Bard® Mesh; Bard® Mesh Pre-Shaped

Bard® Mesh is a nonabsorbable, sterile surgical mesh made of knitted polypropylene monofilaments designed to reinforce soft tissue in hernia and chest wall defect repairs. Bard® Mesh Pre-Shaped is a pre-trimmed version specifically indicated for inguinal hernia repair, with a pre-cut shape to protect the spermatic cord during surgery.

Both the subject and predicate devices are single-layer knitted polypropylene monofilament meshes sterilized by ethylene oxide. The only technological difference is that the subject device includes a pre-shaped configuration as a line extension (introduced in 1991), while the predicate rectangular design remains identical. Both use insertion, placement/positioning, and fixation as their principles of operation.

Not stated in this summary.

The devices share identical intended use (soft tissue reinforcement), identical materials (polypropylene monofilament), identical sterilization methods (ethylene oxide), and identical principles of operation. The predicate device itself included the pre-shaped variant as a line extension marketed in 1991, so the subject device's pre-shaped design is not new. The labeling modifications narrow the indications for the pre-shaped version to inguinal hernias only, which reflects actual surgical use without introducing new risks. Design verification testing confirmed the pre-shaped configuration performs as intended. Therefore, differences in labeling and pre-shaped design do not impact safety or effectiveness, establishing substantial equivalence to the preamendment Bard® Mesh device.