(79 days)
Innovative Technologies Hydrucolloids & Intelligent Hydrocolloids can be used for the management of wounds including, minor scalds and burns, superficial wounds such as abrasions, lacerations and minor cuts and as a protective dressing for such uses as minor blisters. This wound dressing may also bo used under the care of a health care professional for such wounds as, partial - full thickness wounds i. o. artorial ulcers, venous ulcers and diabetic ulcers, post operative surgical wounds. donor sites. If at any time you are unsure of the above conditions or the type of wound consult a health care professional. Discontinue use if any infection of the wound is suspected and seek guidance from a health care professional
Highly floxible and conformable gol formula dressings, which absorb wound exudate producing a soft, gel mass which allows pasy removal of the dressing roducing the potential for delicate peri- wound tissue damage during dressing changes. Innovative Technologies Intelligent wound dressings utilize an intelligent film which allows moisture to transpire the hydrocolloid whilst providing a barrier to water and bacteria
The provided document is a 510(k) premarket notification for Hydrocolloid and Intelligent Hydrocolloid Wound Dressings. It outlines the device's description, intended use, and indicates substantial equivalence to a previously cleared device. However, it does not contain information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement in a study to prove the device meets acceptance criteria.
The document primarily focuses on the regulatory submission process and the FDA's determination of substantial equivalence. It confirms that "Biocompatability results presented in 510(k) K971126 remain current, no changes to raw materials or components which would require the submission of new toxicity data." This suggests that previous testing for the predicate device K971126 is being leveraged, but the specifics of that testing are not detailed here.
Therefore, I cannot provide the requested information from the given text.
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