(75 days)
Island Wound Dressing™ with Microban® is indicated for local management of superficial wounds.
Wounds such as vascular access or peripheral IV sites, orthopedic external pin sites, wound drain sites, surgical wounds (donor and graft sites, incisions, and partial to full thickness dermal ulcers (Stage I-IV pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers). The dressing should be changed as frequently as needed for proper management of the wound.
Not Found
The provided FDA letters for the "Island Wound Dressing With Microban®" are administrative and regulatory documents related to its 510(k) clearance. They announce an administrative change in the product code and confirm substantial equivalence to a predicate device.
These documents do not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
Therefore, I cannot provide the requested information based on the input text. The letters explicitly state that the 510(k) submission was not re-reviewed in the December 2, 2024 letter, and the June 11, 2001 letter confirms substantial equivalence but does not detail the specific studies or data used to establish that equivalence.
N/A