PHILIPS INTURIS CARDIO IMAGE VIEWING PACKAGE

K983821 · Philips Medical Systems North America, Inc. · LLZ · Dec 11, 1998 · Radiology

Device Facts

• Record ID: K983821
• Device Name: PHILIPS INTURIS CARDIO IMAGE VIEWING PACKAGE
• Applicant: Philips Medical Systems North America, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Dec 11, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The PHILIPS Inturis Cardio Image Viewing Package is intended for use in processing and viewing cardiac or cardiovascular images, resulting in quantitative and/or qualitative data that can be used to estimate cardiac or cardiovascular function.

Device Story

Software-based image processing system; operates on Windows NT (4.0) workstation. Inputs: DICOM cardiac images via CD-ROM. Processing: quantitative coronary and left ventricular analysis. Outputs: quantitative and qualitative data for cardiac function estimation. Used by clinicians in clinical settings to assist in diagnostic decision-making regarding cardiac function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based image processing system; runs on Windows NT (4.0) OS; DICOM-compliant; standalone workstation configuration.

Indications for Use

Indicated for processing and viewing cardiac or cardiovascular images to estimate cardiac or cardiovascular function.

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 CD-Medical Viewstation (a.k.a. CDM-3500) (K945460)

Submission Summary (Full Text)

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DEC 1 1 1998

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# Philips Medical Systems

# 510(k) Summary

| Company name: | Philips Medical Systems North America Company |
|----------------------|-----------------------------------------------|
| Address: | 710 Bridgeport Avenue, Shelton, CT 06484 |
| Contact person: | P. Altman |
| Telephone number: | 203-926-7031 |
| Prepared: | October 28, 1998 |
| Device name: | Philips Inturis Cardio Image Viewing Package |
| Classification name: | Image Processing System<br>Class II (90 LLZ) |
| Common/Usual name: | Workstation |

#### Intended use:

The PHILIPS Inturis Cardio Image Viewing Package is intended for use in processing and viewing cardiac or cardiovascular images, resulting in quantitative and/or qualitative data that can be used to estimate cardiac or cardiovascular function.

### System description:

PHILIPS Inturis Cardio Image Viewing Package is software that can be loaded on a workstation which has a Windows NT (4.0) Operating System. The Inturis Cardio Image Viewing workstation provides for viewing and analysis of DICOM Cardiac images which are transported to the workstation via CD-Rom. Quantitative Coronary and Left Ventricular analysis may be performed on these images.

#### Substantial equivalence Information:

The PHILIPS Inturis Cardio Image Viewing Package is substantially equivalent to the Philips CD-Medical Viewstation (a.k.a. CDM-3500), K945460.

> 10 Bridgeport Avenue Shelton, Connecticut 06484-0 Tel: [phone] Fax: [phone]

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 1 1998

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

K983821 Re:

Philips Inturis Cardio Image Viewing Package Dated: October 28, 1998 Received: October 29, 1998 Regulatory class: II 21 CFR 892.2050/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 We have reviews your boden I 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 Device Amendments, or to 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 requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (11 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 announce 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 the Electronic Product 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 ritto 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 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/cdr/dsma/dsmamain.html".

Sincerely yours,

Kiliai Yin

Lillian Kiu, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Philips Inturis Cardio Image Viewing Package Device Name :

Indications For Use :

The PHILIPS Inturis Cardio Image Viewing Package is intended for use in processing and viewing cardiac or cardiovascular images, resulting in quantitative and/or qualitative data that can be used to estimate cardiac or cardiovascular function.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <img alt="Tick" src="tick.png"/> | |
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| Prescription Use (Per 21 CFR 801.109 | OR | Over-The-Counter Use ______ |

| | <div style="text-align:center;">(Division Sign-Off)</div> |
|---------------|--------------------------------------------------------------------|
| | Division of Reproductive, Abdominal, ENT, and Radiological Devices |
| 510(k) Number | K983821 |

(Optional Format 1-2-96)