(61 days)
PriMatrix is intended for the management of wounds that include:
- Partial and full thickness wounds
- Pressure, diabetic, and venous ulcers
- Second-degree burns
- Surgical wounds donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence
- Trauma wounds abrasions, lacerations and skin tears
- Tunneled/undermined wounds
- Draining wounds
PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided in sheet form in a variety of sizes to be trimmed by the surqeon to meet the individual patient's needs.
This document is a 510(k) premarket notification clearance letter for the PriMatrix Dermal Repair Scaffold. It is important to note that this document does not contain a study that proves the device meets specific acceptance criteria in the manner you've described.
The letter explicitly states: "No additional verification and validation test data were required as part of this submission. This 'traditional' 510(k) was submitted to clarify and correct the labeling, without changing the Intended Use of PriMatrix."
This 510(k) submission is for a device that is substantially equivalent to a previously cleared predicate device (PriMatrix Dermal Repair Scaffold, K131286). Substantial equivalence means that the device has the same intended use and technological characteristics as the predicate, or, if there are differences, those differences do not raise different questions of safety and effectiveness.
Therefore, your request for acceptance criteria and study details cannot be fulfilled from this document. This document confirms a regulatory clearance based on substantial equivalence, not a new study demonstrating performance against a specific set of acceptance criteria.
N/A