SCIMED SCEPTOR & SCEPTOR EXCHANGE PTCA GUIDE WIRES

K960563 · Scimed Life Systems, Inc. · DQX · Apr 29, 1996 · Cardiovascular

Device Facts

• Record ID: K960563
• Device Name: SCIMED SCEPTOR & SCEPTOR EXCHANGE PTCA GUIDE WIRES
• Applicant: Scimed Life Systems, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Apr 29, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The SCIMED Sceptor and Sceptor Exchange PTCA Guide Wires are intended to facilitate the placement and exchange of PTCA balloon catheters and other therapeutic devices during angioplasty. The devices are provided sterile and intended for one procedure only.

Device Story

PTCA guide wire; facilitates placement/exchange of balloon catheters and therapeutic devices during angioplasty. Features one-piece stainless steel core wire; tapered distal section; Pebax sleeve; platinum spring coil. Proximal section coated with PTFE; distal tip/sleeve coated with XTRA (silicone). Used in clinical setting by interventional cardiologists. Device provides mechanical support and trackability for catheter navigation through coronary vasculature.

Clinical Evidence

Bench testing only. Evaluation focused on PTFE coating adherence. Results confirmed compliance with requirements and adequacy for intended use.

Technological Characteristics

Materials: stainless steel core, Pebax sleeve, platinum spring coil, PTFE proximal coating, XTRA (silicone) distal coating. Design: tapered distal section. Sterilization: provided sterile. Single-use.

Indications for Use

Indicated for patients undergoing percutaneous transluminal coronary angioplasty (PTCA) requiring placement or exchange of balloon catheters and therapeutic devices.

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 Sceptor PTCA Guide Wire
• SCIMED Sceptor Exchange PTCA Guide Wire
• SCIMED ChoICE PTCA Guide Wire

Submission Summary (Full Text)

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K960563
510(k) Notification
SCIMED Sceptor and Sceptor Exchange PTCA Guide Wire
Page 3
AC-29 1996
SCIMED
LIFE SYSTEMS, INC.

# 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)
February 8, 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® Sceptor™ Guide Wire
SCIMED® Sceptor™ Exchange Guide Wire

## II. Name of Predicate Devices:

SCIMED® Sceptor™ PTCA Guide Wire
SCIMED® Sceptor™ PTCA Exchange Guide Wire
SCIMED® ChoICE™ PTCA Guide Wire

## III. Device Description:

The Sceptor and Sceptor Exchange Guide Wires utilize common biocompatible materials and are constructed in a similar manner as currently marketed devices. The one piece stainless steel core wire has a PTFE (gray or black) coated proximal section and a tapered distal section. The distal section is surrounded by a Pebax® sleeve and platinum spring coil. The spring tip and polymer sleeve are coated with XTRA™ (silicone) coating.

## IV. Intended Use:

The SCIMED Sceptor and Sceptor Exchange PTCA Guide Wires are intended to facilitate the placement and exchange of PTCA balloon catheters and other therapeutic devices during angioplasty. 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 Sceptor and Sceptor Exchange PTCA Guide Wire
Page 4

SCIMED
LIFE SYSTEMS, INC.

## V. Summary of Technological Characteristics:

The Sceptor and Sceptor Exchange PTCA Guide Wires utilize the same materials and method of construction as the currently marketed Sceptor and Sceptor Exchange Guide Wires. This 510(k) describes the use of an alternate proximal coating (PTFE) which is used on the currently marketed SCIMED ChoICE PTCA Guide Wire.

## VI. Non-clinical Test Summary:

Testing and evaluation of the guide wires included teflon coating adherence. Test results verified that the Sceptor and Sceptor Exchange Guide Wires met the minimum requirements and are adequate for their intended use. The Sceptor and Sceptor Exchange PTCA Guide Wires are considered to be substantially equivalent to guide wires currently marketed by SCIMED (Sceptor, Sceptor Exchange and ChoICE Guide Wires) based on a comparison of intended use, design and the results of in vitro testing and evaluation.

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