CAAS MRV

K041682 · Pie Medical Imaging BV · LLZ · Jul 27, 2004 · Radiology

Device Facts

• Record ID: K041682
• Device Name: CAAS MRV
• Applicant: Pie Medical Imaging BV
• Product Code: LLZ · Radiology
• Decision Date: Jul 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The CAAS MRV has been designed for quantitative functional analysis of the left and right ventricle of the heart based on multi-slice, multi-phase cine MRI images. Specifically, it enables the user to: 1. Delineate automatically or semi-automatically the inner and outer wall of the ventricles, as well as the papillary muscles, on the MRI images 2. Derive from these contours the global and regional functional parameters like Ejection Fraction, Stroke Volume, Wall Movement etc. The CAAS MRV has been designed to be used in everyday clinical practice, as well as for research purposes like clinical research trials.

Device Story

CAAS MRV is a software tool for cardiac functional analysis; inputs multi-slice, multi-phase cine MRI datasets from various vendors via CD-ROM, hard disk, or PACS. Software enables automatic, semi-automatic, or manual delineation of inner/outer ventricular walls and papillary muscles. Transforms contours into quantitative outputs: ventricular volumes, ejection fraction, stroke volume, and regional wall motion. Used in clinical practice and research settings by clinicians. Results displayed on-screen or as hardcopy for diagnostic support and clinical decision-making; benefits include standardized, efficient quantification of cardiac function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based image processing system. Operates on multi-slice, multi-phase cine MRI datasets. Features automated, semi-automated, and manual contouring tools for ventricular wall and papillary muscle segmentation. Outputs include volumetric and motion parameters. Standalone software package.

Indications for Use

Indicated for quantitative functional analysis of left and right heart ventricles in patients undergoing multi-slice, multi-phase cine MRI. Used for clinical diagnosis and research trials.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• MRI-Magnetic resonance Analytical Software System (K994283)

Submission Summary (Full Text)

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K041-682

This summary statement complies with 21CFR, section 807.92(c). 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:

JUL 27 2004

| Pie Medical Imaging BV |
|-----------------------------|
| Becanusstraat 13 D 01 |
| 6216 BX Maastricht |
| The Netherlands |
| Phone [phone] |
| Fax [phone] |
| Email: [e-mail] |

| 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:

1. Delineate the inner and outer wall of the ventricles automatically or semi-automatically, as well as the papillary muscles, on MRI images

2. 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 Imaging.

SoftSol Doc. 12556

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 2 7 2004

Ms. Carla de Vries Quality Assurance Officer Pie Medical Imaging bv Becanusstraat 13D 6216 BX Maastricht THE NETHERLANDS

Re: K041682 Trade/Device Name: CAAS MRV Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: June 14, 2004 Received: June 21, 2004

Dear Ms. de Vries:

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. Ilsting 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.

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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 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmaldsmamain.html.

Sincerely yours,

Nancy C. Brygdon

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 | | page 1 of 1 |
|------------------------------|----------|-------------|
| 510(k) number (if known): | K041682 | |
| Device Name: | CAAS MRV | |
| Indications For Use: | | |

The CAAS MRV has been designed for quantitative functional analysis of the left and right ventricle of the heart based on multi-slice, multi-phase cine MRI images. Specifically, it enables the user to: 1. Delineate automatically or semi-automatically the inner and outer wall of the ventricles, as well as the papillary muscles, on the MRI images

2. Derive from these contours the global and regional functional parameters like Ejection Fraction, Stroke Volume, Wall Movement etc.

The CAAS MRV has been designed to be used in everyday clinical practice, 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)

Daniel A. Sypm

(Division Sign-Off) Division of Reproductive, Abde and Radiological Devic 510(k) Number -

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

12552