(167 days)
OTC Use: Prontosan® Wound Gel is intended to cleanse and moisten the wound bed and for the management of minor cuts, abrasions, lacerations, and minor burns.
Professional Use: Prontosan® Wound Gel is intended to cleanse and moisten the wound bed and for the management of ulcers, 1st and 2nd degree burns, partial and full thickness wounds, and surgical incisions. It can be used during wound dressing changes to soften encrusted wound dressings.
Prontosan® Wound Gel is a clear, colorless and virtually odorless gel containing undecylenamidopropyl betaine, polyaminopropyl biguanide, glycerol, hydroxyethylcellulose and purified water. Prontosan Wound Gel is a nonpyrogenic solution used for wound management.
Prontosan Wound Gel will be offered in an over-the-counter (OTC) version and a professional use (Rx only) version. Prontosan Wound Gel is used to moisten the wound bed and clean the wound surface, including those that are difficult to access. Prontosan Wound Gel is aseptically filled into a 30 mL low density polyethylene squeeze bottle with a screw cap.
The provided text is a 510(k) Substantial Equivalence Determination letter from the FDA for a wound gel called Prontosan Wound Gel. This document states that the device is "substantially equivalent" to a legally marketed predicate device (Prontosan Wound Gel, K101882) and does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.
The 510(k) process for this device, in particular, focuses on the manufacturer's claim that no changes have been made to the device design, packaging, manufacturing process, indications for use or the intended use. The submission is purely for labeling content changes.
Therefore, I cannot provide the requested information from this document. The document explicitly states:
- No new studies were conducted or required to demonstrate performance. The substantial equivalence is based on the device being identical to a previously cleared predicate device.
- No acceptance criteria are mentioned because the device's performance is assumed to be equivalent to the predicate, which would have already met its own performance criteria when it was initially cleared.
In summary, the provided document does not contain the information needed to answer your questions regarding acceptance criteria and a study proving the device meets those criteria.
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