RUSCH PEDIATRIC REINFORCED TRAHEAL (OR ENDOTRACHEAL) TUBE - UNCUFFED, STERILE

K954585 · Rusch Intl. · BTR · May 10, 1996 · Anesthesiology

Device Facts

• Record ID: K954585
• Device Name: RUSCH PEDIATRIC REINFORCED TRAHEAL (OR ENDOTRACHEAL) TUBE - UNCUFFED, STERILE
• Applicant: Rusch Intl.
• Product Code: BTR · Anesthesiology
• Decision Date: May 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5730
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The device is designed as single use, sterile, uncuffed tracheal tube for oral or nasal tracheal intubation and indicated for airway management.

Device Story

Single-use, sterile, uncuffed tracheal tube for airway management; oral or nasal intubation. Device consists of clear PVC tube with encapsulated stainless steel reinforcing spiral; graduated with centimeter markings for depth determination; terminated with fully inserted connector. Used by clinicians in hospital settings for pediatric patients. Provides patent airway for ventilation; facilitates gas exchange. Benefits include kink resistance due to spiral reinforcement and ease of placement monitoring via markings.

Clinical Evidence

No clinical data; substantial equivalence based on design, material, and intended use comparison to legally marketed predicate devices.

Technological Characteristics

Materials: Clear PVC tube, encapsulated stainless steel reinforcing spiral. Form factor: Uncuffed tracheal tube, 2.0 mm to 8.0 mm internal diameters (0.5 mm increments). Features: Graduated centimeter markings, integrated connector. Sterilization: Sterile, single-use.

Indications for Use

Indicated for airway management via oral or nasal tracheal intubation in pediatric patients requiring tracheal intubation, available in sizes 2.0 mm to 8.0 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 Uncuffed Tracheal Tube (K844296, K860105)
• SIMS/Concord/Portex Pediatric Reinforced Silicone Tracheal Tube (K830352)
• NCC/Mallinckrodt Reinforced tracheal tube uncuffed without Magill curve (K841872)

Submission Summary (Full Text)

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RUSCH.
INTERNATIONAL
Group Regulatory Affairs
A Subsidiary of Teleflex Incorporated (USA)

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

MAY 10 1996
K954585

To: Whom it may concern

# Substantial Equivalence 510(k) Summary

Reference: Rüsch Pediatric Reinforced Tracheal Tube - Uncuffed, sterile

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

Sheridan Reinforced Uncuffed Tracheal Tube - K844296 & K860105

SIMS/Concord/Portex Pediatric Reinforced Silicone Tracheal Tube - K830352

NCC/Mallinckrodt Reinforced tracheal tube uncuffed without Magill curve - K841872 currently in inter-state commerce.

The device, which is equivalent to other devices currently being marketed, consists of a clear 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 device is designed as single use, sterile, uncuffed tracheal tube for oral or nasal tracheal intubation and indicated for airway management. It will be available in a variety of sizes from 2.0 mm to 8.0 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
29 September 1995