(240 days)
Rx Only (Pad and Ribbon Configurations)
Under the supervision of a healthcare professional, ALGS2 Ag Alginate Wound Dressing may be used for the management of acute and chronic, partial and full thickness wounds including pressure ulcers, leg ulcers, diabetic foot ulcers, surgical wounds, traumatic wounds, partial thickness burns.
For Over-the-Counter use (Pad Configuration)
ALGS2 Ag Alginate Wound Dressing may be used for
. Minor Abrasions
Minor Lacerations
. Minor cuts
. Minor scalds and burns
ALGS2 Ag Alginate Wound Dressing is a soft, highly absorbent, sterile, single use, nonwoven (Rx version pad or ribbon, OTC version pad only) dressing composed of calcium alginate and 0.95% ionic silver which allows for a maximum of 18 mg of silver for a 4 inch x 4 inch dressing. The silver present in the dressing is to prevent or inhibit growth of bacteria within the dressing absorbs wound fluid and creates a soft and cohesive gel which conforms to the wound surface and assists in maintaining a moist environment. The ALGS2 Ag Alginate Wound Dressing helps maintain a moist wound environment which is conducive to wound healing.
The ALGS2 Ag Alginate Wound Dressing is individually packaged in foil pouches and terminally sterilized by gamma radiation.
This document describes a 510(k) submission for the "ALGS2 Ag Alginate Wound Dressing" and its substantial equivalence to a predicate device, the "ALGS6 Ag Alginate Wound Dressing." The focus of the provided text is on demonstrating this equivalence through comparison of technological characteristics and performance testing related to biocompatibility and bench tests. Crucially, this submission does not involve an AI/ML powered device, nor does it detail a clinical study with human readers assessing AI performance.
Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving device performance in the context of AI/ML. The provided information relates to a medical device (wound dressing) and its physical, chemical, and biological properties, not an AI algorithm.
Specifically, the document focuses on:
- Device Description: ALGS2 Ag Alginate Wound Dressing is a sterile, single-use, nonwoven dressing composed of calcium alginate and 0.95% ionic silver.
- Indications for Use: For management of acute and chronic, partial and full thickness wounds (Rx Only) and minor abrasions, lacerations, cuts, scalds, and burns (OTC).
- Predicate Device: ALGS6 Ag Alginate Wound Dressing (K172570) from the same manufacturer.
- Technological Characteristics Comparison: A detailed table comparing parameters like Indications for Use, Intended Use, Device Design, Mechanism of Action, Antibacterial Material/Activity, Hydrophilic Material, Method of Affixation, Wear Time, Integral Removal, Single Use, Sterilization, and Primary Packaging. All parameters are deemed "Substantially Equivalent."
- Performance Data: This section lists biocompatibility and bench testing performed.
- Biocompatibility Testing: Lists tests like Cytotoxicity, Sensitization, Irritation, Pyrogenicity, Acute Systemic Toxicity, Subchronic Toxicity, Implantation Effects (Wound Healing Study), and Bacterial Endotoxins Test. Methods for each are cited (e.g., ISO 10993 series, USP).
- Performance Testing - Bench: Lists tests like Weight/Dimensions, Absorbency, Moisture Content, Acidity, Silver Content, Heavy Metal Analysis, and Evaluation of Antibacterial Effectiveness.
None of the requested components for an AI/ML study (e.g., test set sample size, data provenance, expert ground truth, MRMC study, standalone performance, training set details) are relevant to this 510(k) submission as it is for a traditional medical device (wound dressing), not an AI-powered one.
N/A