MONTGOMERY TRACHEOSTOMY SPEAKING VALVE

K955634 · Boston Medical Products, Inc. · CBP · Jun 10, 1996 · Anesthesiology

Device Facts

• Record ID: K955634
• Device Name: MONTGOMERY TRACHEOSTOMY SPEAKING VALVE
• Applicant: Boston Medical Products, Inc.
• Product Code: CBP · Anesthesiology
• Decision Date: Jun 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5870
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For use as a one-way speaking valve between a tracheostomy tube and ventilation equipment.

Device Story

Montgomery Tracheostomy Speaking Valve; in-line device between tracheostomy tube and ventilator; features thin silicone diaphragm; opens on inspiration, closes on expiration; allows ventilator-dependent patients to speak during both phases of ventilation cycle without waiting for ventilator cycling; used in clinical settings; operated by clinicians/caregivers; output is restored speech capability for patient.

Clinical Evidence

Bench testing only; visual inspection for defects; testing with ISO 5356-1 test gauges for 15mm and 22mm connections.

Technological Characteristics

Silicone diaphragm; 15mm and 22mm connections; ISO 5356-1 compliant connections; mechanical one-way valve operation.

Indications for Use

Indicated for ventilator-dependent patients requiring a one-way speaking valve to facilitate speech during both inspiration and expiration while connected to ventilation equipment.

Regulatory Classification

Identification

A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.

Predicate Devices

• Tracheostomy Speaking Valve (15mm / 22mm), Product No. 007 (Passy and Passy)

Submission Summary (Full Text)

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JUN 10 1996

K955634

# SMDA Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Product: Montgomery Tracheostomy Speaking Valve (15mm / 22mm)

Description: Montgomery® Tracheostomy Speaking Valves are designed to offer ventilator dependent patients the opportunity to speak without having to wait for the ventilator to cycle, allowing patients to speak during inspiration and expiration without interruption. The valve is placed in-line between the tracheostomy tube and the ventilator and features a thin silicone diaphragm which opens on inspiration and closes on expiration.

Indications For Use: For use as a one-way speaking valve between a tracheostomy tube and ventilation equipment.

Predicate Device: Tracheostomy Speaking Valve (15mm / 22mm), Product No. 007 marketed by Passy and Passy (4521 Campus Drive, Irvine, CA).

Testing: Each valve is visually inspected for defects and tested with ISO 5356-1 test gauges for 15mm and 22mm connections prior to packaging.

Submitted by: Stuart K. Montgomery, President

Date: April 9, 1996