PHILIPS EASYVISION

K971965 · Philips Medical Systems, Inc. · LLZ · Jan 30, 1998 · Radiology

Device Facts

• Record ID: K971965
• Device Name: PHILIPS EASYVISION
• Applicant: Philips Medical Systems, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jan 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The CT/MR Quantitative Analysis Package is intended for use where visualization and analysis of CT and MR dynamic studies, showing changes in contrast over time, are useful or necessary.

Device Story

Software option for EasyVision workstation; processes time-series CT/MR dynamic scan data. Inputs: time-series image data (single/multiple slices). Operation: calculates Time Intensity Diagrams (TID) per pixel, ROI, or VOI; applies curve smoothing and fitting to derive functional parameters (e.g., max intensity, wash-in/out, time-to-max, cerebral blood flow, mean transit time). Outputs: numerical functional parameters and functional images (parameter maps). Functional images can be overlaid on anatomical images. Used by clinicians to support diagnostic processes by visualizing physiological changes over time. Benefits: provides quantitative assessment of contrast dynamics to aid clinical decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based quantitative analysis package for CT/MR workstations. Features curve smoothing and curve fitting algorithms for time-series data analysis. Generates functional parameter maps (pixel-based) and overlays. Operates on existing EasyVision workstation hardware.

Indications for Use

Indicated for use in clinical settings where visualization and analysis of CT and MR dynamic studies showing contrast changes over time are required. No specific patient population, age, or gender restrictions are defined.

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 with FuncTool Option (K960265)

Submission Summary (Full Text)

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K971965

Image /page/0/Picture/1 description: The image shows a logo for Philips. The logo is a shield shape with the word "PHILIPS" at the top. Inside the shield is a circle with two stars and three wavy lines. The logo is black and white.

# PHILIPS

JAN 3 0 1998

#### Philips Medical Systems

## 510(k) Summary of Safety and Effectiveness

| Company Name: | Philips Medical Systems North America Company |
|----------------------|-----------------------------------------------------------------------------------------|
| Address: | 710 Bridgeport Avenue<br>Shelton, CT 06484 |
| Contact Person: | Peter Altman |
| Telephone Number: | 203-926-7031 |
| Prepared: | June 23, 1997 |
| Device Name: | Philips Easyvision Family Workstation Option<br>Quantitative Analysis Package |
| Classification Name: | Image Processing System<br>(90 LLZ) |
| Common/Usual Name: | Workstation |
| Predicate Devices: | Philips Gyroview HR (K921219)<br>GE Advantage Windows with<br>FuncTool Option (K960265) |

Intended Use:

The CT/MR Quantitative Analysis Package is intended for use where visualization and analysis of CT and MR dynamic studies, showing changes in contrast over time, are useful or necessary.

> Philips Medical Systems North America Company 710 Bridgeport Avenue P.O. Box 860 Shelton, Connecticut 06484-0917 Tel: [phone] Fax: [phone]

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510(k) Summary

#### System Description:

The quantitative analysis package supports the visualization and analysis of CT and MR dynamic studies which show changes in contrast over time. In a dynamic study, a time series of scans is acquired over a single or multiple slice location. The image contrast variations over time will be displayed in "Time Intensity Diagrams (TID)". These TIDs enable analysis of time dependent behavior per individual pixel, Region of Interest (ROI), or Volume of Interest (VOI). TIDs feature user definable intensity and time axes in combination with curve smoothing and curve fitting to determine modality dependent functional parameters. The functional parameters will be presented numerically and a selection of the functional parameters will be visualized as functional images. Subtraction of time series of contrast enhanced images from non-contrast enhanced images to provide the enhanced contrast only is also a function provided by the package.

Parameter analysis

Depending on the modality and the protocol used, different quantitative parameters can be computed:

=> For general CT or MR dynamic contrast studies:

maximum intensity, wash in, wash out, time to max.

- => For MR Perfusion Analysis(T2* weighted MR): regional Cerebral blood flow, time to peak, mean transit time.
Functional Images

All parameters can be computed per pixel providing new computed images. The functional images provide parameter information instead of anatomical information. These functional images can be overlaid on the anatomical images to optimize the presentation of the information to support the diagnostic process.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, graphic style.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 3 0 998

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

Re:

K971965

Philips EasyVision (Quantitative Analysis Option) Dated: November 5, 1997 Received: November 6, 1997 Regulatory class: Unclassified Procode: 90 LLZ

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 interstate 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, 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question 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" (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,

W. Hiau Yu

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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Page 1 of 1

510(k) Number (if known): Unknown 197196

Device Name : Philips EasyVision Workstation Quantitative Analysis Option

Indications For Use :

The CT/MR Quantitative Analysis Package is indicated for use where visualization and analysis of CT and MR dynamic studies, showing changes in contrast over time are useful of necessary.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Esmid C. Segura
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number

Prescription Use
(Per 21 CFR 801.109

OR

Over-The-Counter Use

(Optional Format 1-2-96)