RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE

K955495 · Rusch, Inc. · BTR · Jun 27, 1996 · Anesthesiology

Device Facts

• Record ID: K955495
• Device Name: RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE
• Applicant: Rusch, Inc.
• Product Code: BTR · Anesthesiology
• Decision Date: Jun 27, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is a single use, sterile, cuffed tracheal tube for tracheal intubation and indicated for airway management.

Device Story

Single-use, sterile, cuffed tracheal tube; used for airway management via tracheal intubation. Device consists of clear, implant-tested PVC tube with encapsulated stainless steel reinforcing spiral; includes graduated markings for intubation depth monitoring; terminated with fully inserted connector. Features low-pressure, high-volume cuff inflated via luer-activated valve, pilot balloon, and inflation lumen. Used by clinicians in hospital settings to maintain patent airway; output is physical airway access; benefits include secure ventilation and airway protection.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Materials: Implant-tested PVC, stainless steel reinforcing spiral. Design: Cuffed tracheal tube with graduated markings, luer-activated valve, pilot balloon, and inflation lumen. Sizes: 5.0 mm to 11.0 mm ID. Sterilization: Sterile, single-use.

Indications for Use

Indicated for airway management in patients requiring tracheal intubation. Available in sizes 5.0 mm to 11.0 mm internal diameters.

Regulatory Classification

Identification

A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.

Predicate Devices

• Sheridan Reinforced Cuffed Tracheal Tube (K844296)
• SIMS/Concord/Portex Reinforced Cuffed Silicone Tracheal Tube (K830352)
• NCC/Mallinckrodt Reinforced Tracheal Tube Cuffed

Submission Summary (Full Text)

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U

RUSCH.

INTERNATIONAL

Group Regulatory Affairs

A Subsidiary of Teleflex Incorporated (USA)

K955495

Tall Pines Park
Jaffrey, NH 03452
[phone]
FAX [phone] or 6108

JUN 27 1995

To: Whom it may concern

## Substantial Equivalence 510(k) Summary

Reference: Rüsch Reinforced Tracheal Tube - Cuffed, sterile

The Rüsch Reinforced Endotracheal Tube - Cuffed, sterile for tracheal intubation applied for in this application is substantially equivalent in design, use and materials to the:

Sheridan Reinforced Cuffed Tracheal Tube - K844296
SIMS/Concord/Portex Reinforced Cuffed Silicone Tracheal Tube - K830352
NCC/Mallinckrodt Reinforced Tracheal Tube Cuffed

currently being marketed and sold in inter-state commerce.

The device, which is equivalent to other devices currently being marketed, consists of a clear, implant tested, P.V.C. tube with an encapsulated stainless steel reinforcing spiral. The tube is graduated with multiple centimeter markings to allow easy determination of the intubated length, and is terminated with a fully inserted connector.

The tube is fitted with a low pressure, high volume cuff, which is inflated through a luer-activated valve, pilot balloon, inflation tube and lumen in the wall of the main tube.

The device is a single use, sterile, cuffed tracheal tube for tracheal intubation and indicated for airway management. It will be available in a variety of sizes from 5.0 mm to 11.0 mm internal diameters in steps of 0.5 mm..

Based upon the equivalence in materials, design and intended use between this tube and others presently being marketed and sold, no difference in safety and effectiveness is forecasted.

signed


Authorized, Regulatory Affairs Department
October 10, 1995