SCIMED CHOICE FAMILY OF PTCA GUIDE WIRES

K970244 · Scimed Life Systems, Inc. · DQX · Mar 28, 1997 · Cardiovascular

Device Facts

• Record ID: K970244
• Device Name: SCIMED CHOICE FAMILY OF PTCA GUIDE WIRES
• Applicant: Scimed Life Systems, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Mar 28, 1997
• 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 Wires are 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 or J-tip configurations; various tip flexibilities (Floppy, Intermediate, Extra Support, Standard, Super Support, Super Support II). Features polymer sleeve over tapered core wire; ICE Hydrophilic Coating. Lengths: 182 cm, 190 cm, 300 cm. Used by physicians in interventional cardiology/radiology to navigate vasculature and facilitate catheter exchange. Provides mechanical support and guidance for therapeutic devices. Sterile, single-use.

Clinical Evidence

No clinical data. Bench testing only. Performance of modified Extra Support wires is supported by data from identical designs in the ChoICE PT Extra Support line (K960657).

Technological Characteristics

Steerable guide wire; 0.014-inch diameter; spring coil; tapered core wire; polymer sleeve; ICE Hydrophilic Coating; fluorinated polymer core coating. Sterilized for single use.

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

• ChoICE (K943192, K950141, K961015, K964551)
• ChoICE Plus (K945129, K961015, K964551, K965023)
• ChoICE Exchange (K950113, K961015, K964551)
• ChoICE PT (K941895, K950835, K960657)
• ChoICE PT Plus (K950216, K960657, K965023)
• ChoICE PT Exchange (K950266, K960657)

Submission Summary (Full Text)

{0}

510(k) Notification
SCIMED ChoICE, ChoICE Plus, and ChoICE Exchange PTCA Guide Wires
SCIMED
Boston Scientific Corporation
SCIMED Life Systems, Inc.
One SCIMED Place
Maple Grove, MN 55311-1566
612·494·1700
K970244
MAR 28 1997

# Summary of Safety and Effectiveness

## Appendix A

### 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**
January 21, 1997

### Device Name

**Proprietary Name**
SCIMED ChoICE PTCA Guide Wire
SCIMED ChoICE Plus PTCA Guide Wire
SCIMED ChoICE Exchange PTCA Guide Wire

**Common or Usual Name**
PTCA Guide Wire

**Classification Name**
Catheter Guide Wire

Continued on next page.

{1}

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

# Summary of Safety and Effectiveness, continued
# Appendix A

## Predicate Devices:

The following predicate devices are available from SCIMED.

| Product | 510(k) | Clearance Date |
| --- | --- | --- |
| ChoICE | K943192 | November 22, 1994 |
| | K950141 | March 3, 1995 |
| | K961015 | May 15, 1996 |
| | K964551 | Submitted Nov. 14, 1996 |
| ChoICE Plus | K945129 | March 3, 1995 |
| | K961015 | May 15, 1996 |
| | K964551 | Submitted Nov. 14, 1996 |
| | K965023 | Submitted Dec. 17,1996 |
| ChoICE Exchange | K950113 | March 31, 1995 |
| | K961015 | May 15, 1996 |
| | K964551 | Submitted Nov. 14, 1996 |
| ChoICE PT | K941895 | May 24, 1996 |
| | K950835 | May 25, 1995 |
| | K960657 | April 29, 1996 |
| ChoICE PT Plus | K950216 | June 22, 1995 |
| | K960657 | April 29, 1996 |
| | K965023 | Submitted Dec. 17, 1996 |
| ChoICE PT Exchange | K950266 | April 14, 1996 |
| | K960657 | April 29, 1996 |

## Device Description

The ChoICE 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 available tip flexibilities are

- Floppy,
- Intermediate,
- Extra Support,
- Standard,
- Super Support, and
- Super Support II

A-2

{2}

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

# Summary of Safety and Effectiveness, continued
# Appendix A

| Device Description continued | 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 are
• ChoICE-190 cm,
• ChoICE Plus-182 cm, and
• ChoICE Exchange-300 centimeters. |
| --- | --- |
| 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 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 ChoICE Guide Wires utilize the same materials and methods of construction as the currently marketed ChoICE Family of Guide Wires and the ChoICE PT Family of Guide Wires. The change consists of a modification to the core wire dimensions. |
| Non-Clinical Test Summary | Additional testing of the modified ChoICE Extra Support Guide Wires was not performed since the identical core wire dimension is present on the ChoICE PT Extra Support Guide Wires.

Testing presented in K960657, ChoICE PT Extra Support on the first support diameter is directly applicable to the ChoICE Extra Support because of the identical design in this section of the wire. |

A-3