(90 days)
KPS-1™, The Kidney Perfusion Solution is intended to be used for flushing and continuous hypothermic machine perfusion of kidneys at the time of their removal from the donor, in preparation for storage, transportation and eventual transplantation into a recipient.
KPS-1™, The Kidney Perfusion Solution (UW Machine Perfusion Solution) is a clear, sterile, non-pyrogenic, non-toxic solution for the invitro flushing and temporary continuous perfusion preservation of explanted kidneys. This solution has an approximate calculated osmolarity of 300mOsM, a sodium concentration of 100mEq/L, a potassium concentration of 25mEq/L, and a pH of approximately 7.4 at room temperature. Based upon the sodium/potassium ratio, the composition is thus consistent with that of an extracellular solution.
KPS-1™ should be cooled to about 5°C (4°C to 8°C) prior to use and should be used in a perfusion machine that is capable of maintaining temperature within the above specified range.
It is recommended that the KPS-1™ be stored between 2 °C and 8 °C. The solution should not be frozen or exposed to excessive heat.
KPS-1™, The Kidney Perfusion Solution is suitable for a mean perfusion time of 29 hours +/~ 8 hours.
KPS-1™ The Kidney Perfusion Solution shelf-life is 6 months from data of aseptic fill. The stability of the perfusion solution was verified by accelerated aging for 6 months equivalency.
The provided text is a compilation of sections from a 510(k) summary and an FDA clearance letter for a medical device called KPS-1, Kidney Perfusion Solution. This document primarily focuses on demonstrating substantial equivalence to a predicate device (KPS-17M), rather than presenting a detailed study proving the device meets specific acceptance criteria through a formal statistically powered performance study.
Therefore, much of the requested information regarding acceptance criteria, specific study design elements (sample size, ground truth establishment, expert involvement, adjudication, MRMC studies, standalone performance), and training set details are not explicitly described in the provided text.
However, based on the information available, here's a breakdown of what can be inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present acceptance criteria in a quantitative table format as one might expect for a performance study. Instead, the "performance" discussed relates to the compositional characteristics and intended use of the solution, which are aligned with the predicate device.
| Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (KPS-1) |
|---|---|
| Approximate calculated osmolarity of 300mOsM | Approximate calculated osmolarity of 300mOsM |
| Sodium concentration of 100mEq/L | Sodium concentration of 100mEq/L |
| Potassium concentration of 25mEq/L | Potassium concentration of 25mEq/L |
| pH of approximately 7.4 at room temperature | pH of approximately 7.4 at room temperature |
| Consistent with extracellular solution based on Na/K ratio | Consistent with extracellular solution based on Na/K ratio |
| Clear, sterile, non-pyrogenic, non-toxic | Clear, sterile, non-pyrogenic, non-toxic |
| Suitable for temporary continuous hypothermic machine perfusion of kidneys | Intended for in-vitro flushing and temporary continuous hypothermic machine perfusion of kidneys |
| Mean perfusion time of 29 hours +/- 8 hours (of predicate) | Suitable for a mean perfusion time of 29 hours +/- 8 hours |
| Shelf-life of 6 months (of predicate) | Shelf-life is 6 months from date of aseptic fill; stability verified by accelerated aging. |
2. Sample size used for the test set and the data provenance
The document does not describe a specific "test set" or clinical study with a defined sample size in the context of proving performance against acceptance criteria. The submission is a 510(k) for device modifications, demonstrating "substantial equivalence" to a predicate, KPS-17M. The "data presented in this submission" refers to information validating that the modified KPS-1 maintains the same technological characteristics and performance as the predicate.
- Sample Size: Not applicable/not provided for a clinical performance study.
- Data Provenance: The data primarily relates to the chemical and physical properties of the solution, as well as stability testing (accelerated aging). The geographical origin of this data or if it involved human or animal subjects is not specified, but it would typically be laboratory-based testing. It's retrospective in the sense that it evaluates the modified device against established characteristics of the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable/not provided as there's no mention of a clinical study involving human or animal subjects that required expert ground truth establishment for a test set. The validation is chemical/physical.
4. Adjudication method for the test set
This information is not applicable/not provided as there's no mention of a clinical study or expert review process requiring adjudication.
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
This information is not applicable/not provided. The device is a kidney perfusion solution, not an imaging or diagnostic device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. The device is a chemical solution, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context would be the established chemical and physical properties of the predicate device (KPS-17M, University of Wisconsin Machine Perfusion Solution Formulation) and standard analytical methods to verify that the modified KPS-1 solution matches these characteristics. For instance:
- Chemical Analysis: To verify osmolarity, sodium, potassium concentrations, and pH.
- Sterility/Pyrogenicity Testing: To ensure the solution is free from contaminants.
- Stability Testing: Accelerated aging studies to determine shelf-life.
8. The sample size for the training set
This information is not applicable/not provided. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
This information is not applicable/not provided as there is no training set.
§ 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).