Search Results

The Weinmann Tracheostomy Exchange Set is intended for adult tracheostomy tube exchange.

The subject device, the Weinmann Tracheostomy Exchange Set, includes a Ciaglia Blue Rhino Percutaneous Tracheostomy Dilator (cleared under K133597), five Ciaglia loading dilators (21-, 24-, 26-, 27-, and 28-Fr; cleared under K133597), an 8-Fr Cook Airway Exchange Catheter (cleared under K162729), and two Rapi-Fit Adapters (cleared under K162729).

The Ciaglia Blue Rhino Percutaneous Tracheostomy Dilator is designed to be advanced over an airway exchange catheter into an existing tracheostomy tube to dilate the stoma, to be prepared for replacement of a new tracheostomy tube. The dilator is 38.0-Fr in outer diameter and 20 centimeters long. This dilator has a depth marking to indicate the skin level, which is placed 11 centimeters from the distal tip. Another feature of the device is the presence of hydrophilic coating on the distal 11 centimeters of the device.

The Ciaglia loading dilators are designed to be inserted into a new tracheostomy tube to facilitate dilation of the stoma and placement of the tube in the airway. The dilators are available in outer diameter of 21 to 28 Fr; all dilators are 20 centimeters long and curved at the distal end.

The airway exchange catheter is designed to be inserted into the previously existing tracheostomy tube in patients prior to removal. The airway exchange catheter keeps the airway open during dilation and placement of a new tracheostomy tube. The airway exchange catheter is 8.0 Fr in outer diameter and 45 centimeters long. The distal end of the airway exchange is a blunt tip with rounded edges.

Two Rapi-Fit adapters (one with a 15-mm connector, and one with a Luer lock connector) are provided to be used with the airway exchange catheter for oxygenation when the requirement for oxygen is high in patients but the tracheostomy tube is not in place. The 15 mm Rapi-Fit adapter is designed for attachment to traditional ventilator sources that are low pressure sources, or so-called continuous positive airway pressure (CPAP) ventilators. The Luer Lock Rapi-Fit adapter is designed for attachment to a highpressure jet ventilation oxygen source. The Luer Lock connection is a male Luer Lock that is compatible with the standard Luer fitting of an oxygen tube which is connected to an oxygen source.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Weinmann Tracheostomy Exchange Set (K180034), structured to answer your specific questions:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of quantitative acceptance criteria for the Weinmann Tracheostomy Exchange Set, nor does it provide specific numerical performance metrics. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device through:

• Identical intended use and similar indications for use.
• Similar technological characteristics, method of operation, and materials of construction.
• Satisfactory results from non-clinical testing.

Based on the available text, here's a conceptual table:

2. Sample size used for the test set and the data provenance

The document describes non-clinical testing, which typically does not involve human subjects. The testing described includes:

• Dimensional and Compatibility Evaluation of the subject device (Accelerated/Real Time Aged).
• Biocompatibility testing.

The document does not specify a "sample size" in terms of number of patients or cases. For non-clinical device testing, sample size would refer to the number of devices or components tested. This information is not provided in the document.

The data provenance is from Cook Incorporated's internal non-clinical testing, as implied by the reference to "applicable non-clinical testing to ensure reliable design and performance under the specified design requirements." There is no mention of country of origin of data, or if it was retrospective or prospective in the clinical sense, as it refers to device testing, not human trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable or not provided. Since the study is a non-clinical device performance and substantial equivalence assessment, it does not involve establishing ground truth from expert consensus on patient cases. Decisions are based on engineering and material science testing standards and comparison to a predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable or not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image review where multiple experts independently assess cases and discrepancies are resolved. This document details non-clinical device component testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There was no MRMC comparative effectiveness study done. This device is a physical medical device (tracheostomy exchange set), not an AI-powered diagnostic or assistive technology. Therefore, the concept of "human readers improve with AI" does not apply.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. The device is a physical medical instrument, not an algorithm, so an "algorithm only" performance study is irrelevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this regulatory submission is established through:

• Engineering specifications and standards: For dimensional, compatibility, and material properties.
• Biocompatibility standards: Often ISO 10993 series.
• Comparison to a legally marketed predicate device: The Ciaglia Blue Rhino® Percutaneous Tracheostomy Introducer Sets (K133597). The predicate device's safety and effectiveness implicitly serve as a benchmark for substantial equivalence.

8. The sample size for the training set

This information is not applicable or not provided. There is no "training set" in the context of this device's non-clinical testing. Training sets are typically associated with machine learning or AI development.

9. How the ground truth for the training set was established

This information is not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply here.

Ask a specific question about this device