(69 days)
OTC: L.A.M. IPM Wound Gel is indicated for the manugement of minor burns (16 degree burns), minor abrasions and minor cuts. Rx: Under the supervision of a healthcare professional L.A.M. IPM Wound Gel is indicated for the management of exudating wounds such as leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds (post-operative incisions and donor sites), mechanically or surgically debrided wounds, and 2nd degree burns
L.A.M. IPM Wound Gel is a clear viscous, odoricss, aqueous gel composed principally of sodium hyaluronate, a derivative salt of Hyaluronic acid. L.A.M. IPM Wound Gel provides a moist wound environment that is supportive to wound healing. Over-thecounter use of L.A.M. IPM Wound Gel is suitable for minor burns, minor abrasions, and minor cuts. Under the supervision of a healthcare professional, L.A.M. IPM Wound Gel is suitable for exudating wounds such as leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds (post-operative incisions and donor sites), for the management of mechanically or surgically debrided wounds, and for second degree burns.
The provided text is a 510(k) summary for a medical device called "L.A.M. IPM Wound Gel." It describes the device, its intended use, and compares it to predicate devices. However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.
The 510(k) process is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, not necessarily on establishing new performance criteria or conducting studies to meet such criteria for novel devices. In this case, the document explicitly states: "There have not been any changes to L.A.M IPM Wound Gel (K020325) since FDA determined that it was substantially equivalent to ConvaTec's HA Absorbent Wound Dressing (K984388) and Fidia Pharmaceutical Corporation's Bionect® Hydrogel (K984413) on April 15, 2002."
Therefore, I cannot extract the requested information as it is not present in the provided text. The document is a regulatory filing focused on demonstrating equivalence and expanding indications, not on a new performance study.
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