(13 days)
- Delineate the inner and outer wall of the ventricles automatically, semi-automatically or manually, as well as the papillary muscles, on different kinds of MRI images.
- Derive from these images and contours quantitative information to be used to assist in cardiac analysis
The CAAS MRV has been designed to be used in everyday clinical practice to support clinical diagnoses, as well as for research purposes like clinical research trials.
The CAAS MRV is a software tool designed for the functional analysis of the heart based on multi-slice, multi-phase MR images of the heart. Therefore it provides functionality to import and view cine MR datasets of the heart from several vendors from CDROM, hard disk or (optionally) a PACS system. Next, the inner and outer wall of the ventricles can be determined either automatically, semi-automatically or manually. From these contours the ventricular volume, the ejection fraction and other related parameters are determined. Next to the quantification of the ventricular volumes, also the motion of the ventricular wall is quantified. All results of the analysis are available on screen as well as hardcopy, and can be saved.
This 510(k) summary does not contain the detailed acceptance criteria or a study demonstrating the device meets such criteria. It focuses on establishing substantial equivalence to a predicate device and describing the intended use and technological characteristics.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence rather than presenting specific performance study results against defined acceptance criteria.
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510(k) Summary
CAAS MRV
This summary statement complies with 21CFR, section 807.92(c). 19 11 Date summary prepared: 19 March 2004
This premarket notification has been submitted by Pie Medical Imaging BV and covers the CAAS MRV software package. Pie 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: carla.devries@pie.nl
| The contact person is: | Ms. Carla de Vries, Quality Assurance Officer |
|---|---|
| The trade name is: | CAAS MRV |
| The common name is: | Magnetic Resonance Ventricular analysis software |
| The classification name is: | Image Processing System (LLZ), CFR 892.2050. |
The above as stated in 21 CFR, part 892.1570, has been classified as regulatory Class II.
The CAAS MRV software package is substantially equivalent to the quantitative analysis software package MRI-Magnetic resonance Analytical Software System, K994283.
The CAAS MRV is a software tool designed for the functional analysis of the heart based on multi-slice, multi-phase MR images of the heart. Therefore it provides functionality to import and view cine MR datasets of the heart from several vendors from CDROM, hard disk or (optionally) a PACS system. Next, the inner and outer wall of the ventricles can be determined either automatically, semi-automatically or manually. From these contours the ventricular volume, the ejection fraction and other related parameters are determined. Next to the quantification of the ventricular volumes, also the motion of the ventricular wall is quantified. All results of the analysis are available on screen as well as hardcopy, and can be saved.
The intended use of CAAS MRV is to enable the user to:
-
Delineate the inner and outer wall of the ventricles automatically or semi-automatically, as well as the papillary muscles, on MRI images
-
Derive from these contours the global and regional parameters like Ejection Fraction, Stroke Volume, Wall Movement etc.
The CAAS MRV has been designed to be used in everyday clinical practice to support clinical diagnoses, as well as for research purposes like clinical research trials.
The CAAS MRV is substantially equivalent to the predicate device mentioned in this summary by using the same technological characteristics and intended use.
The CAAS MRV is produced under the same Quality Assurance system applicable to the development and production of products currently marketed by Pie Medical Innaging.
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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 representation of an abstract symbol, consisting of three angled lines that curve and flow together. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
APR 1 9 2006
Pie Medical Imaging B.V. % Mr. Carl M. Beaurline Official Correspondent Acist Medical Systems 7450 Flying Cloud Drive EDEN PRAIRIE MN 55344
Re: K060941
Trade/Device Name: CAAS MRV Version 3.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 3, 2006 Received: April 6, 2006
Dear Mr. Beaurline:
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 ass slated in the eneresary, 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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/1/Picture/10 description: The image shows the FDA Centennial logo, which includes the years 1906-2006. Below the logo is the text "Protecting and Promoting Public Health" in a decorative font. The logo is circular with the letters FDA in a bold, stylized font at the center. The text is arranged to emphasize the FDA's role in safeguarding and improving public well-being.
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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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premated nectived bevice 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), please rry contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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
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510(k) Notification - CAAS MRV
INDICATION FOR USE STATEMENT
CAAS MRV___
510(k) number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
Indications For Use:
- Delincate the inner and outer wall of the ventricles automatically, semi-automatically or l. manually, as well as the papillary muscles, on different kinds of MRI images.
- Derive from these images and contours quantitative information to be used to assist in 2. cardiac analysis
The CAAS MRV has been designed to be used in everyday clinical practice to support clinical diagnoses, as well as for research purposes like clinical research trials.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR |
|---|---|
| (Per 21 CFR 801.109) | |
Over-The-Counter Use
David A. Symm
(Division Sign-Off)
Division of Reproductive, and Radiological Device 510(k) Number _
(Optional Format 1-2-96)
15274
page 1 of 1
§ 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).