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The intended use for the Worldwide Medical Technologies Introducer Needle for Biopsy Needles is in the co-axial biopsy technique where the introducer needle is first percutaneously placed at the site of the lesion and the biopsy needle is placed through the introducer to take the sample. This allows for accurate multiple sampling of the same lesion. This technique is used in any of the soft tissue organs of the abdomen and thorax.

Worldwide Medical Technologies Introducer Needle for Biopsy Needles

The provided documents, K981889, are a 510(k) clearance letter and an Indications For Use statement for the Worldwide Medical Technologies Introducer Needle. These documents do not contain any information regarding acceptance criteria, device performance studies, or clinical trial data.

Therefore, I cannot provide the requested information. The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, which does not necessarily require new clinical studies if existing data or non-clinical tests are deemed sufficient.

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