(120 days)
Not Found
Unknown
The description mentions "automatically" delineating contours, which could be achieved with traditional image processing or AI/ML. However, there is no explicit mention of AI, ML, or related terms, and no information about training or test sets, which are typical for AI/ML devices.
No
The device is described as a software tool that supports clinical diagnoses and research by delineating blood contours and deriving quantitative cardiovascular analysis results from MR images. It does not directly provide therapy.
Yes
Explanation: The "Intended Use/Indications for Use" explicitly states that the device is "designed to be used in everyday clinical practice to support clinical diagnoses." This directly indicates its role in the diagnostic process.
Yes
The device description explicitly states "The CAAS MR Flow is a software tool" and describes its functionality solely in terms of software operations on imported images. There is no mention of accompanying hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that this software processes MR images of blood in vessels and through heart valves. These are images of the body itself, not specimens taken from the body (like blood, urine, tissue, etc.).
- The analysis is performed on imaging data. The software analyzes the flow and velocity within the contours delineated on the MR images. This is image analysis, not laboratory testing of biological samples.
The device is a software tool for analyzing medical images to support clinical diagnoses and research. This falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The intended use of CAAS MR Flow is to enable the user to:
- Delineate the contours of blood in vessels and through heart valves in Phase-Contrast MR images; manually, semi-automatically or automatically.
- Derive from these images and contours quantitative cardiovascular analysis results. The CAAS MR Flow has been designed to be used in everyday clinical practice to support clinical diagnoses, as well as for research purposes like clinical research trials.
Product codes
L.I.Z, LLZ
Device Description
The CAAS MR Flow is a software tool providing functionality to import and view MR The Critics flow datasets and corresponding referene images. Contours of blood in vessels and through heart valves can be delineated automatically, semi-automatically or manually. Within these contours data on flow and velocity can be derived and parameters of interest for clinical use mose contours and on results of the analysis are available on screen as well as hardcopy, and can be saved.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Phase-Contrast MR images
Anatomical Site
vessels and through heart valves
Indicated Patient Age Range
Not Found
Intended User / Care Setting
everyday clinical practice, research purposes like clinical research trials.
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)
Reference Device(s)
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
§ 892.2050 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
| 510(k) Summary | CAAS MR Flow | Release 1. |
|---|---|---|
| This summary statement complies with 21CFR, section 807.92(c). | ||
| Date summary prepared: 17-Mar-09 |
Dute : and its propared. on has been submitted by Pie Medical Imaging BV and covers the CAAS MR Flow software package. Pic Medical Imaging is located at:
Pie Medical Imaging BV Becanusstraat 13 D 01 6216 BX Maastricht The Netherlands Phone +31.43.3281328 Fax +31.42.3281329 Email: saskia.lloyd@pic.nl
MAY 22 2009
| The contact person is: | Ms. Saskia Lloyd, Quality Assurance Officer |
|---|---|
| The trade name is: | CAAS MR Flow |
| The common name is: | Magnetic Resonance Flow analysis software |
| The classification name is: | Image Processing System (L.I.Z), CFR 892.2050. |
The above as stated in 21 CFR, part 892.1570, has been classified as regulatory Class II.
The CAAS MR Flow software package is substantially equivalent to the quantitative analysis software package CAAS MRV Version 3.0, K060941, integrating flow analysis functionality substantially equivalent to MRI Flow, Medical imaging systems BV, K994282.
The CAAS MR Flow is a software tool providing functionality to import and view MR The Critics flow datasets and corresponding referene images. Contours of blood in vessels and through heart valves can be delineated automatically, semi-automatically or manually. Within these contours data on flow and velocity can be derived and parameters of interest for clinical use mose contours and on results of the analysis are available on screen as well as hardcopy, and can be saved.
The intended use of CAAS MR Flow is to enable the user to:
- e meended the contours of blood in vessels and through heart valves in Phase-Contrast MR 1. images; manually, semi-automatically or automatically.
- Derive from these images and contours quantitative cardiovascular analysis results. The CAAS MR Flow has been designed to be used in everyday clinical practice to support clineal diagnoses, as well as for research purposes like clinical research trials.
The CAAS MR Flow is substantially equivalent to the predicate devices mentioned in this The Original using the same technological characteristics and intended use.
The CAAS MR Flow is produced under the same Quality Assurance system applicable to the development and production of products currently marketed by Pie Medical Imaging.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.
MAY 22 2009
· Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Saskia Lloyd Submission Correspondent Quality Assurance Office Pie Medical Imaging b.v. Becanusstraat 13D, 6216 BX Maastricht THE NETHERLANDS
Re: K090155
Trade/Device Name: CAAS MR Flow Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 23, 2009 Received: April 29, 2009
Dear Mr. Lloyd:
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.
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 (reporting of medical device-related adverse events) (21 CFR 803); 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
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 | |
|---|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 | |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 | |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
[signature]
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
:
510(k) Notification - CAAS MR Flow
| INDICATION FOR USE STATEMENT | page 1 of 1 | |
|---|---|---|
| 510(k) number (if known): | K090155 | |
| Device Name: | CAAS MR Flow | |
| Indications For Use: | ||
| 1. | Delineate the contours of blood in vessels and through heart valves in Phase-Contrast MR images; manually, semi-automatically or automatically. | |
| 2. | Derive from these images and contours quantitative cardiovascular analysis results. The CAAS MR Flow has been designed to be used in everyday clinical practice to support clinical diagnoses, as well as for research purposes like clinical research trials. | |
| Prescription Use | ||
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 1-2-96)
(Division Sigh-Off)
Division of Reproductive, Abdominal and Radiological Devices
| 510(k) Number | K090155 |
|---|---|
| --------------- | --------- |
[QA258]-2.0
Pie Medical Imaging BV
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