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The Phoneris™ Inner Cannulae with Phoneris™ Aero-Flex™ Ventilator Circuit Connector is indicated for airway maintenance of tracheostomised patients. The single use, disposable device is an accessory to a tracheostomy tube, serving as an interlocking, detachable, coupling between the ventilator circuit and tracheostomy tube. The Phoneris™ Inner Cannulae component is designed to replace the disposable inner cannulae component of the Shiley Disposable Cannula Tracheostomy Tube.

The proposed Phoneris™ Inner Cannulae with Phoneris™ Aero-Flex™ Ventilator Circuit Connector device consists of two components, the sterile Phoneris™ Inner Cannulae (Inner Cannulae) and the non-sterile Aero-Flex™ Ventilator Circuit Connector (Aero-Flex™). The Inner Cannulae is designed to replace the disposable inner cannulae component of the Shiley Disposable Cannula Tracheostomy Tube that was cleared for market in K811447. The Inner Cannulae consists of a snap-lock connector with an integral tube. The Inner Cannulae is inserted into the outer cannula of the Shiley Disposable Cannula Tracheostomy Tube and snap-locked into place at the proximal end of the snap-lock connector component of the Inner Cannulae. The distal end of the Inner Cannulae snaplock connector attaches to the proximal end of the Aero-Flex™ in an interlocking fashion. The free end of the Aero-Flex™ in turn attaches to the leading connector of the ventilator tube via a standard tapered connection that complies with ISO 5356-1:2004 "Anaesthetic and Respiratory Equipment - Conical connectors - Part 1: Cones and Sockets". The proposed Phoneris™ Inner Cannulae with Phoneris™ Aero-Flex™ Ventilator Circuit Connector device provides a positive, detachable connection between the Shiley Disposable Cannula Tracheostomy Tube and ventilator circuit. This interlocking coupling design relieves patient discomfort associated with the frequent necessary disconnections and recomections of the outer cannula from the ventilator circuit for maintenance purposes, and reduces the opportunity for inadvertent detachment of the tracheostomy tube from the connected respiratory delivery system. This decreases patient discomfort by relieving the suffocation sensation a ventilator dependent patient may experience with disconnection. It also decreases valuable nursing and respiratory therapists' time needed to repeatedly reconnect the patient to the ventilator as well as decreasing the potentially catastrophic effects of ventilator disconnects. The proposed Phoneris™ Inner Cannulae with Phoneris™ Aero-Flex™ Ventilator Circuit Connector device is not supplied with an outer cannula. Neither component of the proposed device is indicated for insertion into the patient's windpipe.