(151 days)
Belzer UW® Cold Storage Solution (BTLBUW-001) is indicated for the flushing and cold storage of kidney, liver and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient. Belzer UW® Cold Storage Solution (BTLBUW-001) is not indicated for continuous machine perfusion.
Belzer UW® Cold Storage Solution (BTLBUW-001) is a clear to light yellow, sterile, nonpyrogenic solution for hypothermic flushing and storage of organs. The solution has an approximate calculated osmolarity of 320 mosmol/kg, a sodium concentration of 29 mEq/L, a potassium concentration of 125 mEq/L, and a pH of approximately 7.4 at 20°C.
The solution should be used only by medical healthcare staff, adequately trained according to established operating protocols.
The Belzer UW® Cold Storage Solution (BTLBUW-001) is supplied in non-PVC bags: 500 mL bags, shelf carton of 6; 1000 mL in 1-liter bags, shelf carton of 10; and 2000 mL in 2-liter bags, shelf carton of 5. The solution is sterile and is intended for one single use.
The solution should be stored indoors at temperatures controlled between 2° and 25°C (36° and 77°F) until use. Excessive heat and freezing should be avoided. Belzer UW® Cold Storage Solution (BTLBUW-001) should not be used if discolored or if obvious particulate matter, precipitates, or contamination are evident in the solution.
The provided text is an FDA 510(k) Premarket Notification summary for a medical device called "Belzer UW® Cold Storage Solution (BTLBUW-001)". This document is for a cold storage solution used for organ preservation, not for an AI-powered diagnostic device.
Therefore, the document does not contain information related to:
- Acceptance criteria for an AI device's performance metrics (e.g., sensitivity, specificity, AUC).
- Sample sizes for test sets and training sets for an AI model.
- Number and qualifications of experts for ground truth establishment.
- Adjudication methods for test sets.
- MRMC comparative effectiveness studies or effect sizes of human reader improvement with AI assistance.
- Standalone algorithm performance.
- Type of ground truth used for AI models (e.g., pathology, outcomes data).
The document focuses on demonstrating substantial equivalence of the new cold storage solution (Belzer UW®) to a legally marketed predicate device (CoStorSol® Solution). The "study" proving the device meets acceptance criteria is primarily a non-clinical comparison of product characteristics and safety/performance testing (biocompatibility, sterility, shelf life).
Here's a breakdown of the relevant information provided in the document:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present "acceptance criteria" in the typical sense of quantitative thresholds for an AI/diagnostic device's performance (e.g., "Sensitivity > X%"). Instead, it compares the proposed device's characteristics to those of its predicate device to establish substantial equivalence.
| Characteristic | Predicate Device (CoStorSol® Solution) | Subject Device (Belzer UW® Cold Storage Solution) | Comparison / "Acceptance" |
|---|---|---|---|
| Device Description | Clear to light yellow, sterile, non-pyrogenic solution for hypothermic flushing and storage of organs. Approx. calculated osmolarity of 320 mosmol/kg, Na 29 mEq/L, K 125 mEq/L, pH approx. 7.4 at 20°C. Packaged in 1-Liter bags. | Clear to light yellow, sterile, non-pyrogenic solution for hypothermic flushing and storage of organs. Approx. calculated osmolarity of 320 mosmol/kg, Na 29 mEq/L, K 125 mEq/L, pH approx. 7.4 at 20°C. Packaged in 500-mL, 1-L, and 2-L bags. | Same (composition/basic properties) |
| Indications for Use | Flushing and cold storage of kidney, liver, and pancreas organs for storage, transportation, and eventual transplantation. | Flushing and cold storage of kidney, liver, and pancreas organs for storage, transportation, and eventual transplantation. Not indicated for continuous machine perfusion. | Same (though subject explicitly states "not for continuous machine perfusion") |
| Intended Use | Flushing and cold storage of kidney, liver, and pancreas organs for storage, transportation, and eventual transplantation. | Flushing and cold storage of kidney, liver, and pancreas organs for storage, transportation, and eventual transplantation. | Same |
| Storage Temperature | 2° to 25° C | 2° to 25° C | Same |
| Pre-Cooling | Pre-cool solution prior to use (2° to 6° C) | Pre-cool solution prior to use (2° to 6° C) | Same |
| Maintain Cold Organ Temp | Directly cools vasculature during hypothermic storage/transport (not for continuous perfusion). | Directly cools vasculature during hypothermic storage/transport (not for continuous perfusion). | Same |
| Product State | Liquid - Solution | Liquid - Solution | Same |
| Composition | Identical list of components (Pentafraction, Lactobionic Acid, Potassium Phosphate monobasic, etc.) and concentrations as subject device. | Identical list of components and concentrations as predicate device (see Table 1 in document). | Same |
| Osmolality | 320 mOsmol/kg | 320 mOsmol/kg | Same |
| pH | Approximately 7.4 at 20°C | Approximately 7.4 at 20°C | Same |
| Fluid Volume | 1,000 ml | 500 ml, 1,000 ml, 2,000 ml | Equivalent (more options for subject) |
| Single Use Only | Yes | Yes | Same |
| Primary Container | Constructed from Ethylene Vinyl Acetate (EVA). Flexible, clear, durable. Latex-Free, PVC-Free, DEHP-Free. Sterile, non-pyrogenic fluid path. | Constructed from Ethylene Vinyl Acetate (EVA). Flexible, clear, durable. Latex-Free, PVC-Free, DEHP-Free. Sterile, non-pyrogenic fluid path. | Equivalent |
| Protecting Overwrap Bag | Yes | Yes | Same |
| Shelf Life | 24 Months | 6 Months | Same (Subject states ongoing study for 24 months) |
| Pyrogenicity | Non-Pyrogenic | Non-Pyrogenic | Same |
| Sterility | Assured via 0.1 µm membrane filtration | Assured via 0.2 µm and two 0.1 µm membrane filtration | Same (similar method) |
| Sterilization | Aseptic Fill | Aseptic Fill | Same |
| Biocompatibility | In accordance with ISO 10993-1/2/5/10/12. | In accordance with ISO 10993-1/2/5/10/12. | Equivalent |
| Sterile Dispensing/Admin. | Fluid dispensed via sterile port on bag. | Fluid dispensed via sterile port on bag. | Same |
| Bag Connections | Fluid delivery and drug administration ports | Fluid delivery and drug administration ports | Same |
2. Sample sized used for the test set and the data provenance:
Not applicable for this type of device. The "test set" here refers to specific non-clinical tests (biocompatibility, sterility, shelf life stability). The provenance of organs or patient data is not relevant or mentioned. These tests are laboratory-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth for a cold storage solution is established through laboratory analyses and well-defined chemical and biological testing standards, not by expert interpretation of images or patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication is relevant for studies involving human interpretation (e.g., radiology reads), not for direct measurements of solution properties or standard in-vitro biological tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not an AI diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI diagnostic device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance would be established through:
- Chemical analysis to verify composition, osmolarity, and pH.
- Microbiological testing to verify sterility and non-pyrogenicity.
- Biocompatibility testing (in vitro and potentially in vivo animal studies, referenced as ISO 10993 standards) to ensure the material does not cause adverse biological reactions.
- Stability studies to confirm shelf life and maintain properties over time.
- Functional performance testing (e.g., in animal models or ex-vivo organ models, although not explicitly detailed in this summary, would typically be part of the full submission for a device of this nature) to show the solution preserves organs effectively.
8. The sample size for the training set:
Not applicable. This is not an AI diagnostic device.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI diagnostic device.
§ 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).