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PermeaDerm B, CW and Glove are intended for use as wound coverings and to provide a moist wound healing environment on cleanly debrided wounds after hemostasis has been established.

PermeaDerm B is indicated for partial thickness burn wounds, donor sites and coverage of meshed autograff.

PermeaDerm CW is indicated for partial thickness wounds, pressure sores, diabetic ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's, post-laser surgery, podiatric, wound dehiscence, trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds.

PermeaDerm Glove is indicated for debrided partial thickness hand burns.

PermeaDerm B, PermeaDerm CW and PermeaDerm Glove are identical in chemical composition and 3D structure. They are all composed of a monofilament nylon knitted fabric (virgin Indachi Nylon Monofilament Yarn 15/1), bonded to a thin slitted silicone membrane (Unrestricted Medical Grade Silicone, Applied Silicone, Dimethyl-Silicone-Elastomer P/N 40000). The nylon side of this dressing is coated with a mixture of hypoallergenic porcine gelatin (Gelita MedellaPro®) and a pure fraction of Aloe vera (Aloecorp Inc. Immuno-10®).

The physical differences in the two configurations (PermeaDerm B versus PermeaDerm CW and PermeaDerm Glove) are in the number and orientations of slits per unit area.

PermeaDerm B contains 2280 parallel slits (0.25" long) per square foot. PermeaDerm CW contains 4,464 slits (0.180" long) per square foot, and the rows of slits are parallel or perpendicular in orientation. PermeaDerm Glove has identical and physical properties of PermeaDerm CW, except it is sewn into a glove configuration.

The slit configuration creates pores when the dressing is stretched. All configurations provide a moist wound healing environment with a slitted silicone/nylon membrane coated with gelatin and aloe vera extract.

The wound dressings are primary dressings, to be used with secondary absorbent cover dressings.

This document is a 510(k) premarket notification from the FDA, which focuses on demonstrating substantial equivalence to existing devices rather than providing detailed studies for novel acceptance criteria.

Therefore, the information about acceptance criteria and a study proving the device meets them, as requested in your prompt, is not present in this document. This typically includes specifics such as performance metrics, sample sizes for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth for training was established.

This FDA letter and the associated summary primarily address:

• Device Identification and Intended Use: PermeaDerm B, CW, and Glove are wound coverings intended to provide a moist wound healing environment. Specific indications for different PermeaDerm variants are listed.
• Comparison to Predicate Devices: The document focuses on demonstrating that the PermeaDerm devices are substantially equivalent to "AWBAT Plus," "Biobrane," and "Oasis" based on similar intended use, basic design characteristics (porosity, flexibility, size), and material composition (nylon, silicone, gelatin, aloe).
• Biocompatibility and Sterilization: A summary of biocompatibility testing according to ISO 10993 standards and sterilization validation (E Beam to SAL of 10-6) is provided. Shelf life is noted as 7 months with ongoing testing.
• Lack of Animal Performance Studies: The document explicitly states, "No additional animal studies were provided."

In summary, the provided document is a regulatory communication for substantial equivalence and does not contain the detailed performance study information you are requesting.

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