(312 days)
Portex ® UniPerc™ single use Percutaneous Dilation Tracheostomy (PDT) Kits allows the controlled, elective subcricoid perculaneous insertion of an adjustable flange tracheostomy tube for airway management using a Seldings guidewire dilation technique in patients with a large neck and manimum of 50mm of pre-tracheal soft tissue in to the trachea) where standard (up to a maximum of S0mm of pre-tracheal soft tissue anterior to the trached on go noon anatomy (up to a maximum of pre-traches to the trachea) where standard length flange tracheostomy tubes are too short.
Tracheostomy tube maximum period of use 29 days.
The UniPerc™ device has been designed to facilitate percutaneous tracheostomy in patients with a large neck mass and a consequently large skin to anterior trachea depth. The UniPerc™ device is centered on an extra length, wire reinforced, pre-curved, cuffed or uncuffed, tracheostomy tube mounted with an adjustable flange. The tube is supplied with an inner cannula, which can be used to line the internal surface of the tube. Obturators, dilators and other parts are supplied with the various kits.
The UniPerc™ device is designed for insertion using existing, dilating percutaneous or surgical insertion techniques. Care of the device whilst in use also follows existing standards techniques.
The graduated single stage dilator has a lubricious hydrophilic coating when wetted, to improve its ease of insertion.
The provided text does not describe acceptance criteria for a device, nor does it contain a study that proves a device meets those criteria.
Instead, the documents are a 510(k) summary and an FDA clearance letter for the Portex® UniPerc™ Percutaneous Dilation Tracheostomy Kit. This type of regulatory submission focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing performance against pre-defined acceptance criteria through a specific study.
Therefore, I cannot extract the requested information (acceptance criteria table, study details, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth, training set details) from the provided text.
The key points from the provided text are:
- Device: Portex® UniPerc™ Percutaneous Dilation Tracheostomy Kit
- Purpose: To facilitate percutaneous tracheostomy in patients with a large neck mass and large skin to anterior trachea depth, where standard tracheostomy tubes are too short.
- Regulatory Mechanism: 510(k) submission, seeking substantial equivalence to predicate devices (other Portex tracheostomy kits and tubes).
- Basis of Substantial Equivalence: Comparison of technological characteristics, intended use, and materials of composition with predicate devices.
- Intended Use: In a controlled setting (ICU/operating room) with trained personnel, requiring a minimum of two operators. Specifically for patients with a minimum of 50mm of pre-tracheal soft tissue anterior to the trachea. Maximum period of use is 29 days.
- FDA Clearance: The FDA determined the device is substantially equivalent to legally marketed predicate devices.
In summary, the provided content is a regulatory submission for device clearance based on substantial equivalence, not a performance study against acceptance criteria.
§ 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.