PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA

K960429 · Smiths Industries Medical Systems, Inc. · JOH · May 2, 1996 · Anesthesiology

Device Facts

• Record ID: K960429
• Device Name: PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA
• Applicant: Smiths Industries Medical Systems, Inc.
• Product Code: JOH · Anesthesiology
• Decision Date: May 2, 1996
• Decision: SESK
• Submission Type: Traditional
• Regulation: 21 CFR 868.5800
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SIMS PER-FIT™ Percutaneous Tracheostomy Kit with Portex® Tracheostomy Tube and Disposable Inner Cannula is indicated for use in providing percutaneous temporary tracheal access for airway management. The Disposable Inner Cannulae are indicated for use in maintaining airway patency of the outer cannula in the presence of thick tenacious secretions or when it is desirable to minimize the cleaning materials and the nursing time required. The Disposable Inner Cannulae provide a means to protect against the risk of airway obstruction, contamination, and infection. The Per-Fit™ Portex® Percutaneous Tracheostomy Tube is intended for use as a replacement tube for the percutaneous tracheostomy tube that is supplied in the Per-Fit™ Percutaneous Tracheostomy Kit. It is intended to be used for replacement during the initial procedure or as a change-out tube following the procedure.

Device Story

Device facilitates percutaneous tracheostomy tube insertion via serial dilation. Components include polyvinylchloride tracheostomy tube with tapered/beveled distal tip, radiopaque blue line, flexible neck flange, 15mm connector, and low-profile cuff with self-sealing luer valve. Kit includes disposable polyethylene inner cannula for airway maintenance. Used by clinicians for temporary tracheal access; provides airway management; prevents obstruction/infection. Tube design allows smooth insertion through dilated stoma. Inner cannula allows rapid replacement to manage secretions.

Clinical Evidence

Bench testing only.

Technological Characteristics

Tracheostomy tube: biocompatible polyvinylchloride (PVC), radiopaque blue line, 15mm connector, cuff with luer valve. Inner cannula: polyethylene. Sterilization: ethylene oxide. Form factor: percutaneous insertion kit with serial dilators.

Indications for Use

Indicated for patients requiring percutaneous temporary tracheal access for airway management. Disposable inner cannula indicated for maintaining airway patency in patients with thick secretions or to reduce cleaning/nursing requirements.

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

• Percutaneous Tracheostomy Kit (K936133)
• Disposable Inner Cannula (K903730)
• Disposable Inner Cannula (K912124)
• Cook Critical Care Ciaglia Percutaneous Tracheostomy Introducer Set

Submission Summary (Full Text)

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SIMS

SMITHS INDUSTRIES

Medical Systems

K960429

MAY - 2 1996

Internal Correspondence

# K: 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

## 510(K) SUMMARY:

### COMPANY INFORMATION

Smiths Industries Medical Systems, Inc.
15 Kit Street
Keene, NH 03431
[phone]
Contact: Timothy J. Talcott
Manager of Regulatory Affairs

### PREPARATION DATE OF SUMMARY

January 30, 1996

### TRADE NAME

SIMS PER-FIT™ Percutaneous Tracheostomy Kit with Portex® Tracheostomy Tube and Disposable Inner Cannula

### COMMON NAME

Tracheostomy Tube with Disposable Inner Cannula

### PRODUCT CLASS/CLASSIFICATION

Class II, 73 JOH, 21 CFR 868.5800.

### PREDICATE DEVICE

Our current Percutaneous Tracheostomy Kit, K936133 and our current Disposable Inner Cannula, K903730 and K912124. Also, comparison is being made to the Cook Critical Care Ciaglia Percutaneous Tracheostomy Introducer Set.

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# DESCRIPTION

## SIMS PER-FIT™ Percutaneous Tracheostomy Kit with Portex® Tracheostomy Tube and Disposable Inner Cannula

The SIMS PER-FIT™ Percutaneous Tracheostomy Kit with Portex® Tracheostomy Tube and Disposable Inner Cannula is designed to permit percutaneous insertion of a specifically designed tracheostomy tube. This single cannula Percutaneous Tracheostomy Tube has a radiopaque blue line and is constructed of biocompatible polyvinylchloride material and incorporates a tapered and beveled distal tube tip to facilitate insertion through the percutaneously dilated stoma site. The tracheostomy tube has a neck flange, an integral 15 mm connector, and a cuff which deflates to a low profile on the tube for a smooth transition during insertion. The cuff inflation line has a self sealing luer valve. The tracheostomy tube is supplied with a disposable inner cannula of the appropriate size. The Percutaneous Tracheostomy Kit comes with the necessary components for percutaneous tracheostomy tube insertion into a stoma created by serial dilation.

## Disposable Inner Cannula

The Disposable Inner Cannula is made of polyethylene and is ethylene oxide sterilized. The cannula is designated as a single use disposable device for use only with the Portex Percutaneous Tracheostomy Tube.

## Per-Fit™ Portex® Percutaneous Tracheostomy Tube

The Portex® Percutaneous Tracheostomy Tube is designed for insertion via the percutaneous route utilizing the Per-Fit™ Percutaneous Tracheostomy Kit. The tracheostomy tube has a radiopaque blue line and is constructed of biocompatible polyvinylchloride material and incorporates a tapered and beveled distal tip to facilitate insertion through the percutaneously dilated stoma site. The tracheostomy tube features a flexible flange, an integral 15 mm connector, and a cuff that deflates to a low profile for a smooth transition during insertion. The cuff inflation line has a self sealing luer valve. The tracheostomy tube is supplied with a disposable inner cannula of the appropriate size. The tube is supplied with an obturator/dilator sized to match the outer tube and to facilitate insertion.

# INDICATIONS FOR USE

## SIMS PER-FIT™ Percutaneous Tracheostomy Kit with Portex® Tracheostomy Tube and Disposable Inner Cannula

The SIMS PER-FIT™ Percutaneous Tracheostomy Kit with Portex® Tracheostomy Tube and Disposable Inner Cannula is indicated for use in providing percutaneous temporary tracheal access for airway management.

## Disposable Inner Cannula

The Disposable Inner Cannulae are indicated for use in maintaining airway patency of the outer cannula in the presence of thick tenacious secretions or when it is desirable to minimize the cleaning materials and the nursing time required. The Disposable Inner

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Cannulae provide a means to protect against the risk of airway obstruction, contamination, and infection.

## Per-Fit™ Portex® Percutaneous Tracheostomy Tube

The Per-Fit™ Percutaneous Tracheostomy Tube is intended for use as a replacement tube for the percutaneous tracheostomy tube that is supplied in the Per-Fit™ Percutaneous Tracheostomy Kit. It is intended to be used for replacement during the initial procedure or as a change-out tube following the procedure.

## TECHNICAL CHARACTERISTICS

The SIMS PER-FIT™ Percutaneous Tracheostomy Kit with Portex® Tracheostomy Tube and Disposable Inner Cannula has the same technical characteristics as is currently marketed with our existing Percutaneous Tracheostomy Kit, K936133 and our current Disposable Inner Cannula, K903730 and K912124. The guidewire is equivalent to the guidewire supplied in our current device and the Cook Critical Care Ciaglia Percutaneous Tracheostomy Introducer Set.

## CONCLUSION

The testing performed and comparison to the predicate devices demonstrate that the proposed device is safe and effective and is substantially equivalent to the predicate devices.

Very truly yours,

Smiths Industries Medical Systems, Inc.
dba Concord/Portex

Timothy J. Talcott
Manager of Regulatory Affairs

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