(73 days)
Not Found
No
The summary describes a software tool for semi-automatic calculation and display of parameters from MRI data. There is no mention of AI, ML, or related concepts like training or test sets, which are typical indicators of AI/ML use in medical devices. The functionality described appears to be based on traditional image processing and analytical algorithms.
No
This device is a diagnostic tool that supports clinical diagnoses and research by analyzing velocity-encoded cine MRI studies; it does not provide any therapy or treatment.
Yes
The Intended Use section explicitly states that the device's purposes include "supporting clinical diagnoses about the status of the function of the cardiac cambers" and "supporting clinical diagnoses about the flow velocity and volume flow through cardiac and peripheral vessels." Additionally, it mentions that "When interpreted by a trained physician these ameters may be useful in supporting the determination of a diagnosis." This clearly indicates its role in the diagnostic process.
Yes
The device description explicitly states that FLOW is a "state-of-the-art analytical software tool" designed for UNIX and Linux platforms. It facilitates the import and visualization of MRI studies and provides analytical capabilities, all of which are software functions. There is no mention of accompanying hardware components that are part of the device itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The description clearly states that FLOW analyzes velocity-encoded cine MR imaging studies. These are images of the body, not samples taken from the body (like blood, urine, tissue, etc.).
- The intended use is based on analyzing imaging data. The software processes and analyzes imaging data to provide information about flow and velocity within the body.
- The device description focuses on software for image analysis. It describes importing and visualizing MRI studies and calculating parameters from that imaging data.
Therefore, while this device is a medical device used to support clinical diagnoses, it falls under the category of imaging analysis software rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
FLOW has been developed for the objective and reproducible analysis of velocity-encoded cine MR imaging studies of arterial vessels and heart valves. Intended purposes are:
-
- supporting clinical diagnoses about the status of the function of the cardiac cambers:
-
- supporting clinical diagnoses about the flow velocity and volume flow through
- cardiac and peripheral vessels, both under basal and increased flow conditions;
-
- supporting subsequent clinical decision making purposes;
-
- supporting the use in clinical research trials, directed at studying changes in function of the heart chambers and in the flow through cardiac and peripheral vessels as a result of interventions.
FLOW has been developed for the objective and reproducible analy sis of volocity - encoded cine MR imaging studies of arterial vessels and heart valves. The FlOW software package enables to sem-automatically calculate and display of various parameters such as : Mean velocity (also minimum, maximum and Standard deviation) and volume flow in different reqion of interest CROI); Velocity and volume . unction of time; Stroke volume and cardiac but put When interpreted by a trained physician these ameters may be useful in supporting the determination of a diagnosis .
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
Device Description
FLOW is a state-of-the-art analytical software tool designed for UNIX as well as Linux platforms. FLOW facilitates the import and visualization of velocity-encoded cine MRI imaging studies via CD-ROM and digital network. This FLOW functionality is independent of the MRI equipment vendor. FLOW provides objective and reproducible data on velocity and volume flow as a function of time, and other derived data such as mean velocity and volume flow, stroke volume and cardiac output. FLOW is intended to support all clinicians, i.e. cardiologists, and referring physicians involved in the noninvasive assessment of flow and flow velocity in arterial vessels and at heart valves.
Mentions image processing
System, Image Processing;
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
velocity-encoded cine MRI
Anatomical Site
arterial vessels and heart valves, cardiac cambers, cardiac and peripheral vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
all clinicians, i.e. cardiologists, and referring physicians
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)
Not Found
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1000 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.
0
MAR = 2 2000
MRI - FLOW 510(k) Premarket Notification
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS 12
Submission in accordance with the requirements of 21 CFR Part 807.87(h)
| 1) Submitter | : MEDIS medical imaging systems B.V. |
|---|---|
| Address | : Poortgebouw Rijnsburgerweg 10 |
| : 2333 AA Leiden | |
| : The Netherlands | |
| Telephone | : + 31 71 5223244 |
| Fax | : + 31 71 5215617 |
| Contact Person | : J.I. Hollander, Quality Coordinator |
| Prepared | : December 15, 1999 |
| 2) Device Name | : MRI - FLOW analytical software package |
|---|---|
| Common Name | : FLOW |
| Device Class. Name | : System, Image Processing; |
| Regulation Number | : 21 CFR 892.2050 (90 LLZ; Class II) |
-
- Predicate Device : General Electric: 510(k) K924605
4) Description of the device:
FLOW is a state-of-the-art analytical software tool designed for UNIX as well as Linux platforms. FLOW facilitates the import and visualization of velocity-encoded cine MRI imaging studies via CD-ROM and digital network. This FLOW functionality is independent of the MRI equipment vendor. FLOW provides objective and reproducible data on velocity and volume flow as a function of time, and other derived data such as mean velocity and volume flow, stroke volume and cardiac output. FLOW is intended to support all clinicians, i.e. cardiologists, and referring physicians involved in the noninvasive assessment of flow and flow velocity in arterial vessels and at heart valves.
5) Intended use:
FLOW has been developed for the objective and reproducible analysis of velocityencoded cine MR imaging studies of arterial vessels and heart valves. Intended purposes are:
-
- supporting clinical diagnoses about the status of the function of the cardiac cambers:
-
- supporting clinical diagnoses about the flow velocity and volume flow through
- cardiac and peripheral vessels, both under basal and increased flow conditions;
-
- supporting subsequent clinical decision making purposes;
-
- supporting the use in clinical research trials, directed at studying changes in function of the heart chambers and in the flow through cardiac and peripheral vessels as a result of interventions.
1
6) Substantial equivalence Information:
The FLOW software is substantially equivalent to the predicate devices of General Electric K924605 "Flow Analysis Option for Advantage Windows™ 2.0 and 3.1" by using the same technological characteristics and intended use.
Conclusion respecting safety and effectiveness:
It is the opinion of MEDIS medical imaging systems B.V. that FLOW is safe and potential hazards are controlled by a risk management plan for the software development process (see Appendix C), including hazard analysis (see Appendix D), verification and validation tests (see Appendix E). Evaluation by hospitals and literature (see Appendix F) support this statement.
In MEDIS opinion the level of concern for the standalone software to view images is 'minor' and that the use of FLOW software does not change the intended use of magnetic resonance scanners in practice, nor does the use of software result in any new potential hazards.
2
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard Rockville MD 20850
Image /page/2/Picture/2 description: The image shows a logo with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" arranged in a circular fashion around a symbol. The symbol consists of three stylized, curved lines that appear to be flowing or moving upwards. The logo is black and white and has a somewhat grainy quality.
MAR - 2 2000
J.J. Hollander Quality Coordinator Medis Medical Imaging Systems, B.V. Poortgebouw, Rijnsburgerweg 10 2333 AA Leiden The Netherlands
Re:
K994282 MRI-FLOW Analytical Software Packager for MRI Dated: December 16, 1999 Received: December 20, 1999 Regulatory class: II 21 CFR 892.1000/90 LNH
Dear Mr. Holland:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Daniel G. Schultz, M.D Captain, USPHS Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
3
Page / of
510(k) NUMBER (IF KNOWN): K Q942 82 Flow Analytical Software Po DEVICE NAME: ICATIONS FOR USE:
FLOW has been developed for the objective and reproducible analy sis of volocity - encoded cine MR imaging studies of arterial vessels and heart valves. The FlOW software package enables to sem-automatically calculate and display of various parameters such as : Mean velocity (also minimum, maximum and Standard deviation) and volume flow in different reqion of interest CROI); Velocity and volume . unction of time; Stroke volume and cardiac but put When interpreted by a trained physician these ameters may be useful in supporting the determination of a diagnosis .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
ncurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109 OR
Over-The-Counter-Use Optional Format 1-2
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K994282