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Innovative Technologies Calcium Alginate dressings are intended for use under the guidance of a health care professional on partial and full thickness wounds with moderate to heavy exudate, eg: Pressure ulcers Venous ulcers Diabetic ulcers Superficial wounds Donor sites Post-operative wounds Trauma wounds Dermal lesions And for OTC use on wounds such as, abrasions, lacerations, minor cuts and grazes, minor scalds and burns. They are also intended to help control minor bleeding.

These are nonwoven dressings made from 100% pharmaceutical grade calcium alginate harvested from seaweed. The nonwoven alginate fiber dressings are highly conformable, soft, absorbent, sterile, primary wound dressings that become "gels" when they come into contact with wound exudate to form a gelatinous mass which provides a moist wound environment.

The provided text does not contain any information about acceptance criteria, device performance, or any studies with specific metrics.

The document is a 510(k) submission for the "Al-Gen Calcium Alginate Dressing," focusing on establishing substantial equivalence to a predicate device (K953781). The "Testing Summary" section explicitly states: "Biocompatibility test results presented in 510(k) K953781 remains current, no changes to raw materials or components which would require the submission of new toxicity data." This indicates that no new testing was performed or reported for this specific 510(k) submission to demonstrate performance against new acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on prior biocompatibility data and substantial equivalence, not on a new performance study with specific acceptance criteria.

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