SCIMED CHOICE/PTCA GUIDE WIRE/PLUS PTCA GUIDE WIRE/EXCHANGE PTCA GUIDE WIRE

K961015 · Scimed Life Systems, Inc. · DQX · May 15, 1996 · Cardiovascular

Device Facts

• Record ID: K961015
• Device Name: SCIMED CHOICE/PTCA GUIDE WIRE/PLUS PTCA GUIDE WIRE/EXCHANGE PTCA GUIDE WIRE
• Applicant: Scimed Life Systems, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: May 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The SCIMED ChoICE™ Guide Wires are intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The ChoICE™ Guide Wire family is not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.

Device Story

Steerable PTCA guide wires; 0.014-inch diameter; straight shapeable or pre-formed J-Tip configurations. Available in four tip flexibilities (Floppy, Intermediate, Standard, Extra Support). Construction includes tapered core wire, spring coil, and polymer sleeve coated with ICE™ Hydrophilic Coating. Used by physicians in clinical settings to facilitate catheter placement/exchange during interventional procedures. Modifications include distal polyurethane formulation change and alternative proximal spring coil attachment method. Sterile, single-use device.

Clinical Evidence

Bench testing only. Evaluated ICE lubricious coating adherence, polyurethane shear strength, polyurethane adherence, proximal spring coil joint shear, torque testing, and shelf life. Results confirmed design requirements met.

Technological Characteristics

0.014-inch diameter steerable guide wire. Materials: polyurethane, fluorinated polymer coated core wire, spring coil. Coating: ICE™ Hydrophilic. Sterilization: sterile. No software or electronic components.

Indications for Use

Indicated for patients undergoing PTCA or other intravascular interventional procedures requiring placement and exchange of balloon dilatation catheters or therapeutic devices. Contraindicated for use in cerebral vasculature.

Regulatory Classification

Identification

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

Special Controls

*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• SCIMED ChoICE™ PTCA Guide Wire (K961015)
• SCIMED ChoICE™ Plus PTCA Guide Wire (K961015)
• SCIMED ChoICE™ Exchange PTCA Guide Wire (K961015)

Submission Summary (Full Text)

{0}

510(K) Notification
SCIMED CholCE, ChoICE Plus, ChoICE Exchange PTCA Guide Wires
Page 3
SCIMED®
LIFE SYSTEMS, INC.
MAY 15 1996
K961015

# SECTION THREE--SUMMARY OF SAFETY AND EFFECTIVENESS

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
(Pursuant To Section 12 of the SAFE MEDICAL DEVICES ACT of 1990)
Prepared March 12, 1996

## I. General Provisions:

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

Contact Person: Connie J. Del Toro
[phone]

Classification Name: Catheter Guide Wire

Common or Usual Name: PTCA Guide Wire

Proprietary Name: SCIMED ChoICE™ PTCA Guide Wire
SCIMED ChoICE™ Plus PTCA Guide Wire
SCIMED ChoICE™ Exchange PTCA Guide Wire

## II. Name of Predicate Devices:

SCIMED ChoICE™ PTCA Guide Wire
SCIMED ChoICE™ Plus PTCA Guide Wire
SCIMED ChoICE™ Exchange PTCA Guide Wire

## III. Device Description:

The ChoICE, ChoICE Plus, and ChoICE Exchange PTCA Guide Wires are steerable guide wires available in a nominal diameter of 0.014 inches and two tip configurations, straight shapeable and pre-formed J-Tip. The four tip flexibilities available will be Floppy, Intermediate, Standard, and Extra Support. A polymer sleeve, extending from the spring coil to the proximal fluorinated polymer coated core wire, surrounds the tapered core wire and is coated with ICE™ Hydrophilic Coating. The available lengths for the guide wires will be ChoICE-190 cm, ChoICE Plus-182 cm and ChoICE Exchange-300 centimeters.

## IV. Intended Use:

The SCIMED ChoICE™ Guide Wires are intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The ChoICE™ Guide Wire family is not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.

Corporate Headquarters
One SCIMED Place
Maple Grove, MN 55311-1566 USA
612-494-1700

{1}

510(K) Notification
SCIMED
SCIMED ChoICE, ChoICE Plus, ChoICE Exchange PTCA Guide Wires
Page 4
LIFE SYSTEMS, INC.

## V. Summary of Technological Characteristics:

The modified ChoICE, ChoICE Plus, and ChoICE Exchange PTCA Guide Wires utilize the same materials and methods of construction as the currently marketed ChoICE, ChoICE Plus, and ChoICE Exchange PTCA Guide Wires. The modifications consist of a formulation change to the distal polyurethane material, and an alternative manufacturing method for attaching the proximal end of the spring coil.

## VI. Non-Clinical Test Summary:

Testing and evaluation of the guide wires included ICE lubricious coating adherence, polyurethane shear strength, polyurethane adherence, and proximal spring coil joint shear testing. In addition, shelf life testing was performed on test units with the modified polyurethane material. Test results verified that the modified ChoICE, ChoICE Plus, and ChoICE Exchange met the design requirements and are adequate for their intended use. The modified ChoICE, ChoICE Plus, and ChoICE Exchange are considered to be substantially equivalent to the ChoICE, ChoICE Plus, and ChoICE Exchange guide wires currently marketed by SCIMED, based on a comparison of intended use, design and the results of in vitro testing and evaluation.
*Torque testing also performed.*

Corporate Headquarters
One SCIMED Place
Maple Grove, MN 55311-1566 USA
612-494-1700