(61 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" proneered at the University of Wisconsin by Dr Folkert O Belzer Indeed, the cold storage solution is often referred to as "Belzer UW" solution The formulation includes soluble collords, buffers, sodium and potassium salts, redox stabilizers, and phosphoric compounds to and tissue vrability 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, structured to address your specific questions. It's important to note that this document is a summary for regulatory clearance, not a detailed scientific paper, so some requested information may not be explicitly present.
Device Name: CoStorSol® (Organ Storage Solution)
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k), the primary "acceptance criterion" is
substantial equivalence to the predicate device. The performance data presented focuses on demonstrating that the proposed device, stored at ambient temperature, is identical to the predicate device stored under refrigeration, particularly regarding its chemical composition and biocompatibility.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance |
|---|---|
| Material Identity: No change in formulation | "Chemical analyses on both fresh reference samples naturally aged at 25° ± 2°C, show CoStorSol® to be identical to the predicate solution." |
| Biocompatibility: Product remains biocompatible | "Test results have shown CoStorSol® itself to be a biocompatible solution, supplied in flexible solution administration pouches, which have likewise been tested and shown to be biocompatible. The ISO 10993 series of standards were referenced..." |
| Sterility & Non-pyrogenicity: Maintained | "CoStorSol® is supplied sterile and non-pyrogenic... Sterilization processes were validated according to either ISO 17665 or USP Section , as appropriate." |
| Packaging Integrity: Maintained | Flexible solution administration pouches tested and shown to be biocompatible. (Implies packaging integrity for safe use.) |
| Shelf Life (Ambient Temperature): 1 year at up to 25°C | "The proposed CoStorSol® solution is identical to the predicate again, only the long-term storage temperature range has changed." (Supported by "naturally aged" chemical analysis.) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical performance data involving organs or patients, as this submission focuses on demonstrating equivalence through chemical and biocompatibility testing.
- Sample Size:
- For chemical analysis: "both fresh reference samples naturally aged at 25° ± 2°C". The exact number of samples is not stated but implies a comparison between newly manufactured product and product aged under the new storage conditions.
- For biocompatibility: Tests were conducted on CoStorSol® itself and the flexible solution administration pouches. The sample sizes for these specific ISO 10993 tests are not provided but would have been defined by the standards.
- Data Provenance: The data appears to be from bench testing and laboratory analysis, rather than human clinical trials. The country of origin of the data is not explicitly stated but is implied to be from the manufacturer or contracted testing labs. It is retrospective in the sense that the studies were performed on existing product formulations to support a change in storage conditions.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This submission relies on scientific and engineering testing (chemical analysis, biocompatibility, sterility validation) rather than expert consensus on diagnostic interpretations or clinical outcomes. There is no "ground truth" established by human experts in the context of a test set for diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable. There's no "test set" requiring adjudication by multiple readers/experts in this type of submission. The evaluation is based on objective laboratory measurements and adherence to standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study is typically for evaluating the diagnostic performance of a medical imaging device or software. This device is an organ preservation solution, and its evaluation focuses on chemical integrity, safety (biocompatibility, sterility), and stability under new storage conditions.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is not an algorithm or AI system. Its performance is inherent in its chemical properties and physical stability.
7. The Type of Ground Truth Used
The "ground truth" in this context is established by:
- Chemical Analysis: Demonstrating the chemical composition of the proposed device (stored ambient) is identical to the predicate device (stored refrigerated). The "truth" is the established chemical formula and stability profile.
- Biocompatibility Standards: Adhering to the requirements of ISO 10993 series, where the "truth" is that the materials are deemed safe for biological contact.
- Sterility Validation Standards: Adherence to ISO 17665 or USP Section , establishing "truth" through validated sterilization processes.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this device is not a predictive model or AI system.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As explained in point 8, there's no training set for this type of 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).