(17 days)
Innovative Technologies' Sorbcel™ Alginate/CMC Wound Dressings, are highly conformable, sterile, primary wound dressings intended to provide an environment ideally suited for the management of moderate to heavily exuding partial to full thickness wounds.
The non-woven Alginate/CarboxymethyIcellulose fibre preparation, which includes various sizes of flat dressings and wound packing, reacts with wound exudate to form an integral, gelatinous, mass providing for a moist healing environment. The gel may easily be lifted away from the wound, reducing the potential for delicate peri-wound tissue damage during dressing changes. Dressings are supplied sterile in single use pouches or blister packs.
The provided text describes a wound dressing product (Sorbcel™ Alginate/CMC Wound Dressing) and compares it to two similar products (Kaltostat® and Aquacel™). However, it does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria. The document focuses on the product's description, composition, intended use, sterilization, biocompatibility, and a comparative features table with similar products.
Therefore, I cannot extract the requested information from the provided document.
To answer your request, I would need a document that describes:
- Specific, quantifiable acceptance criteria for the device's performance (e.g., minimum absorbency, maximum irritation index, specific efficacy rates).
- Details of a study conducted to evaluate the device against those criteria, including methodology, results, and conclusions regarding meeting the acceptance criteria.
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.