Search Results

The BodyGuard Infusion system is designed to transfer medication and fluids intravenously. The system is intended for patients who require maintenance medications, PCA therapy, Parenteral nutritional fluids and general I.V. fluids therapy in hospital and home care environments.

The BodyGuard Infusion system includes: Infusion Pump Battery Charger Infusion Sets PCA cable (optional) Charging cable (optional)

I am sorry, but the provided text from the U.S. Food and Drug Administration (FDA) K070718 letter and the "Indications for Use" document for the "Body Guard Infusion System" does not contain information about acceptance criteria, device performance, study details (like sample size, data provenance, ground truth, or expert qualifications), or any comparative effectiveness studies with human readers and AI.

The documents primarily consist of a 510(k) clearance letter confirming that the device is substantially equivalent to a legally marketed predicate device, and a separate "Indications for Use" statement describing the intended purpose of the device.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or details about a study that proves the device meets these criteria based on the provided text.

Ask a specific question about this device