Edwards MC3 Tricuspid annuloplasty ring (4900)

The Edwards MC3 Tricuspid annuloplasty ring, Model 4900, is a titanium alloy ring with a silicone rubber and polyester velour sewing margin used in tricuspid valve repair surgery. It is designed to correct annular dilatation, increase leaflet coaptation, reinforce annular suture lines, and prevent further dilatation of the tricuspid valve annulus.

The device has identical structure, materials of composition (titanium alloy with silicone rubber and polyester velour), sterilization method, size range, sizing accessories, packaging, and anatomical site of application compared to the predicate device K020864. Both are oval rings with a rectilinear septal segment and curved anterior/posterior segment, open at the anteroseptal commissure.

MRI testing was conducted in accordance with applicable standards and guidance to verify device design meets safety and performance requirements. Specific standard names or numbers are not cited in this summary.

The device is substantially equivalent because it shares the same intended use (tricuspid valve repair), indications for use, principle of operation, fundamental scientific technology, structure, materials, sterilization, and size range as the predicate. MRI compatibility testing was performed to demonstrate substantially equivalent safety and effectiveness outcomes, confirming the technological comparison supports equivalence.