(105 days)
The BodyGuard Infusion system is designed to transfer medication and fluids intravenously. The system is intended for patients who require maintenance medications in hospital and home care environments. The system is intended for delivery of patient controlled analgesia (PCA) The system is intended for delivery of pain therapy (EPIDURAL)
Not Found
I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the "BodyGuard Pain Management Infusion System," indicating that the device has been found substantially equivalent to a predicate device.
The document discusses:
- The device name and regulation number.
- The indications for use of the device.
- Regulatory information regarding marketing the device.
However, it does not include any details about:
- Acceptance criteria and reported device performance.
- Sample sizes, data provenance, ground truth establishment, or expert qualifications for any studies.
- Adjudication methods.
- Comparative effectiveness studies (MRMC) or standalone algorithm performance studies.
Therefore, I cannot fulfill your request for this specific device based on the information provided.
§ 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).