(157 days)
The BD ChloraShield IV Dressing with CHG antimicrobial is intended to cover and protect catheter sites and to secure devices to the skin. Common applications include securing IV catheters, other intravascular catheters and percutaneous devices.
The BD ChloraShield™ IV Dressing with CHG antimicrobial consists of a transparent adhesive dressing integrated with Chlorhexidine Gluconate (CHG), a well known antiseptic agent with broad-spectrum antimicrobial activity, which serves as a preservative within the dressing.
This document is a 510(k) Summary for a medical device called the "BD ChloraShield IV Dressing with CHG antimicrobial." It describes the device, its intended use, and the rationale for its substantial equivalence to a predicate device.
It does NOT contain information about acceptance criteria or a study proving that a device meets acceptance criteria for an AI/algorithm-based system.
The document focuses on a change in the sterilization method (from gamma radiation to Ethylene Oxide gas) for an existing medical dressing. The performance testing section (Section 7) states that "Performance testing for the BD ChloraShield™ IV Dressing with CHG antimicrobial utilized the same test methodology as the predicate device within K113836." It emphasizes that the CHG concentration, materials, and manufacturing methods remain unchanged and that the sterility requirements (Sterility Assurance Level - SAL) of 10^-6 are met without compromising the device's performance.
Therefore, I cannot extract the requested information regarding AI/algorithm acceptance criteria or study details from this document. The questions about sample sizes, expert qualifications, ground truth establishment, MRMC studies, or standalone performance are not relevant to the content of this 510(k) summary.
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