(252 days)
The Flowable Wound Matrix 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, 2nd degree burns, skin tears) and draining wounds.
The Flowable Wound Matrix is a wound management device consisting of particulate Porcine Small Intestinal Submucosa (SIS) and fructose, a natural carrier. The device is an addition to the family of SIS-based wound management devices (Oasis Wound Matrix (K061711) and Cook ECM Powder (K152033)) already manufactured by Cook Biotech Incorporated. The device is supplied dry, rehydrated with saline at the time of application, and delivered topically to the wound through a pre-supplied syringe. SIS, which composes the majority of the device, is the same base material as that of the predicate device Oasis Wound Matrix (K061711) and reference device Cook ECM Powder (K152033). In addition to SIS, the device also contains fructose, a carrier added only to facilitate the preparation and delivery of the device. Fructose is a sugar naturally found in the body and is readily metabolized. The Flowable Wound Matrix is meant to be employed by the user to manage wounds of the types outlined in the intended use of the device. The device achieves its intended use by providing a scaffold for cellular invasion and capillary growth, and maintaining a supportive environment for wound management.
I am sorry, but the provided text only contains a 510(k) summary for the "Flowable Wound Matrix" device. It outlines the device description, its intended use, comparison to predicate/reference devices, and a summary of non-clinical tests conducted for substantial equivalence.
However, the document does not contain the specific details required to answer your request regarding acceptance criteria and a study proving the device meets them. Specifically, it lacks:
- A table of acceptance criteria and reported device performance. It only lists performed tests (biocompatibility, rehydration and deployment, package integrity, shelf life, collagen characterization).
- Sample sizes used for a test set, data provenance, or details about ground truth establishment.
- Information on the number of experts or adjudication methods.
- Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
- Sample size for a training set or how ground truth for a training set was established.
This document is focused on demonstrating substantial equivalence to a predicate device, primarily through non-clinical bench testing and comparison of features, rather than presenting a clinical study with detailed performance metrics against specific acceptance criteria.
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