and teal bodies. The text "MEDIIMG" is written in black below the logo.
Rm 6, Startup-Center, 2F, 172, Dolma-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea (13605) 510(k) Summary
September 5, 2024
Submitter Information & Contact Person 1.
| Name of Manufacturer | Mediimg Corp. |
|---|---|
| Address | Rm 6, Startup-Center, 2F, 172, Dolma-ro, Bundang-gu, Seongnam-si,Gyeonggi-do, Republic of Korea (Zip : 13605) |
| Contact Name | Byeong-Uk Jeon / R&D manager |
| Telephone No. | +82-10-9011-9694 |
| Email Address | RND_jeon@mediimg.com |
2. Trade Name, Common Name, Classification
Common name: Cerebrovascular imaging software Trade name: VINT
| Regulation Description | 21 CFR Section | Product Code |
|---|---|---|
| Medical image management and processing system | 892.2050 | LLZ |
As stated in 21 CFR parts 892.2050, devices of this type have been classified as Class II.
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Image /page/5/Picture/0 description: The image shows a logo for MEDIIMG. The logo features a stylized letter 'M' in blue, with two orange circles above the two vertical lines of the 'M'. The word "MEDIIMG" is written in a sans-serif font below the symbol.
Rm 6, Startup-Center, 2F, 172, Dolma-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea (13605) Identification of Predicate Device
The identified predicate devices and reference device within this submission are shown as follow:
Predicate device A
| 510(k) Number | K172803 |
|---|---|
| Applicant | Infinitt Healthcare Co.,Ltd. |
| Regulation Name | Medical image management and processing system |
| Product code | LLZ |
| Device Name | Infinitt PACS 7.0 |
Predicate device B
| 510(k) Number | K222854 |
|---|---|
| Applicant | Cardio Flow Design Inc. |
| Regulation Name | Medical image management and processing system |
| Product code | LLZ |
| Device Name | iTFlow |
Reference device
| 510(k) Number | K213583 |
|---|---|
| Applicant | Philips Medical Systems Nederland B.V. |
| Regulation Name | Magnetic resonance diagnostic |
| Product code | LNH |
| Device Name | Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems |
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Image /page/6/Picture/0 description: The image shows a logo for MEDIIMG. The logo features two stylized figures connected at the shoulders, forming a shape resembling the letter 'M'. The figures are colored with an orange gradient at the top, transitioning to a blue gradient at the bottom. Below the figures, the text "MEDIIMG" is written in a simple, sans-serif font.
Rm 6, Startup-Center, 2F, 172, Dolma-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea (13605)
4. Description of the Device
4.1. General description
VINT is a standalone medical software device designed for processing, analyzing, viewing, and quantifying cerebral artery MR images. The software is intended to visualize and quantify MRI data imported in DICOM format. The key functions of the VINT software are 2D and 3D viewing, multiphase series support, zoom, pan, window level, rotate, ROI Markers: Ability to create preset shapes or freehand ROI for measurements or segmentations, provide heatmaps to help users understand the distribution of arterial signal intensity gradient at a glance, and show measured numbers in a table.
VINT is intended for use with adult (22 years or more) populations who can undergo MRA.
It can also be used to analyze multi-slice signal intensity gradient of a TOF-MRA to visualize and analyze the blood flow characteristics of cerebral arteries, without any-contrast medium for MR angiography.
Medical data (patient information, etc.) is not sent over communication channels and is used only locally.
Nevertheless, use network firewall and antivirus software to prevent patient information leakage.
4.2. Key Performance Specifications
The key functions of the VINT software are 2D and 3D viewing, multi-phase series support, zoom, pan, window level, rotate, ROI Markers: Ability to create preset shapes or freehand ROI for measurements or segmentations, provide heatmaps to help users understand the distribution of arterial signal intensity gradient at a glance, and show measured numbers in a table.
4.3. Quantitative imaging function
| Contents | Operational Environment |
|---|---|
| · Equation | · $SIG = (Φb - Φa) / Xb - Xa $· Φa, signal intensity at wall point A [Xa], Φb, signal intensity at inner-wall point B [Xb] |
| · Output | · Set of real values· Unit: $Signal intensity(SI)/mm$ |
| · SIG value (Output) display | · Provided at wall point A [Xa] |
| · Resolution | · Same as TOF-MRA (the number of pixels within a specified Field of View (FOV) |
| · validation | · 2D PC-MR velocity gradient |
| · Level of automatism | · Semi-automatic |
| · Iso-value setting forsegmentation | · Semi-automatic segmentation: the threshold segmentation method by binary algorithm(default)· Manual setting |
- Information on signal intensity gradient (SIG)
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Image /page/7/Picture/0 description: The image shows a logo for a company called MEDIIMG. The logo features a stylized letter "M" in blue, with two orange circles on top of the letter. The circles are positioned to resemble the heads of two people standing side by side. The company name, "MEDIIMG," is written in a sans-serif font below the letter "M".
Rm 6, Startup-Center, 2F, 172, Dolma-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea (13605) 2) Information on artery degree of angle
| Contents | Operational Environment |
|---|---|
| • Equation | • The coordinates at the ends of the region of interest are denoted as C1 = (x1, y1, z1), C2 = (x2, y2, z2), The differences between these coordinates are calculated as X = x2 - x1, Y = y2 - y1, Z = z2 - z1.A total of 6 pairs of coordinates, spaced 60 degrees apart, are used.$Angle = \frac{arccos(\frac{Z}{\sqrt{X^2 + Y^2 + Z^2}}}) * 180}{\pi}$ • This process is repeated for each frame in the region of interest. |
| • Output | • A real value• Unit: degree |
| • Angle (Output) display | • Angle of the region of interest |
| • validation | • Comparison with Predicate device Infinitt PACS |
| • Level of automation | • Semi-automatic |
| • Thresholding methods | • Vessel segmentation: Thresholding based on binarization algorithms• The threshold is automatically determined through image analysis. (default)• Manual threshold setting is also possible. |
| • Iso-value setting forsegmentation | • Semi-automatic segmentation: Separate the background area and vessels usinga binarization algorithm based on image pixel value distribution. The thresholdis automatically determined through image analysis. (default)• Manual threshold setting is also possible. |
3) Information on coordinate system
| Contents | Operational Environment |
|---|---|
| • Equation | • World Position =• X = Xx * i + Yx * j + Sx• Y = Xy * i + Yy * j + Sy• Z = Xz * i + Yz * j + Sz• (X, Y, Z) : World coordinate system• (i, j) : Pixel coordinates within the image• (Xx, Xy, Xz) : X-direction vector• (Yx, Yy, Yz) : Y-direction vector• (Sx, Sy, Sz): image position (patient)This transformation utilizes DICOM tag information:Image Position (Patient) (0020,0032): (Sx, Sy, Sz)Image Orientation (Patient) (0020,0037): (Xx, Xy, Xz, Yx, Yy, Yz)Pixel Spacing (0028,0030): Pixel size• Length = $\sqrt{(X2 – X1)^2 + (Y2 – Y1)^2 + (Z2 − Z1)^2}$ |
| • Output | • World Position: Real-world coordinates• Length: A real value, Unit: mm |
| • Output display | • Output information for each point |
| • Validation | • Comparison with Predicate device Infinitt PACS |
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Image /page/8/Picture/0 description: The image shows a logo for MEDIIMG. The logo features a stylized letter "M" in teal, with two orange circles above the letter. The circles are positioned to resemble the heads of two people. The text "MEDIIMG" is written in a sans-serif font below the letter "M".
| Contents | Operational Environment |
|---|---|
| • Level of automation | • Semi-automatic |
| • Thresholding methods | • Vessel segmentation: Thresholding based on binaryzation algorithms |
Rm 6, Startup-Center, 2F, 172, Dolma-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea (13605)
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Image /page/9/Picture/0 description: The image shows the logo for MEDIIMG. The logo features a stylized letter 'M' in blue, with two orange circles above the two peaks of the 'M'. The letter 'M' is designed to resemble two people standing side-by-side, with the circles representing their heads. Below the symbol is the text "MEDIIMG" in a simple sans-serif font.
Rm 6, Startup-Center, 2F, 172, Dolma-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea (13605) 4. Indications for Use
VINT is a software that allows for the viewing, post-processing, and quantitative evaluation of cerebrovascular MRI data (in DICOM-compliant format).
It enables:
-
Importing DICOM-compliant MR Images.
-
Quantitative analysis of imported images.
-
Visualization and analysis of blood flow characteristics of cerebral arteries in MR images.
-
Advanced correction options such as offset correction, background phase correction, and antialiasing.
-
Data visualization as a graph or output as an image or numerical data.
-
Providing the right and left carotid and vertebral arteries wall signal intensity gradient (SIG), an image-based indirect marker for velocity gradient from TOF-MRA.
VINT is intended for use with adult (22 years or more) populations who can undergo MRA.
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Image /page/10/Picture/0 description: The image shows a logo for a company called MEDIIMG. The logo features a stylized letter 'M' in blue, with two orange circles on top of the letter. The circles are positioned to resemble the heads of two people, suggesting a focus on individuals or collaboration. The company name, 'MEDIIMG,' is written in a simple, sans-serif font below the letter 'M'.
Rm 6, Startup-Center, 2F, 172, Dolma-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea (13605) 5. Determination of Substantial Equivalence
| Sort | Proposed Device | Predicate Device A | Predicate Device B | Reference Device | SEDecision |
|---|---|---|---|---|---|
| DeviceName | VINT | Infinitt PACS 7.0 | iTFlow | Achieva, Ingenia, IngeniaCX, Ingenia Elition andIngenia Ambition MRSystems | - |
| 510(k)Number | - | K172803 | K222854 | K213583 | - |
| Classification | Same | Class II | Class II | Class II | - |
| RegulationNumber | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.1000 | - |
| RegulationName | Medical image managementand processing system | Medical image managementand processing system | Medical image managementand processing system | Magnetic resonancediagnostic | - |
| ProductCode | LLZ | LLZ | LLZ | LNH | - |
| IntendedUse | VINT is a software thatallows for the viewing, post-processing, and quantitativeevaluation of cerebrovascularMRI data (in DICOM-compliant format).It enables:- Importing DICOM-compliant MR Images.- Quantitative analysis ofimported images.- Visualization and analysis ofblood flow characteristics ofcerebral arteries in MRimages.- Advanced correction optionssuch as offset correction,background phase correction,and anti-aliasing.- Data visualization as a graphor output as an image ornumerical data.- Providing the right and leftcarotid and vertebral arterieswall signal intensity gradient(SIG), an image-basedindirect marker for velocitygradient from TOF-MRA.VINT is intended for use withadult (22 years or more)populations who can undergoMRA | Infinitt PACS 7.0, is asoftware device thatreceives medical imagesand data from variousimaging sources. Imagesand data can be stored,communicated, processed,and displayed within thesystem or across computernetworks at distributedlocations.Only preprocessed DICOMfor presentation images canbe interpreted for primaryimage diagnosis inmammography. Lossycompressed mammographicimages and digitized filmscreen images must not bereviewed for primary imageinterpretations.Mammographic imagesmay only be interpretedusing a monitor that meetstechnical specificationidentified by FDA.Typical users of this systemare trained professionals,e.g. physicians, radiologists,nurses, and medicaltechnicians. | The iTFlow software will beutilized in situations wherevisualization of blood flowin a heart and its majorvessels are required for acardiac diagnosis. iTFlowallows for the viewing, post-processing, and thequantitative evaluation ofcardiovascular MRI data (inDIRECTOR-compliantformat)It enables:- The import of DICOM-compliant MR Images.- The support of a clinicaldiagnosis by the quantitativeanalysis of the importedimages.- Quantitative measurementof the size, area, blood flow,volume and mass of theheart and adjacent vessels.-Advanced correctionoptions such as offsetcorrection, backgroundphase correction, and anti-aliasing.-Data visualization as agraph or output as an imageor numerical data.iTFlow software will assistclinicians with propertraining in cardiac treatmentdecision making and inproviding a conclusivediagnosis for patients. It isintended to analyzecardiovascular MRI imagedata, that are acquired via | Philips Magnetic Resonance(MR) systems are MedicalElectrical Systems indicatedfor use as a diagnosticdevice. This MR systemenables trained physiciansto obtain cross-sectionalimages, spectroscopicimages and/or spectra of theinternal structure of thehead, body or extremities, inany orientation, representingthe spatial distribution ofprotons or other nuclei withspin.Image appearance isdetermined by manydifferent physical propertiesof the tissue and theanatomy, the MR scantechnique applied, andpresence of contrast agents.The use of contrast agentsfor diagnostic imagingapplications should beperformed consistent withthe approved labeling forthe contrast agent.The trained clinical user canadjust the MR scanparameters to customizeimage appearance,accelerate image acquisitionand synchronize with thepatient's breathing orcardiac cycle.The systems can usecombinations of images toproduce physicalparameters, and related | Similar |
| Rm 6, Startup-Center, 2F, 172, Dolma-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea (13605) | acquisition, gradient echo cine sequence, and phase contrast time-resolved multi-slice sequence, without any-contrast medium for MR angiography. Patient populations are not restricted. | spectra, and measurements of physical parameters, when interpreted by a trained physician, provide information that may assist diagnosis and therapy planning. The accuracy determined physical parameters depends on system and scan parameters, and must be controlled and validated the clinical user. In addition the Philips MR systems provide imaging capabilities, such as MR fluoroscopy. to guide and evaluate interventional and minimally invasive procedures in the head, body and extremities. MR Interventional procedures, performed inside or adjacent to the Philips MR system, must be performed with MR Conditional or MR Safe instrumentation as selected and evaluated by the clinical user for use with the specific MR system configuration in the hospital. The appropriateness and use of information from a Philips MR system for a specific interventional procedure and specific MR system configuration must be validated by the clinical user. | |||
| Areas of Use | Radiology | Radiology | Radiology | Radiology | Same |
| Data Source | TOF-MRA | TOF-MRA, PC-MR, MRI | TOF-MRA, PC-MR (4D Flow) | TOF-MRA, PC-MR, MRI | Same |
| Target Organ/ System | Cerebrovascular | Brain, body, extremities | Cardiovascular | Brain, body, extremities | Different |
| DICOM formats | DICOM 3.x | DICOM 3.x | DICOM 3.x | DICOM 3.x | Same |
| Key Functionality / Features | 2D and 3D viewing, multi-phase series support, zoom, pan, window level, rotate ROI Markers: Ability to create preset shapes or freehand ROI for measurements or segmentations Provide heatmaps to help | 2D and 3D viewing, multi-phase series support, zoom, pan, window level, rotate ROI Markers: Ability to create preset shapes or freehand ROI for measurements or segmentations | 2D, 3D and 4D viewing, multi-phase series support, zoom, pan, window level, rotate ROI Markers: Ability to create preset shapes or freehand ROI for measurements or segmentations Provide heatmaps to help | For MR Workspace: 2D and 3D viewing, multi-phase series support, zoom, pan, window level, rotate ROI Markers: Ability to create preset shapes or freehand ROI for measurements or | Same |
| users understanddistribution of blood flowand signal intensitygradient at-a-glance• Data visualization as animage or numerical data | • Data visualization as animage or numerical data | users understanddistribution of blood flowat-a-glance• Data visualization as animage or numerical data | segmentations• Data visualization as animage or numerical data | ||
| Segmentation ofregionofinterest | Yes | Yes | Yes | Yes | Same |
| Natureofarterialimage | Blood flow | Blood flow | Blood flow | Blood flow | Same |
| Imageresolution | Same as MR image | Same as MR image | Same as MR image | Same as MR image | Same |
| QuantitativeAnalysis, arterialradius | Yes | Yes | Yes | Yes | Same |
| QuantitativeAnalysis, Velocitygradient | • YesSignal intensity gradient(difference of signalintensity/radius) tosubstantiate velocitygradient | N/A | • YesVelocity gradient as afunction ofvelocity/radius | • YesVelocity gradient canbe calculated as itoutputs velocity andradius information | Samewithpredicatedevice BandReferenceDevice |
| Interpolation | • Trilinear interpolation | N/A | • Interpolation methodsincluding trilinear orLagrangian, usedvariously | N/A | Samewithpredicatedevice B |
| Calculated innerdistancefromvesselsurface | • 0.03mm (default) | N/A | • Usually not-reported(hidden) | N/A | Different |
| Quantitativeanalysis,angle | Yes | Yes | Yes | Yes | Same |
| Quantitativeanalysis,length | Yes | Yes | Yes | Yes | Same |
| Quantitativeanalysis,volume | Yes | Yes | Yes | Yes | Same |
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Image /page/11/Picture/0 description: The image shows a logo for MEDIIMG. The logo features a stylized letter 'M' in blue, with two orange circles on top, resembling heads. The word "MEDIIMG" is written in black below the symbol.
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Image /page/12/Picture/0 description: The image shows a logo for MEDIIMG. The logo features a stylized letter "M" that is formed by two figures standing side-by-side, with their arms raised to form the letter's shape. The figures are colored in a gradient from blue at the bottom to orange at the top. Below the "M" is the text "MEDIIMG" in a simple, sans-serif font.
Rm 6, Startup-Center, 2F, 172, Dolma-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea (13605)
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Image /page/13/Picture/0 description: The image contains a logo for MEDIIMG. The logo features a stylized letter "M" in blue, with two orange circles above it, resembling two people standing side-by-side. The word "MEDIIMG" is written in a sans-serif font below the symbol, with "MEDI" in a lighter shade and "IMG" in a darker shade.
Rm 6, Startup-Center, 2F, 172, Dolma-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea (13605) 6.1. Comparison between Subject and Predicate Devices
SIMILARITIES TO PREDICATE DEVICES
Subject device provides identical qualitative (2D/3D viewing) and quantitative analysis data for arterial length, and le, radius, and volume compared to the predicate device A. Additionally, subject device shares the same intended use with the three predicate devices: visualizing vascular Magnetic Resonance (MR) images in the field of radiology as a graph or outputting them as an image or numerical data. A rigorous comparison of key parameters, including data source, DICOM format, core functionalities, segmentation capabilities, image characteristics, resolution, and quantitative analysis metrics such as arterial radius, length, angle, and volume, has demonstrated that Subject device is substantially equivalent to the predicate devices.
In terms of velocity gradient and interpolation, subject device exhibits performance similar to predicate device B.
Subject device provides the same quantitative analysis data for arterial length, angle, radius, and volume as predicate device A.
DIFFERENCES TO PREDICATE DEVICES
Correlation between TOF-MRA and PC-MR
The SIG obtained from TOF-MRA showed a highly significant correlation with the velocity gradient calculated from PC-MR. This indicates that TOF-MRA provides information similar to that of PC-MR.
Difference from Predicate B (K222854)
The difference between subject device and the approved device B: K222854 is that the SIG from VINT is based solely on TOF-MRA, whereas the velocity gradient from the approved device B: K222854 is based on both TOF-MRA and PC-MR.
Validation of TOF-MRA SIG for velocity gradient from PC-MR
Bench tests were performed using the subject device and the reference device (K213583) to validate TOF-MRA SIG as a reliable measure of shear rate obtained from PC-MR data. The SIG from TOF-MRA showed highly significant correlations with velocity gradient calculated from the PC-MR, both in tubal experiments and human studies. TOF-MRA is an examination for blood flow and the signal intensities can be used to derive arterial SIG, an image-based indirect marker for velocity gradient.
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Image /page/14/Picture/0 description: The image shows a logo for MEDIIMG. The logo is a stylized letter "M" in blue, with two orange circles on top of the letter. The circles are positioned to look like the heads of two people. The text "MEDIIMG" is written in black below the letter "M".
Rm 6, Startup-Center, 2F, 172, Dolma-ro, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea (13605) 7. Performance verification
Non-Clinical Test Summary
Bench testing was conducted with Predicate Device A to evaluate general performance metrics, including arterial length, and volume. To assess the correlation between the velocity gradient from PC MR data and the signal intensity (SIG) from TOF-MRA, a comparative validation was performed between the subject device and the reference device.
Additionally, the software validation activities and cybersecurity assessment and testing were performed in accordance with IEC 62304:2006 Ed. 1.1 Medical device software - Software life cycle processes, FDA Guidance documents, "Content of Premarket Submissions for Device Software Functions", "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" and AAMI TIR57:2016 - Principles For Medical Device Security – Risk Management.
Clinical Test Summary
No clinical studies are considered necessary and performed.
Conclusion
The differences observed have been validated through comparative verification and do not raise any new potential safety risks. There is no impact on the safety or efficacy of the subject device when compared to the predicate devices. Consequently, the subject device is substantially equivalent to the predicate devices.
§ 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).