(a) Identification. A hemorrhoid prevention pressure wedge provides mechanical support to the perianal region during the labor and delivery process. External mechanical support of the perianal region is intended to help prevent the occurrence of external hemorrhoids associated with vaginal childbirth.
(b) Classification. Class II (special controls). The special controls for this device are:
(1) The sale, distribution, and use of this device are restricted to prescription use in accordance with 801.109 of this chapter.
(2) The labeling must include specific instructions regarding the proper placement and use of the device.
(3) The device must be demonstrated to be biocompatible.
(4) Mechanical bench testing of material strength must demonstrate that the device will withstand forces encountered during use.
(5) Safety and effectiveness data must demonstrate that the device prevents hemorrhoids in women undergoing spontaneous vaginal delivery, in addition to general controls.