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K Number
K960450
Device Name
HEBELER SAFE-T-TUBE
Manufacturer
BOSTON MEDICAL PRODUCTS, INC.
Date Cleared
1996-04-19

(80 days)

Product Code
BTR
Regulation Number
868.5730
Type
Traditional
Panel
Anesthesiology
Reference & Predicate Devices
K961917,K981146,K033333
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

To be used as a tracheostomy tube for the following indications:

    1. Provide a secondary airway:
    1. Acute tracheal or larvngeal injuries:
    1. A need to support intrathoracic tracheal stenosis;
    1. A need to support a reconstituted trachea;
    1. A need to support a reconstructed trachea;
    1. Tracheal stenosis when the cervical or thoracic trachea cannot be repaired; and
    1. Segmental resection and anastomosis.
Device 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.

AI/ML Overview

The provided text does not contain information about acceptance criteria and a study proving the device meets them.

The document is a "SMDA Summary" for a 510(k) submission, which describes a new medical device (Hebeler Safe-T-Tube) and compares it to a predicate device (Montgomery Safe-T-Tube). It focuses on:

  • Product Description: What the device is and how it works.
  • Indication For Use: What the device is intended for.
  • Predicate Device: The existing device it's being compared to.
  • Testing: Only mentions that "Finished device sample passed cytotoxicity testing and were determined to be nonreactive and non-cytotoxic based on Elution Test, USP 23." This is a basic safety test, not a performance study compared to specific acceptance criteria.

Therefore, I cannot populate the requested table or answer the specific questions about sample size, expert ground truth, MRMC studies, or training sets, as this information is not present in the provided text.

{0}------------------------------------------------

K960X450

APR 1 9 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:
    1. Acute tracheal or larvngeal injuries:
    1. A need to support intrathoracic tracheal stenosis;
    1. A need to support a reconstituted trachea;
    1. A need to support a reconstructed trachea;
    1. Tracheal stenosis when the cervical or thoracic trachea cannot be repaired; and
    1. 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 nonreactive and non-cytotoxic based on Elution Test, USP 23.

Submitted by: Shd/h/h/h/h/h, PRESIDENT

Stuart K. Møntgomery, President

Date:

1/29/96

§ 868.5730 Tracheal tube.

(a)
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.(b)
Classification. Class II (performance standards).