TransForm McCarthy Mitral Annuloplasty Ring (TF)

The TransForm™ McCarthy Mitral Annuloplasty Ring is an implantable, semi-rigid ring used to support and stabilize the mitral annulus during mitral valve repair surgery in patients with diseased or damaged mitral valves. The ring maintains a 'D' saddle shape during systole and flattens to an 'O' shape during diastole, with stiffened anterior and posterior segments and flexible commissure regions. It comes in sizes from 24mm to 40mm with 2mm increments.

The subject device and predicate device have identical size, shape, and similar material composition. Both are manufactured under equivalent conditions. The device features MP35N alloy stiffeners (0.71 mm diameter), an elastic silicone core, and braided polyester fabric construction with four green radial markers positioned at the trigones and mid-anterior/mid-posterior locations.

ISO 11137-1 (sterilization validation); ISO 10993-5 (cytotoxicity), 10993-10 (sensitization), 10993-23 (intracutaneous irritation), 10993-4 (hemocompatibility, complement activation), 10993-6 (implantation), 10993-17 (toxicological risk assessment), 10993-18 (chemical characterization); USP <151> (pyrogenicity), 10993-11 (acute systemic toxicity); ASTM F756 (hemolysis), F2888 (leukocyte/platelet assay), F2382 (partial thromboplastin time).

The device is substantially equivalent because it has identical intended use (mitral valve repair support and annulus stabilization), same principle and mechanism of operation, and identical size and shape to the predicate K232599. Nonclinical testing demonstrates that braid tensile strength, suture pullout strength, and structural performance meet or exceed pass/fail criteria with adequate safety factors, and comprehensive biocompatibility testing shows no new safety or effectiveness concerns. No clinical, technical, or biological differences in performance testing were identified that would raise questions about safety or effectiveness.