RED

RED is a gastrointestinal motility monitoring device designed to evaluate a patient's neuromuscular ability to expel rectal contents and to qualitatively test for rectal hypersensitivity. It consists of an open-cell foam ball enclosed in a balloon attached to a hollow catheter with a rounded insertion tip. When inserted and opened, the foam passively expands to displace 52ml of air, triggering the desire to defecate in patients, which is assessed by questioning according to London Classification criteria. The device is intended for use by trained healthcare providers in clinical settings for adult populations.

RED uses passive foam expansion (displacing 52ml when inflated) instead of electronic inflation systems required by predicate devices. The device is electronically-free and software-free, simplifying its design compared to the THD Anopress system. Both the subject device and predicates employ a balloon-catheter approach for rectal sensation and expulsion testing, with similar materials and insertion methods, but RED eliminates the equipment complexity of the primary predicate.

Inflation Time and Diameters Testing per ISO 10555-4:2023; Tensile Force Testing per ISO 10555-1:2023; Stiffness Testing per ISO 10555-1:2023; and Simulated Removal Testing. Clinical evidence came from a prospective trial of 60 adults with functional constipation defined by Rome IV criteria.

RED is substantially equivalent because it performs the same intended function as predicates (evaluating rectal sensitivity and expulsion) using similar technological principles (balloon-catheter approach) and comparable materials, despite using passive instead of active inflation. The 52ml volume difference does not introduce new safety or effectiveness concerns because patients experiencing urge-to-defecate at RED volumes would be classified as hypersensitive under London criteria. RED actually improves access to hypersensitivity testing by eliminating the equipment complexity that limits predicate use, while the sensitivity evaluation adds no additional risk beyond standard rectal expulsion testing. Bench and clinical testing confirmed safe and effective performance without raising new safety or effectiveness questions.