(21 days)
Stage I - IV Pressure ulcers Venous stasis ulcers Vehous stasio aread by mixed vascular etiologies Diabetic skin ulcers . First and second degree burns Post-surgical incisions Cuts and abrasions
AmeriGel® Wound Dressing PLUS is a hydrogel that maintains a moist environment to support wound healing. We added 4% Lidocaine HCL to the formulation in our predicate device, AmeriGel® Wound Dressing. AmeriGel® Wound Dressing has been on the market for many years. With so many painful wounds, particularly venous stasis ulcers, we wanted to offer a wound gel that would help reduce the discomfort patients feel. Since AmeriGel® Wound Dressing has been doing so well for all these years, adding the 4% Lidocaine to the Polyethylene glycol (PEG) base will finally provide relief for those patients with painful wounds. When the Lidocaine was added to our formulation of Oakin (oak extract), Meadowsweet extract, water and Zinc acetate, the physical properties remained at a pH range of 7.0 - 7.2. Lidocaine HCL is well known to be GRASE (Generally regarded as safe and effective) and AmeriGel® Wound Dressing is also well known to be safe and effective, the combination of chemicals were found compatible, safe and effective.
This document (K092086) is a 510(k) summary for a medical device called "AmeriGel® Wound Dressing PLUS." It primarily focuses on demonstrating substantial equivalence to existing predicate devices rather than providing a detailed study that proves the device meets specific acceptance criteria in a quantitative sense.
Therefore, many of the requested sections regarding acceptance criteria, study performance, sample sizes, expert ground truth, adjudication, and comparative effectiveness studies are not applicable or not provided in the given document. This is common for 510(k) submissions, especially for devices undergoing minor modifications (like adding an existing drug component to a previously cleared base).
Here's a breakdown based on the information available:
1. A table of acceptance criteria and the reported device performance
- Not explicitly provided as a quantitative table.
- The acceptance criteria for this 510(k) submission are implicitly based on demonstrating that the new device, AmeriGel® Wound Dressing PLUS, performs at least as well as, and is as safe and effective as, its predicate devices (AmeriGel® Wound Dressing and Regenecare® Wound Gel).
- The reported "performance" is primarily a claim of substantial equivalence supported by the fact that:
- The formulation is identical to AmeriGel® Wound Dressing, except for the addition of 4% Lidocaine HCL.
- Lidocaine HCL is "well known to be GRASE (Generally regarded as safe and effective)."
- AmeriGel® Wound Dressing is "well known to be safe and effective" and has been marketed for almost ten years without adverse events.
- Physical properties (pH range of 7.0 - 7.2) remained compatible after adding Lidocaine.
- Biocompatibility was previously established for AmeriGel® Wound Dressing (dermal irritation test on rabbits, sensitization test on guinea pigs, in-vitro cytotoxicity test).
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. No specific "test set" in the context of a performance study with a sample size is mentioned in this 510(k) summary. The submission relies on the established safety and efficacy of its components and predicate devices.
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 / Not provided. No expert review committee or ground truth establishment relevant to an AI/diagnostic device performance study is described. The "ground truth" here is the established safety and efficacy of the individual components (Lidocaine HCL, AmeriGel® Wound Dressing).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No adjudication method is mentioned as there was no specific performance study requiring such a process.
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 device is a medicated wound gel, not an AI or diagnostic imaging device. Therefore, no MRMC study or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a medicated wound gel, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this submission is based on:
- Prior regulatory classifications and approvals: Lidocaine HCL is GRASE (Generally Regarded As Safe and Effective).
- Long-standing market history and absence of adverse events: AmeriGel® Wound Dressing has been on the market for almost ten years without reported adverse events, providing real-world outcomes data as evidence of its safety and effectiveness.
- Bench testing: Biocompatibility tests (dermal irritation, sensitization, in-vitro cytotoxicity) performed previously on the predicate device.
8. The sample size for the training set
- Not applicable. This device is not an AI/machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable. No training set exists for this type of device.
In summary:
This 510(k) relies on demonstrating substantial equivalence to predicate devices and the established safety and efficacy of its components, rather than presenting a de novo clinical study with quantitative performance metrics for "acceptance criteria" in the way one might expect for a novel diagnostic or AI device. The "study" proving the device meets criteria is implicitly the regulatory history and proven safety record of the existing ingredients and base product.
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