(315 days)
The ANGIODYNAMICS, Inc. PulseSpray Injector is intended for the automatic infusion of thrombolytic fluids into the peripheral vasculature through the ANGIODYNAMICS, Inc. PulseSpray Pulsed Infusion System.
Not Found
This document is a 510(k) clearance letter for the AngioDynamics, Inc. Pulse*Spray Injector, indicating that the device has been found substantially equivalent to a pre-amendments device. It does not contain information about acceptance criteria or a study proving device performance against such criteria. The letter primarily focuses on the regulatory clearance for marketing the device based on its substantial equivalence.
Therefore, I cannot provide the requested information from the provided text. The document does not describe:
- Acceptance criteria and reported device performance.
- Sample sizes, data provenance, or expert qualifications for a test set.
- Adjudication methods.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
- Details of a standalone algorithm performance study.
- Type of ground truth used.
- Training set sample size or how its ground truth was established.
§ 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).