(43 days)
The T34L 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 T34L SYRINGE DRIVER SYSTEM includes: Syringe Pump External Charger Extension Tube Bolus cable (optional)
This document is a 510(k) clearance letter from the FDA for a medical device called the "T34L Syringe Driver." It is an approval for marketing the device based on substantial equivalence to a legally marketed predicate device. This type of document does not contain the detailed acceptance criteria and study results you are asking for.
The information requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone performance would typically be found in the 510(k) submission document itself, not in the FDA's clearance letter. The clearance letter only states that the device is substantially equivalent and can be marketed.
Therefore, I cannot provide the requested information from the provided text.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).