(594 days)
Silverlon® Island Wound Dressings is a multi-layer, sterile, non-adherent, antimicrobial barrier wound dressing.
The Over-The-Counter Indications:
Local management of superficial wounds, minor burns, abrasions and lacerations.
Under the supervision of a healthcare professional Silverlon Island Wound Dressings are intended for up to 7 day use for wounds such as vascular access or peripheral IV sites, orthopedic external pin sites, surgical wounds (donor and graft sites, incisions), and partial to fill thickness dermal ulcers (stage I-IV pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers).
Silverlon® Island Wound Dressing is indicated for the management of infected wounds', as the silver in the dressing provides an antimicrobial barrier that may be helpful in managing these wounds. In addition, the moist wound healing environment and control of wound bacteria within the Silverlon® Island Wound Dressing may help reduce the risk of wound infection and support the body's healing process.
Silverlon® Island Wound Dressing may be used for the management of painful wounds' Silverlor® Island Wound Dressing's non-adherent wound contact layer reduces pain during dressing changes and evaporation of moisture in the dressing may sooth the wound.
1Clarified/New Indication, not previously included in this format under K984208.
Silverlon® Island Wound Dressing is a self-adhesive, elastomeric wound dressing composed of 5 distinct layers (in innermost to outermost order):
· Layer 1 is a non-adherent wound contact layer that consists of a single layer of knitted continuous nylon fiber coated with metallic silver at the rate of 5.05 mg/cm (50.5 g/m²); the silver surface coating is approximately 0.8 - 1.0 um thick and contains approximately 1% silver oxide).
- · Layer 2 is a polyethylene film used to bond the nylon substrate to the pad layer described below;
- · Laver 3 is a laminate pad with an absorptive capacity of 65 oz/yd2 to absorb wound exudate;
· Layer 4 is an apertured high density polyethylene film that bonds the pad to the outer polyester fabric described below; and,
· layer 5 is a non-woven, medical grade polyester fabric coated on the skin-contacting side with a self-curing acrylic, pressure-sensitive, medical grade adhesive covered with a silicone-coated (one side) paper liner.
Laver 1 delivers antimicrobial silver ions in the dressing when activated by moisture. The silver ions in the dressing kill wound bacteria held in the dressing and provides an antimicrobial barrier to protect the wound bed. This dressing absorbs high amounts of wound fluid and the dressing intimately conforms to the wound surface.
The provided text is a 510(k) summary for the Silverlon® Island Wound Dressing, a medical device. This document focuses on establishing substantial equivalence to predicate devices rather than providing a detailed study proving performance against specific acceptance criteria in the manner typically seen for algorithmic devices. Therefore, much of the requested information regarding AI/algorithm performance studies is not directly applicable or available in this specific document.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria with reported device performance in the typical sense of a clinical trial for diagnostic or prognostic devices. Instead, the "acceptance criteria" for K122817 are implicitly defined by demonstrating substantial equivalence to predicate devices and meeting established safety and effectiveness standards for wound dressings.
| Acceptance Criteria Category | Reported Device Performance (as demonstrated for Substantial Equivalence) |
|---|---|
| Biocompatibility | Silverlon® Island Dressings have been subjected to independent standard in vitro and in vivo biocompatibility tests, including cytotoxicity, sensitization and intracutaneous reactivity. All tests were performed in accordance with ISO 10993 Standard Series. (Results implied to be acceptable for safety). |
| Antimicrobial Effectiveness (Stability) | In vitro accelerated stability testing for antimicrobial effectiveness, equivalent to 5 years, was conducted. (Results implied to be acceptable, demonstrating sustained antimicrobial properties). |
| Antimicrobial Susceptibility | Kirby-Bauer Standard Antimicrobial Susceptibility Test and ASTM E2315 Time Kill Assay for Antimicrobial Agents Report were conducted. (Results implied to be acceptable, demonstrating the silver's antimicrobial action). |
| Technological Characteristics Equivalence | Silverlon® Island Wound Dressing has substantially the same characteristics as AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING (K080383) and ACTICOAT FLEX 7 DRESSING (K083113) and has not changed from previously cleared Silverlon® Island Wound Dressing and Silverlon Pad (K984208). Any technological differences do not raise new questions of safety and effectiveness. (Demonstrated through comparison of materials, design, mechanism of action – silver release for antimicrobial effect, absorptive capacity, non-adherence). |
| Intended Use Equivalence | The device has the same intended use as the predicate devices: managing various wound types, including infected wounds, painful wounds, surgical incisions, and dermal ulcers, by providing an antimicrobial barrier, absorbing exudate, and maintaining a moist healing environment. (Demonstrated by comparing Indications for Use). |
| Safety and Effectiveness (No New Questions) | The technological characteristics and intended use are similar enough to predicate devices that no new questions of safety or effectiveness are raised. This is supported by product specifications, testing (biocompatibility, antimicrobial), and scientific studies. (Conclusion drawn from the submission, leading to substantial equivalence finding). |
2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of an AI/algorithm evaluation. The studies mentioned are primarily pre-clinical (in vitro/in vivo biocompatibility) and in vitro (antimicrobial effectiveness).
- Biocompatibility Studies: Specific sample sizes for cytotoxicity, sensitization, and intracutaneous reactivity tests are not provided, but these are standard tests performed according to ISO 10993. The provenance would be the testing laboratories that conducted these standard tests.
- Antimicrobial Effectiveness: No specific sample size is given for the "accelerated stability testing for antimicrobial effectiveness" or "Kirby-Bauer Standard Antimicrobial Susceptibility Test." These are laboratory-based in vitro studies. The "Microbiological Consultants - ASTM E2315 Time Kill Assay for Antimicrobial Agents Report" would also be an in vitro lab study.
These are not clinical studies with human participants that would typically have a "test set" for performance evaluation in the way requested for AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as there is no mention of a "test set" requiring expert ground truth in the context of an AI/algorithm evaluation in the provided summary. The studies are laboratory-based for material properties and antimicrobial activity.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as there is no mention of a "test set" requiring adjudication or expert review in the provided summary.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No such study was done. This document is for a traditional wound dressing, not an AI-powered device, and therefore MRMC studies or AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No such study was done. The device is a physical wound dressing and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the studies mentioned:
- Biocompatibility: Ground truth is established by standard ISO 10993 criteria for material safety.
- Antimicrobial Effectiveness: Ground truth is based on established microbiological testing methods (e.g., Kirby-Bauer, ASTM E2315) and scientific principles of bacterial inhibition/kill.
8. The sample size for the training set
This is not applicable. The device is a physical wound dressing, not an AI/algorithmic device that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated above.
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