Cntrl+ Bladder Support Pessary

The Cntrl+ Bladder Support Pessary is a vaginal pessary made of medical-grade Santoprene that is inserted into the vagina to support the urethra and reduce stress urinary incontinence in women over 18 years old. It is worn for up to 12 hours daily, is reusable for 30-90 uses, and is prescribed by a physician based on individual sizing needs.

The subject device is cone-shaped with a smaller diameter range (1.47-1.76 inches) and shorter duration of use (up to 12 hours daily, reusable for 90 days) compared to the predicate Uresta™ Pessary, which is bell-shaped with a larger diameter range (1.73-4.77 inches) and longer duration (up to 24 hours). Both devices are made of Santoprene, are prescription-only, and designed for single-patient reuse.

ISO 10993-1:2018 for biocompatibility testing; FDA Guidance on Use of International Standard ISO 10993-1 (2016); internal sponsor protocols for durability testing, compression force testing, and maximum force exerted on vaginal wall.

Although the subject device differs from the predicate in shape, size, and duration of use, these differences do not raise different questions of safety or effectiveness because performance testing demonstrated the subject device meets all acceptance criteria. Additionally, the subject device is nearly identical in design, geometry, and materials to the Contiform pessary (marketed in Australia and UK), which has clinical evidence demonstrating a 67-72% median reduction in urine loss with similar adverse event profiles, supporting that the Cntrl+ device can effectively treat stress urinary incontinence in the intended population.