(115 days)
The barrier functions of Urgocell Ag, antimicrobial wound dressing with silver, may help reduce infection in moderately to high exuding partial and full thickness wounds, including decubitus ulcers, venous static ulcers, diabetic ulcer, first and second degree burns, donor and graft sites.
Urgocell® Ag, antimicrobial wound dressing with silver, is a non-adhesive, non-occlusive, antimicrobial absorbent dressing, composed of 3 layers:
- in contact with the wound, a polyester mesh impregnated with a matrix comprising of hydrocolloid particles (carboxymethylcellulose), cohesion polymers, petroleum jelly and silver sulphate (3.22 mg/sq.in)
- a non-sensitising, super-absorbent polyurethane foam pad,
- a protective, semi-permeable polyurethane backing.
The provided text describes a 510(k) premarket notification for a medical device called Urgocell® Ag Antimicrobial Wound Dressing with Silver. The focus of the submission is to demonstrate substantial equivalence to a legally marketed predicate device (Urgocell Ag K062559).
The document does not describe a study that uses acceptance criteria in the traditional sense of a clinical trial proving specific performance metrics with statistical significance. Instead, it relies on demonstrating equivalence through various comparisons, primarily related to antimicrobial activity and safety.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The concept of "acceptance criteria" for a new, modified device in a 510(k) submission is typically focused on demonstrating that the modified device is as safe and effective as the predicate device. For this submission, the key acceptance criteria revolve around antimicrobial activity and safety.
| Acceptance Criteria Category | Specific Criteria/Comparison | Reported Device Performance |
|---|---|---|
| Indications for Use | Identical to predicate device | Urgocell® Ag has identical indications for use as predicate Urgocell Ag (K062559): "The barrier functions of Urgocell® Ag, antimicrobial wound dressing with silver, may help reduce infection in moderately to high exuding partial and full thickness wounds, including decubitus ulcers, venous static ulcers, diabetic ulcer, first and second degree burns, donor and graft sites." |
| Structure | Identical to predicate device | Urgocell® Ag has identical three-layer structure as predicate Urgocell Ag (K062559): polyester mesh with hydrocolloid particles, cohesion polymers, petroleum jelly and silver sulphate; super-absorbent polyurethane foam pad; protective, semi-permeable polyurethane backing. |
| Antimicrobial Activity | Antimicrobial activity against specified strains, including additional strains compared to predicate. | Demonstrated antimicrobial activity against MRSA, Pseudomonas aeruginosa, Streptococcus pyogenes (as per predicate) AND against Enterococcus faecalis, Escherichia coli, and Candida albicans (new strains for this submission). The exact level or quantitative measure of activity is not provided, only that "Studies of antimicrobial activity" were done. |
| Safety and Biocompatibility | Comparable to predicate devices and other silver-containing wound dressings. | "The standard battery of safety and biocompatibility studies that were previously conducted showed the Urgocell Ag to be comparable to predicate devices and other silver containing wound dressings. These studies included: Cytotoxicity, Irritation study in rabbit, and Sensitization study in guinea pigs." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Antimicrobial Activity Studies: The text only states "Studies of antimicrobial activity were previously conducted" and "data was submitted concerning the antimicrobial activity of Urgocell® Ag on three new strains." It does not specify the sample size (e.g., number of replicates or experiments) for these in-vitro tests, nor does it explicitly state the data provenance (country or retrospective/prospective). These are typically laboratory-based, prospective studies.
- Safety Studies (Cytotoxicity, Irritation, Sensitization): These are standard biocompatibility tests, likely conducted in a preclinical (animal or in-vitro) setting. The sample sizes (e.g., number of rabbits, guinea pigs, or cell cultures) are not specified in this summary. The text implies these were "previously conducted," suggesting prospective studies.
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)
This type of information is not applicable to this submission. The "ground truth" (e.g., presence or absence of infection) for efficacy is not established by expert review of patient data, but rather through in vitro microbiological testing (for antimicrobial activity) and preclinical safety studies. There's no human diagnostic component that would require expert consensus for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there is no human interpretation or diagnostic task involved that would require adjudication.
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
This is not applicable. This submission is for a wound dressing, not an AI-powered diagnostic device or a system that involves human readers interpreting images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a wound dressing, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Antimicrobial Activity: The "ground truth" for antimicrobial activity is established through direct laboratory microbiological assays (e.g., measuring zones of inhibition, reduction in bacterial count).
- Safety Studies: The "ground truth" for safety (cytotoxicity, irritation, sensitization) is established through standardized preclinical testing protocols (e.g., observing cellular viability, skin reactions, immune responses) as defined by ISO standards and regulatory guidelines.
8. The sample size for the training set
This is not applicable. The device is a physical wound dressing; it does not involve machine learning or a "training set."
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
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