(19 days)
Intended to provide continuous infusion of a local anesthetic directly into the intraoperative site for postoperative pain management.
Not Found
I am sorry, but the provided text only contains a 510(k) clearance letter for the Stryker PainPump and an "Indications for Use Statement."
This document does not contain information about:
- Acceptance criteria for the device's performance.
- Data from a study proving the device meets acceptance criteria.
- Sample sizes for test or training sets.
- Data provenance.
- Number or qualifications of experts.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance studies.
- Type of ground truth used.
- How ground truth for a training set was established.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided 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).