SCIMED 5 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS

K964859 · Scimed Life Systems, Inc. · DQO · Feb 10, 1997 · Cardiovascular

Device Facts

• Record ID: K964859
• Device Name: SCIMED 5 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS
• Applicant: Scimed Life Systems, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: Feb 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The SCIMED IMPULSE Angiographic Catheters are designed to provide a pathway to be used for delivering contrast media to selected sites in the vascular system during an angiographic procedure.

Device Story

Diagnostic intravascular catheter used to deliver contrast media to vascular sites during angiography. Device consists of a multi-layer shaft (inner Pebax/polyurethane, braided stainless steel middle, outer Pebax) and a polycarbonate hub. Operator (physician) inserts catheter into vascular system; torque control and kink resistance provided by braided stainless steel. Radiopaque materials allow visualization under fluoroscopy. Device is single-use and sterile. Benefits include improved contrast delivery and navigation through vascular anatomy.

Clinical Evidence

Bench testing only. Testing included pressure burst, tip bond tensile, hub tensile, dye flow, maximum dye flow, tip coefficient of friction, force transmitted by the catheter tip, device radiopacity, and pigtail straightener peel-away force. Biocompatibility and shelf-life testing were also performed.

Technological Characteristics

5 French diagnostic catheter. Materials: Pebax, Polyurethane, stainless steel braid, polycarbonate hub. Features: Selective, Pigtail, and Multipurpose curve styles; optional side holes. Radiopaque components for visualization. Sterilized for single-use. Transitional stiffness extrusion and annealing processes used for shaft mechanical properties.

Indications for Use

Indicated for use in patients undergoing angiographic procedures requiring the delivery of contrast media to selected sites within the vascular system.

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

• SCIMED® 5 French EXPO™ Angiographic Catheter
• Cordis® Corporation 5 F Infiniti™ Angiographic Catheter

Submission Summary (Full Text)

{0}

510(k) Notification
SCIMED® 5 F Diagnostic Catheter
K964859
Section 4
Summary of Safety and Effectiveness

(Pursuant To Section 12 of the SAFE MEDICAL DEVICES ACT of 1990)
Prepared April 2, 1996
FEB 10 1997

I. General Provisions

Submitter’s Name and Address
SCIMED Life Systems, Inc.
One SCIMED Place
Maple Grove, Minnesota 55311

Contact Person
Angela Raun
[phone]

Classification Name
Diagnostic Intravascular Catheters
(21CFR Part 870.1200)

Common or Usual Name
Diagnostic Intravascular Catheter

Proprietary Name
SCIMED® 5 French IMPULSE™
Angiographic Catheters

II. Name of Predicate Devices
SCIMED® 5 French EXPO™ Angiographic
Catheter, and Cordis® Corporation 5 F
Infiniti™ Angiographic Catheter

III. Device Description
The 5 French SCIMED IMPULSE Angiographic Catheters will be available in 3
models; 0.045” ID Selective curve styles, 0.047” ID Selective curve styles, and the
0.045” ID Pigtail and Multipurpose curve styles whose tip ID tapers from 0.045” to
0.041” distally. Curve styles will be available with optional side holes.

The shafts of all 3 models utilize common biocompatible materials and consist of
the following three layers: 1) The inner layer provides a smooth surface to allow for
dye delivery and ease of guide wire movement. The Selective models utilize
Pebax® for the inner layer, while the Pigtail and Multipurpose catheters utilize a
Polyurethane/Pebax coextrusion, 2) The middle layer is made of braided stainless
steel wire that extends from the shaft to the tip to provide torque control, kink
resistance and support, and 3) the outer layer, which is also manufactured from
Pebax, provides stiffness and curve retention. Radiopaque materials are utilized in
the inner shaft, outer shaft and tip to allow visualization of the catheter during the
procedure.

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510(k) Notification
SCIMED® 5 F Diagnostic Catheter

# Section 4 Summary of Safety and Effectiveness, cont.

The tips of the Selective models are made from polyurethane, while the multipurpose and pigtail tips are composed of Pebax. Both tips are radiopaque to allow visualization during a procedure. The tips are heat fused to the distal end of the shaft.

The catheters utilize a polycarbonate hub and Pebax strain relief. The hub is molded to the proximal end of the catheter shaft. The devices will be provided sterile and are intended for one procedure use only.

## IV. Intended Use

The SCIMED IMPULSE Angiographic Catheters are designed to provide a pathway to be used for delivering contrast media to selected sites in the vascular system during an angiographic procedure.

## V. Summary of Technological Characteristics

The 5 French SCIMED IMPULSE Angiographic Catheters are a modification of SCIMED’s currently marketed 5 French EXPO Angiographic Catheters. Changes are summarized as follows:

- The ID has been increased in one Selective model to 0.047".
- The inner shaft material has been changed from Polyurethane/Pebax to Pebax in the Selective models.
- Radiopaque loading components have been changed for the inner shaft layer, outer shaft layer, strain relief and tip material.
- A UV stabilizer has been added to the primary shaft material of all new models.
- The colorants in the primary shaft, inner shaft, catheter tip and strain relief have been changed.
- The inner shaft material durometers have been modified on the Selective models.
- The distal 1" to 5" of the Selective models will decrease in shaft stiffness using transitional stiffness extrusion processing. The proximal end of the shaft will increase in shaft stiffness due to an added annealing process.
- A pigtail straightener is being provided for the pigtail models, which allows the pigtail to be introduced into the sheath more easily.
- The braid wire material has been changed to a different grade of stainless steel and the braiding pattern has been slightly modified.

## VI. Non-clinical Test Summary

Functional testing consisted of pressure burst, tip bond tensile, hub tensile, dye flow, maximum dye flow, tip coefficient of friction, force transmitted by the catheter tip, device radiopacity, and pigtail straightener peel-away force testing. Biocompatibility and shelf life testing has also been conducted. Test results verified

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510(k) Notification
SCIMED® 5 F Diagnostic Catheter

## Section 4 Summary of Safety and Effectiveness, cont.

that the 5 F IMPULSE Angiographic Catheters are adequate for their intended use. The 5 F IMPULSE Angiographic Catheters are considered substantially equivalent to angiographic catheters currently marketed by SCIMED and Cordis based on a comparison of intended use, the design and the results of *in-vitro* testing and evaluation.

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