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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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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:

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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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.

Prontosan Wound Irrigation Solution is a clear, colorless containing liauid 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 and 350 mL squeeze 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 provided text is a 510(k) summary for a medical device (Prontosan™ Wound Irrigation Solution). It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about a study proving the device meets acceptance criteria in the context of performance metrics like sensitivity, specificity, accuracy, or expert agreement that would typically be found in an AI/software as a medical device (SaMD) submission.

This document focuses on demonstrating substantial equivalence to an existing predicate device based on:

1. Similar Indications for Use: The new device and the predicate device (Dermacyn® Wound Care solution) are both intended for cleaning and irrigating wounds and moistening wound dressings.
2. Biocompatibility Testing: To ensure the materials used are safe for bodily contact.
3. Functional Performance Testing: To verify the solution performs its intended physical functions.
4. Shelf Life Testing: To ensure stability over time.
5. Comparison Testing: Directly comparing the proposed device with the predicate device to show similarities and confirm no new safety/effectiveness issues.

Therefore, for the type of information requested (acceptance criteria and study details related to device performance metrics, human-in-the-loop, ground truth, etc., typically found in SaMD studies), the provided text does not contain this information.

Here's a breakdown of why each requested point cannot be addressed from the given text:

1. A table of acceptance criteria and the reported device performance: This document doesn't provide specific performance metrics or acceptance criteria in the way an AI/software device would (e.g., sensitivity, specificity thresholds). It only states that comparison testing "demonstrated that Prontosan Wound Irrigation Solution, the proposed device is similar to Dermacyn Wound Care solution, the predicate device."
2. Sample sized used for the test set and the data provenance: Not applicable or provided. The "testing" mentioned is likely laboratory or chemical analysis, not clinical trials with sample sizes in the context of disease detection or diagnosis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a wound irrigation solution would relate to its chemical composition, sterility, physical properties, and safety, not expert interpretation of images or clinical data.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This type of study demonstrates improved human performance with AI assistance, which is irrelevant for a wound irrigation solution.
6. Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable. This device is a solution, not an algorithm.
7. Type of ground truth used: For this type of device, the "ground truth" would be established by rigorous chemical analysis, sterility testing, and biocompatibility standards, not expert consensus or pathology in a diagnostic sense.
8. Sample size for the training set: Not applicable. There is no AI model being trained.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary for a physical wound irrigation solution, not an AI/software medical device. As such, it relies on different types of evidence (biocompatibility, functional testing, comparison to predicate) to establish substantial equivalence, rather than the performance metrics and study designs typically associated with AI/SaMD devices.

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