(86 days)
Anspach Surgical Irrigation Systems are indicated for use with Anspach Surgical Motor Systems for providing controlled, cooling irrigation during cutting, shaping and removal of bone, including bones of the skull and spine.
The Anspach Irrigation Pump System is designed to deliver a constant flow (0 to 30 mL/min) of irrigation fluid by means of a peristaltic pump. The peristaltic pump itself is integral to the control box which is designed for placement on a table or equipped with a connection device to permit secure attachment to an IV Pole. Anspach Irrigation pump systems are designed to be compliant with requirements of UL 2601-1/C, SA 601.1, IEC 60601-1 for UL Classification and EMC Testing.
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance metrics, or study details such as sample sizes, data provenance, expert qualifications, or adjudication methods for the Anspach Irrigation System.
The document primarily focuses on establishing substantial equivalence to predicate devices, operational characteristics, warnings, and regulatory classification for a 510(k) submission. It does not contain the kind of detailed study information you are requesting.
§ 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).