(171 days)
MaPerSol® organ preservation solution is intended for in-vitro flushing and continuous hypothermic machine perfusion of explanted kidneys.
Preservation Solutions, Inc. manufacturers MaPerSol® according to a "recipe" pioneered at the University of Wisconsin by Dr. Folkert O. Belzer and Dr. James Southard. The kidney flushing and perfusion storage solution may still be referred to as Belzer-MPS™, UW Machine Perfusion Solution, and is currently sold under that trade name (Trans-Med Corporation, Elk River, MN), as well as under the trade name KPS-1 (Organ Recovery Systems, Des Plaines, IL). The formulation includes soluble colloids, buffers, sodium and potassium salts, redox stabilizers, and compounds to aid tissue viability by enabling regeneration of adenosine triphosphate (ATP).
MaPerSol® is a colorless, sterile, non-toxic solution for in-vitro flushing and continuous perfusion of explanted kidnevs. The solution is packaged in 1-liter bags.
This document outlines the acceptance criteria and study information for MaPerSol®, an organ preservation solution.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (MaPerSol®) |
|---|---|---|
| Formulation Equivalence | Identical formulation to predicate devices (KPS-1 and Belzer-MPS™) | MaPerSol® is stated to be identical in formulation to both KPS-1 Kidney Perfusion Solution (K022391) and Belzer-MPS™ UW Machine Perfusion Solution (K972066). |
| Biocompatibility | Verified as biocompatible | Verification that MaPerSol® is biocompatible has been performed. |
| Particulate Matter Limits | Meets particulate matter limits for large volume parenterals (LVPs) | MaPerSol® meets the particulate matter limits for large volume parenterals (LVPs). |
| Sterilization | Sterilization processes validated following national and international standards | Sterilization processes have been validated following national and international standards and guidance documents. |
| Shelf Life | Confirmed 1-year shelf life | A shelf life of 1 year was confirmed using chemical, microbiological, and toxicological tests, as well as Fourier transformed infrared spectrometry. Stored MaPerSol® (12 months) compares favorably with fresh MaPerSol®. |
| Chemical Consistency (Osmolarity/Osmolality, pH) | Consistent equivalence among MaPerSol® and predicate devices | Routine chemical tests for osmolarity/osmolality and pH show consistent equivalence among MaPerSol® and the two predicates. |
| Packaging Integrity/Stability | No deleterious effects due to aging in its flexible pouch container | No deleterious effects due to aging occur in its flexible pouch container after 12 months. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes a premarket notification (510(k)) primarily based on substantial equivalence to predicate devices. It does not contain information about a "test set" in the context of clinical performance evaluations with human patient data. Instead, the "testing" described refers to:
- Bench Testing: Chemical, microbiological, toxicological tests, and Fourier transformed infrared spectrometry for shelf life and basic chemical properties.
- Biocompatibility Testing: The number of samples or specific method details for biocompatibility verification are not provided in this summary.
- Sterilization Validation: Details on the number of samples for sterilization validation are not provided.
Therefore, information on the sample size for a "test set" (as typically understood in AI/imaging studies) and data provenance (e.g., country of origin, retrospective/prospective) is not applicable as this is a device for organ preservation primarily assessed through chemical and physical equivalence to existing approved devices, not through a clinical performance study with patient outcomes data in the format of an AI device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the submission does not involve expert-reviewed ground truth for a clinical "test set" in the typical sense of diagnostic or image analysis devices. The "ground truth" for this device revolves around established chemical and physical properties, safety standards (biocompatibility, sterility), and the known performance of its identical predicate devices.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated in point 3.
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
An MRMC comparative effectiveness study was not done. This device is an organ preservation solution, not an AI-assisted diagnostic or imaging tool involving human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study (in the context of an algorithm) was not done. This device is a chemical solution, not a software algorithm.
7. The type of ground truth used
The "ground truth" for this submission is based on:
- Established chemical formulations: The exact recipe for the organ preservation solution.
- Performance profiles of legally marketed predicate devices: The functionality and safety of the KPS-1 Kidney Perfusion Solution and Belzer-MPS™ UW Machine Perfusion Solution.
- Standardized testing: Results from biocompatibility, sterility, particulate matter, and shelf-life tests adhering to recognized national and international standards.
- Physical/chemical measurements: Data on osmolarity/osmolality and pH.
There is no "expert consensus," "pathology," or "outcomes data" specifically generated as a ground truth for a novel clinical performance claim in this 510(k) summary. The "ground truth" relies on the established characteristics and regulatory acceptance of the predicate devices and standard laboratory testing.
8. The sample size for the training set
The concept of a "training set" is not applicable to this 510(k) submission. This device is an organ preservation solution whose substantial equivalence is established through its identical formulation to predicate devices and adherence to established chemical and physical standards, not through machine learning or AI models that require training data.
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set" for this 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).