(280 days)
For the Over-The-Counter Indications: For normal skin and minor wounds, ulcerations and burns, abraded skin, and irritated areas. Aids in removal of excessive skin oils, dirt and debris. Effective cleansing action. For Professional Prescription Indications: To cleanse, moisten and irrigate skin and dermal lesions; Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations.
A buffered skin and wound cleansing solution that is intended for the external cleansing of dermal wounds and skin. The mechanical action of the fluid moving across the skin or wound surface provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris. The product contains a surfactant (soap), cocamidopropyl betaine, to assist with the removal foreign material such as dirt and debris. After application the wound is rinsed with water or normal saline. The Silvaklenz Antibacterial Silver Skin & Wound Cleanser is clear, odorless and colorless. The product is available in 2 oz, 4 oz, 8 oz and 16 oz spray bottles.
The provided text describes a 510(k) premarket notification for the "Silvaklenz™ Antibacterial Silver Skin & Wound Cleanser." This submission focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and biocompatibility, rather than providing performance data against specific acceptance criteria for an AI device.
Therefore, the following information cannot be extracted or inferred from the provided text:
- A table of acceptance criteria and reported device performance (for an AI device).
- Sample sizes used for a test set, data provenance, number of experts, qualifications of experts, or adjudication methods for establishing ground truth for a test set (as this is not an AI device submission).
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or effect sizes for human readers with and without AI assistance.
- Whether a standalone (algorithm only) performance study was done.
- The type of ground truth used (e.g., expert consensus, pathology, outcomes data), as this is not relevant to the described device.
- The sample size for the training set, or how the ground truth for a training set was established (as this is not an AI/ML device).
What the document does describe regarding performance assessment:
The document outlines an "Assessment of Performance Data" (Section 7.6) for the Silvaklenz product. This assessment is focused on safety and antimicrobial effectiveness, typical for a wound cleanser, and not on AI-driven diagnostic or analytical performance.
Acceptance Criteria and Reported Device Performance (based on provided text for a wound cleanser):
| Acceptance Criteria Category | Device Performance (as reported) |
|---|---|
| Biocompatibility Testing | Silvaklenz Antibacterial Silver Skin & Wound Cleanser has been subject to: |
- in vitro and in vivo biocompatibility (ISO Modified Intracutaneous Study, the USP and ISO Modified Systemic Toxicity Study and the ISO Maximization Sensitization)
- cytotoxicity testing (Agarose Overlay Method).
These tests reportedly "support the safe use of Silvaklenz Antimicrobial Silver Skin & Wound Cleansing Solution in contact with breached or compromised skin." |
| Antimicrobial Effectiveness | In vitro Antimicrobial testing was assessed by: - standard MIC and MBC Dilution Methods.
- Zone of Inhibition.
- USP Antimicrobial Effectiveness Test .
- USP Microbial Limit Test .
- Bioburden Aerobic Total Count.
- Microbial Challenge Test.
(The specific results of these tests are not provided in this summary, but the types of tests conducted are listed as evidence of performance.) |
| Mechanical Action | The device description notes that the "mechanical action of the fluid moving across the skin or wound surface provides for the mechanism of action and aids in the removal of foreign objects such as dirt and debris." The surfactant (cocamidopropyl betaine) further "assists with mechanical cleansing and debridement" by reducing surface tension. (This is a functional claim rather than a quantifiable performance metric in the provided text.) |
| Antimicrobial Agent (Ionic Silver) | Ionic silver (drug component) functions as an antimicrobial agent. (This is a functional claim, with the detailed antimicrobial testing described above presumably supporting this function, though specific results are not included in this summary.) |
N/A