(80 days)
Permacol™ Surgical Implant is intended for use as a soft tissue implant to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is specifically indicated for the repair of abdominal, inguinal, diaphragmatic, femoral, scrotal, umbilical, incisional, parastomal hernias, muscle flap reinforcement and abdominal wall defects.
Permacol ™ Surgical Implant is a sterile, off-white, moist, tough and flexible, fibrous flat sheet of acellular porcine dermal collagen and its constituent elastin fibers. Presented moist in sterile saline, Permacol ™ Surgical Implant is double vacuum packed and heat sealed peel-open aluminum foil (inner) and peel-open polyester/polyethylene (outer) pouches.
The provided text is a 510(k) summary for the Permacol™ Surgical Implant, a surgical mesh device. The submission explicitly states that "No new performance data has been included in this submission." This means that the 510(k) relies on the substantial equivalence to a predicate device (Permacol™ Surgical Implant, K043366) and does not present new studies with acceptance criteria or device performance data for the current submission.
Therefore, the requested information cannot be filled out from the provided document as it does not contain details of an acceptance criteria study for the current device submission.
However, based on the principle of substantial equivalence for a 510(k) submission, the performance of the predicate device (Permacol™ Surgical Implant, K043366) would have been used to establish its safety and effectiveness, and the current device is deemed to meet those same performance characteristics due to its identical nature. The document explicitly states: "Permacol TM Surgical Implant is identical to the predicate device, Permacol TM Surgical Implant, K043366, in terms of its technological characteristics." and "No material changes are proposed in this submission."
Since no new performance data or study is presented in the provided K120605 submission, the table and other details related to a specific study cannot be extracted.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.