(132 days)
TRACOE Vario Tracheostomy Tubes are indicated for providing tracheal access for airway management in patients with unusual anatomy or thick neck patients.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA regarding Tracoe-Vario Tracheostomy Tubes. It states that the device is substantially equivalent to a legally marketed predicate device (Bivona TTS Adjustable Neck Flange Tracheostomy Tube).
However, this document does not contain any information about:
- Acceptance criteria for device performance.
- A study proving the device meets acceptance criteria.
- Sample sizes for test or training sets.
- Data provenance.
- Number of experts or their qualifications for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) studies or effect sizes.
- Standalone algorithm performance.
- Type of ground truth used.
- How ground truth for training was established.
Therefore, I cannot fulfill your request using the provided input. The document is solely an FDA clearance letter based on substantial equivalence, not a detailed study report.
§ 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.