(250 days)
No
The summary describes image processing and quantitative analysis software, but there is no mention of AI, ML, or related concepts like training sets or performance metrics typically associated with AI/ML models.
No
The device is a software for viewing, post-processing, and quantitative evaluation of cerebrovascular MRI data. It does not directly treat or diagnose a disease.
Yes
The device enables "quantitative evaluation of cerebrovascular MRI data," "quantitative analysis of imported images," "visualization and analysis of blood flow characteristics of cerebral arteries," and provides an "image-based indirect marker for velocity gradient." These functions are used to assess the state of the cerebral arteries and blood flow, which are diagnostic purposes. The performance studies also compare its SIG output with velocity gradient from PC-MR, indicating its role in providing diagnostic information.
Yes
The device is explicitly described as a "standalone medical software device" and its functions are solely related to processing, analyzing, viewing, and quantifying imported MR images. There is no mention of any accompanying hardware component that is part of the device itself.
Based on the provided information, VINT is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- VINT's Function: VINT processes and analyzes medical images (MRI data) of the human body. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for viewing, post-processing, and quantitative evaluation of cerebrovascular MRI data. This is image analysis, not specimen analysis.
Therefore, VINT falls under the category of medical imaging software, not In Vitro Diagnostics.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRI, TOF-MRA
Anatomical Site
Cerebrovascular, cerebral arteries, right and left carotid and vertebral arteries
Indicated Patient Age Range
adult (22 years or more)
Intended User / Care Setting
Not Found
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
No clinical studies are considered necessary and performed.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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).
0
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"
1
(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.
2
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
3
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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.
5
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 |
6
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 for | |
| segmentation | · Semi-automatic segmentation: the threshold segmentation method by binary algorithm |
| (default) | |
| · Manual setting |
- Information on signal intensity gradient (SIG)
7
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 for | |
| segmentation | • Semi-automatic segmentation: Separate the background area and vessels using |
| a binarization algorithm based on image pixel value distribution. The threshold | |
| is 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 |
8
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)
9
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.
10
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 | SE
Decision |
|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| Device
Name | VINT | Infinitt PACS 7.0 | iTFlow | Achieva, Ingenia, Ingenia
CX, Ingenia Elition and
Ingenia Ambition MR
Systems | - |
| 510(k)
Number | - | K172803 | K222854 | K213583 | - |
| Classific
ation | Same | Class II | Class II | Class II | - |
| Regulati
on
Number | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.2050 | 21 CFR 892.1000 | - |
| Regulati
on
Name | Medical image management
and processing system | Medical image management
and processing system | Medical image management
and processing system | Magnetic resonance
diagnostic | - |
| Product
Code | LLZ | LLZ | LLZ | LNH | - |
| Intended
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 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 | Infinitt PACS 7.0, is a
software device that
receives medical images
and data from various
imaging sources. Images
and data can be stored,
communicated, processed,
and displayed within the
system or across computer
networks at distributed
locations.
Only preprocessed DICOM
for presentation images can
be interpreted for primary
image diagnosis in
mammography. Lossy
compressed mammographic
images and digitized film
screen images must not be
reviewed for primary image
interpretations.
Mammographic images
may only be interpreted
using a monitor that meets
technical specification
identified by FDA.
Typical users of this system
are trained professionals,
e.g. physicians, radiologists,
nurses, and medical
technicians. | The iTFlow software will be
utilized in situations where
visualization of blood flow
in a heart and its major
vessels are required for a
cardiac diagnosis. iTFlow
allows for the viewing, post-
processing, and the
quantitative evaluation of
cardiovascular MRI data (in
DIRECTOR-compliant
format)
It enables: - The import of DICOM-
compliant MR Images. - The support of a clinical
diagnosis by the quantitative
analysis of the imported
images. - Quantitative measurement
of the size, area, blood flow,
volume and mass of the
heart and adjacent vessels.
-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.
iTFlow software will assist
clinicians with proper
training in cardiac treatment
decision making and in
providing a conclusive
diagnosis for patients. It is
intended to analyze
cardiovascular MRI image
data, that are acquired via | Philips Magnetic Resonance
(MR) systems are Medical
Electrical Systems indicated
for use as a diagnostic
device. This MR system
enables trained physicians
to obtain cross-sectional
images, spectroscopic
images and/or spectra of the
internal structure of the
head, body or extremities, in
any orientation, representing
the spatial distribution of
protons or other nuclei with
spin.
Image appearance is
determined by many
different physical properties
of the tissue and the
anatomy, the MR scan
technique applied, and
presence of contrast agents.
The use of contrast agents
for diagnostic imaging
applications should be
performed consistent with
the approved labeling for
the contrast agent.
The trained clinical user can
adjust the MR scan
parameters to customize
image appearance,
accelerate image acquisition
and synchronize with the
patient's breathing or
cardiac cycle.
The systems can use
combinations of images to
produce physical
parameters, 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 understand
distribution of blood flow
and signal intensity
gradient at-a-glance
• Data visualization as an
image or numerical data | • Data visualization as an
image or numerical data | users understand
distribution of blood flow
at-a-glance
• Data visualization as an
image or numerical data | segmentations
• Data visualization as an
image or numerical data | |
| Segment
ation of
region
of
interest | Yes | Yes | Yes | Yes | Same |
| Nature
of
arterial
image | Blood flow | Blood flow | Blood flow | Blood flow | Same |
| Image
resolutio
n | Same as MR image | Same as MR image | Same as MR image | Same as MR image | Same |
| Quantita
tive
Analysis
, arterial
radius | Yes | Yes | Yes | Yes | Same |
| Quantita
tive
Analysis
, Velocity
gradient | • Yes
Signal intensity gradient
(difference of signal
intensity/radius) to
substantiate velocity
gradient | N/A | • Yes
Velocity gradient as a
function of
velocity/radius | • Yes
Velocity gradient can
be calculated as it
outputs velocity and
radius information | Same
with
predicate
device B
and
Reference
Device |
| Interpol
ation | • Trilinear interpolation | N/A | • Interpolation methods
including trilinear or
Lagrangian, used
variously | N/A | Same
with
predicate
device B |
| Calculat
ed inner
distance
from
vessel
surface | • 0.03mm (default) | N/A | • Usually not-reported
(hidden) | N/A | Different |
| Quantita
tive
analysis,
angle | Yes | Yes | Yes | Yes | Same |
| Quantita
tive
analysis,
length | Yes | Yes | Yes | Yes | Same |
| Quantita
tive
analysis,
volume | Yes | Yes | Yes | Yes | Same |
11
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.
12
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)
13
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.
14
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.