PHILIPS EASYVISION

K972103 · Philips Medical Systems North America, Inc. · LLZ · Sep 2, 1997 · Radiology

Device Facts

• Record ID: K972103
• Device Name: PHILIPS EASYVISION
• Applicant: Philips Medical Systems North America, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Sep 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The MR Cardiac Analysis Package is intended for use in processing cardiac or cardiovascular MR images, resulting in quantitative and/or qualitative data that can be used to estimate cardiac or cardiovascular function.

Device Story

MR Cardiac Analysis Package is an image processing software option for the Philips Easyvision Workstation. It processes MR images of the heart acquired at multiple slices and phases. The device provides computer-assisted detection of left ventricle heart boundaries; users may edit and must approve these boundaries. Right ventricle boundaries are detected manually. The system calculates quantitative parameters including ejection fraction, stroke volume, diastolic/systolic volume, ventricular mass, and wall thickness. It also allows for papillary muscle error correction and displays synchronized movies of heart phases/slices. Results are presented in user-defined print layouts combining statistical/graphical data with images. Used in clinical settings by healthcare professionals to assist in cardiac function assessment, potentially improving diagnostic efficiency by automating tedious manual contouring tasks.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based image processing package for the Easyvision Workstation. Operates on MR image data acquired via dedicated sequences. Features computer-assisted boundary detection for the left ventricle. Connectivity via integration with the Easyvision Workstation platform. No specific hardware materials or sterilization methods applicable as this is a software-only workstation option.

Indications for Use

Indicated for use in association with cardiac and cardiovascular examinations where it is useful or necessary to perform qualitative or quantitative analysis.

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

• Philips Gyroview HR (K921219)
• GE Advantage Windows Review Workstation (K960613)
• GE Advantage Windows Review Workstation (K942120)
• GE Advantage Windows Review Workstation (K913770)
• Philips Gyroscan Rel 2 MR Systems (K920578)
• Philips Gyroscan Rel 2 MR Systems (K920791)

Submission Summary (Full Text)

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**PHILIPS**

## K972103

SEP - 2 1997

## 510(k) Summary of Safety and Effectiveness

Philips Medical Systems North America Company Company Name: 710 Bridgeport Avenue Address: Shelton, CT 06484 Peter Altman Contact Person: 203-926-7031 Telephone Number: June 24, 1997 Prepared: Philips Easyvision Family Workstation Option Device Name: MR Cardiac Analysis Package Image Processing System Classification Name: (90 LLZ) Workstation Common/Usual Name: Philips Gyroview HR (K921219) Predicate Devices: GE Advantage Windows Review Workstation (K960613, K942120, and K913770). Philips Gyroscan Rel 2 MR Systems (K920578 and K920791)

Intended Use:

The MR Cardiac Analysis Package is intended for use in processing cardiac or cardiovascular MR images, resulting in quantitative and/or qualitative data that can be used to estimate cardiac or cardiovascular function.

> Philips Medical Systems North America Company 710 Bridgeport Avenue P.O. Box 860 Shelton, Connecticut 06484 Tel: [phone] Fax: [phone]

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System Description:

Quantitative analysis of MR Cardio exams is normally a tedious and time consuming procedure. The MR Cardiac Analysis Package provides off-line viewing and processing functions for cardiac and cardio-vascular examinations, acquired with Magnetic Resonance, to simplify the process.

Historically the user had to outline the end-systolic and end-diastolic ventricle areas in one or all slices. To reduce the time required for the analysis, the MR Cardiac Analysis Package provides a facility for computer assisted detection of the heart boundaries of the left ventricle. The user may edit the computer generated boundary and must always approve the selection. The right ventricle boundary must still be detected manually.

To use the MR Cardiac Analysis Package, MR images of the heart are acquired with dedicated MR sequences at multiple slices and different phases of the heart cycle and transferred to the Easyvision Workstation. Processing these images provides data that can be used to estimate various quantitative parameters, e.g., ejection fraction, stroke volume, diastolic and systolic volume, ventricular mass, and wall thickness. It can also provide a display of cardiac functional parameters and permits correction for errors caused by papillary muscle. . All quantitative results can be printed in a dedicated, user definable, print lavout for cardiac analysis, where analysis data (statistical and graphical) can be reported in combination with the image data.

The package will also provide viewing capabilities such as direct access to images, defined by slice location or heart phase, and synchronized movies for the different heart phases and/or slices.

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Image /page/2/Picture/0 description: The image shows a logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings. The words "DEPARTMENT O. HEALTH &" are arranged vertically along the left side of the logo.

Food and Drug Administration. 9200 Corporate Boulevard Rockville MD 20850

Peter Altman Director of Regulatory Affairs Philips Medical Systems North America Company 710 Bridgeport Avenue P.O. Box 860 Shelton, CT 06484-0917

Re: K972103

EasyVision Family Workstation Option: MR Cardiac Analysis Software Package Dated: June 2, 1997 Received: June 4, 1997 Unclassified Procode: 90 LLZ

SEP - 2 1997

Dear Mr. Altman:

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 devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 requirement, 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 regulatory 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 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 marked 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 vitto diagnostic devices), please contact the Office of Compliance at [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 of the regulation of the regulation of the dr "Misbranding by reference to premarket notification" (21 CFR 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours

h)liau Yin
Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Unknown- K972/03 510(k) Number (if known): __ Device Name : Philips Easy Vision Workstation MR Cardiac Analysis Option Indications For Use :

The MR Cardiac Analysis Package is indicated for use in association with cardiac and cardiovascular examinations where it is useful or necessary to perform qualitative or quantitative analysis.

## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Bergren

(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number

Prescription Use
( Per 21 CFR 801.109

OR

Over-The-Counter Use

(Optional Format 1-2-96)