(201 days)
The device is indicated as a dura substitute for the repair of dura mater.
The proposed device is composed of bovine pericardium processed through a proprietary tissue preservation and sterilization process which includes gamma irradiation. The proposed device is composed of collagenous connective tissue with three-dimensional intertwined fibers and can be fixed regardless of the direction of the device. Collagenous connective tissue with multidirectional fibers retains the mechanical strength and elasticity of the native tissue, while providing the basic structure to support replacement by new endogenous tissue. The proposed device in its unopened, undamaged package is sterile.
The provided document describes the K132850 submission for a Bovine Pericardium Suturable Dural Graft, Tutopatch™ DM Graft, or Tutoplast® Bovine Pericardium DM. The submission focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria with a specific study framework for entirely new performance standards.
Here's a breakdown based on the information provided, tailored to your request but highlighting the context of a 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
In a 510(k) submission for substantial equivalence, "acceptance criteria" are typically defined by demonstrating performance comparable to legally marketed predicate devices, rather than predefined absolute thresholds for a novel device. The document uses predicate device performance as the benchmark for "substantial equivalence."
| Test Category | Test | Acceptance Criteria (Implicit by Equivalence to Predicate) | Reported Device Performance | Conclusion (Device meets criteria) |
|---|---|---|---|---|
| Biocompatibility | Cytotoxicity - Inhibition of Cell Growth Assay | No leachable materials released in cytotoxic concentrations (comparable to predicate) | No leachable materials were released in cytotoxic concentrations from the device. The proposed device is non-cytotoxic. | Substantially equivalent |
| Pyrogenicity (LAL Assay) | Endotoxin level |
§ 882.5910 Dura substitute.
(a)
Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).(b)
Classification. Class II (performance standards).