(50 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 Folkert O. Belzer, MD and James H. Southard, PhD. Indeed, the cold storage solution is often referred to as "Belzer UW" solution. The formulation includes soluble colloids, buffers, sodium and potassium 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, which must be chilled to between 2° and 6° C prior to use. The solution may be used without any point of use filtration.
The provided text describes a 510(k) premarket notification for a medical device called CoStorSol®, an organ storage solution. The submission aims to demonstrate substantial equivalence to a previously cleared version of CoStorSol® (K083453 and K073693) but without the need for a microfilter at the time of use.
The document heavily focuses on demonstrating substantial equivalence by showing that the unfiltered CoStorSol® is equivalent to the filtered CoStorSol®. It does not describe a study to prove a device meets specific acceptance criteria for performance in a traditional sense (e.g., diagnostic accuracy, sensitivity, specificity). Instead, it describes a study proving an attribute of the device (lack of need for filtration) does not negatively impact its performance or safety compared to the predicate device.
Below is an attempt to respond to your request based on the available information, noting where specific details are not provided in the text.
Acceptance Criteria and Device Performance for CoStorSol® (K091245)
The acceptance criteria for K091245 focused on demonstrating that CoStorSol® without instructions for final filtration is substantially equivalent to the predicate CoStorSol® with filtration instructions, particularly regarding safety and biological compatibility. The key performance attributes evaluated were related to particulate matter and sterility/pyrogenicity without the final filtration step.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Material Safety (Biocompatibility) | CoStorSol® itself is biocompatible (ISO 10993 series referenced). | "Test results have shown CoStorSol® itself to be a biocompatible solution..." | Demonstrated through testing, although specific results are not detailed. |
| Packaging Biocompatibility | Flexible solution administration pouches are biocompatible (ISO 10993 series referenced). | "...supplied in flexible solution administration pouches, which have likewise been tested and shown to be biocompatible." | Demonstrated through testing, specific results not detailed. |
| Particulate Matter | Particulate matter does not exceed limits set in USP Section for large volume injections. | "Particulate matter does not exceed the limits set in USP Section , for large volume injections." | Directly stated that the device met this specific quantitative standard. |
| Sterility | Solution supplied sterile and non-pyrogenic. Sterilization processes validated according to ISO 17665 or USP Section. | "CoStorSol® is supplied sterile and non-pyrogenic in order to assure safety for transplant recipients. Sterilization processes were validated according to either ISO 17665 or USP Section , as appropriate." | Validation conducted against recognized standards, confirming sterility and non-pyrogenicity. |
| Equivalence to Predicate | Unfiltered CoStorSol® is equivalent to filtered CoStorSol® for its intended use (flushing and cold storage of kidney, liver, and pancreas organs). | "Preservation Solutions, Inc. has compiled data showing that unfiltered CoStorSol® is equivalent to filtered CoStorSol®." | This is the overarching claim for the 510(k) submission, supported by the above tests. |
2. Sample Size Used for the Test Set and Data Provenance:
- The document does not specify the sample size for the tests conducted (biocompatibility, particulate matter, sterility validation).
- The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). However, given that it's a 510(k) submission to the US FDA, the tests would typically be conducted under GLP (Good Laboratory Practice) guidelines. The phrase "Preservation Solutions, Inc. has compiled data" suggests internal company testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- This information is not applicable in the context of this device and submission. This is a medical device for organ preservation, not a diagnostic or AI-driven device requiring expert adjudication of images or clinical outcomes for ground truth. The "ground truth" here is established by adherence to recognized scientific and regulatory standards (USP, ISO, biocompatibility testing).
4. Adjudication Method for the Test Set:
- This information is not applicable to this type of device submission. Adjudication methods like 2+1 or 3+1 are used for expert consensus in clinical studies, particularly for diagnostic accuracy, which is not the focus here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic imaging devices or AI tools, often involving human readers. CoStorSol® is a chemical solution for organ preservation.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- This question is not applicable as CoStorSol® is not an algorithm or AI-driven device. The "standalone" performance here refers to the chemical and physical properties of the solution itself, which were evaluated through various bench tests and validations (biocompatibility, particulate matter, sterility).
7. The Type of Ground Truth Used:
- The "ground truth" for this device's acceptance criteria primarily relies on established scientific and regulatory standards, including:
- Pharmacopoeia standards: USP Section for particulate matter, USP Section for sterilization.
- International standards: ISO 10993 series for biocompatibility, ISO 17665 for sterilization.
- The fundamental "ground truth" being demonstrated is that the absence of a final filtration step does not compromise the safety or equivalence of the product compared to its predicate.
8. The Sample Size for the Training Set:
- This question is not applicable as CoStorSol® is not an AI/machine learning device that requires a training set. The "training" in manufacturing comes from validating processes against established standards.
9. How the Ground Truth for the Training Set Was Established:
- This question is not applicable for the same reason as point 8.
§ 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).