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The Texan™ Foreign Body Retrieval Device is indicated for use as a tool to retrieve and manipulate foreign bodies from distal peripheral vessels of the cardiovascular system.

The Texan™ is comprised of the following:

• A nitinol wire formed into a loop. The wire is secured distally to the catheter body; the proximal wire end is attached to a shaft that functions as a push-rod, and passes through a dedicated catheter lumen. The "loop" portion of the wire has a radiopaque feature, comprised of Nitinol wire with a platinum core and tungsten sheath
• A two-lumen catheter body. One lumen is dedicated for use by the loop wire, which is secured to the push-rod (shaft) at the proximal end of the loop wire. The second and larger lumen is dedicated for use of a guidewire and contrast. The proximal catheter end is to be attached to a hemostasis valve with a flush port.
• The hemostasis valve has 2 ports:
• side port having access to the guidewire-dedicated lumen for contrast injection; and
• primary port dedicated for a guidewire, and having a Tuohy-Borst connector.

The loop is activated by pushing the shaft distal to the Touhy-Borst connector while holding the Touhy-Borst stationary. The device should be manipulated in such a way that the loop can surround the foreign body. To capture the foreign body, the user shall slowly tighten the loop around the foreign body by pulling the shaft proximally while the device is held stationary in position. Once the loop is tightened around the foreign body the shaft shall be locked by rotating the homeostasis valve connected to the proximal end of the shaft clockwise. Retrieval of the foreign body is performed by slowly withdrawing the Texan™ and the foreign body as a unit into the sheath.

The provided text is a 510(k) summary for the Texan™ Foreign Body Retrieval Device. It primarily focuses on demonstrating substantial equivalence to a predicate device and details non-clinical performance testing. It does not contain information about acceptance criteria in the form of specific performance metrics or a study designed to prove the device meets these criteria in the context of clinical or comparative effectiveness.

Here’s a breakdown of the information that is and is not available:

1. A table of acceptance criteria and the reported device performance:

This information is not present in the provided document in the format of specific, quantifiable acceptance criteria and corresponding reported device performance values. The document states that the device "successfully passed all functional and safety testing requirements to ensure substantial equivalence to the predicate device," but it does not list these requirements as specific acceptance criteria (e.g., success rate > X%, retrieval time

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