(34 days)
For use as a prosthesis for the surgical repair of soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, and hernias (diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal and umbilical).
Supple Peri-Guard® is prepared from bovine pericardium which is crosslinked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Supple Peri-Guard is chemically sterilized using ethanol and propylene oxide. Supple Peri-Guard has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. Supple Peri-Guard is packaged in a container filled with sterile, nonpyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile.
This document presents a 510(k) Summary for the Supple Peri-Guard Pericardium device. However, it does not contain specific acceptance criteria, performance data, or details of a study that proves the device meets acceptance criteria in the format typically requested for AI/diagnostic studies.
Instead, this document is a regulatory submission demonstrating the substantial equivalence of the Supple Peri-Guard Pericardium to a predicate device (which is itself) for purposes of market clearance. The "Technology/Device Testing" section explicitly states: "Supple Peri-Guard is identical to the predicate device, clarification of labeling only." This indicates that no new performance testing was conducted for this specific 510(k) submission because the device itself, and its performance, are considered the same as the already cleared predicate.
Therefore, I cannot populate the table and answer the questions as requested based on the provided text, as the information simply isn't present in this type of regulatory document. This submission relies on the prior clearance of the predicate device (K921895 and K923657) and asserts sameness, rather than presenting new performance data against specific acceptance criteria.
§ 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.