(143 days)
Silverlon® Antimicrobial Wound Contact Negative Pressure Dressing and the Silverlon® Easy Ag™ Antimicrobial Wound Contact Negative Pressure Dressing are intended to provide moist wound environment and are used for the management of chronic, acute, surgical, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic}, partial-thickness burns, flaps and grafts; when used in conjunction with an NPWT pump that is intended to be used for negative pressure wound therapy (NPWT), the NPWT system is indicated for patients who benefit from wound management therapy via the application of negative pressure wound of fluids and excess exudates, infectious material, and tissue debris which may promote wound healing. It provides a non-adherent, conformable, antimicrobial barrier and may help reduce infection when placed under reticulated foam, gauze, or other wound fillers. Silverlon® Fenestrated Wound Contact Dressings may be cut or overlapped to fit any wound size.
Silverlon® Fenestrated Wound Contact Dressings-Models Silverlon® Antimicrobial Wound Contact Negative Pressure Dressing and Silverlon® Easy Ag™ Antimicrobial Wound Contact Negative Pressure Dressing are sterile, porous, non-adherent, knitted with 99% elemental silver and 1% silver oxide. The dressings may promote wound healing via assisting the removal of fluids, including body fluids, wound exudates and infectious materials. The Silverlon® Fenestrated Wound Contact Dressing 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.
The Silverlon® Fenestrated Wound Contact Dressings are used as the primary wound contact layer for NPWT dressing sets and is placed under reticulated foam, gauze, or other wound fillers. Silverlon® Antimicrobial Wound Contact Negative Pressure Dressing are non-adherent, wound care dressings designed to be used in negative pressure wound therapy dressing sets up to seven (7) days.
Silverlon® Easy Ag™ Antimicrobial Wound Contact Negative Pressure Dressing is a non- adherent, wound care dressings designed to be used in negative pressure wound therapy dressing sets up to three (3) days.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies, formatted as requested:
Device Name: Silverlon® Antimicrobial Wound Contact Negative Pressure Dressing and Silverlon® Easy Ag™ Antimicrobial Wound Contact Negative Pressure Dressing
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Met ISO 10993 Standard Series for Biological Evaluation of Medical Devices. (Cytotoxicity, sensitization, intracutaneous reactivity) |
| Antimicrobial Effectiveness (In-vitro) | Demonstrated "Antimicrobial effectiveness in the dressing was addressed in separate in-vitro laboratory evaluations using licensed commercial reference laboratories." |
| Demonstrated antimicrobial effectiveness on samples aged to the equivalent of 5 years (accelerated stability testing). | |
| Passed Kirby-Bauer Standard Antimicrobial Susceptibility Test. | |
| Passed ASTM E2315 Time Kill Assay for Antimicrobial Agents Report. | |
| Fluid Removal (Simulated) | "Bench testing using simulated wound exudate demonstrated that the porous single layer structure of the dressing allows substantially the same amount of fluid removal when compared to NPWT dressing sets currently on the market." |
| Material Composition | Composed of single layer woven nylon fiber substrate plated with metallic silver (99% elemental silver and 1% silver oxide). |
| Non-Adherence | Stated as "non-adherent" in description. |
| Porous Nature | Stated to be "porous" for fluid passage. |
| Barrier Function | Functions as an antimicrobial barrier preventing materials and microbes in the dressing set from entering the wound. |
2. Sample size used for the test set and the data provenance
The text describes in-vitro and bench testing. These are not clinical studies involving human or animal subjects, so the concept of "sample size for the test set" in the context of human data or "data provenance" (country of origin, retrospective/prospective) is not directly applicable here. The testing was conducted on samples of the device and simulated wound exudate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The reported studies are in-vitro and bench testing, which do not involve expert interpretation or ground truth establishment based on clinical observations. The ground truth for these tests would be the chemical and biological reactions observed and measured.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept pertains to clinical studies where multiple experts evaluate cases; the provided studies are scientific laboratory and bench tests.
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. The device is a wound dressing, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical wound dressing, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the in-vitro and bench testing:
- Biocompatibility: Ground truth established through standardized biological evaluations (ISO 10993 series) measuring cellular responses, reactivity, etc.
- Antimicrobial Effectiveness: Ground truth established through standardized microbiological testing methods (e.g., Kirby-Bauer, ASTM E2315) measuring bacterial growth inhibition or kill rates.
- Fluid Removal: Ground truth established through quantitative measurements of fluid passage in a simulated environment using established engineering principles.
8. The sample size for the training set
Not applicable. The device is a physical product, not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.