PHILIPS INTEGRIS H5000

K971365 · Philips Medical Systems North America, Inc. · IZI · May 14, 1997 · Radiology

Device Facts

• Record ID: K971365
• Device Name: PHILIPS INTEGRIS H5000
• Applicant: Philips Medical Systems North America, Inc.
• Product Code: IZI · Radiology
• Decision Date: May 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1600
• Device Class: Class 2

Device Story

Integris H 5000 and BH 5000 are cardio/vascular imaging systems. Used in clinical settings for diagnostic and interventional procedures. Systems acquire X-ray images for visualization of cardiovascular and vascular structures. Operated by trained medical professionals. Output provided to clinicians for diagnostic assessment and procedural guidance. Benefit includes enhanced visualization of anatomy to support clinical decision-making during cardiovascular and vascular interventions.

Clinical Evidence

No clinical data provided; reliance on past experience with substantially equivalent predicate devices and compliance with safety standards.

Technological Characteristics

Cardio/vascular X-ray imaging system. Manufactured per UL 187 and UL 2601 safety standards. Subject to 21CFR part 1000 Federal Performance Standards.

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.

Submission Summary (Full Text)

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MAY 1 4 1997

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## Philips Medical Systems

P.O. Box 10000, 5680 DA Best, The Netherlands Department of Health and Human Services Center for Devices and Radiological Health Office of Device Evaluation Pre-Market Notification section.

> TOM XRD Best XDB087-970107/RR/TT

1997.02.25

## SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

for

## PHILIPS INTEGRIS H 5000 and BH 5000 CARDIO / VASCULAR SYSTEMS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

The undersigned certifies that the 510(k) Pre-Market notification for the above referenced product contains adequate information and data to enable CDRH to determine substantial equivalence.

This information and data is summarized as follows:

- 1. The Integris H 5000 / BH 5000 systems are subject to Federal Performance Standards, defined in 21CFR - part 1000;
- 2. The Integris H5000 / BH 5000 systems will be manufactured in accordance with voluntary safety standards, such as UL 187 and UL 2601;
- 3. The information for Users contains comprehensive information to insure safe and effective use;
- 4. Past experience with substantially equivalent predicate devices has shown our device to be safe and effective when used as directed in the Information for Users.

**Ing. R.W.Rijntjes**
Approbation manager

Approbation manager Quality Assurance dept. XSB / XCB Philips Medical Systems Nederland BV Best, The Netherlands.

522 104 2893