(147 days)
ROCHAL Antimicrobial Wound Gel is intended for the management of ulcers (including diabetic foot and leg ulcers and pressure ulcers), first- and second-degree burns, partial- and full-thickness wounds, large surface area wounds, and surgical incisions.
ROCHAL Antimicrobial Wound Gel is intended for the management of minor skin scrapes, minor cuts, minor lacerations, minor burns (1st degree burns), minor irritations.
ROCHAL Antimicrobial Wound Gel provides a moist environment to wound surfaces. ROCHAL Antimicrobial Wound Gel is a safe and gentle colorless gel. The gel provides preservative properties through the antimicrobial (PHMB). ROCHAL Antimicrobial Wound Gel:
- Resists microbial colonization within the dressing during shelf storage.
- Provides an amorphous gel covering
- Facilitates autolytic debridement through a moist wound environment. Wounds experience some level of autolytic debridement where the body's own enzymes breakdown necrotic tissue.
ROCHAL Antimicrobial Wound Gel contains:
Water, Poloxamer 407, Sodium Chloride, Ethylhexylglycerin, Octane-1-2-diol, Polyaminopropyl Biguanide (preservative: PHMB 0.1% w/w) Edetate disodium (EDTA), Edetate trisodium (EDTA)
The provided text describes the 510(k) premarket notification for Rochal Antimicrobial Wound Gel, comparing it to a predicate device, Prontosan Wound Gel X (K130857). This submission is for a medical device that is a wound dressing, not an AI/ML medical device. Therefore, the information requested in the prompt regarding acceptance criteria, study data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and effect sizes of human readers with AI assistance is not applicable to this document.
The document discusses performance testing relevant to a wound gel, which includes:
- ISO 10993 Biocompatibility Studies: These studies demonstrate that the device is safe for biological contact.
- Large-Animal, Full-Thickness Wound Healing Study: This study was conducted to demonstrate the safety of the device in a relevant biological model.
- USP Preservative Effectiveness Testing: This confirms the appropriateness of the chosen preservative (Polyaminopropyl Biguanide - PHMB) in the product formulation.
- Real-time Aging Study: This study assesses the stability and performance of the product over its proposed shelf life of six months.
The conclusion drawn is that the Rochal Antimicrobial Wound Gel is substantially equivalent to the predicate device based on similar intended uses, product form, and function, and demonstrated safety and effectiveness through the battery of tests mentioned above.
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