(567 days)
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No
The summary describes a cold storage solution for organs and provides performance data comparing it to existing solutions. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML.
No.
The device is a cold storage solution used to preserve organs for transplantation, which is an ancillary medical product rather than a therapeutic device that directly treats a disease or condition in a patient.
No
The device, Belzer UW Cold Storage Solution, is a preservation and cold storage medium for organs (liver, pancreas, and kidney) intended for transplant. It is not used to diagnose a disease or condition.
No
The device is a cold storage solution, which is a chemical substance used for preserving organs, not a software program.
Based on the provided information, the Belzer UW Cold Storage Solution is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the preservation of organs (liver, pancreas, kidney) through cold storage. This is a direct interaction with biological material (organs) outside of the body, but its purpose is to maintain the viability of the organ for transplantation, not to diagnose a condition or provide information about a patient's health status.
- Device Description: While not found, the description of its function (cold storage solution) aligns with a preservation medium, not a diagnostic test.
- Mentions of IVD-related terms: There are no mentions of analyzing samples (blood, urine, tissue), detecting analytes, or providing diagnostic information.
- Performance Studies: The performance studies focus on the outcome of organ transplantation after storage in the solution (survival rates, organ function markers like SGOT, SGPT, amylase, glucose), not on the accuracy of a diagnostic test.
IVDs are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Belzer UW Cold Storage Solution's function is to preserve an organ for later use in a patient, which falls outside the scope of an IVD.
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Intended Use / Indications for Use
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.
Product codes
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Device Description
The Belzer UW Cold Storage Solution
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
kidney, liver, pancreas
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Preclinical Data - Kidney:
A comparison of EuroCollins' solution to BELZER UW-CSS in a dog transplant model.
Sample size: Not specified (multiple dogs).
Study Type: Preclinical animal model.
Key results: 80% survival of dogs receiving kidneys stored for 48 hours in EuroCollins', but no dog survived after organ storage for 72 hours in this solution. In contrast, all dogs transplanted with kidneys preserved in BELZER UW-CSS for 48 to 72 hours survived. Initial post transplant renal function was better in kidneys stored in BELZER UW-CSS, as indicated by serum creatinine values immediately post-transplant and the rapid return of renal function to normal.
Clinical Data - Liver:
A clinical study compared EuroCollins' Solution (ECS) and the BELZER UW-CSS as preservation and cold storage media for livers harvested for orthotopic transplant.
Sample size: 126 livers preserved in ECS and 122 livers preserved in BELZER UW-CSS (248 liver transplants in 219 patients).
Data source: ECS data collected retrospectively, BELZER UW-CSS data gathered prospectively.
Study Type: Clinical comparative study.
Key results: Mean liver preservation times were significantly different for the two treatment groups, with BELZER UW-CSS livers preserved 88% longer than ECS livers. Mean levels of SGOT and SGPT in BELZER UW-CSS patients were significantly lower than ECS patients on the first day after surgery. Total bilirubin and alkaline phosphatase differences became apparent in the seven-day follow-up period; at seven days, alkaline phosphatase levels in BELZER UW-CSS patients were significantly lower than ECS patients, while total bilirubin levels were slightly higher in BELZER UW-CSS patients. The need for retransplantation was higher in the ECS group (19 vs. 10). Deaths were 23 for ECS patients over 21.5 months compared to 7 for BELZER UW-CSS over four months. Hepatic artery thrombosis was greater for ECS patients (7 vs. 3).
Clinical Data - Pancreas:
A clinical study was performed to compare the effectiveness of ECS and the BELZER UW-CSS as preservation media for cold storage of human pancreas grafts intended for transplant.
Sample size: Six ECS grafts and nine BELZER UW-CSS grafts.
Data source: ECS data collected retrospectively, BELZER UW-CSS data obtained prospectively.
Study Type: Clinical comparative study.
Key results: The mean preservation time for pancreas grafts stored in BELZER UW-CSS was significantly longer than for those stored in ECS. No statistically significant differences in mean Day 1 serum amylase, urinary amylase or blood glucose levels between the two treatment groups, although Day 1 serum amylase values were higher in ECS versus BELZER UW-CSS patients. Over the seven day postoperative period, serum and urinary amylase levels were not significantly different. Blood glucose values tended to increase at the end of the week in ECS patients, but decreased in BELZER UW-CSS patients.
Key Metrics
Liver Study:
Mean Preservation Time (hours): ECS: 5.53+/-0.14, BELZER UW-CSS: 10.39+/-0.47 (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).
0
APR 22 1996
SUMMARY OF SAFETY AND EFFICACY SUBMITTED IN 1988 TO SUPPORT ORIGINAL 510(k) FILING
Introduction
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. Use of BELZER UW-CSS could transform liver and pancreas transplantation from emergency operations to semi-elective procedures.
Preclinical Data
Kidney
Currently, kidneys are preserved by cold storage in Collins' or EuroCollins' solution (ECS) for cold storage transportation for clinical transplantation. Preservation in these solutions is limited to 48 hours. A comparison of EuroCollins' solution to BELZER UW-CSS in a dog transplant model gave 80% survival of dogs receiving kidneys stored for 48 hours in EuroCollins', but no dog survived after organ storage for 72 hours in this solution. In contrast, all dogs transplanted with kidneys preserved in BELZER UW-CSS for 48 to 72 hours survived. Initial post transplant renal function was better in kidneys stored in BELZER UW-CSS, as indicated by serum creatinine values immediately post-transplant and the rapid return of renal function to normal. Thus, storage in BELZER UW-CSS produces less damage to the kidney than storage in ECS. The results of this study indicate the equivalency, and suggest superiority of the BELZER UW-CSS to ECS for kidney preservation.
Clinical Data
Liver
A clinical study compared EuroCollins' Solution (ECS) and the BELZER UW-CSS as preservation and cold storage media for livers harvested for orthotopic transplant. Data for ECS were collected retrospectively, while BELZER UW-CSS data were gathered prospectively. The sample consisted of 126 livers preserved in ECS and 122 livers preserved in BELZER UW-CSS.
Once a donor became available, the liver was isolated and flushed in sity with lactated Ringer's solution and/or ECS solution. The final ex-vivo flush utilized either ECS or BELZER UW-CSS with subsequent storage in the same medium. The preservation time for each liver was recorded. After transplantation, graft function was assessed by the following selected clinical laboratory variables (SGOT, SGPT, alkaline phosphatase, total bilirubin, prothrombin time and partial thromboplastin time) for seven days after surgery and at one month post transplant. Post transplant patient follow up included monitoring for indication of graft dysfunction or rejection, which might indicate the need for a retransplantation. Donor and recipient selection followed the requirements established by the respective institutions sponsoring the transplant procedure.
Two hundred forty-eight liver transplants (126 in ECS group and 122 in the BELZER UW-CSS group) were done in 219 patients. Mean liver preservation times were significantly different for the two treatment groups, with BELZER UW-CSS livers preserved 88% longer than ECS livers (see Table 1).
1
| Table 1 | ||
|---|---|---|
| ECS | ||
| (n=126) | BELZER UW-CSS | |
| (n=122) | ||
| Mean Preservation Time (hours) | 5.53±0.14 | 10.39±0.47 (p |