(185 days)
CoStorSol® is intended 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.
Preservation Solutions, Inc. manufacturers CoStorSol® according to a "recipe" pioneered at the University of Wisconsin by Dr. Folkert O. Belzer. The cold storage solution is still referred to as "Belzer UW" solution, even though it has been marketed under the trade name ViaSpan®. The formulation includes soluble colloids, buffers, sodium and postassium salts, redox stabilizers, and phosphoric compounds to aid tissue viability by enabling regeneration of adenosine triphosphate (ATP).
CoStorSol® is a clear to light yellow, sterile, non-pyrogenic solution for hypothermic flushing and storage of organs. The solution is packaged in 1-liter bags.
Here's an analysis of the provided 510(k) summary regarding the CoStorSol® device, focusing on acceptance criteria and supporting studies:
Summary of Acceptance Criteria and Device Performance for CoStorSol®
The provided 510(k) summary for CoStorSol® establishes substantial equivalence by demonstrating that the device is identical in composition, intended use, and performance to a legally marketed predicate device, ViaSpan® (Belzer - UW) Organ Solution (K944866). Therefore, the "acceptance criteria" are implicitly met by demonstrating this identity and confirming essential safety and functional characteristics.
| Acceptance Criteria Category | Specific Criteria/Tests Conducted | Reported Device Performance (CoStorSol®) |
|---|---|---|
| Substantial Equivalence to Predicate | Identical chemical composition | "identical solution with exactly the same intended use and chemical composition" as ViaSpan® (Belzer - UW). Fourier transformed infrared scans confirmed stability and chemical identity. |
| Identical intended use | "exactly the same intended use" as ViaSpan® (Belzer - UW), i.e., flushing and cold storage of kidney, liver, and pancreas. | |
| Material/Solution Biocompatibility | ISO 10993 series of standards | CoStorSol® itself shown to be a biocompatible solution. Flexible solution administration pouches also tested and shown to be biocompatible. |
| Sterility & Non-Pyrogenicity | Sterilization validation (ISO 17665 or USP Section ) | Supplied sterile and non-pyrogenic. Sterilization processes were validated. |
| Chemical Stability & Identity | Chemical analyses (fresh and aged samples) | Chemical analyses on fresh and aged samples show identity to the predicate solution. |
| Fourier transformed infrared scans | Confirmed stability and chemical identity. | |
| Packaging | Flexible 1-liter bags | Supplied in 1-liter flexible bags, designed to ease connection to standard administration sets. |
| Storage Requirements | Refrigerated storage without freezing | Designed for refrigerated storage without freezing. |
| Use Conditions | Use cold as vasculature flush and cold storage medium | Used cold as a vasculature flush medium for organs and then as a cold storage medium. |
Study Details:
The 510(k) submission for CoStorSol® primarily relies on demonstrating substantial equivalence to a predicate device rather than conducting a de novo clinical study with specific performance endpoints. The "study" here refers to the testing and analysis performed to prove this equivalence.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- No specific "test set" in the sense of a patient cohort or a dataset with ground truth labels is described for this type of device. The samples used were samples of the CoStorSol® product itself for various chemical, biological, and physical tests.
- The provenance of these test samples (e.g., manufacturing location, specific batch numbers) is not detailed. The tests performed are laboratory-based.
- This is not a retrospective or prospective human clinical study. The data is generated from laboratory testing of the solution and its packaging materials.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This is not applicable. The "ground truth" for this type of device is established through validated laboratory methods for chemical composition, sterility, biocompatibility, and physical characteristics, rather than expert interpretation of medical images or clinical outcomes. The experts involved would be laboratory scientists, chemists, and microbiologists adhering to established standards (e.g., ISO, USP).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are typically employed in studies where human interpretation or consensus is required (e.g., pathology review, clinical endpoints). Here, objective laboratory measurements are the basis of evaluation.
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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 device is an organ preservation solution, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant in this context.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a medical solution, not a software algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The "ground truth" here is the established scientific and regulatory standards for chemical identity, sterility, biocompatibility, and stability, as demonstrated through objective laboratory testing. The predicate device's established efficacy and safety, based on its identical formulation, serves as the ultimate benchmark.
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The sample size for the training set:
- Not applicable. There is no "training set" as this is not a machine learning model.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set.
Conclusion from the 510(k) Summary:
The 510(k) submission for CoStorSol® demonstrates substantial equivalence to the predicate device, ViaSpan® (K944866), by showing that it is an identical solution with the same intended use and chemical composition. Supporting evidence includes:
- Biocompatibility testing against ISO 10993.
- Validation of sterilization processes against ISO 17665 or USP .
- Chemical analyses and Fourier transformed infrared scans confirming identity and stability to the predicate.
This approach is common for devices that are direct copies or minor modifications of existing, legally marketed products, where the safety and effectiveness profile is already well-established by the predicate. Therefore, the "study" demonstrating the device meets acceptance criteria is primarily a series of laboratory tests and analyses confirming identity and adherence to relevant standards.
§ 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).