(23 days)
Tegagen HI & HG alginate dressings are intended for use on partial and full thickness wounds with moderate to heavy exudate, eg:
- Pressure ulcers Arterial Ulcers Venous ulcers Diabetic ulcers Superficial wounds; such as cuts and abrasions Donor wounds Post-operative wounds Trauma wounds Dermal lesions
Tegagen HI & HG alginate dressings 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 healing environment. Use of any dressing, including Tegagen HG and HI alginate dressings, should be part of a well defined protocol for dermal wound management.
This document is a 510(k) summary for the 3M™ Tegagen™ HI Alginate Dressing and 3M™ Tegagen™ HG Alginate Dressing. It states that substantial equivalence was provided in previous 510(k) applications (K953781 and K980989) and that biocompatibility test results were also presented in those previous applications. Therefore, there is no new study or acceptance criteria information in the provided text to describe.
The letter explicitly states: "The 510(k) submission was not re-reviewed." (Page 0, K982638, Jun 11, 2023 letter) and "This letter corrects our substantially equivalent letter of August 21, 1998." (Page 1, K982638, Mar 1 9 2007 letter). This indicates that the current document is an administrative update and a correction to previous approvals, not a new submission with new performance studies.
Hence, I cannot provide the requested information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or ground truth details. This information would have been contained in the original 510(k) submissions (K953781 and K980989) which are not provided here.
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