(28 days)
Rx: The coactiv+™ Antimicrobial Wound Gel is indicated for management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), 1st and 2nd degree burns, partial & full thickness wounds and surgical incisions for adult populations.
OTC: The coactiv+™ Antimicrobial Wound Gel is indicated for management of minor lacerations, minor burns (1st degree burns) and abrasions for adult populations.
The coactiv+™ Antimicrobial Wound Gel is a white, odorless gel that provides a moist wound environment conducive to wound healing. The coactiv+™ Antimicrobial Wound Gel provides preservative properties through an antimicrobial (PHMB) to help inhibit microbial colonization within the gel during shelf storage. Chronic wounds are known to contain non-viable tissue. The coactiv+™ Antimicrobial Wound Gel can facilitate debridement through a moist wound environment.
The coactiv+™ Antimicrobial Wound Gel contains water, Poloxamer 407, Glycerol, Trisodium citrate, PHMB (0.1% w/w), Citric acid, Disodium EDTA.
The coactiv+™ Antimicrobial Wound Gel dressing will be supplied in 0.7 oz. (21 g) white/opaque polypropylene (19 x 100 mm) screw cap tubes.
The device will be available as both a Rx and OTC product.
This FDA 510(k) summary describes the coactiv+™ Antimicrobial Wound Gel and its substantial equivalence to a previously cleared predicate device (K223259). The submission is a special 510(k) for a change to the submitter's own legally marketed device, specifically a labeling change to remove a usage restriction.
Acceptance Criteria and Device Performance:
The document primarily focuses on demonstrating the continued safety and effectiveness of the device after a labeling change. The "performance" in this context refers to the device maintaining its original safety and functional characteristics despite the change.
| Acceptance Criteria (based on predicate device performance) | Reported Device Performance (after labeling change) |
|---|---|
| Biocompatibility: Meet ISO 10993 standards for surface devices with prolonged contact on breached or compromised surfaces. | Met: A biocompatibility evaluation was conducted in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1. Testing included Cytotoxicity, Sensitization, Intracutaneous reactivity, Implantation, Acute Systemic toxicity, Pyrogenicity, and Genotoxicity. (No specific results provided, but the statement implies compliance). |
| Preservative Effectiveness: Demonstrate that the 0.1% PHMB preservative is effective and appropriate for the product formulation (USP ). | Met: USP preservative effectiveness testing was performed and demonstrates the chosen preservative is performing as intended and appropriate for product formulation. (No specific numerical results provided). |
| Stability: Maintain product stability and performance for a 2-year shelf-life (e.g., pH, viscosity, appearance, microbial limits). | Met: Real-time and accelerated aging studies were conducted, indicating the product is stable and maintains performance for the proposed shelf-life of 2 years. Testing included pH , Viscosity , Appearance , TAMC/TYMC , and Preservative Effectiveness . (No specific numerical results provided). |
| Non-negative impact on wound healing: Demonstrate that the gel does not negatively affect normal wound healing. | Met: The effect of the coactiv+™ Antimicrobial Wound Gel on full thickness wound healing was evaluated using a porcine model to demonstrate that it does not negatively impact normal wound healing. (No specific numerical results or direct comparison to a control group provided). |
| Safety and Effectiveness after increased usage (due to label change): A Toxicological Risk Assessment should provide assurance of safety for increased usage. | Met: The labeling restriction on usage (21g/week, 90 g/month) was eliminated, supported by a Toxicological Risk Assessment providing assurance of the safety of the coactiv+. (No details of the risk assessment or specific safety metrics are provided, but the conclusion is that safety is assured). |
Study Details:
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Sample size for the test set and data provenance:
- Biocompatibility Testing: Not specified, but standard ISO 10993 tests for cytotoxicity, sensitization, intracutaneous reactivity, implantation, acute systemic toxicity, pyrogenicity, and genotoxicity are usually performed on representative samples of the final device material. No human subjects are involved.
- Performance Testing (USP , stability): Not specified. These are laboratory-based tests on product batches.
- Animal Testing (Wound Healing): A "porcine model" was used. The exact number of animals or wounds tested is not specified. This is a preclinical study.
- Toxicological Risk Assessment: This is a theoretical assessment based on chemical composition and potential exposure, not directly a "test set" with a sample size in the traditional sense. It would utilize existing toxicological data for the components. The provenance is internal to the manufacturer.
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Number of experts used to establish the ground truth for the test set and qualifications:
- Not applicable in the conventional sense for these types of non-clinical, laboratory, and animal studies. Ground truth is established by the accepted scientific standards and methodologies (e.g., ISO, USP guidelines).
- The Toxicological Risk Assessment would be performed by qualified toxicologists, but the number of "experts" to establish a ground truth for a test set is not relevant here.
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Adjudication method for the test set:
- Not applicable. The studies mentioned are laboratory tests, animal studies, and toxicological assessments. These do not typically involve human adjudication of results in the way clinical studies or diagnostic AI algorithms do. Results are based on direct measurement and interpretation against predefined criteria.
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Multi-reader multi-case (MRMC) comparative effectiveness study:
- No, an MRMC comparative effectiveness study was not done. This device is a wound gel, not a diagnostic imaging device or an AI algorithm intended to assist human readers. Therefore, the concept of human readers improving with AI assistance is not relevant.
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Standalone (i.e., algorithm only without human-in-the-loop performance) study:
- No, this is not an AI/algorithm-based device. It is a medical device (wound gel). Therefore, a standalone algorithm performance study is not applicable.
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Type of ground truth used:
- Biocompatibility: Established scientific standards and methodologies (ISO 10993 series).
- Performance Testing: Pharmacopoeial standards (USP , , , , ).
- Animal Testing: Physiological wound healing as observed and measured in a porcine model.
- Toxicological Risk Assessment: Toxicology databases, literature, and expert knowledge on chemical safety.
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Sample size for the training set:
- Not applicable. This device does not involve machine learning or AI, so there is no "training set."
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.
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