(567 days)
The Belzer UW Cold Storage Solution preserves organs, by cold storage, just as well as currently marketed media, such as Collins' solution. Belzer UW Cold Storage Solution, hereafter known as BELZER UW-CSS, can be used for cold storage of the liver, pancreas, and kidney. BELZER UW-CSS has the potential to be used as a general solution for most organs, both for initial cooling during in situ donor organ flushing and for subsequent cold storage.
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Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: BELZER UW Cold Storage Solution (BELZER UW-CSS)
Purpose: Preservation of organs (liver, pancreas, kidney) by cold storage for transplantation.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating equivalence or superiority to existing solutions (Collins' or EuroCollins' Solution - ECS) in terms of preservation time and post-transplant organ function.
| Organ | Acceptance Criteria (Implicit) | Reported BELZER UW-CSS Performance |
|---|---|---|
| Kidney | Equivalence/superiority to ECS in preserving kidneys for successful transplantation, including acceptable post-transplant renal function. | Superiority: All dogs survived after kidney storage for 48-72 hours in BELZER UW-CSS, compared to 0% survival after 72 hours in ECS and 80% survival after 48 hours in ECS. Initial post-transplant renal function (serum creatinine) was better with BELZER UW-CSS. |
| Liver | Equivalence/superiority to ECS in extending preservation time and demonstrating comparable or improved post-transplant liver function. | Superiority: Mean preservation time significantly longer (10.39 hours vs. 5.53 hours for ECS, p |
§ 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).