(147 days)
The Ciaglia Percutaneous Tracheostomy Introducer Set is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube placement, using the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel.
The Ciaglia Blue Rhino® Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube placement, using the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel.
The Ciaglia Blue Rhino® G2 Advanced Percutaneous Tracheostomy Introducer Set/Tray is intended for percutaneous dilational tracheostomy for management of the airway in adults only. Tube placement, using the technique described herein, should be performed in a controlled setting (e.g., ICU or operating room) with the assistance of trained personnel.
The Cook Ciaglia percutaneous tracheostomy devices are designed for percutaneous dilational tracheostomy for management of the airway. More specifically, the devices allow for two approaches to the dilation of the stoma: serial dilation (Ciaglia Percutaneous Tracheostomy Introducer Set) or single-stage dilation (Blue Rhino® and Blue Rhino® G2 Advanced Percutaneous Tracheostomy Introducer Set). Serial dilation is achieved using numerous progressively larger dilators. Single-stage dilation is achieved with a single rhino-horn-shaped dilator using an in-and-out motion. The Cook Ciaglia percutaneous tracheostomy devices are sold sterile for single use. There are multiple configurations that include various set and tray components (Table 1) associated with the procedure and/or in gaining percutaneous access.
The provided document describes the Cook Ciaglia percutaneous tracheostomy devices and their substantial equivalence to a predicate device, K041348: Portex® Ultraperc® Percutaneous Dilation Tracheostomy kit. The submission focuses on non-clinical testing and a summary of existing clinical literature rather than a new standalone clinical study for this 510(k) submission.
Here's the information requested, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes several non-clinical tests with associated acceptance criteria, but it primarily states that the test article met the predetermined acceptance criteria or was greater than/less than or equal to the acceptance criterion/predicate. Specific numerical acceptance criteria or performance metrics are not explicitly detailed in the tables or text.
| Test Category | Acceptance Criteria (Stated) | Reported Device Performance (Stated) |
|---|---|---|
| Tracheostomy Tube Fit / Removal Testing | Successfully inserted into intended tube & not fall out; successfully removed. | Test article can successfully be inserted into the intended tracheostomy tube and will not fall out under its own weight, and can be successfully removed. |
| Tensile Testing | Peak tensile load ≥ acceptance criterion | Peak tensile load of each test article was greater than or equal to the acceptance criterion. |
| Compression Testing | Withstand axial peak compressive load without kinking. | Test article will withstand the axial peak compressive load without kinking. |
| Flexibility with Guiding Catheter | Mean force to displace tip of guiding catheter |
§ 868.5800 Tracheostomy tube and tube cuff.
(a)
Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.(b)
Classification. Class II.