§ 868.5095 Retrograde intubation device.

(a) Identification. A retrograde intubation device is a prescription device used to perform retrograde intubation via the cricothyroid membrane. The device may contain or be labeled for use with guidewires and intubating catheters, in addition to needles (§ 868.5090), syringe (§ 880.5860 of this chapter), and hemostats (§ 878.4800 of this chapter). (b) Classification. Class II (special controls). The special controls for this device are: (1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following: (i) Wire guide tensile, flex, fracture, and corrosion testing; (ii) Catheter tensile strength testing at likely points of failure; (iii) Catheter kink radius testing; (iv) Compatibility of device components that interact, including compatibility in connection, disconnection, and ability to transfer fluids; (v) Dimensional validation; (vi) Accuracy testing of markings; and (vii) Validation of the maximum airway pressure. (2) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (3) The device must be demonstrated to be biocompatible. (4) Labeling must include: (i) Instructions for use; and (ii) Package labels that clearly identify the minimum compatible size of endotracheal tube.