(143 days)
MULTIDEX* Gel in a multi-use container is indicated for the management of stage II, III, IV pressure sores/ulcers, venous stasis ulcers, varicose ulcers, ischemic arterial ulcers, diabetic ulcers, neuropathic ulcers, poorly healing non-neoplastic wounds/ulcers and wounds/ulcers due to trauma. These are the identical indications as the predicate device.
MULTIDEX* (polyglucose) Gel contains 66.9 percent Maltodextrin NF, one percent Ascorbic Acid, USP, 10 percent glycerin USP, 22 percent Purified Water USP, and 0.1 percent sorbic acid in a multi-use container. MULTIDEX Gel in a multi-use container contains the same ingredients as the predicate device with the addition of 0.1 percent sorbic acid as a preservative. It is packaged in a 90 gram low density polyethylene tube.
The provided document is a 510(k) summary for a medical device called MULTIDEX* (polyglucose) Gel. This summary describes the device composition, indications for use, and a comparison to a predicate device.
However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth, or statistical analyses typically associated with proving a device meets acceptance criteria.
Therefore, I cannot extract the requested information. The document focuses on the contents of the gel, its indications, and its similarity to a previously approved device, primarily for regulatory clearance purposes by demonstrating substantial equivalence. It does not include the detailed study outcomes or performance metrics that would be necessary to answer your questions.
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