SELECTOR ANGIOGRAPHIC CATHETER (VARIOUS MODELS)

K960801 · North American Instrument Corp. · DQO · Mar 29, 1996 · Cardiovascular

Device Facts

• Record ID: K960801
• Device Name: SELECTOR ANGIOGRAPHIC CATHETER (VARIOUS MODELS)
• Applicant: North American Instrument Corp.
• Product Code: DQO · Cardiovascular
• Decision Date: Mar 29, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The Selector Angiographic Catheter is intended to deliver contrast medium during angiography as well as to provide a conduit for various diagnostic and therapeutic procedures. Selector Angiographic Catheters are intended for single-patient use only.

Device Story

Radiopaque catheter shaft with female luer lock hub; flexible section; optional soft distal tip. Variable length, diameter, curve style, and side hole configurations. Introduced via cutdown or percutaneous entry. Used by physicians in clinical settings for contrast media delivery and as conduit for diagnostic/therapeutic interventions. Single-patient use.

Clinical Evidence

Bench testing only. Verification of tensile strength, dynamic pressure, flow rate, dimensions, and radiopacity performed. Biocompatibility data leveraged from predicate device (K922552) due to identical material composition.

Technological Characteristics

Radiopaque shaft; molded female luer lock hub. Variable dimensions (length, diameter, curve, side holes). Single-patient use. Sterilization method consistent with existing NAMIC devices.

Indications for Use

Indicated for patients undergoing angiography requiring contrast medium delivery or diagnostic/therapeutic procedures via vascular access.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• Selector Angiographic Catheter (K922552)

Submission Summary (Full Text)

{0}

PREMARKET NOTIFICATION
K960801

# VII: 510(K) SUMMARY

**Manufacturer:** NAMIC USA Corporation
Glens Falls, New York 12801
**Contact Person:** Mary Meagher Rubin
Regulatory Affairs Specialist
Telephone Number [phone]
Facsimile Number [phone]
**Date Prepared:** February 26, 1996
**Trade Name:** Selector Angiographic Catheter
**Common Name:** Angiographic Catheter
**Classification Name:** Catheter, Angiographic
Catheter, Cardiovascular
Catheter, Intravascular, Diagnostic
**Predicate Device:** Selector Angiographic Catheter (K922552)

## Intended Use:

The Selector Angiographic Catheter is intended to deliver contrast medium during angiography as well as to provide a conduit for various diagnostic and therapeutic procedures. Selector Angiographic Catheters are intended for single-patient use only.

## Product Description:

The Selector Angiographic Catheter consists of a radiopaque shaft with an attached molded female luer lock hub. The shaft of the catheter includes a flexible section and an optional soft distal tip. The Selector Angiographic catheter may vary with respect to length, diameter, curve style, and the number of side holes present.

Selector Angiographic Catheters can be introduced into the selected blood vessel by either cutdown or percutaneous entry techniques.

Selector™
Angiographic Catheter
NAMIC® USA CORPORATION
Page 44

{1}

PREMARKET NOTIFICATION

VII. 510(K) Summary (Continued).

## Comparison to Predicate Device:

The Selector Angiographic Catheter is equivalent to the currently marketed Selector Angiographic Catheter. The proposed new Selector Angiographic Catheter will be offered in a larger French size (diameter) than the currently marketed device.

The Selector Angiographic Catheter is manufactured in the same manner as the predicate device. Packaging and sterilization for the Selector Angiographic Catheter are the same as for other NAMIC devices.

## Performance Testing:

The new Selector Angiographic Catheter has been subjected to non-clinical performance testing to provide data supporting the safety and effectiveness of the device. The test protocol included verification of tensile, dynamic pressure testing, flow rate, diameters, and radiopacity. The resultant data demonstrates that the device meets the required performance criteria.

## Biocompatibility:

Biocompatibility testing has been performed on the currently marketed Selector Angiographic Catheter (K922552). The material composition of the new Selector Angiographic Catheter is the same as currently marketed NAMIC products.

Selector™
Angiographic Catheter
NAMIC® USA CORPORATION
Page 45