(80 days)
Not Found
No
The device description and intended use are purely mechanical and do not mention any computational or data-driven features. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
Yes
The device is a tracheostomy tube designed to provide a secondary airway, support the trachea in various conditions, and maintain an adequate airway, which are all therapeutic functions.
No
The device description indicates it is a "tracheal T-Tube" used to "maintain an adequate airway as well as to provide support in the stenotic trachea." Its stated uses are to provide a secondary airway, support injured or reconstructed tracheas, and help with tracheal stenosis. These are all therapeutic or supportive functions, not diagnostic ones.
No
The device description clearly describes a physical tracheostomy tube with a molded internal balloon and other hardware components (ring washers, plug). There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description of the Hebeler Safe-T-Tube clearly indicates it is a medical device designed to be inserted into the body (specifically the trachea) to maintain an airway and provide support. It is a physical device used for treatment and support, not for analyzing samples from the body.
- Intended Use: The intended uses listed are all related to providing or supporting an airway within the body, not performing diagnostic tests on samples.
Therefore, the Hebeler Safe-T-Tube is a medical device, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
To be used as a tracheostomy tube for the following indications:
-
- Provide a secondary airway:
-
- Acute tracheal or larvngeal injuries:
-
- A need to support intrathoracic tracheal stenosis;
-
- A need to support a reconstituted trachea;
-
- A need to support a reconstructed trachea;
-
- Tracheal stenosis when the cervical or thoracic trachea cannot be repaired; and
-
- Segmental resection and anastomosis.
Product codes
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
trachea, largyngeal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Finished device sample passed cytotoxicity testing and were determined to be nonreactive and non-cytotoxic based on Elution Test, USP 23.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Montgomery Safe-T-Tube
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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:
-
- Provide a secondary airway:
-
- Acute tracheal or larvngeal injuries:
-
- A need to support intrathoracic tracheal stenosis;
-
- A need to support a reconstituted trachea;
-
- A need to support a reconstructed trachea;
-
- Tracheal stenosis when the cervical or thoracic trachea cannot be repaired; and
-
- 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