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Turbo-Ject Peripherally Inserted Central Venous Catheter (PICC) Sets and Trays are intended for short- or long-term use for venous pressure monitoring, blood sampling, administration of drugs and fluids, and for use with power injectors for delivery of contrast in CT studies. The Turbo-Ject PICC is indicated for multiple injections of contrast media through a power injector. The maximum pressure limit setting for Power Injectors used with the Turbo-Ject PICC may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated.

The 3.0, 4.0, 5.0, and 6.0 Fr Turbo-Ject PICC Sets with various lumen configurations are radiopaque polyurethane peripherally inserted central venous catheters for short- or long-term use, and can be inserted through a Peel-Away® introducer or over-the-wire. The set components may include the PICC, obturator, Peel-Away introducer, entry needles, wire guide, and other convenience components. The set is supplied sterile and is intended for one-time use.

This document is a 510(k) summary for the Cook Incorporated Turbo-Ject PICC Sets, indicating substantial equivalence to previously marketed predicate devices. It describes the device's intended use and technological characteristics but does not contain information regarding the acceptance criteria, study that proves the device meets the acceptance criteria, or any of the other specific details requested in the prompt (sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, etc.) relevant to the evaluation of a medical device’s performance against acceptance criteria.

The document primarily focuses on regulatory approval based on demonstrating substantial equivalence to predicate devices through various standard tests (ISO 10555-1, ISO 10993-1) for physical properties and biocompatibility.

Therefore, I cannot provide the requested information based on the provided text. The document states that "Testing demonstrated the proposed device met the predetermined acceptance criteria following accelerated aging" for several tests, but it does not specify what those acceptance criteria were or describe the detailed results of a study to prove they were met.

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