(208 days)
The Fenestrated Flexible D.I.C. Tracheostomy Tube is indicated for airway management of the tracheostomized patient for providing tracheal access where the use of a fenestration is desirable in order to allow for safe and effective weaning from mechanical ventilation or adjunctive airway support. With the cuff deflated, primary ventilation is allowed to be spontaneous through the fenestrations and around the main tube. This provides a means for phonation when the patient breaths through his/her upper airway. A red decannulation cap can be used to occlude the proximal end of the tracheostomy tube.
The Fenestrated Flexible D.I.C. Tracheostomy Tube is made of implant tested, polyvinyl chloride with compatible profile, high volume, low pressure cuff. Radiopaque material is incorporated into the full length of the Fenestrated Flexible D.I.C. Tracheostomy Tube. The cuff inflation line has an inflation indicator and a self sealing luer one-way valve. The tracheostomy tube has three fenestrations on the radius of the tube.
The provided document is a 510(k) summary for the Fenestrated Flexible D.I.C. Tracheostomy Tube. It explicitly states in the "SUMMARY OF PERFORMANCE DATA", "SUMMARY OF NONCLINICAL AND CLINICAL TESTS", and "CONCLUSION OF NONCLINICAL AND CLINICAL TESTS" sections that these are "Not required."
Therefore, based on the provided text, there is no information available regarding:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with/without AI assistance.
- If a standalone performance study was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
The 510(k) pathway for this device relied on demonstrating substantial equivalence to predicate devices already on the market, rather than requiring new performance studies. The document states: "The location of the fenestrations are relocated to accomodate a greater percentage of the population. The location of the fenestrations has been determined based on a literature search taking into account the mean sagittal diameter and mean skin to trachea dimension." This indicates that design decisions were based on existing medical literature rather than new clinical or non-clinical studies for performance 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.