(112 days)
Silver Shield™ Antimicrobial Skin and Wound Gel is intended for OTC use for Abrasions and lacerations and under the supervision of a health care professional in the management of Stage 1-1V Pressure Ulcers, Partial and Full thickness Wounds, Diabetic Foot and Leg Ulcers, Grafted and donor sites,
Silver Shield Antimicrobial Skin and Wound Gel is a clear, amorphous hydrogel wound dressing that helps maintain a moist wound environment that is conducive to healing, by either absorbing the wound exudates or donating the moisture while delivering antimicrobial silver. The gel matrix of the Silver Shield™ Antimicrobial Skin and Wound Gel is composed of a silver complex and an inert viscosity-modifying agent that imparts viscous hydrogel properties. Silver Shield™ Antimicrobial Skin and Wound Gel will be supplied in collapsible blind ended, heatsealed, co-extruded tubes fitted with a "flip top" dispenser closure. This reusable tube will be placed in a chipboard dispenser box with a package insert.
This document describes the acceptance criteria and the study that proves the device, Silver Shield™ Antimicrobial Skin and Wound Gel, meets those criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Antimicrobial Efficacy | Effective antimicrobial barrier, inhibiting the growth of common bacteria (Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Serratia marcescens, including antibiotic-resistant strains: MRSA & VRE) and fungi (Candida albicans, Aspergillus niger). | "USP preservative efficacy testing was performed to establish that Silver Shield Antimicrobial skin and Wound Gel is an effective antimicrobial barrier. The test was performed using the test organisms in accordance with USP and some additional bacterial strains such as antibiotic resistant Methicillin Resistant Staphylococcus aureus (MRSA), and Vancomycin resistant Enterococcus (VRE). Various test models were used for determining the anti-micorbial barrier properties. All tests have met or exceeded the requirements as set forth in USP for preservative efficacy test as well as the testing performed for the predicate device K011994." |
| "The performance testing exceeds the requirements as set forth by USP as well exceeds those demonstrated by the predicate device." | ||
| Moisture Management | Maintain a moist wound environment conducive to healing, by either absorbing wound exudates or donating moisture. | "Silver Shield™ Antimicrobial Skin and Wound Gel is a clear, amorphous hydrogel wound dressing that helps maintain a moist wound environment that is conducive to healing, by either absorbing the wound exudates or donating the moisture..." |
| "Silver Shield™ Antimicrobial Skin and Wound Gel exhibits the capacity to absorb moisture and control light wound exudate." | ||
| Biocompatibility | Safe for intended use and biocompatible. | "The biocompatibility testing and the performance testing performed for the device also demonstrated that the device is safe and effective for the indications of use." |
| Manufacturing Quality | Manufactured according to product specifications and Good Manufacturing Practices (GMP). | "Silver Shield™ Antimicrobial skin and Wound Gel will be manufactured according to product specifications and under the guidelines of Good Manufacturing Practices (GMP). Risk analysis has been performed to identify possible failure mode during manufacturing. Manufacturing controls have been developed and implemented to address the identified risk factors based on the criticality of the failure mode. All established GMPs will assure that the device manufactured at Anacapa™ Technologies, Inc meets all the established specification prior to release and is safe and effective for its intended use." |
| Substantial Equivalence | Substantially equivalent in indications for use, technological properties, and performance to a legally marketed predicate device (AcryDerm Silver Antimicrobial Wound Gel, K011994). | "The indications of use, technological properties, performance testing described above, for the Silver Shield Antimicorbial Skin and Wound Gel are substantially equivalent to those of predicate device AcyrDerm Silver Antimicrobial wound Gel, Acrymed, Inc., OR; AKA Silvasorb™ Antimicrobial Wound Gel, 510(K) # K011994." |
Study Proving Acceptance Criteria are Met:
The provided document describes a premarket notification (510(k)) submission for the Silver Shield™ Antimicrobial Skin and Wound Gel. The "study" in this context refers to the performance testing conducted to demonstrate substantial equivalence to a predicate device and to confirm the device's stated characteristics.
2. Sample Size Used for the Test Set and Data Provenance:
The document describes "USP preservative efficacy testing" and "Various test models" for determining antimicrobial barrier properties. It does not explicitly state a sample size for these tests in terms of the number of unique wound samples or patients. Instead, the "test set" (in the context of microbiological testing) would refer to the specific bacterial and fungal strains used in the in vitro efficacy tests. These included:
- Standard USP test organisms
- Antibiotic-resistant strains: Methicillin Resistant Staphylococcus aureus (MRSA) and Vancomycin resistant Enterococcus (VRE).
- Additional common bacteria: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Proteus mirabilis, Serratia marcescens.
- Fungi: Candida albicans and Aspergillus niger.
The data provenance is from laboratory testing (in vitro) as opposed to clinical data from patients or a specific country of origin. This appears to be a retrospective analysis in terms of comparing the device's performance to the established USP requirements and the predicate device's performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable in the typical sense for this type of device. The "ground truth" for the antimicrobial efficacy was established by:
- USP standards and methodologies: The United States Pharmacopeia (USP) provides a compendium of standards for the quality and purity of medicines, including testing methods for antimicrobial efficacy. These standards are developed by scientific experts and consensus.
- Performance of the predicate device (K011994): The performance of an already legally marketed and established device served as a benchmark for substantial equivalence.
There is no mention of individual "experts" establishing a ground truth for individual cases in a test set, as this was not a clinical or diagnostic imaging study.
4. Adjudication Method for the Test Set:
Not applicable. This was not a study involving human interpretation of data requiring adjudication. The results of the laboratory tests (e.g., inhibition zones, microbial counts) would be quantitatively measured and compared against predefined acceptance criteria from the USP.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not conducted. This type of study is typically performed for diagnostic imaging devices to evaluate the impact of an AI algorithm on human reader performance. The Silver Shield™ Antimicrobial Skin and Wound Gel is a medical device (wound dressing) where efficacy is determined through laboratory performance tests and biocompatibility, not by human reader interpretation.
6. Standalone (Algorithm Only) Performance:
Not applicable. The Silver Shield™ is a physical medical device (wound gel), not a software algorithm. Its "standalone performance" refers to its intrinsic physical, chemical, and antimicrobial properties demonstrated through in vitro testing. The provided document describes exactly this standalone performance of the device itself.
7. Type of Ground Truth Used:
The ground truth used was primarily:
- Established scientific and regulatory standards: Specifically, the USP (United States Pharmacopeia) preservative efficacy test requirements.
- Benchmark performance of a legally marketed predicate device: The performance of AcryDerm Silver Antimicrobial Wound Gel (K011994).
- Biocompatibility testing standards: Although not detailed, implied by the statement "biocompatibility testing... also demonstrated that the device is safe and effective."
8. Sample Size for the Training Set:
Not applicable. This device is not an AI/ML algorithm that requires a "training set." The development of the gel formulation and manufacturing process would involve internal R&D and optimization, but not in the context of a "training set" for an algorithm.
9. How Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set mentioned or implied for this device.
N/A