Search Results

The Sterican™ Cannula is intended for the aspiration of fluids for fluid transfer and may be used with a syringe for transferring fluids from stoppered vials, glass or plastic ampoules. The Sterican™ Cannula is intended for drug admixture only.

The Sterican™ Cannula is a semi blunt, 18G (1.20mm) x 1½ inch (40 mm) cannula configuration with a single cut bevel (40°). The hub can be used to establish either slip fit or locking type connections to male 6% (Luer) taper slip fit or locking type adapters.

The provided document is a 510(k) premarket notification for a medical device (Sterican™ Cannula) and does not contain detailed information about acceptance criteria or a study with specific performance metrics in the format requested.

The document indicates that "Biocompatibility and performance testing was performed with Sterican™ Cannula to support substantial equivalence to the predicate device." However, it does not provide specific acceptance criteria or the results of these performance tests in a quantitative manner.

Therefore, I cannot directly extract the table of acceptance criteria and reported device performance, nor can I answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from the provided text.

The document is primarily a regulatory filing demonstrating "substantial equivalence" to a predicate device (K944931: Becton Dickinson Blunt Steel Cannula) based on similar indications for use, technological properties, and performance, along with biocompatibility testing (ISO 10993-1). It concludes that the device is "safe and effective for its intended use" based on these tests, but the detailed results and criteria are not presented in this summary.

Ask a specific question about this device