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To sample blood or administer drug solutions, blood products, and other fluids intravenously. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy.

The subject catheter is a long term, single use, intravascular catheter of various French sizes and lengths which is designed to provide access to the central venous system. It is inserted into the vascular system through a spittable introducer catheter.

The provided text describes a 510(k) premarket notification for a medical device, the FIRST PICC™ Catheter with Dual Lumens. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a study with performance metrics in the way an AI/ML device submission would.

Therefore, the information required in the prompt (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present for this specific device in the provided text, as it describes a traditional medical device submission (Preamendments device) and not an AI/ML powered device.

The submission confirms that the device is a "long term, single use, intravascular catheter of various French sizes and lengths which is designed to provide access to the central venous system." The key change from the predicate device is a modification to the "stylet and labeling." The FDA's letter states that the device is substantially equivalent to a predicate device and may be marketed.

In summary, none of the requested information regarding acceptance criteria, study details, or performance metrics in a structured way (as expected for an AI/ML device) can be extracted from this document.

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