Frova Intubating Introducer (C-CAE-14.0-70-FII); Frova Intubating Introducer (C-CAE-14.0-70-FI); Frova Intubating Introducer (C-CAE-14.0-70-FIC); Frova Intubating Introducer (C-CAE-14.0-70-FIC-SPOPS)

The Frova Intubating Introducer is a 14 French, 70 cm long radiopaque tube designed to facilitate endotracheal intubation in patients with inadequate visualization of the glottis (grade II and III Cormack-Lehane views). It features a blunt curved tip, through-lumen design with two distal sideports for airflow, and can be used with single-lumen endotracheal tubes 6 mm or larger in diameter. The device also permits transient oxygenation or jet ventilation when used with compatible Rapi-Fit adapters.

The technological characteristics remain identical to the predicate device. The introducer is made from radiopaque polyethylene with centimeter markings, measures 14 French and 70 cm in length, and incorporates a through-lumen design with two distal sideports. It is supplied as single-use in a Tyvek peel pouch, sterilized by ethylene oxide gas, and is compatible with endotracheal tubes with inner diameters of 6 mm or larger.

Not stated in this summary.

The device is substantially equivalent because it is identical in intended use, design, and technological characteristics to the predicate Frova Intubating Introducer (K161813). The only changes proposed are to labeling and instructions for use to achieve global harmonization across regulatory regions, not to the device's materials, design, manufacturing processes, packaging, or sterilization. Since no changes were made to the design, manufacturing, or principles of operation, no new performance testing was required.