(74 days)
To create a percutaneous dilational tracheostomy using guidewire, pre-dilator, forceps and components of this product, which allows for tracheal access for airway management.
Portex Percutaneous Tracheostomy Kit
This document is a FDA 510(k) clearance letter for a medical device called the "Portex Percutaneous Tracheostomy Kit." It does not contain any information about acceptance criteria or a study proving the device meets said criteria.
The letter primarily:
- Confirms a review of the premarket notification (510(k)).
- Determines substantial equivalence to a legally marketed predicate device.
- States that the device can be marketed subject to general controls and, if applicable, special controls.
- Outlines general responsibilities under the Federal Food, Drug, and Cosmetic Act.
- Includes an "Indications for Use" statement.
Therefore, I cannot provide the requested information about acceptance criteria or a study from the given text.
§ 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.