Results, Continued Safety & FDA Considerations Fluid-Filled Cervical Dilator

• The syringe in the pump will hold only enough saline to dilate the balloons to a maximum of 5-6 cm • The balloon is capable of expanding more than 7 cm to prevent rupture • The balloons are made of polyurethane so they are non-toxic and latex free. • In case of rupture, saline will not adversely react with body [3]. • The physician will have complete override control in the case of any emergency. • A non-toxic lubricant needed for easy insertion. • The dilator is classified as a Class II device, which means that it is not life sustaining, but it must meet specific performance standards. Some of these standards include premarket notification (501(k)), registration, device listing, good manufacturing practices (GMP), proper record keeping, and specific performance standards • FDA may require clinical or laboratory studies to prove safety and efficacy. Methods, Continue