(366 days)
The Rusch UltraTracheoflex®Tracheoflex® Tracheostomy Tube Kits are intended for use in airway management of tracheostomized patients.
Tracheoflex® Fenestrated Tracheostomy Set-Cuffed, Tracheoflex® The Ultra Tracheostomy Set-Uncuffed, Tracheoflex® Fenestrated Tracheostomy Set-Uncuffed, are sterile, disposable, single use cuffed, or uncuffed fenestrated fixed length fenestrated tracheostomy tubes with a fixed flange. The kit may include a radiopaque tube, a tube obturator, a cough cap, a 15 mm airway connector, phonation value, a sealing cap, exchangeable inner cannulas, and a neck band. The inner cannula will be also available as a separate item.
The provided text describes medical device submission for tracheostomy tube kits, not an AI/ML device. Therefore, it does not contain information about acceptance criteria or study data for an AI/ML device.
Specifically, the document states: "No clinical testing was completed." This directly indicates that no study was performed to assess the device's performance against specific acceptance criteria. The submission focuses on demonstrating substantial equivalence to already marketed devices based on features, materials, and dimensions.
Therefore, I cannot provide the requested information.
§ 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.