(143 days)
For professional use, Procellera™ antimicrobial wound dressing is indicated for partial and full-thickness wounds such as: pressure ulcers, venous ulcers, diabetic ulcers, burns, surgical incisions, and donor and/or recipient graft sites.
For over-the-counter use, Procellera™ wound dressing is indicated for minor cuts, scrapes, irritations, and abrasions.
Procellera™ is a single layer dressing consisting of a woven absorbent polyester fabric containing elemental silver and zinc which are held in position on the polyester with a biocompatible binder. The polyester fabric is single ply and is made from multi-filament spun threads woven together. A small amount of current is produced and it occurs because it is inherent to the design. In the presence of exudate, the device should be used with an appropriate secondary barrier to maintain a moist wound healing environment.
The provided 510(k) summaries for Procellera™ (both professional and over-the-counter use) do not describe specific acceptance criteria in terms of quantitative performance metrics, nor do they detail a study designed to prove the device meets such criteria.
Instead, the submission relies on demonstrating substantial equivalence to a predicate device (CMB Antimicrobial Dressing - K060237) based on technological characteristics and general performance data relevant to safety and biocompatibility.
Here's an analysis based on the provided documents:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Explicitly Stated as Quantitative Metrics. The primary "acceptance criterion" for 510(k) clearance is demonstrating substantial equivalence to a legally marketed predicate device. This is achieved by showing similar technological characteristics and acceptable performance in areas of safety and effectiveness. | Technological Equivalence to Predicate Device: |
| "Procellera™ and the predicate device (CMB™ Antimicrobial Wound Dressing) are identical. Procellera™ is the same device as the predicate CMB™." |
Performance Data Categories:
Antimicrobial testing
Animal testing
Bench testing
Biocompatibility testing (cytotoxicity, irritation, sensitization, pyrogenicity, systemic injection, 28-day subcutaneous implantation) |
Detailed Breakdown of Study Information (Based on Available Text):
The provided text describes the type of performance data gathered, but does not detail the specifics of studies that would allow for the reconstruction of a typical acceptance criteria table and performance comparison as requested for a diagnostic or AI device.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not specified. The document mentions "antimicrobial, animal, bench and biocompatibility testing" but does not provide sample sizes, study designs (prospective/retrospective), or data provenance for these tests.
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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. The tests described are laboratory and animal-based performance tests (e.g., biocompatibility, antimicrobial activity), not studies requiring expert interpretation of diagnostic data to establish ground truth in the way a clinical study for a diagnostic algorithm would.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This concept typically applies to clinical studies involving human observers and their interpretations, not to the types of performance tests described (e.g., in vitro antimicrobial assays, biocompatibility tests).
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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 device is a wound dressing, not a diagnostic algorithm or an AI-assisted diagnostic tool. Therefore, MRMC studies are not relevant to its clearance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. As stated above, this is a wound dressing, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance data mentioned would be established by the standard scientific and regulatory protocols for the specific tests performed:
- Antimicrobial testing: Likely based on standardized microbiological assays (e.g., bacterial reduction, zone of inhibition) with objective measurements.
- Animal testing: Likely based on objective physiological responses and observations in animal models.
- Bench testing: Objective measurements against predefined physical or chemical properties.
- Biocompatibility testing: Compliance with ISO 10993 standards, using objective measurements of cellular response, systemic effects, and local tissue reactions. The "ground truth" here is the adherence to these accepted standards.
- The "ground truth" for the performance data mentioned would be established by the standard scientific and regulatory protocols for the specific tests performed:
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The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no concept of a "training set."
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How the ground truth for the training set was established:
- Not applicable. No training set for an AI/ML algorithm is involved.
Summary of Device Acceptance:
The acceptance of Procellera™ for marketing was based on demonstrating substantial equivalence to a predicate device (CMB Antimicrobial Dressing, K060237) under the 510(k) pathway. This means the FDA concluded that Procellera™ is as safe and effective as the predicate device. The evidence provided for this conclusion consisted of:
- Identical Technological Characteristics: The Procellera™ is explicitly stated to be "the same device as the predicate CMB™."
- Performance Data: General categories of testing were conducted (antimicrobial, animal, bench, and various biocompatibility tests following established guidelines). These tests are aimed at supporting the safety and effectiveness claim by demonstrating the device performs as expected for a wound dressing and does not pose undue risks.
The 510(k) summaries do not present quantitative acceptance criteria or detailed results from specific studies in a format typically seen for devices that require complex performance metrics (e.g., sensitivity, specificity for diagnostic devices). Instead, the regulatory pathway relies on the direct comparison to an already cleared device and general safety assessments.
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