INPUT TUOHY-BORST LOCKING DEVICE

K960445 · C.R. Bard, Inc. · DYB · Aug 12, 1996 · Cardiovascular

Device Facts

• Record ID: K960445
• Device Name: INPUT TUOHY-BORST LOCKING DEVICE
• Applicant: C.R. Bard, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Aug 12, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Input Lock functions as a removable, adjustable valve indicated as an adjunctive measure to help secure a catheter to a USCI Input Introducer in order to reduce the risk of inadvertent catheter movement.

Device Story

Input Lock is a single-channel, adjustable valve device used in angiographic/angioplasty procedures. It consists of a body, an internal silicone gland, and a threaded end cap. The device attaches to an introducer sheath hub. Operation involves inserting a catheter through the device and tightening the end cap; this compresses the internal gland around the catheter, securing it in place to prevent inadvertent movement. It is a manual, mechanical accessory used by clinicians in a clinical setting. It provides a secure interface between the introducer and the catheter, reducing the risk of catheter displacement during procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: ABS body, Nylon end cap, Silicone gland. Dimensions: 1.0" nominal length. Mechanism: Threaded end cap compresses internal silicone gland to constrict around catheter. Connectivity: None. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for use as an adjunctive measure to secure a catheter to an introducer sheath to reduce the risk of inadvertent catheter movement during angiographic 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 Disposable Y-Connector w/Modified Tuohy-Borst Adapter (K890325)

Submission Summary (Full Text)

{0}

K960445
AUG 12 1996
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:**
January 31, 1996

- **Name of Device:**
USCI® Input™ Tuohy-Borst Locking Device

- **Common/Usual Name of Device:**
Angiographic/Angioplasty Accessory Device

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

BARD
36

{1}

37

- **Predicate Device:**
USCI® Disposable Y-Connector w/Modified Tuohy-Borst Adapter

- **Description and Intended Use of Device:**
The USCI® Input™ Tuohy-Borst Locking Device (hereinafter referred to as the Input Lock) is comprised of a single channel (body) which at its distal segment connects to the introducer sheath hub and ends proximally with a threaded segment containing an internally seated gland. Attached to this threaded proximal segment is an end cap which when thread tightened compresses the gland and secures the indwelling catheter.

The Input Lock functions as a removable, adjustable valve indicated as an adjunctive measure to help secure a catheter to an introducer in order to reduce the risk of inadvertent movement.

{2}

38

## 6.2 Summary of Similarities and Differences

Please refer to Exhibit 6.2, on the following page, for a Table of the Similarities and Differences.

The Input Lock is new to the USCI line of accessory devices. It utilizes the "locking" design characteristic of the USCI® Disposable Y-Connector with Modified Tuohy-Borst Adapter (K890325, concurrence received March 15, 1989 and hereinafter referred to as the Disposable Y-Connector). Both devices consist of a body, and an end cap, both which differ in configuration, and a gland. The Disposable Y-Connector differs such that the body contains a distal fitting that rotates (with an internal O-ring for ease of rotating movement) and a washer side by side with the gland. The Disposable Y-Connector also contains a second proximal channel for connection to a manifold. The Input Lock is a less bulky device that attaches to the introducer sheath hub while the Disposable Y-Connector attaches to a catheter hub.

The two devices have the identical mechanism for reducing the risk of inadvertant catheter movement. When the end caps of both devices are thread tightened to the body, the I.D. of the internal gland constricts around the I.D. of the indwelling catheter.

The Disposable Y-Connector is indicated for PTA, PTCA pressure monitoring, dye infusion and flushing. However, the Instructions for Use (IFU) provided in the 510(k) Premarket Notification (K890325) indicate that this device has "... an adjustable gland adjusting to form a seal with or without a guide wire in place." The IFU contains two precautions "Do not collapse the lumen of the balloon dilatation catheter or impair free movement of the guide wire by adjusting the Tuohy-Borst adapter" (compression of the gland) "too tightly." and "Excessive tightening of the Tuohy-Borst adapter may inhibit the ability to monitor distal pressures, manipulate the steerable guide wire, or deflate the balloon."

{3}

The Input Lock functions as a removable, adjustable valve indicated as an adjunctive measure to help secure a catheter to a USCI Input Introducer in order to reduce the risk of inadvertent catheter movement.

{4}

Exhibit 6.2
Table of Similarities and Differences

| Component/Characteristic | Input Lock | Disposable Y-Connector |
| --- | --- | --- |
| Body* | ABS** | Polycarbonate |
| End Cap | Nylon | Polycarbonate |
| Gland | Silicone | Silicone |
| Washer (side by side w/gland) | N/A | Teflon |
| "O" Ring (internal to distal fitting) | N/A | Silicone |
| Distal Fitting (of the body) | threaded & stationary | threaded & rotates |
| Distal Fitting | attaches to introducer sheath | attaches to catheter hub |
| Body Length (nominal) | 1.0" | 2.6" |
| Gasket I.D. (nominal) | .120" | .075" |
| Channel I.D. (nominal) | .110" | .125" |

* The Input Lock body with distal fitting is one molded segment. The Disposable Y-Connector body and distal rotating fitting is comprised of three (3) parts: the molded Y-body, the O-ring and the molded rotating fitting which houses the O-ring.

** Acrylonitrile Butadiene Styrene

40