(a) Identification. A pressure wedge for the reduction of cesarean delivery is a prescription device that provides external mechanical support to the perianal region during the labor and vaginal delivery process. External mechanical support of the perianal region is intended to help reduce the occurrence of cesarean delivery.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) The patient contacting materials must be evaluated to be biocompatible.

(2) Nonclinical performance data must demonstrate that the device will not break when subjected to the forces it will be exposed to during labor.

(3) Performance data must validate the sterility of the device.

(4) Performance data must support the shelf life of the device by demonstrating continued sterility and package integrity over the labeled shelf life.

(5) Clinical performance data must be provided that characterizes the rate of skin/tissue trauma.

(6) The labeling must include:

(i) Specific instructions regarding the proper placement and use of the device.

(ii) A shelf life.

[82 FR 61448, Dec. 28, 2017]