(391 days)
The ambIT PCA*PIB Pump is used to infuse medicines and/or fluids into patients primarily for pain management.
The routes of administration are generally intravenous, epidural and/or regional.
The ambIT PCA*PIB Pump is not intended to supersede, augment, or replace any other medical device or drug indications for use or intended uses.
The ambIT PCA*PIB Pump is intended to be used in the home and in healthcare facilities.
The new ambIT PCA*PIB is an electro-mechanically controlled, rotary-peristaltic, infusion pump that consists of two components: (1) the reusable pump driver; and (2) the sterile, single-use cassette (tubing set).
The ambIT PCAPIB Pump has a microprocessor-controlled motor that turns the rollers in the cassette at a set frequency to provide the desired infusion rate/therapy. The ambIT PCAPIB Pump is powered by two (2) standard 1.5-volt "AA" batteries, and cannot be powered by electrical mains. The batteries are replaceable but cannot be recharged inside the pump.
The controls consist of two buttons and an OFF/ON switch. One button toggles the pump between pause and infusing. The other button (BOLUS button) is used to request a bolus. An LCD display shows the pump status, alarms, and history. The pump monitors downstream occlusions, pump malfunctions, and other pump error conditions. The materials of construction are all medical grade plastics. Specifically, the materials are ABS, polycarbonate, nylon, and glass-filled nylon.
The part of the pump that comes into indirect contact with the body is the cassette or tubing set. The medications flow through the tubing into a catheter and then into the body. The tubing set is classified to be used for less than 30 days. The length of time the pump is used is based on the therapy requirements.
The ambIT PCA*PIB product has been validated and verified to meet healthcare providers', lay users', and patients' needs for pain management infusions. The pump meets all applicable national and international consensus standards.
The provided text does not describe acceptance criteria for a medical device in terms of performance metrics or a study designed to prove the device meets those criteria. Instead, it is a 510(k) premarket notification for infusion pumps (ambIT PCAPIB, ambIT PIB, ambIT PIBPCA, ambIT PIEB, and ambIT Programmable Intermittent Pump).
The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (ambIT PCA Pump, K002434) and a reference device (CADD-Solis Ambulatory Infusion Pump, K130394), rather than presenting a study against specific acceptance criteria for performance.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria, reported performance, or details about a study proving the device meets acceptance criteria, as this information is not present in the provided text.
Specifically, the document states:
- "Non-Clinical Performance Data: Both the predicate ambIT PCA Pump and the new ambIT PCAPIB Pump meet the same non-clinical performance data. The bench testing on the ambIT PCAPIB Pump demonstrates that the new pump meets the same volumetric accuracy requirements (when delivering high, low, and median flow rates and bolus volumes), the same usability requirements, and the same downstream occlusion alarm specifications. The volumetric accuracy and occlusion alarm were tested and the results show that the new pump meets the same specifications as the predicate pumps."
- "Clinical Performance Data: Clinical Performance Data was not relied on to show substantial equivalence."
This indicates that while performance testing was done (e.g., volumetric accuracy, usability, occlusion alarm), the purpose was to show the new device meets the same specifications as the predicate, not to meet pre-defined acceptance criteria for a new clinical performance study. The exact numerical specifications for these tests are not provided, nor is a detailed study report.
§ 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).