(59 days)
ASAP® Silver Antibacterial Wound Dressing Gel is indicated for use in the management of 1st and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites and donor sites.
ASAP® Silver Antibacterial Wound Dressing Gel is a water based gel wound dressing that contains silver that in laboratory tests has been shown to inhibit the growth of microorganisms such as: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, antibiotic resistant strains, MRSA and VRE as well as fungi such as Candida albicans.
The high moisture content gel contains a base matrix composed of hydrophilic and buffering compounds and contains silver from American Biotech Labs' proprietary silver hydrosol suspension. ASAP® Antibacterial Silver Wound Dressing Gel is supplied in a multi-dose gel pump and a tube (collapsible, low-density polyethylene lined metal tube, sealed on one end and fitted with a pop-open screw cap on the other end).
The provided document is a 510(k) summary for the ASAP® Antibacterial Silver Wound Dressing Gel. It focuses on demonstrating substantial equivalence to predicate devices and detailing the device's characteristics and intended use.
However, the document does not contain information about:
- Specific acceptance criteria for device performance. It broadly states that "Antibacterial effectiveness was established through testing with appropriate organisms," but no quantitative criteria or targets are provided.
- A study that proves the device meets specific acceptance criteria. The document refers to "laboratory tests" for inhibiting microbial growth and "standard biocompatibility tests (ISO 10993)," but does not describe the methodology, results, or statistical analysis of any specific study.
- Test set sample size, provenance, ground truth establishment, expert qualifications, or adjudication methods.
- Any multi-reader multi-case (MRMC) comparative effectiveness study or human-in-the-loop performance.
- Details regarding the training set for any AI/algorithm component (as this is a wound dressing gel, not an AI device).
Therefore, I cannot provide the requested table or detailed information on the study.
Based on the available information, here's what can be extracted:
- Device Name: ASAP® Antibacterial Silver Wound Dressing Gel
- Indication for Use: Management of 1st and 2nd degree burns, wounds such as stasis ulcers, pressure ulcers, diabetic ulcers, lacerations, abrasions, skin tears, surgical incision sites, device insertion site wounds, graft sites and donor sites.
- Key Feature: Contains silver that in laboratory tests has been shown to inhibit the growth of microorganisms such as: Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, antibiotic resistant strains, MRSA and VRE as well as fungi such as Candida albicans.
- Proof of Performance (General):
- Biocompatibility established through standard ISO 10993 tests.
- Antibacterial effectiveness established through testing with appropriate organisms.
Since this is a wound dressing gel and not an AI/imaging device, many of the requested fields (e.g., AI assistance, MRMC study, training set, experts for ground truth) are not applicable. The core of this submission is demonstrating substantial equivalence to already cleared wound dressing gels, primarily concerning the use of silver as an antibacterial agent and its physical characteristics.
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