(71 days)
Dermaphylyx Calcium Alginate Wound Dressings are intended for use in the management of a variety of partial and full-thickness wounds. The dressings are additionally intended to help control minor bleeding by application of pressure to the wound.
The following Indications are for Prescription Use or under the direction of a health care professional:
- Venous ulcers
- Diabctic ulcers
- Pressure ulcers
- Ancrial ulcers
- Superficial burns
- Abrasions and laccrations
- Donor sites
- Postoperative wounds
The following Indications are for Over-the-Counter Usc:
- Abrasions
- Minor Burns
- Minor Cuts
- Minor Laccrations
Dermaphylyx Calcium Alginate Wound Dressings are soft, non-woven, and absorptive. The Dressings consist of calcium alginate fibers fabricated into a felt or rope configuration.
Dermaphylyx Calcium Alginate Wound Dressings are engineered to absorb substantial quantities of wound exudate. During the absorption of exudate the dressing forms a gel/fiber mat which provides an environment conducive to moist wound healing. The formation of the gel/fiber mat facilitates trauma free removal from the wound.
This document is a 510(k) summary for the Dermaphylyx Calcium Alginate Wound Dressing, submitted by Dermaphylyx, Inc. The purpose of this summary is to demonstrate substantial equivalence to legally marketed predicate devices.
The document does not contain information regarding acceptance criteria, study performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment relevant to the acceptance criteria for an AI/ML device.
The provided text describes a medical device (wound dressing) and aims to establish its substantial equivalence to existing devices based on its description, intended use, and general characteristics. It is not an AI/ML device, and therefore, the requested information (acceptance criteria, study performance characteristics, sample sizes, etc.) related to AI/ML device validation does not apply to this submission.
§ 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.