(201 days)
Disposable device intended to recirculate, filtrate and perfuse physiologically compatible sterile solution (i.e. saline solution) in the thoracic or abdominal cavity. The device is intended for use in a single procedure.
The Hang&Go PAC, just like the Hang&Go HT Basic, is a disposable, single use kit intended to circulate and filtrate physiologically compatible sterile solution (i.e. saline solution) in the thoracic or abdominal cavity. The Hang&Go PAC is supplied sterile and packaged in a proprietary-design container and it is intended to be used only with the PERFORMER HT. The Hang&Go PAC, just like the Hang&Go HT Basic, includes all necessary tubing and components for the treatment execution: circulation tubing, heater bag, reservoir, table pack (Patient inlet and outlet tubing) with thermal protections. The Flow Reverse is a disposable, sterile component of the Hang&Go PAC. It is supplied sterile, individually packaged and included in the Hang&Go PAC carton box. The crossed layout of the 4 tubing segments allow to exchange the Patient's inlet and outlet flows by selectively opening / closing two segments at a time with the provided manual clamps.
I am sorry, but the provided text does not contain the specific information required to answer your request about acceptance criteria and the study that proves the device meets them. The document is a 510(k) premarket notification from the FDA regarding an infusion pump named "Hang&Go PAC." While it details the device's indications for use, comparison to a predicate device, and a list of non-clinical tests and applicable standards, it does not provide a table of acceptance criteria with reported device performance or information about sample sizes for test sets, expert involvement, adjudication methods, or specific details of standalone or MRMC studies.
The document primarily focuses on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and compliance with recognized standards for general safety, biocompatibility, sterilization, and packaging. It mentions specific tests conducted (e.g., static priming volume, pressure drops, temperature probe qualification, physical integrity verification for the Flow Reverse component), but it does not present the acceptance criteria for these tests nor the detailed results in a format that would allow filling out the requested table.
Therefore, I cannot provide the detailed information you requested based on the input 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).