(90 days)
The Kendall Curity Iodoform Packing Strip is intended for wet to dry packing of deep wounds including nasal and sinus passages. It helps control/prevent bleeding, encourages drainage and assists in removing necrotic tissue. It is indicated for general wound packing.
The proposed Kendall Curity Iodoform Packing Strip is a sterile, single-use, wound dressing consisting of a cotton gauze strip impregnated with a formulated Iodoform solution. It is packaged in HDPE amber colored bottles and is available in 14" x 5yd, 1/2" x 5yd, 1" x 5yd and 2" x 5yd sizes.
The provided text is related to a 510(k) submission for a medical device called the "Kendall Curity Iodoform Packing Strip." This document focuses on demonstrating substantial equivalence to a predicate device based on material, function, and intended use, rather than presenting a performance study with specific acceptance criteria and performance metrics.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for AI performance is not available in the provided text.
The document states that "Biocompatibility testing of the Kendall Curity Iodoform Packing Strip has demonstrated that it contains no bioactive components. Testing performed on the product was based upon guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1."
This indicates that some non-clinical testing was performed for biocompatibility, but the details of acceptance criteria and reported performance for this testing are not provided in a format that would allow for a table similar to what's expected for a diagnostic device's performance study.
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