RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE

K955564 · Rusch, Inc. · JOH · Jun 28, 1996 · Anesthesiology

Device Facts

• Record ID: K955564
• Device Name: RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE
• Applicant: Rusch, Inc.
• Product Code: JOH · Anesthesiology
• Decision Date: Jun 28, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Rüsch Ultra Tracheoflex® Tracheostomy Set-Cuffed is a tracheostomy tube with accessories, intended for intubation through a surgical incision into the trachea, for the purpose of providing a patent airway.

Device Story

Sterile, single-use cuffed tracheostomy tube with fixed flange; includes radiopaque tube, obturator, cough cap, 15mm airway connector, inner cannulas, neck band. Used in clinical settings for airway management. Device provides patent airway via surgical tracheal incision. Features spring (Bespack) valve for cuff pressure maintenance and ISO standard screw-luer fitting for secure connection to airway accessories. Physician-operated.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Radiopaque tracheostomy tube; materials meet ASTM F1242-89. Includes spring (Bespack) valve for cuff inflation and ISO standard screw-luer fitting. Complies with ISO 5366-1 (connectors), ISO 5366-2 (adult tracheostomy tubes), ISO 5356 (conical connectors), and ISO 5361 (cuffs/tubes). Sterile, disposable, single-use.

Indications for Use

Indicated for patients requiring a patent airway via surgical tracheostomy incision.

Regulatory Classification

Identification

A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.

Predicate Devices

• Safetyflex® Tracheotomy Set (pre-1976)
• Tracheoflex® Tracheotomy Set (pre-1976)
• Portex Flexible D.I.C. Tracheostomy Tube (K934465)

Submission Summary (Full Text)

{0}

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

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

JUN 28 1995
K955564

510(K) SUMMARY

ULTRA TRACHEOFLEX® TRACHEOSTOMY SET - CUFFED

Submitter Information:

Neil R. Armstrong
Group Regulatory Affairs Manager
Rusch International
Tall Pines Park
Jaffrey, NH 03452
Phone Number: [phone]
Fax Number: [phone]

Date 510(k) Summary Prepared: October 10, 1995

Name of the Device:

Trade or Proprietary Name: Rusch Ultra Tracheoflex® Tracheostomy Set - Cuffed

Common Name: Tracheostomy Set-Cuffed, Fixed length

Classification Name: Tracheostomy tube and tube cuff, and accessories: 21 CFR 868.5800

Airway Connector: 21 CFR 868.5810

Attachment 1

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Identification of Legally Marketed Device to which the Submitter Claim Equivalence:

The Ultra Tracheoflex® Tracheostomy set cuffed is substantially equivalent to two products marketed by Rüsch prior to May 28, 1976: These are the Safetyflex® Tracheotomy Set available since April, 1974, and the Tracheoflex® Tracheotomy Set, available since April 1971. This device is also similar to the Portex Flexible D.I.C. Tracheostomy Tube found substantially equivalent under K934465.

The subject devices are similar or equivalent to the predicates in significant features, materials, dimensions, and intended use.

## Description of the Subject Devices:

The Ultra Tracheoflex® Tracheostomy Set-Cuffed is a sterile, disposable, single use cuffed tracheostomy tube with a fixed flange. The set includes a radiopaque tube, a tube obturator, a cough cap, a 15 mm airway connector, exchangeable inner cannulas, and a neck band. The inner cannula will be also available as a separate item.

These devices meet applicable portions of the following voluntary standards:

- ASTM F1242-89, Standard Specification for Cuffed and Uncuffed Tracheal Tubes.
- ISO 5366-1, Tracheostomy Tubes, Part 1, Connectors for Tubes for Adults
- ISO 5366.2, Basic requirements for Tracheostomy Tubes for Adults.
- ISO 5356: Anesthesia and Respiration Equipment, Conical Connectors, Cones and Sockets.
- ISO 5361, Tracheal Tubes, Part 5: Requirements and Tests for Cuffs and Tubes.

Attachment 1

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# Intended Use of Subject Device

The Rüsch Ultra Tracheoflex® Tracheostomy Set-Cuffed is a tracheostomy tube with accessories, intended for intubation through a surgical incision into the trachea, for the purpose of providing a patent airway.

# Technological Characteristics of the Subject Devices

The subject device and the predicates have the same technological characteristics as the predicate devices except for:

1. The subject device's tube cuff is filled via a pilot balloon tube that ends in a spring (Bespack) valve. The Rüsch predicate devices have a balloon that ended in a capped luer. This technological improvement was made to aid in the prevention of the loss of cuff pressure due to the improper placement of the cap after cuff inflation.

2. The Rüsch predicate devices had a 15 mm airway connector permanently attached to the tube flange. The subject device has a ISO standard screw-luer fitting permanently attached. This allows a locking connections to a 15 mm airway connector, a cough cap, or other connectors as needed.

No clinical testing was completed.

Attachment 1