Bard Soft Mesh; Bard Soft Mesh Pre-Shaped

Bard Soft Mesh is a nonabsorbable, sterile surgical mesh made of knitted polypropylene monofilaments used to reinforce soft tissue deficiencies in adults. Bard Soft Mesh is indicated for repair of ventral, incisional, and inguinal hernias, while the Pre-Shaped variant is specifically indicated for inguinal hernia repair. The mesh comes in various rectangular and pre-shaped sizes ranging from 2"×4" to 12"×12".

The subject device is identical to the predicate device in design (single-layer knitted polypropylene monofilaments), materials, manufacturing, packaging, sterilization method (ethylene oxide), biocompatibility, and shelf-life. The subject device adds a 12"×12" size option and clarifies indications to specify ventral, incisional, and inguinal hernias rather than broad hernia repair language, but these are labeling modifications only with no physical device changes.

The submission references the FDA Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh issued March 2, 1999. Non-clinical testing included mesh thickness, knit construction, pore size, density, tensile strength, stiffness, ball burst strength, tear resistance, and suture pull-out testing.

The subject and predicate devices are substantially equivalent because the subject device has identical intended use (soft tissue reinforcement for hernia repair), identical technological characteristics (same material, design, and manufacturing), and identical principles of operation. The differences are labeling clarifications and a size extension (12"×12"), which do not constitute new risks or new intended uses since both devices are indicated for the same tissue type and disease entity. Risk analysis determined the labeling changes result in no new or increased risks, and non-clinical testing confirmed historical changes including the size extension do not impact safety or effectiveness.