(78 days)
The BodyGuard infusion Pump system is designed for infusion and monitoring. The pump is intended for infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through 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). Monitoring accessory currently includes Pulse Oximeter, used for non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The system is intended for patients who require maintenance medications, analgesics, PCA therapy, parenteral and enteral nutrition fluids, chemotherapeutic agents and general fluids therapy. The system is indicated for use with adult, pediatric and neonatal patients in hospital and home care environments.
The BodyGuard Infusion system includes: Infusion Pump (one/dual channel models) Docking Station Bolus cable (optional) Drop sensor (optional) Pulse Oximeter (optional)
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for an infusion pump system. It mainly discusses regulatory aspects and indications for use. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies as you requested.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.
§ 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).