(79 days)
Innovative Technologies' Alginate/Pectin 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/Pectin 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 document is a Safety & Effectiveness Summary for a medical device called "Innovative Technologies' Alginate/Pectin Wound Dressings." It details the device's characteristics, intended use, and comparative features with similar predicate devices.
However, this document does not contain information about acceptance criteria, device performance metrics, or a study proving the device meets specific performance criteria in terms of efficacy or diagnostic accuracy. The document focuses on:
- Device Description: What the wound dressing is made of, how it works, and how it's sterilized.
- Biocompatibility: Confirmation that biocompatibility testing was successfully completed.
- Comparison to Predicate Devices: A table comparing its material, surface, integrity, indications, packaging, and sterilization method to two other wound dressings (Kaltostat and Granuflex).
Therefore, I cannot extract the requested information (1-9) as it is not present in the provided text. The document serves as an initial submission for regulatory approval, emphasizing safety and substantial equivalence to existing devices, rather than a clinical performance study with defined acceptance criteria and results.
§ 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.