(70 days)
3M Tegasorb™ Hydrocolloid Dressings are intended for use as a dressing for partial and full thickness dermal ulcers, leg ulcers, superficial wounds, abrasions, first- and second-degree burns, and donor sites.
The following conditions are considered appropriate for OTC use by the lay person: Superficial wounds such as cuts, lacerations, or abrasions First-degree burns
The following conditions are considered appropriate for OTC use under the supervision of a health care professional: Partial or full 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.
The provided text is related to the 510(k) premarket notification for the 3M Tegasorb™ Hydrocolloid Dressing (K982893). This submission is for package insert changes only, and explicitly states that the comparative products remain identical to those submitted in the premarket notification K940624. Therefore, the acceptance criteria and the study proving the device meets those criteria are not detailed in this document. Instead, it refers back to K940624 and highlights biocompatibility test results from that earlier submission.
Based on the provided text, I can infer the following:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the given document for K982893 as this submission is for labeling changes only and refers to K940624 for performance data. The document for K982893 primarily focuses on the device's intended use and substantial equivalence to previously cleared devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the given document. The document refers to K940624 for "biocompatibility test results."
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 information is not provided in the given document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the given document.
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 is not applicable. The device is a wound dressing, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a wound dressing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not explicitly stated for K982893, as it defers to K940624 for testing. However, given that it's a hydrocolloid dressing, the relevant "ground truth" for biocompatibility would typically be established through standardized in vitro and in vivo toxicology and irritation tests, often comparing results against established safety benchmarks and historical controls rather than expert consensus on diagnostic images or pathology.
8. The sample size for the training set:
This is not applicable as the device is a medical product (wound dressing), not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established:
This is not applicable as the device is a medical product (wound dressing), not an AI algorithm that requires a training set.
In summary:
The provided document for K982893 is a 510(k) summary for labeling changes only. It explicitly states that the premarket notification for performance and substantial equivalence refers to K940624, which "provided biocompatibility test results to support 3M Tegasorb™ Hydrocolloid Dressing as acceptable for its intended use." Therefore, the detailed information regarding acceptance criteria and the study that proves the device meets them would be found in the K940624 submission, not in the provided K982893 document.
§ 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.