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To create a percutaneous dilational tracheostomy using guidewire, single stage dilator and components of this product which allows for tracheal access for airway management.

The new kit is designed to permit percutaneous creation of a tracheostomy stoma and subsequent insertion of a size 7, 8 or 9mm tracheostomy tube. It employs the well understood and established procedure for dilating a stoma and introducing the tracheostomy tube using the Seldinger over a guide wire system. The kit contains all of the standard components to which the user are accustomed: scalpel, needle and cannula, syringe, guidewire, guiding catheter, Gauze pads, short pre-dilator, dilator system, and tracheostomy tube introducers. The kit differs from the above two kits in that it employs a single tapered dilator to replace the multiple serial dilators. The packaging is the same as that used in K022212. It is designed with an outer blister, which contains an inner tray. The tray layout is designed to present the user with the components in the order of use. Each pack is EO sterilised and individually packed in a carton together with the directions for use.

The provided text is a 510(k) summary for a medical device (Percutaneous Dilation Tracheostomy Kit) and a letter of substantial equivalence from the FDA. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details as typically found in an AI/ML device submission.

The document describes a physical medical device and its equivalence to predicate devices, focusing on its design, intended use, and regulatory classification. It does not involve any AI/ML components or performance metrics related to diagnostic accuracy, sensitivity, or specificity.

Therefore, I cannot provide the requested table and study details based on the input text.

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