(391 days)
OTC: For minor wounds, minor ulcerations, minor abrasions, minor surgical wounds and minor skin irritations.
IONSIL GEL™ is a moist amorphous hydrophilic silver chloride gel designed to act as a barrier for wounds, as a moist wound dressing. The viscous hydrogel of the device contains silver in the form of silver chloride which acts as a self preservative that inhibits the growth of broad spectrum of micro organisms in the dressing.
The product is available in a 1.5 oz (45 gm) polyethylene heat sealed tube container. The tubes will be packed in a cardboard box.
This document is a 510(k) premarket notification for a medical device called IONSIL GEL™, an unclassified wound hydrogel. The FDA determined it is substantially equivalent to a predicate device.
Here's an analysis of the acceptance criteria and supporting study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in terms of quantitative performance metrics for the device itself (e.g., specific percentages for effectiveness, sensitivity, or specificity). Instead, it focuses on demonstrating substantial equivalence to a predicate device and safety through biocompatibility and antimicrobial testing.
| Criterion Type | Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|---|
| Intended Use | Equivalent to predicate device's intended use. | IONSIL GEL™ is intended for OTC use in the management of normal skin and minor wounds, ulcerations, minor abrasions, minor surgical wounds and minor skin irritations. This is stated to be substantially equivalent to the predicate device's indications. |
| Technological Characteristics | Similar to predicate device; moist wound dressing, silver as self-preservative. | IONSIL GEL™ is a moist amorphous hydrophilic silver chloride gel designed to act as a barrier for wounds. It contains silver in the form of silver chloride as a self-preservative inhibiting microbial growth. This is stated to be substantially equivalent to the predicate device (Acryderm Silver Antimicrobial Wound Gel) in form and function. |
| Biocompatibility | Safe for intended use (non-toxic, non-sensitizing, non-irritating). | Biocompatibility testing (systemic toxicity, cytotoxicity, sensitization and irritation) performed with IONSIL GEL™ demonstrates that the dressing is safe for its intended use. Testing was conducted according to ISO Standards. |
| Antimicrobial Properties | Effectiveness against microorganisms (as a self-preservative). | In vitro antimicrobial testing was assessed by the standard Zone of Inhibition and USP Antimicrobial Effectiveness Test and USP microbial limit test . The results of these tests are not explicitly detailed as numerical values but are presented as evidence supporting the silver's self-preservative function and overall antimicrobial effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical performance data for the device. The data mentioned relates to laboratory (in vitro) testing for biocompatibility and antimicrobial properties.
- Biocompatibility Testing: The text states "Biocompatibility testing... was conducted according to ISO Standards." This implies a set of standardized samples (e.g., material extracts, cell cultures, animal models) as prescribed by the specific ISO standards, but no sample size for a "test set" is provided in the document.
- Antimicrobial Testing: "In vitro antimicrobial testing was assessed by the standard Zone of Inhibition and USP Antimicrobial Effectiveness Test and USP microbial limit test ." Again, the sample sizes for these in vitro tests (e.g., number of bacterial cultures, replicates) are not specified.
- Data Provenance: The studies are laboratory-based (in vitro), not involving human subjects or clinical data in the traditional sense. Therefore, country of origin of data (besides the submitting company's location in India) and retrospective/prospective categories are not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable as the document describes laboratory (in vitro) studies for biocompatibility and antimicrobial efficacy, not a human reader or clinical performance evaluation requiring expert ground truth in the diagnostic sense. The "ground truth" for these tests would be the standardized results and observations of the laboratory assays themselves, interpreted by qualified lab personnel.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3. There is no human observer adjudication mentioned for these in vitro tests.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document does not describe any human reader studies, either standalone or assisted by AI. The device is a wound hydrogel, not an AI-powered diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. The device is a physical product (wound hydrogel), not a software algorithm.
7. The Type of Ground Truth Used
For the laboratory studies:
- Biocompatibility: The "ground truth" is established by the defined endpoints and criteria of the ISO standards used (e.g., cellular viability, irritation scores in validated models).
- Antimicrobial Properties: The "ground truth" reflects the measurable outcomes of the USP and tests and Zone of Inhibition assays, such as bacterial growth inhibition zones or reduction in microbial counts according to standardized methodologies.
8. The Sample Size for the Training Set
This information is not applicable. The device is not an AI/ML algorithm that requires a "training set" for its development.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
N/A