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The Nanostim™ Introducer Kit is intended to provide a conduit into the venous system for insertion of diagnostic and other interventional devices.

The St Jude Medical Nanostim Introducer Kit is designed to perform as a guiding sheath for introduction of diagnostic and interventional devices. The Nanostim™ Introducer Kit is comprised of an Introducer sheath and a dilator. The Introducer Kit is compatible with 0.035" and 0.038" guidewires and is available in 18F and one length of 30 cm. The introducer sheath is fitted with a hemostasis valve to prevent blood loss and minimize air introduction during introducer insertion and/or exchange. A sideport with a three-way stopcock is provided for air or blood aspiration and fluid infusion. The introducer features a radiopaque tip marker incorporated within the sheath material to identify the location of the distal tip of the sheath.

This document is a 510(k) summary for the St. Jude Medical Nanostim Introducer Kit and does not contain information about a study proving the device meets specific acceptance criteria in the context of AI/ML performance, nor does it involve expert reviews or clinical trials in the way typically associated with AI/ML medical devices. The document concerns a physical medical device (catheter introducer) and its substantial equivalence to predicate devices.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets those criteria, as the provided document does not contain this information in the context you've outlined.

The document discusses:

• The device's intended use and technological characteristics.
• Non-clinical testing (e.g., visual, dimensional, tensile, leak tests, biocompatibility).
• A statement that clinical evaluation is not required.
• A comparison to predicate devices to establish substantial equivalence.

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