CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE

K965023 · Scimed Life Systems, Inc. · DQX · Mar 4, 1997 · Cardiovascular

Device Facts

• Record ID: K965023
• Device Name: CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE
• Applicant: Scimed Life Systems, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Mar 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The SCIMED ChoICE Plus, ChoICE PT Plus and the 182 cm ChoICE PT Vision 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 Plus, ChoICE PT Plus and the 182 cm ChoICE PT Vision Guide Wires are not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.

Device Story

PTCA guide wires facilitate placement/exchange of balloon dilatation catheters or other therapeutic devices during intravascular interventional procedures. Device consists of differential magnetic (Hiperco) core wire encased in FEP or PTFE coated stainless steel hypotube; proximal assembly attached to distal stainless steel core wire via weld and adhesive bond. Used in clinical settings by physicians during interventional procedures. Modification involves alternative manufacturing method for attaching proximal core wire/hypotube assembly. Provides mechanical support and guidance for catheter navigation within vasculature.

Clinical Evidence

Bench testing only. Testing included proximal tensile, joint kink, and fatigue testing. Results verified that the modified proximal section met all minimum requirements.

Technological Characteristics

Proximal section: Hiperco core wire, stainless steel hypotube, FEP or PTFE coating. Distal section: stainless steel core wire. Assembly: weld and adhesive bond. Sterile, single-use. Mechanical device; no software or energy source.

Indications for Use

Indicated for patients undergoing PTCA or other intravascular interventional procedures requiring placement and exchange of balloon dilatation catheters or other therapeutic devices. Not indicated 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

• ChoICE Plus (K945129, K961015, K964551)
• ChoICE PT Plus (K950216, K960657)
• EnTre III (K942333, K946240, K950534, K960563)
• EnTre II (K931514, K935022, K935577)
• 182 cm ChoICE PT Vision (K962572)

Submission Summary (Full Text)

{0}

510(k) Notification
SCIMED ChoICE Plus, ChoICE PT Plus, and 182 cm 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
K965023
MAR - 4 1997

# Summary of Safety and Effectiveness

## Section 6

### Submitter's Information

**Name and Address**
SCIMED Life Systems, Inc.
One SCIMED Place
Maple Grove, Minnesota 55311

**Contact Person**
Connie J. Del Toro
[phone]

**Date**
December 13, 1996

### Device Name

**Proprietary Names**
SCIMED ChoICE Plus PTCA Guide Wires
SCIMED ChoICE PT Plus PTCA Guide Wires
SCIMED 182 cm ChoICE PT Vision PTCA Guide Wires

**Common or Usual Name**
PTCA Guide Wire

**Classification Name**
Catheter Guide Wire (per 21CFR 870.1330)

Continued on next page.

{1}

510(k) Notification
SCIMED ChoICE Plus, ChoICE PT Plus, and 182 cm ChoICE PT Vision PTCA Guide Wires
SCIMED
Boston Scientific Corporation
SCIMED Life Systems, Inc.

# Summary of Safety and Effectiveness, Continued

## Section 6

### Substantial Equivalence Comparison

The modified proximal section on the ChoICE Guide Wires is substantially equivalent to the proximal section on the following SCIMED products.

| Product | 510(k) | Clearance Date |
| --- | --- | --- |
| ChoICE Plus | K945129 | March 3, 1995 |
| | K961015 | May 15, 1996 |
| | K964551 | Submitted November 14, 1996 |
| ChoICE PT Plus | K950216 | June 22, 1995 |
| | K960657 | April 29, 1996 |
| EnTre III
(marketed as the Sceptor Guide Wire) | K942333 | August 31, 1994 |
| | K946240 | March 31,1995 |
| | K950534 | April 28, 1996 |
| | K960563 | April 29, 1996 |
| EnTre II | K931514 | June 25, 1993 |
| | K935022 | January 18, 1993 |
| | K935577 | November 17, 1993 |
| 182 cm ChoICE PT Vision | K962572 | Submitted July 1, 1996. |

### Proximal Section Description

The proximal section of the guide wire consists of a differential magnetic (Hiperco*) core wire encased in a FEP or PTFE coated stainless steel hypotube. The Hiperco* core wire/hypotube assembly is attached to the distal stainless steel core wire assembly by means of a weld and an adhesive bond. There are no other changes being made to the proximal section of the guide wires.

Continued on next page.

{2}

510(k) Notification
SCIMED ChoICE Plus, ChoICE PT Plus, and 182 cm ChoICE PT Vision PTCA Guide Wires
SCIMED
Boston Scientific Corporation
SCIMED Life Systems, Inc.

# Summary of Safety and Effectiveness, Continued Section 6

## Intended Use

The SCIMED ChoICE Plus, ChoICE PT Plus and the 182 cm ChoICE PT Vision 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 Plus, ChoICE PT Plus and the 182 cm ChoICE PT Vision Guide Wires are not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.

## Summary of Technological Characteristics

The modified proximal section on the ChoICE Guide Wires utilize the same materials and methods of construction as the proximal section on the ChoICE Plus, ChoICE PT Plus, EnTre III, EnTre II, and the recently submitted 182 cm ChoICE PT Vision Guide Wires. The modification to the proximal section consists of an alternative manufacturing method for attaching the proximal Hiperco*core wire/hypotube assembly.

## Non-Clinical Test Summary

Testing and evaluation of the guide wires included

- Proximal Tensile,
- Joint Kink, and
- Fatigue testing.

### Results

Test results verified that the modified proximal section of the ChoICE Guide Wires met all of the minimum requirements and is adequate for it’s intended use.

### Summary

The modified proximal section of the ChoICE Guide Wires is substantially equivalent to the proximal section on the ChoICE Plus, ChoICE PT Plus, EnTre III, EnTre II, and the recently submitted 182 cm ChoICE PT Vision Guide Wire, based on a comparison of intended use, design and the results of in vitro testing and evaluation.

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