SCIMED CHOICE PT VISION PTCA GUIDE WIRE

K962572 · Scimed Life Systems, Inc. · DQX · Dec 17, 1996 · Cardiovascular

Device Facts

• Record ID: K962572
• Device Name: SCIMED CHOICE PT VISION PTCA GUIDE WIRE
• Applicant: Scimed Life Systems, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Dec 17, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The SCIMED ChoICE PT Vision PTCA 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 PT Vision PTCA Guide Wires are not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.

Device Story

Steerable guide wire; 0.014-inch diameter; 182/300 cm lengths. Distal stainless steel core wire; polyurethane sleeve; ICE hydrophilic coating; proximal PTFE coating. Used by physicians during PTCA or intravascular interventions to facilitate catheter placement/exchange. Manual operation; provides tactile feedback and steerability to navigate vasculature. Benefits patient by enabling precise delivery of therapeutic devices to target lesion sites.

Clinical Evidence

Bench testing only. No clinical data presented. Testing included tip tensile, tip torsion, combined load, tip flexibility, J-Tip curve retention, polyurethane shear strength, torque response, and PTCA catheter compatibility. Results confirmed device met all minimum requirements.

Technological Characteristics

0.014-inch diameter guide wire; stainless steel core; polyurethane sleeve; ICE hydrophilic coating (distal); PTFE coating (proximal). Available in multiple tip flexibilities (Floppy, Intermediate, Extra Support, Standard, Super Support, Super Support II). Sterile, single-use. Manual operation.

Indications for Use

Indicated for patients undergoing PTCA or other intravascular interventional procedures requiring placement and exchange of balloon dilatation catheters or therapeutic devices. Not 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 (K943192 & K961015)
• SCIMED ChoICE Plus PTCA Guide Wire (K945129 & K961015)
• SCIMED ChoICE Exchange PTCA Guide Wire (K950113 & K961015)
• SCIMED ChoICE PT PTCA Guide Wire (K941895 & K960657)
• SCIMED ChoICE PT Plus PTCA Guide Wire (K950216 & K960657)
• SCIMED ChoICE PT Exchange PTCA Guide Wire (K950266 & K960657)
• SCIMED Sceptor and Sceptor Exchange PTCA Guide Wire (K960563)

Submission Summary (Full Text)

{0}

510(k) Notification
SCIMED ChoICE PT Vision PTCA Guide Wires
K962572

SCIMED
Boston Scientific Corporation
SCIMED Life Systems, Inc.
One SCIMED Place
Maple Grove, MN 55311-1566
612·494·1700

DEC 17 1996

# 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 June 28, 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 PT Vision PTCA Guide Wires

## II. Name of Predicate Devices:

| 510(k) Reference No. | Predicate Device |
| --- | --- |
| K943192 & K961015 | SCIMED ChoICE PTCA Guide Wire |
| K945129 & K961015 | SCIMED ChoICE Plus PTCA Guide Wire |
| K950113 & K961015 | SCIMED ChoICE Exchange PTCA Guide Wire |
| K941895 & K960657 | SCIMED ChoICE PT PTCA Guide Wire |
| K950216 & K960657 | SCIMED ChoICE PT Plus PTCA Guide Wire |
| K950266 & K960657 | SCIMED ChoICE PT Exchange PTCA Guide Wire |
| K960563 | SCIMED Sceptor and Sceptor Exchange PTCA Guide Wire
(Alternative Black PTFE Coating) |

{1}

510(k) Notification
SCIMED ChoICE PT Vision PTCA Guide Wires
SCIMED Boston Scientific Corporation
SCIMED Life Systems, Inc.
One SCIMED Place
Maple Grove, MN 55311-1566
612·494·1700

## III. Device Description:

The ChoICE PT Vision PTCA Guide Wires are steerable guide wires available in a nominal diameter of 0.014 inches and nominal lengths of 182 and 300 centimeters. The available tip flexibilities will be Floppy, Intermediate, Extra Support, Standard, Super Support, and Super Support II. The distal two centimeters of all models are straight shapeable or available in a pre-formed J-Tip.

The tapered, distal stainless steel core wire is surrounded by a polyurethane sleeve and is coated with ICE™ Hydrophilic Coating. The Floppy, Intermediate, Extra Support, and Standard guide wires will have the distal 38 centimeters surrounded by the polyurethane sleeve and are available in radiopaque lengths of 2 and 38 cm. The Super Support and Super Support II guide wires will have the distal 10 centimeters surrounded by the polyurethane sleeve, and are available in radiopaque lengths of 2 and 10 cm. The proximal wire is coated with polytetrafluoroethylene (PTFE)

## IV. Intended Use:

The SCIMED ChoICE PT Vision PTCA 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 PT Vision PTCA Guide Wires are not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.

## V. Summary of Technological Characteristics:

The ChoICE PT Vision PTCA Guide Wires utilize the same materials and methods of construction as the currently marketed ChoICE and ChoICE PT family of Guide Wires.

{2}

510(k) Notification
SCIMED ChoICE PT Vision PTCA Guide Wires

SCIMED
Boston Scientific Corporation
SCIMED Life Systems, Inc.
One SCIMED Place
Maple Grove, MN 55311-1566
612·494·1700

## VI. Non-Clinical Test Summary:

Testing and evaluation of the guide wires included tip tensile, tip torsion, combined load, and tip flexibility. Additionally, J-Tip curve retention, polyurethane shear strength, torque response, and PTCA catheter compatibility were performed. Test results verified that the ChoICE PT Vision PTCA Guide Wires met all of the minimum requirements and are adequate for their intended use. The ChoICE PT Vision PTCA Guide Wires are considered to be substantially equivalent to guide wires currently marketed by SCIMED (ChoICE, and ChoICE PT Guide Wires) based on a comparison of intended use, design and the results of in vitro testing and evaluation.