RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS

K984545 · Philips Medical Systems North America, Inc. · IZI · Feb 25, 1999 · Radiology

Device Facts

• Record ID: K984545
• Device Name: RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS
• Applicant: Philips Medical Systems North America, Inc.
• Product Code: IZI · Radiology
• Decision Date: Feb 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1600
• Device Class: Class 2

Intended Use

The Philips Integris Series Release 2 systems are intended for use in acquiring diagnostic quality images during cardiac, angiographic, vascular, neurovascular, and interventional applications.

Device Story

Philips Integris Series Release 2 systems (H5000, BH5000, V5000, BV5000, HM2000) are integrated single and biplane cath lab X-ray systems. Systems acquire diagnostic quality images for cardiac, angiographic, vascular, neurovascular, and interventional applications. Operated by clinicians in clinical settings; output used for diagnostic visualization and procedural guidance. Systems comply with DICOM standards for digital imaging communication.

Clinical Evidence

No clinical data provided. Compliance with safety standards (21 CFR 1020, UL 187, UL 2601) and DICOM standards cited.

Technological Characteristics

Integrated single and biplane X-ray cath lab systems. Connectivity via ACR/NEMA DICOM standard. Compliance with 21 CFR 1020, UL 187, and UL 2601 safety standards.

Indications for Use

Indicated for patients requiring diagnostic imaging during cardiac, angiographic, vascular, neurovascular, and interventional procedures.

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

• Philips Integris V5000
• Philips Integris H5000

Submission Summary (Full Text)

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0/25/99

Image /page/0/Picture/1 description: The image shows the Philips logo. The logo consists of the word "PHILIPS" in bold, uppercase letters above a circular emblem. The emblem contains two wavy lines representing water and four stars. The stars are positioned above and below the wavy lines.

Image /page/0/Picture/2 description: The image shows the word "PHILIPS" in large, bold, black letters. Above the word "PHILIPS" is a handwritten number that appears to be "K984545". The font of the word "PHILIPS" is sans-serif and the letters are closely spaced. The image is black and white.

# Philips Medical Systems

## 510(k) Summary

| Company name: | Philips Medical Systems North America Company |
|----------------------|-----------------------------------------------------------------|
| Address: | 710 Bridgeport Avenue<br>Shelton, CT 06484 |
| Contact person: | P. Altman |
| Telephone number: | 203-926-7031 |
| Prepared: | December 21, 1998 |
| Device name: | Philips Integris Series Release 2 systems |
| 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): | Philips Integris V5000 and H5000 |

#### Intended use:

The Philips Integris Series Release 2 systems are intended for use in acquiring diagnostic quality images during cardiac, angiographic, vascular, neurovascular, and interventional applications.

#### System description:

The Philips Integris Series Release 2 systems include the Integris H5000, BH5000, V5000, BV5000, and HM2000. These systems are fully integrated, single and biplane, cath labs.

### Safety / Software Information

An overview of the software description, the design, the summary of hazard analysis results and technical and safety information was included. The systems are designed in compliance with the applicable sections of Title 21 CFR part 1020, UL 187 and 2601, and comply with the ACR/NEMA DICOM digital imaging communication standard.

AK-5

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

FEB 2 5 1999

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

K984545 Philips Integris Series Release 2 Systems Dated: December 21, 1998 Received: December 22, 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 have headly we have reviewed your seculor of the indications for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce procles with the provisions of the mailkeled predicale devices marketed in merced in accordance with the provisions of the the pages lease Medical Device Antendheins, or to devices that hure between market the device, subject to the general controls, controls Federal Food, Drug, and Cosment controls provisions of the Act include requirements for annual registration, listing of
provisions of the Act. The general controls provision provisions of the Act. The general controls promotio of the netinst misbranding and adulteration.

If your device is classified (see above) into either class III (Special Controls) or class III (Premarket Approval), it may it your device is classified (see above) into elited in (e.g.) (2) in the can be found in the Code of be subject to such additional controls. Existing major rogalization assumes comes compliance with Federal Regulations, Thue 21, Parts ooo oo oour rrents, as set forth in the Quality System Regulation (QS) for the Food Manufacturing Prados requirements) and that, through periodic QS inspections, the Food and Medical Devices. "General regulations. Failure to comply with the GMP regulation may result in Drug Administration (1 DA) will volly dail assumediation of the announcements concerning your device in the Federal register. In addition, I DA may pablion remarket notification submission does not affect any obligation your Register. Prease fore: this response to your promation in 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 for for I fills letter will anow you to begin marked to a legally marketed in your case 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 Pat 801 and additionally 809.10 for in il you desire specific advice in your don'tee of Compliance at [phone]. Additionally for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Allso, the promotion and advertising of your donoor po by reference to premarket notification"(21 CFR 807.97). Other please note tre regulation entitled internation to prohained 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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Philips Integris Systems, Release 2 Device Name :

K984545

Indications For Use :

The Philips Integris Series Release 2 systems are intended for use in acquiring diagnostic quality images during cardiac, angiographic, vascular, neurovascular, and interventional applications.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David G. Syverson
(Division Sign Off)

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

Prescription Use
(Per 21 CFR 801.109

OR

**Over-The-Counter Use**

(Optional Format 1-2-96)