SCIMED 6-10 F TRIGUIDE GUIDE CATHETERS 6F,7F,8F,9F & 10F

K961280 · Scimed Life Systems, Inc. · DQY · May 15, 1996 · Cardiovascular

Device Facts

• Record ID: K961280
• Device Name: SCIMED 6-10 F TRIGUIDE GUIDE CATHETERS 6F,7F,8F,9F & 10F
• Applicant: Scimed Life Systems, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: May 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The SCIMED guide catheters are designed to provide a pathway through which medical instruments, such as balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. These devices are not intended for use in the cerebral vasculature.

Device Story

Guide catheter; provides pathway for interventional devices (balloon catheters, guide wires). Three-layer shaft construction: inner PTFE liner (low friction); middle braided stainless steel wire (torque control/support); outer Pebax layer (stiffness/radiopacity). Distal tip heat-fused; proximal Pebax hub/strain relief. Used by physicians in clinical settings for coronary procedures. Facilitates device delivery to target site; enhances procedural efficiency. Single-use; sterile.

Clinical Evidence

Bench testing only. Functional testing included pressure burst, material adhesion, and device passage testing. Results verified the modified PTFE-lined catheter is adequate for its intended use.

Technological Characteristics

Three-layer shaft: inner PTFE liner, middle braided stainless steel wire, outer Pebax layer. Distal tip and proximal hub/strain relief made of Pebax. Radiopaque. Sterile, single-use. Dimensions: 6-10 French.

Indications for Use

Indicated for use as a pathway for the introduction of medical instruments, such as balloon dilatation catheters, guide wires, or other therapeutic devices. Contraindicated for use in the cerebral vasculature.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• SCIMED® 6,7,8,9 and 10 French TRIGUIDE® Guide Catheters
• Cordis® Corporation Vista Brite Tip™ Guide Catheter

Submission Summary (Full Text)

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510(k) Notification
SCIMED® 6-10 French Guide Catheters
K961280
MAY 15 1996

# SECTION 3
## 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 April 2, 1996

## I. General Provisions:

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

Contact Person: Angela Raun
[phone]

Classification Name: Similar to Diagnostic Intravascular
Catheters (21CFR Part 870.1200)

Common or Usual Name: Coronary Guide Catheter

Proprietary Name: SCIMED® 6,7,8,9 and10 French
TRIGUIDE® Guide Catheters

## II. Name of Predicate Devices:

SCIMED® 6,7,8,9 and10 French
TRIGUIDE® Guide Catheters, and
Cordis® Corporation Vista Brite Tip™
Guide Catheter

## III. Device Description:

The modified 6F-10F SCIMED guide catheter shafts consist of three layers: 1) the inner polytetrafluoroethylene (PTFE) layer that provides a low coefficient of friction and facilitates easy passage of medical devices such as balloon dilatation catheters, guide wires or other therapeutic devices, 2) the middle layer which is made of braided stainless steel wire that extends from the shaft to the tip to provide torque control and support and 3) the outer layer, manufactured from Pebax®, which provides stiffness, memory and radiopacity. The distal tip is made of Pebax and is radiopaque. The tip is heat fused to the distal end of the shaft. The catheters utilize a one piece Pebax hub/strain relief that is molded to the proximal end of the guide catheter shaft. The devices will be provided sterile and are intended for one procedure use only.

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510(k) Notification
SCIMED® 6-10 French Guide Catheters

## IV. Intended Use:

The SCIMED guide catheters are designed to provide a pathway through which medical instruments, such as balloon dilatation catheters, guide wires or other therapeutic devices may be introduced. These devices are not intended for use in the cerebral vasculature.

## V. Summary of Technological Characteristics:

The modified 6-10 French guide catheters are identical to SCIMED's currently marketed 6-10 French guide catheters with the one exception being that the catheter's inner fluoropolymer liner is composed of polytetrafluoroethylene (PTFE) instead of fluorinated ethylene propylene (FEP).

## VI. Non-clinical Test Summary:

Functional testing consisted of pressure burst, material adhesion and device passage testing. Test results verified that the modified catheter with the PTFE inner liner is adequate for its intended use. The modified SCIMED 6-10 French guide catheters are considered substantially equivalent to guide catheters currently marketed by SCIMED and Cordis based on a comparison of intended use, the design and the results of in-vitro testing and evaluation.

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