The SureSkin II STANDARD and SureSkin II BORDER hydrocolloid wound dressings are indicated for the management of lightly to heavily exudating wounds, such as pressure sores and leg ulcers.
The SureSkin™ II THIN hydrocolloid wound dressing is indicated for the management of dry or lightly exudating wounds, such as dermal ulcers, post-operative wounds, superficial wounds and abrasions.
The SureSkin™ II dressings are also indicated for use on second degree burns and donor sites.
The SureSkin II wound dressings are identical to the SureSkin Plus products with the exception that the formulation has been slightly modified. The SureSkin II hydrocolloid wound dressing formulation includes the same well known materials w that are used in other hydrocolloid wound dressings.
The adhesive hydrocolloid surface of these wound dressings is in contact with the wound bed. Polyurethane foam (Standard) and polyurethane film (Border/Thin) backings provide an occlusive covering of the wound. The polyurethane backing (foam or film) is impermeable to water and bacteria. The dressing maintains a constant thickness of hydrocolloid material to the edge of the dressing (Standard and Thin). The thickness of the hydrocolloid material is decreased at the edges (beveled edges) of the Border Dressing to improve adherence and reduce the risk of the dressing rolling up. The border itself is a continuation of the hydrocolloid adhesive material. The dressings can be left in place up to seven days if exudate is minimal.
The provided text (K992363) is a 510(k) summary for a medical device: SureSkin™ II Hydrocolloid Wound Dressings. This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a novel study.
Therefore, the K992363 document does not contain the information requested regarding acceptance criteria and a study proving the device meets them because it's focused on demonstrating equivalence.
Here's why and what the document does state:
- No specific acceptance criteria: The document does not define numerical acceptance criteria for performance metrics (e.g., specific exudate absorption rates, wear time, healing percentages with a certain statistical significance).
- No dedicated performance study: The document does not describe a clinical trial or a detailed performance study designed to test the SureSkin™ II against acceptance criteria for efficacy or performance.
- Focus on Biocompatibility: The only "performance testing" mentioned is "Biocompatibility testing... in accordance with the International Organization for Standardization recommendations," which demonstrated the device is "suitable for its intended use." This is crucial for safety but not for proving comparative efficacy against specific clinical outcomes.
- Substantial Equivalence: The core of a 510(k) submission, as highlighted in the FDA's letter, is to show that the new device is "substantially equivalent" to legally marketed predicate devices. This means it has the same intended use and technological characteristics, or if there are differences, those differences do not raise new questions of safety or effectiveness.
In summary, based on the provided text, I cannot complete the requested tables and information because the document describes a 510(k) clearance process based on substantial equivalence, not a study designed to meet specific performance acceptance criteria.
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