(86 days)
The Over-The-Counter Indications:
Local management of superficial wounds, minor burns, abrasions and lacerations.
Prescription Indications:
Silverlon® Wound Contact, Burn Contact Dressings are indicated for use up to 7 days for partial and full thickness wounds including traumatic wounds (donor and graft sites, incisions), 1st and 2nd degree burns, as well as dermal ulcers (stage I-IV pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), vascular access or peripheral IV sites, orthopedic external pin sites and wound drain sites.
Silverlon® dressings are 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® Dressings may help reduce the risk of wound infection and support the body's healing process.
Silverlon® Wound Contact, Burn Contact Dressings may be used for the management of painful wounds. Silverlon® Wound Contact, Burn Contact Dressings is a non-adherent wound contact layer that reduces pain during dressing changes and evaporation of moisture in the dressing may sooth the wound.
Silverlon® Wound Contact, Burn Contact Dressings are sterile, porous, non-adherent, knitted nylon plated with 99% elemental silver and 1% silver oxide. Silverlon® Wound Contact, Burn Contact Dressings 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® Wound Contact, Burn Contact Dressings are used as the primary wound contact layer and is placed under reticulated foam, gauze, or other wound fillers. Silverlon® Wound Contact, Burn Contact Dressings are non-adherent, wound care dressings designed to be used up to seven (7) days.
The provided document is a 510(k) premarket notification for Silverlon® Wound Contact, Burn Contact Dressings. The core of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, rather than to prove safety and effectiveness through new clinical studies against specific acceptance criteria. This means the information typically sought for device acceptance criteria and study outcomes (like those for AI/ML devices) is not directly present in this type of regulatory submission.
Here's a breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance
This document does not contain specific acceptance criteria with corresponding device performance metrics in the way a study for a novel device or AI/ML algorithm would. The device, Silverlon® Wound Contact, Burn Contact Dressings, is seeking clearance based on substantial equivalence to predicate devices (K023612, K073213, K122817).
Instead, the submission focuses on demonstrating:
- Same intended use: "Local management of superficial wounds, minor burns, abrasions and lacerations" (OTC) and for various partial and full-thickness wounds (Prescription) up to 7 days, including infected and painful wounds.
- Same technological characteristics: Composed of knitted nylon fiber substrate coated with metallic silver, delivering antimicrobial silver ions when activated by moisture, acting as a barrier, and permitting oxygen/fluid passage.
- No new questions of safety or effectiveness: Supported by biocompatibility testing and antimicrobial efficacy testing, showing it performs similarly to the predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This submission relies on non-clinical (in vitro) testing and comparison to predicate devices, not human subject testing with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth for a test set is not established in this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set or human reader adjudication involved.
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
Not applicable. This is not an AI/ML device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical tests conducted, the "ground truth" would be established by:
- Biocompatibility: Established ISO 10993 standards and methodologies (cytotoxicity, sensitization, intracutaneous reactivity).
- Antimicrobial effectiveness: Standardized in vitro tests like Kirby-Bauer Standard Antimicrobial Susceptibility Test and ASTM E2315 Time Kill Assay for Antimicrobial Agents Report. The "ground truth" here is the measured bacterial reduction or inhibition according to the test standards.
8. The sample size for the training set
Not applicable. There is no AI/ML model or training set discussed in this document.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML model or training set discussed in this document.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as per this 510(k) submission):
The "study" in this context is a collection of non-clinical (in vitro) tests and a demonstration of substantial equivalence.
- Biocompatibility Testing: In vitro and in vivo biocompatibility tests were conducted according to ISO 10993 standards, covering cytotoxicity, sensitization, and intracutaneous reactivity. The successful completion of these tests demonstrates the device is biologically safe for its intended use, meeting the implicit acceptance criteria of being non-toxic and non-irritating.
- Antimicrobial Effectiveness Testing: In vitro tests were performed including:
- Accelerated stability testing for antimicrobial effectiveness on samples aged to the equivalent of 5 years.
- Kirby-Bauer Standard Antimicrobial Susceptibility Test.
- ASTM E2315 Time Kill Assay for Antimicrobial Agents Report.
These tests demonstrate the sustained ability of the silver in the dressing to provide an antimicrobial barrier and reduce bacterial growth within the dressing, thereby supporting the proposed indications related to managing infected wounds and reducing infection risk. The acceptance criteria for these tests would be defined by the specific standards, e.g., a certain percentage reduction in bacterial count for the time kill assay, or specific zones of inhibition for Kirby-Bauer. The report states these tests were conducted to demonstrate safety and effectiveness.
- Comparison to Predicate Devices: The core of the K150256 submission is a comparison against legally marketed predicate devices (K023612, K073213, K122817). The "study" concludes that there are "no technological differences" or "minor technological differences that do not raise new questions of safety and effectiveness." This comparison, along with the specified in vitro testing, is the primary means of demonstrating that the device meets the implicit acceptance criteria for safety and effectiveness that were established for the predicate devices.
Key takeaway for this specific document: This 510(k) submission seeks regulatory clearance by demonstrating equivalence to existing devices through non-clinical testing and comparison, rather than through a clinical study with explicit performance acceptance criteria typical for novel devices or AI/ML. No clinical studies were conducted for this premarket notification.
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