(162 days)
The intended use of the Belmont Hyperthermia Pump is to raise the temperature of the thoracic or pentoneal cavity to the desired target temperature by continuously lavaging the cavity with circulating warmed sterile solution, according to a protocol to be selected by the physician.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the "Belmont Hyperthermia Pump", not an AI/ML device. Therefore, the questions related to acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training data are not applicable to this document. These questions are typically relevant for AI/ML device submissions where performance is measured against ground truth and compared to human readers.
This document only states the "Indications for Use" for the device, which is: "The intended use of the Belmont Hyperthermia Pump is to raise the temperature of the thoracic or peritoneal cavity to the desired target temperature by continuously lavaging the cavity with circulating warmed sterile solution, according to a protocol to be selected by the physician."
No performance data, acceptance criteria, or study details are provided in this regulatory letter.
§ 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).