(77 days)
None
No
The summary describes semi-automated measurement functions and productivity improvements, but does not mention AI, ML, or any related terms. The description focuses on standard image processing and measurement techniques.
No.
The device is described as a tool for analysis and measurement of MRA data, intended to support clinical diagnoses and decision-making by a physician, not to directly treat or cure a disease.
Yes
The device aids trained physicians in determining clinical diagnoses by analyzing MRA data to assess vessel parameters like lumen length, cross-sectional parameters, and percent stenosis, which are used to support diagnostic decisions.
Yes
The description focuses solely on the software's functionality for analyzing MRA data and providing measurements. There is no mention of any accompanying hardware component being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that MRA-CMS analyzes MRA data sets (Magnetic Resonance Angiography), which are medical images. It performs measurements on these images to assess vessels.
- Input Modality: The input is MRA data sets, not biological samples.
- Intended Use: The intended use is to analyze vessels from MRA data and provide parameters to support clinical diagnoses and decision-making, based on image analysis.
Therefore, MRA-CMS is a medical image analysis software and not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
MRA has been developed for the objective and reproducible analysis of MRA data The intended purposes are:
-
- Supporting clinical diagnoses about the status of the global and regional function and anatomy of the human heart;
-
- Supporting the subsequent clinical decision making processes;
-
- Supporting the use in clinical research trials, directed at studying changes in function and anatomy of the heart chambers as a result of treatment.
MRA-CMS has been developed for the objective and reproductble analysis of vessels from MRA data sets. The MRA software parameters may be used to semi-automatically determine lumen length, cross sectional parameters and percent stenosis. When interpreted by a trained physician these parameters may be useful in supporting the determination of clinical diagnoses and subsequent clinical decision making processes.
- Supporting the use in clinical research trials, directed at studying changes in function and anatomy of the heart chambers as a result of treatment.
Product codes
90 LLZ
Device Description
MRA-CMS can be utilized to determine lumen lengths; minimum and maximum cross sectional diameters and percent stenosis. MRA-CMS improves productivity of the clinician by semi-automating the measurement function for routine vascular measurements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MRA
Anatomical Site
human heart; vessels
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician, trained physician
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Ko4o746
JUN = 8 2004
MRA-CMS 510(k) Pre-market Notification
12. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Submission in accordance with the requirements of 21 CFR Part 807.87(h)
| 1. Submitter | : MEDIS medical imaging systems bv |
|---|---|
| Address | : Schuttersveld 9 |
| : 2316 XG Leiden, The Netherlands | |
| Telephone | : +31 71 522 3244 |
| Fax | : +31 71 521 5617 |
| Contact Person | : J.I. Hollander, Quality Coordinator |
| Prepared | : March 17, 2004 |
| 2. Device Name | : MRA-CMS |
| Common Name | : MRA |
| Classification Name | : 90 LLZ (21 CFR 892.2050) |
3. Predicate Device(s)
4. Description of the device:
MRA-CMS can be utilized to determine lumen lengths; minimum and maximum cross sectional diameters and percent stenosis. MRA-CMS improves productivity of the clinician by semi-automating the measurement function for routine vascular measurements.
5. Intended use:
MRA has been developed for the objective and reproducible analysis of MRA data The intended purposes are:
-
- Supporting clinical diagnoses about the status of the global and regional function and anatomy of the human heart;
-
- Supporting the subsequent clinical decision making processes;
-
- Supporting the use in clinical research trials, directed at studying changes in function and anatomy of the heart chambers as a result of treatment.
6. Substantial equivalence Information:
MRA-CMS is substantially equivalent to the Predicate Device of Vital Images, K002519 "Vitrae 2, version 2.1", using the same technological technique for the same intended use.
Conclusion respecting safety and effectiveness:
It is the opinion of Medical imaging systems bv that MRA-CMS 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). Evaluations by hospitals and literature (See Appendix F) support this statement. The software package MRA-CMS itself will not have any adverse effects on health. This tool calculates and displays the anatomy and function of the left and right ventricular contours and regions-of-interest will be interpreted by the operator, who can choose to accept or reject the outlines, and then decide to use the derived data to compare against earlier images or images from other patients.
It is the opinion of Medis medical imaging systems bv that the level of concern for the stand alone software to view images is 'minor' and that the use of MRA-CMS software does not change the intended use of MR scanners in practice, nor does the use of software result in any new potential hazards.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 8 2004
Mr. J.I. Hollander Quality Coordinator Medis Medical Imaging Systems bv Schuttersveld 9 2316 XG Leiden P.O.Box 384, 2300 AJ Leiden THE NETHERLANDS
Re: K040746 Trade/Device Name: MRA-CMS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: March 17, 2004 Received: March 23, 2004
Dear Mr. Hollander:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin manieting your and equivalence of your device to a legally premarket nothcation. The PDA miding of bassification 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), please If you desire specific advise to: your are of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Adultionally, 101 questions on the prosses note the regulation entitled, "Misbranding Other of Comphanoo at (2017 ->>>>>>>>>>>>>>> (21CFR Part 807.97) you may obtain. Other general by relefence to premarket notification - (21 cc may be obtained from the Division of Small miorination on your responsionities and its toll-free number (800) 638-2041 or Manufacturers, Titlemational and Colress http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
-510(k) Number (if known): ソバイダ イアイ
- Device Name: - MRA-CMS
Indications For Use
MRA-CMS has been developed for the objective and reproductble
analysis of vessels from MRA data sets. The MRA software parameters be used to semi-automatically only sectional parameters and percent stenosis.
Such as: Jumen length, cross sectional parameters and percent may bo nee such as tumen reign, cross sectional physician these parameters may be useful.
When interpreted by a trained physician these parameters may be useful.
in supporting the deter
(Please do not write below this line-continue on another Page I EDED)
Concurrence of CDRH, Office of Device Evaluation (ODE
escription Use
David H. Lehman
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices K () 4) 510(k) Number
(Optional Format 3-10-98)