TS PERCUTANEOUS ARTERIAL/VENUS CATHETER INTRO SET

K955785 · C.R. Bard, Inc. · DYB · Mar 12, 1996 · Cardiovascular

Device Facts

• Record ID: K955785
• Device Name: TS PERCUTANEOUS ARTERIAL/VENUS CATHETER INTRO SET
• Applicant: C.R. Bard, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Mar 12, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

Input TS & TL are indicated as percutaneous introducers that are used to facilitate placing a catheter through the skin into a vein or artery. Input TS & TL are recommended for initial percutaneous introduction of a closed end catheter, temporary pacing electrode catheter or probe, or a balloon catheter. They may also be used as an instrument to exchange catheters during a procedure.

Device Story

Input TS & TL are percutaneous catheter introducer sets consisting of an uncoated teflon sheath, locking dilator, guide wire, and optional locking obturator. Used in cardiac catheterization labs by physicians to facilitate vascular access for diagnostic or therapeutic catheters. The obturator provides structural support to the sheath, preventing kinking or collapse when the introducer remains in the vessel post-procedure. This support allows patients to sit in a Semi-Fowler position (up to 60°) post-PTCA, enhancing comfort compared to mandatory flat-back positioning. Devices are sterile, single-use, and intended for clinical settings.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and intended use comparisons to the predicate device.

Technological Characteristics

Components: uncoated teflon sheath, polyurethane strain relief, black PE dilator, latex gasket, guide wire, and locking obturator. Sterile, single-use. Mechanical design facilitates percutaneous vascular access and catheter exchange.

Indications for Use

Indicated for percutaneous introduction of closed end catheters, temporary pacing electrode catheters, probes, or balloon catheters into veins or arteries; also for catheter exchange. Applicable to patients undergoing cardiac catheterization or angioplasty procedures.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• USCI® Input™ Introducer Set (K940092)

Reference Devices

• Hemaquet Introducer (K781954)
• Hemaflex Introducer (K915553)

Submission Summary (Full Text)

{0}

KGS 285
USCI

USCI Division
C.R. Bard, Inc.
Clinical and Regulatory Affairs
1200 Technology Park Drive
P.O. Box 7025
Billerica, MA 01821
[phone]
FAX: [phone]

SECTION 6.0 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

As required under Section 12, part (a)(i)(3A) of the Safe Medical Device Act of 1990, an adequate summary of any information respecting safety and effectiveness follows.

6.1 General Information

- Name and Address of Submitter:
USCI Division of C.R. Bard, Inc.
1200 Technology Park Drive
Billerica, MA 01821

- Contact:
Robert T. Miragliuolo
Director, Regulatory Affairs

- Date of Summary:
December 18, 1995

- Name of Device:
USCI® Input® TS and Input TL Percutaneous Arterial/Venous Catheter Introducer Set

- Common/Usual Name of Device:
Catheter Introducer

- Device Classification:
Cardiopulmonary Bypass Adapter, Stopcock, Manifold or Fitting

BARD
57

{1}

Appendices

- Predicate Device:
USCI® Input™ Introducer Set (K940092, concurrence received August 10, 1995)

- Description and Intended Use of Device:
Input TS & TL consists of an introducer sheath (uncoated), a locking dilator (may contain a single or double dilator), and a guide wire. Certain model numbers will also contain a locking obturator. These components are presented in Section 3.0, Exhibit 3.2. The components described in this submission are equivalent to those mentioned in the USCI Input Introducer Set, 510(k) #K940092. The latex gasket, teflon sheath with polyurethane strain relief and black PE materials, although new to the Input Introducer line of products, are not new to USCI. These materials are currently used in various other USCI introducers such as the Hemaquet Introducer (K781954/concurrence received November 29, 1978) and the Hemaflex Introducer (K915553/concurrence received February 21, 1991). Both the Hemaquet and Hemaflex Introducers have a latex gasket, a teflon sheath with a polyurethane strain relief and a black PE dilator.

The Input Introducer Set (K940092), the predicate device, consists of an introducer sheath (hydrophilic coated), a locking dilator (that may contain a single or double dilator), and a guide wire. Certain model numbers also contain a locking obturator.

Input TS & TL are indicated as percutaneous introducers that are used to facilitate placing a catheter through the skin into a vein or artery. Input TS & TL are recommended for initial percutaneous introduction of a closed end catheter, temporary pacing electrode catheter or probe, or a balloon catheter. They may also be used as an instrument to exchange catheters during a procedure. This indication statement is identical to the indication provided in the Input Introducer Set 510(k) #K940092.

{2}

During cardiac catheterization laboratory procedures, through either angiographic diagnostic or angioplasty therapeutic approaches, a physician may elect to leave an introducer in place (within the vessel). The current practice is for patients to lay flat on their backs for several hours post-PTCA. Without the support of a catheter the introducer sheath may collapse or kink. This introducer kit supplies an obturator (the obturator is also supplied as an individual component) to be used as a means of support while the introducer remains in place. The obturator material is flexible, thereby allowing the patient to sit-up in bed in the Semi-Fowler position (up to a 60° angle) post-PTCA rather than lying flat. Allowing the patient to sit up in bed at a 60° angle has the potential to enhance their comfort.

The current Input Introducer Set (predicate device), with a pebax sheath, was described in K940092 (concurrence received August 10, 1995) as a device which allows for this alternative post-PTCA patient care procedure. A statement and illustration was added to the Instructions for Use that advises physicians that patients may sit up-right (up to a 60° angle) post-procedure. The devices covered under this 510(k) Premarket Notification, with a teflon sheath, will include the same statement and illustration.

Input TS & TL contains an obturator to be used as a means of support while the introducer remains in place.

These devices are supplied sterile and are intended for one time use only.