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The devices are indicated for airway management in patients, during surgical procedures involving the head, neck, or mouth, to provide a clear surgical field by directing the circuit and connectors away from the operative area and reduce the risk of kink.

The subject device of this premarket 510(k) notification is referred to as Shiley™ Oral/Nasal RAE Tracheal Tube, Murphy Eye. The Shiley™ Oral/Nasal RAE Tracheal Tube, Murphy Eye has a translucent polyvinyl chloride (PVC) tube shaft with a radiopaque filament along its length. The subject device is offered as cuffless or cuffed in various sizes, for either oral or nasal use. All tubes are single use, sterilized by ethylene oxide, and supplied with a standard 15mm connector. The subject device and its packaging are not made with rubber latex or DEHP.

Five families of the subject devices share the same indications for use and intended use but differ in specific design features such as size, cuff presence, cuff shape, and number of murphy eyes.

a) Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye
b) Shiley™ Nasal RAE Tracheal Tube Cuffless Murphy Eye
c) Shiley™ Oral RAE Tracheal Tube Cuffed Murphy Eye
d) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff Murphy Eye
e) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff Murphy Eye

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These devices are intended for oral or nasal intubation and are indicated for use in airway management, including those procedures requiring flexing of the neck or movement of the patient (e.g., to a lateral or prone position).

The subject devices are sterile, single-use tracheal tubes that incorporate a pre-formed Magill curve and have a continuous stainless-steel spiral wire incorporated into the wall to reduce the risk of collapse or kinking during patient positioning. All tracheal tubes feature standard depth marks, glottic depth marks and 15mm connector. The cuffed devices are provided with two different low-pressure cuff types, featuring a thin compliant wall that, when inflated, adapts and conforms to the irregular borders of the tracheal wall. The cuffed devices have an inflation system consisting of an inflation line, pilot balloon and self-sealing inflation valve, allowing for inflation and deflation of the cuff.

Five families of the subject devices share the same indications for use and intended use but differ in specific design features such as size, cuff presence, cuff shape, presence of murphy eye and stylet.

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