(20 days)
Prontosan® Wound Irrigation Solution is intended for cleaning wounds and moistening absorbent wound dressings for the management of minor cuts, abrasions, lacerations and minor burns.
The subject device of this submission is Prontosan® Wound Irrigation Solution indicated for over-the-counter use. Prontosan Wound Irrigation Solution is currently cleared in a prescription use only version. Prontosan Wound Irrigation Solution is a clear, colorless and nearly odorless liquid intended for the management of wounds. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of foreign material such as dirt and debris. The subject device is offered in 40 ml ampoules and 350 ml squeeze bottles with screw caps. The solution contains polyhexanide, a preservative that inhibits microbial growth within the product.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Prontosan® Wound Irrigation Solution:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Microbial Growth Inhibition (USP Category 2) | Demonstrated effectiveness to inhibit the growth of microorganisms within the product. (Specific results not quantified, but stated as effective for all tested organisms.) |
2. Sample Size Used for the Test Set and Data Provenance:
The document describes an Antimicrobial Effectiveness Testing study.
- Test Set Organisms: The study used a standard panel of Gram-positive and Gram-negative bacteria, and fungi.
- Bacteria: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, methicillin-resistant Staphylococcus aureus, Vancomycin-resistant enterococcus, Serratia marcescens, Acinetobacter baumannii, Proteus mirabilis, Staphylococcus epidermidis, Enterococcus faecalis, Enterobacter cloacae.
- Fungi: Candida albicans, Aspergillus brasilienis (niger).
- Data Provenance: Not explicitly stated, but it's an in-vitro laboratory test conducted according to USP standards. This is generally considered a controlled laboratory environment rather than patient data from a specific country, and it's a prospective test designed to evaluate the product's preservative efficacy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Not applicable. The study is a laboratory-based antimicrobial effectiveness test, not one requiring expert human interpretation of medical images or clinical outcomes. The "ground truth" is defined by the objective measurement of microbial growth inhibition according to USP protocol.
4. Adjudication Method for the Test Set:
Not applicable. This was a laboratory test with objective measurements based on USP methodology, not requiring adjudication of human interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This submission is for a wound irrigation solution, not for an AI-powered diagnostic or interpretive device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No. This concept is not applicable to a wound irrigation solution. The "performance" here refers to the chemical and preservative efficacy of the solution itself, not an algorithm.
7. The Type of Ground Truth Used:
The ground truth used was objective laboratory measurements based on a validated standard (USP ) for antimicrobial effectiveness. This involves inoculating the product with specific microorganisms and observing their growth or inhibition over time, rather than expert consensus, pathology, or outcomes data in a clinical setting.
8. The Sample Size for the Training Set:
Not applicable. This device is a wound irrigation solution, not an AI or machine learning model that requires a training set. The "training set" concept is irrelevant here.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
Summary of the Study:
The study described is an Antimicrobial Effectiveness Testing conducted according to USP category 2. This non-clinical test evaluated the ability of the Prontosan® Wound Irrigation Solution (intended for over-the-counter use) to inhibit the growth of common bacterial and fungal microorganisms within the product itself. The listed organisms represent typical pathogens found in wound beds. The study concluded that the device was effective in inhibiting microbial growth, thereby demonstrating its stability and preservative efficacy. This testing was performed to support the substantial equivalence claim, particularly regarding the solution's identity (formulation and processing) with its prescription-use predicate and its similarity in active ingredients to Prontosan® Wound Gel.
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