(84 days)
CoStorSol® plus G is intended for the flushing and cold storage of liver, kidney, 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® plus G according to a "recipe" pioneered at the University of Wisconsin by Folkert O. Belzer, MD and James H. Southard, PhD. Indeed, this 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.
CoStorSol® plus G 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, to which 0.922 g of sterile glutathione may be added just prior to use. The solution must be chilled to between 2° and 6° C prior to use.
The provided text describes a 510(k) premarket notification for a medical device called "CoStorSol® plus G," a solution for organ preservation. The document primarily focuses on establishing substantial equivalence to a predicate device, CoStorSol®, rather than presenting a detailed study with specific acceptance criteria and performance data in the typical sense of a diagnostic or interventional device.
The "device performance" and "acceptance criteria" here relate to demonstrating that the new device, CoStorSol® plus G, is as safe and effective as the predicate device by showing that the added component (glutathione) does not change its fundamental function or properties.
Here's an attempt to extract and organize the information according to your request, with the caveat that a traditional "study" proving performance against acceptance criteria for a new AI or diagnostic device isn't present in this regulatory document.
Acceptance Criteria and Device Performance for CoStorSol® plus G
The acceptance criteria for CoStorSol® plus G are primarily focused on demonstrating substantial equivalence to its predicate device, CoStorSol®, particularly in chemical composition, intended use, preparation for use, sterility, storage, actions and functions, particulate matter, biocompatibility, and interaction with other medical technology. The key "performance" here is that the modified device remains functionally equivalent to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Expected Outcome) | Reported Device Performance (CoStorSol® plus G) | Equivalence Status |
|---|---|---|---|
| Intended Use | Identical intended use as predicate. | "CoStorSol® plus G is intended for the flushing and cold storage of liver, kidney, and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient." (Identical to predicate) | Identical |
| Preparation for Use | Identical preparation steps, including required and optional additives. | "Chill to 2° to 6° C without freezing; Required addition to 1L of CoStorSol®: Penicillin G-200,000 units, Insulin-40 Units, Dexamethasone-16mg; Optional addition to 1L CoStorSol®: glutathione 0.922g" (Identical to predicate) | Identical |
| Chemical Composition | Identical synthetic medium, pH, and osmolality. | "A synthetic medium of defined organic, and inorganic, soluble chemical compounds with specified purity. pH = 7.4 nominal osmolality ≈ 320 mOsM" (Identical to predicate) | Identical |
| Packaging - How Supplied | Packaging and sterility. Glutathione is now included with the product. | "Filter sterilized using 0.1μm membrane(s) and aseptically filled into biocompatible, 1 liter flexible solution bags... The bags have integrated delivery set ports, and are packaged with a single 10mL polyethylene terephthalate (PETG) vial holding 0.922 g sterile non-pyrogenic glutathione." (Substantially Equivalent - inclusion of glutathione) | Substantially Equivalent |
| Sterility | Sterility assured via 0.1 μm membrane filtration. | "Sterility Assured via 0.1 μm membrane filtration" (Identical to predicate) | Identical |
| Storage Temperature & Shelf Life | Identical storage conditions and shelf life. | "Indoors with temperature controlled at 2°-25°C, without freezing; 1 year (12 month) shelf life" (Identical to predicate) Also, "Preservation Solutions, Inc. has validated shelf life for CoStorSol® plus G using a combination of accelerated aging and natural aging protocols, supporting expiry periods of up to 1 year." | Identical |
| Actions and Functions | Identical mechanism of action: flushing, cold storage, and maintenance of histological viability. | "Use cold solution to flush organ immediately before and/or after removal to clear blood from the vasculature. Store organs cold in aliquot of the same solution to maintain histological viability by depressing metabolism." (Identical to predicate) | Identical |
| Particulate Matter & Biocompatibility | Particle counts below USP limits for large volume injections; Biocompatible per ISO 10993-1 battery of tests for prolonged indirect contact. | "Particle Counts less than limits for Large Volume Injections per USP ; Biocompatible per ISO 10993-1 battery of tests for Externally Communicating Blood Path Indirect Contact for prolonged periods >24 hours." (Identical to predicate) Also, "Test results have shown CoStorSol® plus G to be a biocompatible solution..." | Identical |
| Interaction with Other Medical Technology | Not intended for continuous perfusion; requires standard surgical expertise. | "CoStorSol® plus G is not intended for continuous perfusion. Standard transplantation surgical expertise and techniques are required." (Identical to predicate) | Identical |
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail a "test set" in the context of clinical or AI performance evaluation. Instead, testing was conducted on the device itself (CoStorSol® plus G solution and its packaging) to confirm its physical, chemical, and biological properties are equivalent to the predicate.
- Sample Size for Test Set: Not explicitly stated as a number of "cases" or "patients." Testing was performed on batches of the CoStorSol® plus G solution and its components (e.g., bags, glutathione vials).
- Data Provenance: The testing appears to be internal validation by Preservation Solutions, Inc. and conducted according to relevant international standards (e.g., ISO, USP). The location of these tests (e.g., country of origin) is not specified, but the company is U.S.-based (Elkhorn, Wisconsin). The nature of the tests (biocompatibility, particulate matter, chemical identity, general appearance, weight loss, package integrity, shelf life) indicates a prospective series of laboratory and bench tests on the manufactured device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This is not applicable as the "ground truth" here is based on established scientific and regulatory standards (e.g., chemical purity, pH, osmolality, sterility, biocompatibility standards like ISO 10993, and USP for particulate matter) rather than clinical expert consensus on complex medical diagnoses. The company's Quality Assurance Director (William Wagner) is the contact person, implying oversight, but no panel of experts for "ground truth" establishment is mentioned.
4. Adjudication Method for the Test Set
N/A. Adjudication methods like 2+1 or 3+1 are typically used for clinical ground truth establishment in studies involving human interpretation or subjective assessments. Here, the "truth" is determined by objective laboratory measurements against defined specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
N/A. This document is a 510(k) submission for a non-diagnostic, non-AI medical device (organ preservation solution). An MRMC study is not relevant to its type of evaluation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
N/A. This product is a chemical solution, not an algorithm or AI. Standalone performance is not applicable.
7. Type of Ground Truth Used
The "ground truth" for evaluating CoStorSol® plus G is based on defined scientific, chemical, and biological specifications and standards. These include:
- Chemical identity and purity of components.
- Physical properties (pH, osmolality, particulate matter count).
- Sterility (absence of microorganisms).
- Biocompatibility (based on ISO 10993 series of tests).
- Stability and shelf life (demonstrating consistency over time).
- Functional equivalence in vitro/ex vivo (implied by chemical similarity and predicate equivalence, but no specific organ performance studies are detailed in this document for the new device).
8. Sample Size for the Training Set
N/A. A "training set" is relevant for AI/machine learning models. This document describes a chemical solution.
9. How the Ground Truth for the Training Set Was Established
N/A. Not applicable 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).