(188 days)
Local management of skin wounds, including pressure ulcers, venous stasis ulcers, first and second degree burns, and superficial wounds and scrapes.
MPM Regenecare™ Wound Gel is a viscous hydrogel wound dressing intended for use in the local management of skin wounds. The product is supplied sterile in 3 oz. plastic tubes.
Biocompatibility of the device has been established by a primary dermal irritation test in rabbits, a sensitization test in guinea pigs, and an in vitro cytotoxicity test.
This document is a 510(k) premarket notification for a medical device called "MPM Regenecare™ Wound Gel". A 510(k) is a submission made to the FDA by medical device manufacturers to demonstrate that their device is substantially equivalent to a legally marketed predicate device. This process typically relies on demonstrating equivalence through comparison to an existing device, rather than new extensive clinical studies that would establish acceptance criteria and device performance in the way clinical trials do for new drugs.
Therefore, the provided document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The information requested (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set size, and ground truth establishment for training) generally comes from performance studies, which are not typically part of a 510(k) summary focused on substantial equivalence.
Based on the provided text, the following can be extracted:
- Device Name: MPM Regenecare™ Wound Gel
- Intended Use: Local management of skin wounds, including pressure ulcers, venous stasis ulcers, first and second degree burns, and superficial wounds and scrapes.
- Predicate Device: MPM Hydrogel™ Dressing (K952276)
- Studies Mentioned (for biocompatibility, not performance of wound healing efficacy):
- Primary dermal irritation test in rabbits
- Sensitization test in guinea pigs
- In vitro cytotoxicity test
The 510(k) process focuses on demonstrating substantial equivalence in terms of intended use, technological characteristics, and safety and effectiveness information, often without the need for new clinical data, especially for devices like wound dressings that have well-established predicates. The biocompatibility tests listed are to ensure the material itself is safe, not to prove the clinical efficacy of wound healing according to specific performance metrics.
In summary, there are no acceptance criteria or studies providing performance metrics for the wound healing efficacy of the device within this 510(k) summary.
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