HEBELER SAFE-T-TUBE

K960450 · Boston Medical Products, Inc. · BTR · Apr 19, 1996 · Anesthesiology

Device Facts

• Record ID: K960450
• Device Name: HEBELER SAFE-T-TUBE
• Applicant: Boston Medical Products, Inc.
• Product Code: BTR · Anesthesiology
• Decision Date: Apr 19, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To be used as a tracheostomy tube for the following indications: 1. Provide a secondary airway; 2. Acute tracheal or laryngeal injuries; 3. A need to support intrathoracic tracheal stenosis; 4. A need to support a reconstituted trachea; 5. A need to support a reconstructed trachea; 6. Tracheal stenosis when the cervical or thoracic trachea cannot be repaired; and 7. Segmental resection and anastomosis.

Device Story

Tracheal T-Tube with molded internal balloon; balloon inflation enables intermittent closure of upper intraluminal limb for anesthesia/ventilation; deflation restores upper respiratory access. Device maintains airway and provides structural support for stenotic, reconstituted, or reconstructed tracheas. Features ridges/grooves on extraluminal limb for ring washer attachment to prevent posterior displacement. Supplied as set including tube, ring washers, and plug. Used by clinicians in surgical or clinical settings to manage tracheal patency and support healing.

Clinical Evidence

Bench testing only. Finished device samples passed cytotoxicity testing (non-reactive, non-cytotoxic) per USP 23 Elution Test.

Technological Characteristics

Tracheal T-tube with internal balloon; silicone/elastomeric construction (implied by medical grade T-tube standards); features extraluminal ridges/grooves for ring washer fixation. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients requiring a secondary airway, suffering from acute tracheal or laryngeal injuries, or requiring support for intrathoracic tracheal stenosis, reconstituted/reconstructed tracheas, or segmental resection and anastomosis.

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

• Montgomery Safe-T-Tube (Boston Medical Products, Inc.)

Submission Summary (Full Text)

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K960450

APR 19 1996

# 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: Hebeler Safe-T-Tube

**Description:** The Hebeler Safe-T-Tube is a tracheal T-Tube with a molded internal balloon designed to be inflated for intermittent closure of the upper intraluminal limb. During anesthesia or ventilation, the balloon is inflated, closing the upper end of the Safe-T-Tube. Inflation of the internal balloon creates a closed system between the tracheotomy and lungs. Following anesthesia or ventilation, the balloon is deflated and the upper limb becomes open for upper respiratory access.

The Hebeler Safe-T-Tube is designed to maintain an adequate airway as well as to provide support in the stenotic trachea which has been reconstituted or reconstructed. The exclusive design of ridges and grooves along the extraluminal limb of the tube allows a ring washer to be attached, significantly reducing the possibility of accidental posterior displacement. All Hebeler Safe-T-Tubes are supplied as a set which includes the tube, ring washers and a plug.

**Indication For Use:** To be used as a tracheostomy tube for the following indications:

1. Provide a secondary airway;
2. Acute tracheal or laryngeal injuries;
3. A need to support intrathoracic tracheal stenosis;
4. A need to support a reconstituted trachea;
5. A need to support a reconstructed trachea;
6. Tracheal stenosis when the cervical or thoracic trachea cannot be repaired; and
7. Segmental resection and anastomosis.

**Predicate Device:** Montgomery Safe-T-Tube, manufactured and marketed by Boston Medical Products, Inc.

**Testing:** Finished device sample passed cytotoxicity testing and were determined to be non-reactive and non-cytotoxic based on Elution Test, USP 23.

Submitted by: Stuart K. Montgomery, President

Date: 1/29/96