Does the device come into contact with injured skin or mucous membrane?
Is the device intended to be used principally for injuries to skin which have breached the dermis or mucous membrane and can only heal by secondary intent?
The dermis is the layer of skin that lies beneath the epidermis and above the subcutaneous layer. It is the thickest layer of the skin, and is made up of fibrous and elastic tissue. Thus it provides strength and flexibility to the skin.
A mucous membrane or mucosa is a membrane that lines various cavities in the body and covers the surface of internal organs. It consists of one or more layers of epithelial cells overlying a layer of loose connective tissue.
Second intention, also termed secondary healing, is the healing that occurs when a wound is left open to heal by granulation, contraction, and epithelialization.
Is the device principally intended to manage the micro-environment of injured skin or mucous membrane?
Is the device intended to be used as a mechanical barrier, for compression or for absorption of exudates?
An exudate is any fluid that filters from the circulatory system into lesions or areas of inflammation. It can be a pus-like or clear fluid. When an injury occurs, leaving skin exposed, it leaks out of the blood vessels and into nearby tissues. The fluid is composed of serum, fibrin, and leukocytes.