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The Rynel Epitech™ Island Dressing is intended for use in the local management of sureral incisions. Iacerations. trauma inflicted wounds, abrasions, superficial burns, secondate dressings for packed wounds and donor sites. The dressing is also appropriate for prossure diabcuc and venous stasis ulcers. It is intended to be used to protect the skin from octentral irritation, maceration and to manage exudate.

The Rynel Epitech™ Island dressing pad will be manufactured from hydrophilic polyurethane foam and the border material will be either a polyurethane film or a nonwoven polyester fabric coated with a nonsensitizing acrylic pressure sensitive adhesive.

The dressing will be offered as sterile stand alone dressings and will be individually packaged. Pouch material and construction will be consistent with current packaging in use by industry to safety package sterile wound dressings.

This document is a 510(k) premarket notification for a medical device called "Epitech™ Island Dressing." It is a regulatory submission to the FDA (Food and Drug Administration) in the United States, seeking clearance to market the device. The document states that the device is "substantially equivalent" to a predicate device, meaning it is similar in terms of safety and effectiveness to a device already legally on the market.

However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The document is a regulatory approval letter and a summary of the device's intended use and contact information, not a detailed study report.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding studies as requested, because that information is not present in the provided text.

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