PHILIPS INTEGRIS 3D RA OPTION

K983877 · Philips Medical Systems North America, Inc. · IZI · Dec 21, 1998 · Radiology

Device Facts

• Record ID: K983877
• Device Name: PHILIPS INTEGRIS 3D RA OPTION
• Applicant: Philips Medical Systems North America, Inc.
• Product Code: IZI · Radiology
• Decision Date: Dec 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1600
• Device Class: Class 2

Intended Use

The Integris 3D RA Option is intended to assist physicians when analyzing two dimensional, DSA X-ray images by creating three dimensional views from sets of two dimensional images created during Rotational angiographic runs.

Device Story

Device is an image processing workstation add-on for existing angiographic X-ray systems. Input: 2D digital subtraction angiography (DSA) images acquired during rotational angiographic runs. Processing: Workstation reconstructs 3D images from the 2D rotational image set. Output: 3D reconstructed object viewable from multiple angles. Context: Used in angiography suite control room; operated by physicians/technicians. Clinical utility: Assists physicians in visualizing vascular anatomy in 3D to support clinical decision-making and analysis of angiographic data.

Clinical Evidence

No clinical data provided. Safety and effectiveness supported by risk management plan, hazard analysis, system software quality assessment, software validation, and external hospital evaluations.

Technological Characteristics

Image processing workstation; DICOM connectivity; software-based 3D reconstruction from 2D rotational angiography inputs. Operates as an add-on to existing angiographic X-ray systems.

Indications for Use

Indicated for use by physicians to assist in the analysis of 2D DSA X-ray images by generating 3D views from rotational angiographic image sets.

Regulatory Classification

Identification

An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Advantx LCN+ and LCLP+ (K974367)

Submission Summary (Full Text)

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DEC 2 1 1998

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# 510(k) Summary Philips Medical Systems

K983877

| 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 30, 1998 |
| Device name: | Philips Integris 3D RA Option |
| Classification name: | Angiographic X-ray system, 21 CFR 892.1600<br>Class II (90 IZI) |
| Common/Usual name: | Angiographic x-ray system |
| Predicate Device(s): | Advantx LCN+ and LCLP+ (K974367). |

#### Intended use:

The Integris 3D RA Option is intended to assist physicians when analyzing two dimensional, DSA X-ray images by creating three dimensional views from sets of two dimensional images created during Rotational angiographic runs.

### System description:

The Integris 3D-RA option is comprised of an image processing computer loaded with 3D-RA software. It is linked through a DICOM port to the Integris system and is intended to be placed in the control room of the Angiography suite. The set of 2-Dimensional images from the rotational angiographic examination are transferred via DICOM Connection to the 3D RA Workstation. A 3-Dimensional image is reconstructed from the delivered image information resulting in an object which can be viewed from almnost any angle.

#### Substantial equivalence Information

The Integris 3D RA Option is substantially equivalent to the 3D image reconstruction and image intensifier distortion capabilities of the GE Medical Sytems' Advantx LCN+ and LCLP+ (K974367). Differences between the new and predicate device are identified in a Comparison matrix.

#### Conclusion:

It is the opinion of Philips Medical Systems that Integris 3D-RA is safe and potential hazards are controlled by a risk management plan including hazard analysis, system software quality assessment plan, software validation statement, test activities and external evaluations by hospitals. The use of Integris 3D-RA option does not change the intended use of the angiographic systems with which it is used.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 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

#### Re: K983877

Philips/Integris 3D RA Option for Angiographic X-Ray System Dated: October 30, 1998 Received: November 2, 1998 Regulatory class: II 21 CFR 892.1600/Procode: 90 IZI

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 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). 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 Requlations. 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 (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 requlatory 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 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 vitro 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 requlation 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/dsma/dsmamain.html".

Sincerely yours,

Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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n98381 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ -Unknown

Device Name : Philips Integris 3D RA Option

Indications For Use :

The 3D RA Option is intended to assist physicians when analyzing two dimensional, DSA X-ray images by creating three dimensional views from sets of two dimensional images created during Rotational angiographic runs.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Seym

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 1983877 510(k) Number _

Prescription Use ( Per 21 CFR 801.109 OR

Over-The-Counter Use

(Optional Format 1-2-96)