(140 days)
For over-the-counter use, Procellera® wound dressing is intended for the management of wounds to provide a moist wound environment and is indicated for superficial wounds such as minor cuts, scrapes, irritations, abrasions, blisters, etc.
For prescription use, Procellera® antimicrobial wound dressing is intended for the management of wounds to provide a moist wound environment and is indicated for partial and full-thickness wounds such as pressure ulcers, venous ulcers, diabetic ulcers, first and second degree burns, surgical incisions, donor and/or recipient graft sites, etc.
Procellera® is a single layer dressing; it consists of a polyester substrate containing elemental silver and elemental zinc bound to the surface by a biocompatible binder in a well-characterized dot matrix pattern.
In the presence of a conductive fluid, such as wound exudate or moisture, a small amount of current is produced at the surface of the device, and it occurs because it is inherent to its design. The device is self-contained and has no accessories.
Silver and zinc in the dressing produce microcurrent which helps the dressing to be preserved and to minimize or prevent growth of microorganisms within the dressing.
Procellera® is a primary contact layer dressing and it should be used under a secondary dressing or bandage, which keeps it in place and helps maintain a moist wound environment.
The provided text describes a 510(k) submission for the Procellera® Wound Dressing (K130350), which is a re-submission for over-the-counter use of a device previously cleared for prescription use (K081977). This submission primarily focuses on demonstrating substantial equivalence to predicate devices, drawing heavily on the previous clearances.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: | |
| (Implicit by reference to biocompatibility and substantial equivalence) | The device was tested per ISO 10993 and found to be biocompatible, covering cytotoxicity, irritation, sensitization, pyrogenicity, and 28-day subcutaneous implantation. No new safety concerns were identified in comparison to predicate devices. |
| Effectiveness: | |
| Ability to provide a moist wound environment for superficial wounds (minor cuts, scrapes, irritations, abrasions, blisters, etc.) | Based on substantial equivalence to predicate devices (K081977, CMB™ dressing K060237), which are also wound dressings intended to provide a moist wound environment. The device's design (single layer, polyester substrate, used under a secondary dressing) supports its ability to maintain a moist environment. |
| Mechanical/Electrical Performance: | |
| Sustained measurable voltage generation (inherent to design with elemental silver and zinc) | Voltage potential testing (in-house) confirmed a sustained measurable voltage is generated on the surface of the device for up to 30 days when immersed in a conductive fluid. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical test set with a specific sample size for demonstrating performance and safety for this over-the-counter clearance. The submission relies on demonstrating substantial equivalence to previously cleared devices.
The "Performance Data" section mentions "in-house" testing for voltage potential, but this is a technical verification of the device's inherent characteristic, not a clinical study on human subjects or a test set as typically understood in AI/diagnostic device validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable as there was no clinical test set or diagnostic algorithm requiring ground truth established by experts. The substantiation is based on similarity to predicate devices and inherent material characteristics.
4. Adjudication Method for the Test Set
This information is not applicable as there was no clinical test set requiring 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 information is not applicable. The device is a wound dressing, not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or AI performance evaluation was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a wound dressing and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable in the context of clinical performance evaluation for this 510(k). The primary "ground truth" or basis for clearance is demonstrating substantial equivalence to predicate devices (K081977, K060237), based on similar materials, technological characteristics, and intended use. The biocompatibility testing followed ISO standards, which provide their own established criteria (a form of 'ground truth' for safety).
8. The sample size for the training set
This information is not applicable. This is not an AI/ML device, and therefore, no training set was used.
9. How the ground truth for the training set was established
This information is not applicable. As there is no training set mentioned, no ground truth needed to be established for it.
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