Search Results

3M Tegasorb™ THIN Hydrocolloid Dressing is intended for use as a dressing for partial thickness dermal ulcers, leg ulcers, superficial wounds, abrasions, first- and second-degree burns, and donor sites. It may also be used as a protective dressing on at-risk, undamaged skin or on skin beginning to show signs of damage from friction or shear.

The following conditions are considered appropriate for OTC use by the lay person:
Superficial wounds such as cuts, lacerations, or abrasions
First-degree burns
Skin needing protection from friction or sheer

The following conditions are considered appropriate for OTC use under the supervision of a health care professional:
Partial thickness dermal ulcers
Leg ulcers
Second-degree burns
Donor sites

[3M Tegasorb™ and] 3M Tegasorb™ Thin Hydrocolloid Dressings are sterile wound dressings which consist of a hypoallergenic hydrocolloid adhesive with an outer clear adhesive cover film. The film is moisture vapor permeable and water and bacteria impermeable. The products are not designed, sold or intended for use except as indicated. Over the wound site, [3M Tegasorb and] 3M Tegasorb THIN Hydrocolloid dressings interact with wound fluid to create a soft, semi-transparent absorbent mass. The dressings maintain a moist wound environment, which has been shown to enhance wound healing.

This document, K982892, is a 510(k) summary for labeling changes to the 3M Tegasorb™ THIN Hydrocolloid Dressing. It states that the premarket notification refers to package insert changes only and that the comparative products remain identical to those submitted in the previous premarket notification, K924280, which was cleared on May 12, 1993.

Therefore, this specific submission (K982892) does not contain new acceptance criteria or new study data proving the device meets acceptance criteria. Instead, it references the original submission, K924280, for such information.

The relevant section states:
"See K924280 which provided Summary of Testing: biocompatibility test results to support 3M Tegasorb™ THIN Hydrocolloid Dressing as acceptable for its intended use."

To answer your request comprehensively, one would need to review the K924280 submission. However, based solely on the provided K982892 document, I can only provide information about the lack of new studies and the reference to a previous submission.

Based on the provided document (K982892):

1. Table of acceptance criteria and the reported device performance:

   • This document does not contain a table of acceptance criteria or new reported device performance. It refers to the previous submission, K924280, for "biocompatibility test results to support 3M Tegasorb™ THIN Hydrocolloid Dressing as acceptable for its intended use."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • This document does not provide this information. It refers to the previous submission, K924280.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • This document does not provide this information. It refers to the previous submission, K924280.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • This document does not provide this information. It refers to the previous submission, K924280.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • This device is a wound dressing, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be applicable. This document does not mention any such study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • This device is a wound dressing, not an algorithm. Therefore, a standalone algorithm performance study would not be applicable. This document does not mention any such study.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • This document does not provide this information. It refers to the previous submission, K924280, which mentions "biocompatibility test results." For a wound dressing, ground truth would typically relate to clinical outcomes (healing rates, infection rates, adverse reactions) or established biocompatibility standards.

8. The sample size for the training set:

   • This document refers to biocompatibility testing, not an AI algorithm requiring a training set. No such information is provided.

9. How the ground truth for the training set was established:

   • This document refers to biocompatibility testing, not an AI algorithm requiring a training set. No such information is provided.

In summary: K982892 is a 510(k) for labeling changes only and explicitly states that the substantial equivalence relies on the previous K924280 submission for all testing and performance data.

Ask a specific question about this device