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The GuardianPICC™ is a sterile, disposable, single lumen catheter intended for I.V. administration. The catheter may be used for delivery of TPN nutritional solutions, antibiotics, pain medications, chemotherapy and hurritional concernis inserted peripherally and provides a mechanism for the administration of IV medications to the large central veins of the body.

The GuardianPICC™ is a sterile, disposable, single lumen catheter intended for I.V. administration.

The provided document is a 510(k) premarket notification letter from the FDA for a medical device called GuardianPICC™ Percutaneous Central Venous Catheter. This type of document does not contain information about acceptance criteria, study details, or performance metrics of the device.

The 510(k) pathway is primarily focused on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than on proving new safety and effectiveness through extensive clinical trials with detailed performance metrics like those requested in your prompt.

Therefore, I cannot provide the requested information based on the given text. The document is a clearance letter, not a study report.

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