(150 days)
Prontosan Wound Irrigation Solution is intended for cleaning wounds and for moistening and lubricating absorbent wound dressings for ulcers, burns, post-surgical wounds and abrasions.
Wound Irrigation Solution is a clear. clear. colorless liquid containing Prontosan undecylenamidopropyl betaine, polyaminopropyl biguanide, sodium hydroxide and purified water. The solution is aseptically filled using a blow fill seal process into low density polyethylene 40 mL ampoules; 350 mL squeeze bottles and 1000 mL bottles with screw caps. Prontosan Wound Irrigation Solution is used for cleaning wounds and for moistening and lubricating absorbent wound dressings for ulcers, burns, post- surgical wounds and abrasions. The mechanical action of moving across the wound provides for the mechanism of action and aids in the removal of foreign material such as dirt and debris. The Prontosan Wound Irrigation Solution Adaptor is a component that may be screwed on to the current Prontosan Wound Irrigation Solution containers (350 ml and 1000 ml bottles) and provides alternate spout geometry for which to access the solution inside the bottle. It is provided in sterile form, labeled for single patient use only.
The provided document is a 510(k) premarket notification for a medical device called "Prontosan Wound Irrigation Solution." This document pertains to regulatory approval rather than a scientific study on the device's performance against detailed acceptance criteria in a clinical or standalone setting.
Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria.
Specifically, the document states:
- "The subject device and the predicate device are exactly the same. No changes have been made to the device, manufacturing process, the packaging process or the intended use. The modification subject to this 510(k) is for labeling content only." (Page 4)
- "No new non-clinical testing has been performed for this submission. The changes to the labeling are test results from testing previously performed on this product and submitted to the FDA in a prior submission." (Page 4)
This indicates that the current submission is not based on new performance data or a new study, but rather a labeling change for a substantially equivalent device. Consequently, none of the requested study details (sample size, ground truth, expert qualifications, MRMC, standalone performance, etc.) are present in this document.
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