(345 days)
Rx Indications for Use: Under the supervision of a healthcare professional, Microdacyn Wound Care Solution is intended for the cleansing, irrigation, moistening, debridement and removal of foreign material and debris from exudating wounds, acute and chronic dermal lesions including stage I-IV pressure ulcers, diabetic ulcers, post-surgical wounds, first- and second-degree burns, abrasions, minor irritations of the skin, diabetic foot ulcers, ingrown toe nails, grafted/donor sites and exit sites. It is also intended for use to moisten and lubricate wound dressings and for use with devices intended to irrigate wounds.
OTC Indications for Use: Microdacyn Wound Care Solution is intended for OTC management of minor skin abrasions, minor lacerations, minor irritations and intact skin of the face, eyelid and eyelashes.
Microdacyn Wound Care Solution is a clear solution that aids in the mechanical removal of debris and foreign material from the application site. The solution contains sodium hypochlorite and hypochlorous acid as preservatives to reduce/prevent the growth of microorganisms within the solution.
This document is a 510(k) Pre-market Notification summary for a medical device called "Microdacyn Wound Care Solution." It categorizes the device as unclassified and uses predicate devices to establish substantial equivalence.
The document does not describe acceptance criteria or a study proving the device meets the acceptance criteria in the manner one would typically expect for an AI/ML medical device submission (e.g., performance metrics like sensitivity, specificity, AUC for diagnostic accuracy). Instead, it focuses on demonstrating substantial equivalence to legally marketed predicate devices based on technological characteristics, indications for use, safety, and performance.
Therefore, I cannot provide the information requested in the prompt (acceptance criteria table, sample size, expert ground truth, MRMC study, standalone performance, etc.) because the provided text does not contain this type of data or study design. The "performance testing" mentioned is an "Antimicrobial Effectiveness Test" (USP ), which is a microbiological test, not a clinical performance study measuring accuracy or efficacy in the context of disease diagnosis or treatment effectiveness in a human population.
Here's why the requested information isn't present in this type of submission:
- Device Type: Microdacyn Wound Care Solution is a physical chemical product (a wound cleanser), not an AI/ML diagnostic or prognostic device.
- Regulatory Pathway: A 510(k) submission primarily demonstrates substantial equivalence to a predicate device. For devices like this, the "acceptance criteria" are based on comparing characteristics like composition, mechanism of action, intended use, and safety, rather than statistical performance metrics from a clinical trial.
- "Study" Definition: The "studies" mentioned (Biocompatibility and Antimicrobial Effectiveness Tests) are laboratory tests to ensure safety and product integrity, not clinical trials to assess diagnostic accuracy or the impact of an AI algorithm on human reader performance.
If this were an AI/ML device submission, the requested information would be crucial. However, for this specific 510(k) for a wound care solution, the provided text contains the relevant information for its regulatory pathway.
N/A