(70 days)
The Provox HME system is a heat and moisture exchanger (HME) that heats and humidifies inhaled air by reclaiming heat and moisture from exhaled air in the device. For use by laryngectomees. The HME may also facilitate voicing.
The Provox HME system is a heat and moisture exchanger (HME)
This FDA document is a 510(k) clearance letter for the Provox HME System, not a study report or clinical trial. Therefore, it does not contain the information requested regarding acceptance criteria and a study proving device performance.
The letter simply states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It lists the indications for use but does not provide any performance metrics, study design, or results.
To answer your questions, one would need to access the actual 510(k) submission (K014102) itself, or any associated clinical study reports that were part of that submission, which are not provided in the 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.