(176 days)
Belzer~MPS™ is the UW-gluconate perfusion solution indicated for the flushing and continuous hypothermic machine perfusion of donor kidneys.
Belzer-MPSTM is the UW-gluconate perfusion solution
The provided text is a 510(k) clearance letter from the FDA for the Belzer-MPS™ device. It confirms that the device is substantially equivalent to previously marketed devices for the flushing and continuous hypothermic machine perfusion of donor kidneys.
However, this document does not contain any information regarding acceptance criteria, device performance results, details of a study (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance), or how ground truth was established.
Therefore, I cannot provide the requested table and study details based on the input text.
§ 876.5880 Isolated kidney perfusion and transport system and accessories.
(a)
Identification. An isolated kidney perfusion and transport system and accessories is a device that is used to support a donated or a cadaver kidney and to maintain the organ in a near-normal physiologic state until it is transplanted into a recipient patient. This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set.(b)
Classification. Class II (performance standards).