(90 days)
The Boussignac/ Vygon Endotracheal Tube is indicated for airway management. The insufflation canals permit the delivery of intermittent jet ventilation and the administration of oxygen during tracheobronchial suctioning procedures. They also provide a supplemental means for administering oxygen during bronchoscopies. In these ventilatory modes, the main lumen serves as a channel for the elimination of expired gases. When the insufflation port is capped, The Boussignac/ Vygon Endotracheal Tube can function as a standard tracheal tube with ventilation occurring through the main lumen. The Boussignac/ Vygon Endotracheal Tube is intended for oral/nasal intubation.
The monitoring/irrigation lumens may be used for monitoring airway pressure, for irrigation of a patient's tracheobronchial tree, to aid in the removal of accumulated secretions, for sampling tracheal gases, for anesthetizing the trachea, or for introducing suitable medication in accordance with standard medical practice.
The Boussignac/ Vygon Endotracheal Tube is a standard endotracheal tube available in pediatric and adult use. The tube design includes a Magill curve, a tip, printed depth markings (in one centimeter increments), a low-pressure cuff (adult models only) and self-sealing valve with attached pilot balloon for cuff inflation/deflation. The tube also features a radiopaque line to assist in radiographic visualization. The device, including featured characteristics listed above, conforms to ISO 5361: Anesthetic and Respiratory Equipment – Tracheal Tubes and Connectors.
The tube has a main lumen and eight (8) separate canals, or "capillaries", embedded in the tube wall. For adult models, six (6) of these canals are used for gas insufflation, two (2) for pressure control, CO2 monitoring, or irrigation, and as in any endotracheal tube, one (1) for pressure control. CO2 monitoring, or irrigation. For the uncuffed pediatric model, six (6) of the imbedded canal is reserved for gas insufflation, while two (2) are used for pressure control, CO2 monitoring, or irrigation.
The provided text is a 510(k) summary for the Boussignac/Vygon Endotracheal Tube. It does not contain any information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to the request.
The document primarily focuses on establishing substantial equivalence to predicate devices, providing a device description, intended use, and comparison to existing products. It mentions "Performance testing was presented" and "Clinical publications were presented" but does not elaborate on the details or results of these tests.
Therefore, I cannot fulfill the request for information regarding acceptance criteria and the study that proves the device meets them based on the provided text.
§ 868.5730 Tracheal tube.
(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).