Search Results

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.

Ask a specific question about this device

Rx: Prontosan® Wound Gel X is indicated for the management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), 14 and 2nd degree burns, partial and full thickness wounds, large surface area wounds and surgical incisions.
OTC: Prontosan Wound Gel X is indicated for the management minor cuts, minor lacerations, minor burns (131 degree burns), and abrasions.

Prontosan Wound Gel X is a ready to use, clear, odorless, amorphous hydrogel wound dressing that helps maintain a clean, moist wound environment. It is intended as a barrier to resist microbial colonization within the dressing and reduce microbial penetration through the dressing. The gel matrix includes the preservative, polyhexanide, a viscosity modifying agent and a betaine surfactant. GelX is supplied sterile in blind ended, heat sealed polyfoil 250g tubes fitted with PP screw caps.

The document describes the Prontosan® Wound Gel X, a wound dressing, and its substantial equivalence to predicate devices. It mentions that performance testing was conducted to support this claim.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide specific details on the sample sizes used for the biocompatibility, USP , or Strike Through Barrier tests. It also does not specify the provenance of the data (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not provided. The testing described appears to be laboratory-based performance and biocompatibility testing, not studies requiring expert interpretation of results to establish ground truth in the context of medical imaging or diagnostic devices.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. The testing described does not involve adjudication as it's not a study where human readers or algorithms interpret data against a ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The document focuses on demonstrating substantial equivalence through biocompatibility and performance testing, not on comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable as Prontosan® Wound Gel X is a wound dressing, not an algorithm or AI device. The studies mentioned are traditional medical device performance tests.

7. Type of Ground Truth Used

The ground truth for the performance tests (Biocompatibility, USP , Strike Through Barrier Test) would be established by the defined standards and protocols of these specific tests. For example, for biocompatibility, the ground truth is adherence to the requirements of ISO 10993-1. For USP , it likely refers to antimicrobial effectiveness testing against predefined microorganisms and reduction criteria.

8. Sample Size for the Training Set

This is not applicable and not provided. Prontosan® Wound Gel X is a medical device (wound dressing), not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reason as above; there is no training set for this type of medical device.

Ask a specific question about this device