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The Seal-Away CS™ Introducer Kit is a percutaneous catheter introducer kit with peelaway sheath that is indicated for the introduction of catheters into a vessel.

The Seal-Away™ Hemostasis Adapter is indicated for the introduction of pacing leads, angiographic catheters, closed end catheters, balloon catheters and electrodes into a vessel where minimizing blood loss is essential.

The Seal-Away CST™ introducer kit includes a Peel-Away Introducer, Obturator, Seal-Away™ detachable hemostasis valve, Guidewire, Syringe and Needle. The introducer kits are provided sterile, and are intended for single-use only.

The provided text describes a 510(k) submission for a medical device called the "Seal-Away CST™ Introducer Kit." However, the document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

The 510(k) summary focuses on establishing "substantial equivalence" to a predicate device (Peel away Sheath Introducer and Obturator from St. Jude Medical, Daig Division) rather than presenting a performance study with acceptance criteria.

The submission states: "All technological characteristics of the Seal-Away™ CS introducer kit are substantially equivalent to the predicate device including product design, packaging, sterilization, and labeling." This indicates that the regulatory pathway chosen was based on demonstrating similarity to an already approved device, not on conducting new performance studies against predefined acceptance criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory equivalence rather than a detailed performance study with acceptance criteria.

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