(170 days)
The indications for use of the MicroJect Model PCA-1 Driver is in the field of pain management. The Driver and associated, sterile Cassettes have been designed for the infusion of medications which are used to control pain. In addition to use by health care professionals, it is also indicated to be used by the patient for infusion of pain medications on an as-needed basis (patient controlled analgesia). The system is indicated for infusion of pain medications into intravenous, subcutaneous, and epidural access routes from standard drug containers, including flexible solution bags and syringes.
MicroJect Model PCA-1
This document is a 510(k) clearance letter for the MicroJect Model PCA-1 infusion pump. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The letter confirms that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information based on the given 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).