(162 days)
The BodyGuard infusion Pump system is designed for infusion of continuous or intermittent delivery at medically-controlled infusion rates through clinically acceptable routes of administration (e.g. intravenous, subcutaneous, percutaneous, intraarterial, epidural, enteral, in close proximity to nerves, and into an arterial, regional, or surgical wound site). The system is intended for patients who require maintenance medications, analgesics, parenteral and enteral nutrition fluids, chemotherapeutic agents or PCA therapy; parenteral fluids therapy in hospital and home care environments.
The BodyGuard Infusion system includes: Infusion Pump Battery Charger Infusion Sets (Microset/ BodySet) Bolus cable (optional) Drop sensor (optional)
I regret to inform you that the documents you provided do not contain the specific information needed to fulfill your request.
The provided text is an FDA 510(k) clearance letter for the "BodyGuard Infusion Pump System." This letter confirms that the device is substantially equivalent to a predicate device and can be marketed. However, it does not include details about:
- Acceptance criteria for device performance.
- A study describing performance results against those criteria.
- Sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods.
- Information regarding MRMC studies, standalone performance, or training set details.
The letter focuses on the regulatory clearance process and the device's indications for use, not the detailed performance studies or the methodology behind them.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the other specific questions based on the input 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).