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The T34 SYRINGE DRIVER is designed for infusion of medications or fluids requiring continuous or intermittent delivery at precisely controlled infusion rates through all clinically acceptable routes of administration including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, enteral, in close proximity to nerves, and into an intraoperative site (soft tissue/body cavity/surgical wound site). The system is intended for patients who require maintenance medications, analgesics, PCA therapy, parenteral and enteral nutrition fluids, chemotherapeutic agents and general fluids therapy in hospital and home care environments.

The T34 SYRINGE DRIVER SYSTEM includes: Syringe Pump Extension Tube Bolus cable (optional)

This document is a 510(k) premarket notification from the FDA for a device called the T34 SYRINGE DRIVER. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance testing, ground truth, sample sizes, or expert qualifications.

Therefore, I cannot fulfill your request for that specific information based on the provided text. The document primarily focuses on regulatory approval and indications for use.

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