(29 days)
Replacement battery for Sherwood Medical Systems 10489 Kangaroo Feeding Pump Models 524, 224, 324, 510(k) Number K945964.
This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.
Rechargeable Battery Part Number MS06224
I am sorry, but the provided text is a 510(k) clearance letter for a replacement battery, and it does not contain the specific information requested about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a medical device's performance evaluation. The document focuses on regulatory approval rather than technical performance studies.
§ 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).