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ACell® MatriStem® Wound Sheet is intended for the management of wounds including: partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, seconddegree burns, skin tears) and draining wounds. The device is intended for one-time use.

ACell® MatriStem® Wound Sheets are sterile, porcine-derived, lyophilized single or multi-layer extracellular matrix sheets available in various sizes with or without fenestrations or meshed.

This 510(k) submission (K092926) for the ACell® MatriStem® Wound Sheet does not contain acceptance criteria or study data demonstrating device performance against specific criteria.

Instead, the submission relies on demonstrating substantial equivalence to a previously cleared predicate device (ACell® UBM Lyophilized Wound Dressing, K021637). The core argument is that the new device is "identical to the predicate device with respect to fundamental scientific technology, materials, processing and intended use." It explicitly states that "The addition of multiple layers and fenestrations/meshes do not raise new issues of safety and effectiveness."

Therefore, the requested information about acceptance criteria and study details is not available within this document. The FDA cleared this device based on its similarity to an already approved device, rather than requiring new performance studies against specific acceptance criteria.

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