(77 days)
For the local management of pressure ulcers, stasis ulcers, 1st and 2nd degree burns, and full and partial thickness wounds.
The Dermaplex Hydrogel Wound Dressing is a solid hydrogel dressing covered with a polyester liner which is removed prior to application. The product is available in three sizes (3" × 3", 5" , and 6" × 10") and is supplied sterile in sealed aluminum/plastic laminate pouches.
The provided text is a 510(k) summary for the Dermaplex Hydrogel Wound Dressing. It describes the device, its intended use, and comparison to a predicate device.
However, this document does not contain the information required to answer your request about acceptance criteria and a study proving the device meets those criteria.
Specifically, the text does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for testing or data provenance. The only tests mentioned are "primary dermal irritation test in rabbits," "sensitization test in guinea pigs," and "USP Cytotoxicity Test (Agarose Diffusion)," but no sample sizes or detailed results are provided.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
- Information about a standalone performance study. The phrase "standalone" usually refers to algorithm-only performance in AI device studies, which is not applicable here as this is a physical wound dressing.
- Type of ground truth used.
- Sample size for the training set.
- How the ground truth for the training set was established.
The document primarily focuses on administrative details, a brief device description, and a statement of substantial equivalence to a predicate device based on composition, function, and intended use, rather than a detailed performance study with acceptance criteria.
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510 (k) SUMMARY
1. ADMINISTRATIVE
Submitter: Maxxim Medical, Inc 104 Industrial Boulevard Suqar Land, Texas 77478 713-240-2442
Contact Person: Ernest J. Henley
Date of Preparation: July 8, 1996
DEVICE NAME 11.
Proprietary Name: Dermaplex Hydrogel Wound Dressing Common Name: Wound Dressing Classification Name: Hydrogel wound and burn dressing
III. PREDICATE DEVICE
Curagel Hydrogel Wound Dressing; Kendall Healthcare Products Co.; K950412
IV. DEVICE DESCRIPTION
The Dermaplex Hydrogel Wound Dressing is a solid hydrogel dressing covered with a polyester liner which is removed prior to application. The product is available in three sizes (3" × 3", 5" , and 6" × 10") and is supplied sterile in sealed aluminum/plastic laminate pouches.
Biocompatibility of the device has been established by a primary dermal irritation test in rabbits and a sensitization test in guinea pigs. The product meets the requirements of the USP Cytotoxicity Test (Agarose Diffusion).
V. INTENDED USE
For the local management of pressure ulcers, stasis ulcers, 1st and 2nd degree burns, and full and partial thickness wounds.
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K962513
pg. 2 of 2
510 (k) SUMMARY
VI. COMPARISON TO PREDICATE DEVICE
The Dermaplex Hydrogel Wound Dressing is similar in composition, function and intended use to the Curagel Hydrogel Wound Dressing (Kendall Healthcare Products Co.) and other legally marketed wound dressing products consisting of solid hydrogel.
Accordingly, Maxxim Medical, Inc. concluded that the Dermaplex Hydrogel Wound Dressing is as safe and effective for its intended use and performs at least as well as legally marketed predicate devices, such as the Curagel Hydrogel Wound Dressing.
N/A