(138 days)
The McKinley SP is indicated for intravenous, intra-arterial, enteral, subcutaneous and epidural infusion of medications or fluids requiring continuous delivery at controlled infusion rates. The McKinley SP is also intended to provide continuous infusion of a local anaesthetic directly into the intraoperative site for postoperative pain management.
McKinley SP Disposable Infusion Pump
I am sorry, but the provided text does not contain the detailed information necessary to answer your request. The document is a 510(k) clearance letter from the FDA for a medical device (McKinley SP Disposable Infusion Pump). It states that the device is substantially equivalent to a pre-amendment device but does not include:
- A table of acceptance criteria and reported device performance.
- Details about a study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).
- Information about training sets or their ground truth establishment.
The document primarily focuses on regulatory approval and indications for use, without detailing the performance studies conducted to support the substantial equivalence claim.
§ 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).