(88 days)
KPS-I™, The Kidney Perfusion Solution is intended to be used for in-vitro flushing and temporary 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-I™, 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 votassium concentration of 25mEg/1, 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.
The provided text is a 510(k) summary for KPS-ITM, The Kidney Perfusion Solution, seeking substantial equivalence to a predicate device, Belzer MPS™. It does not describe a study involving device performance against acceptance criteria in the typical sense of a clinical trial or algorithm performance evaluation. Instead, it argues for substantial equivalence based on identical indications for use, technological characteristics, and formulation.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set information) are not applicable or cannot be extracted from this document as the submission is not for a new medical device that requires clinical performance data in the same way a diagnostic algorithm or a surgical tool would.
Here's the information that can be extracted, along with explanations for categories that are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied for Substantial Equivalence) | Reported Device Performance (as stated in the 510k) |
|---|---|
| Indications for Use (Identical to Predicate) | KPS-I™ Indications for Use are "identical in intended use to Belzer MPS™" (for flushing and continuous hypothermic machine perfusion of explanted donor kidneys in preparation for storage, transportation, and eventual transplantation). |
| Technological Characteristics (Similar to Predicate) | KPS-I™ and Belzer MPS™ are both:Clear, sterile, non-pyrogenic, non-toxic solutions.Contain various components (ions, pH buffers, impermeants, colloids, pharmacologics) to reduce metabolism and preserve physiological conditions.Have a pH value of 7.4 +/- 0.15.Have an osmolarity of 300 +/- 15 mOsm/L.Have a sodium/potassium ratio characteristic of an extracellular solution, suitable for hypothermic machine perfusion. |
| Formulation (Identical to Predicate) | "The solution formulation is identical" to Belzer MPS™. Both have "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." |
| Packaging System (Identical to Predicate) | "packaging system that is employed is identical to the predicate device." |
| Perfusion Time Suitability | KPS-I™ is "suitable for a mean perfusion time of 29 hours +/- 8 hours." (This is a specific performance claim for KPS-I™ and aligns with general expectations for such solutions, not directly stated as an acceptance criterion against the predicate in the same quantitative way as other characteristics, but implied as sufficient for its intended use). |
2. Sample Size Used for the Test Set and Data Provenance
This is Not Applicable (N/A) in the context of this 510(k) submission. The submission relies on establishing substantial equivalence to a legally marketed predicate device based on identical indications for use, similar technological characteristics, and identical formulation and packaging, rather than a clinical study with a "test set" of patient data. Performance data provided (e.g., mean perfusion time) would typically come from internal testing or literature, but the specific "sample size" and "provenance" for a test set as described are not detailed because it's not a performance study in the classic sense.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This is Not Applicable (N/A). Ground truth established by experts is typically for evaluating diagnostic or algorithmic performance against a gold standard. This 510(k) is for a medical solution, and its equivalence is based on its composition and functional characteristics relative to a predicate, not on expert interpretations of medical data.
4. Adjudication Method for the Test Set
This is Not Applicable (N/A) for the same reasons as #3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is Not Applicable (N/A). An MRMC study is relevant for evaluating the impact of an AI or diagnostic device on human reader performance. KPS-I™ is a perfusion solution, not a diagnostic or AI device.
6. Standalone (Algorithm Only) Performance Study
This is Not Applicable (N/A). KPS-I™ is a medical solution, not a standalone algorithm.
7. Type of Ground Truth Used
This is Not Applicable (N/A) in the sense of expert consensus, pathology, or outcomes data used to validate an algorithm or diagnostic tool. The "ground truth" here is the established characteristics and performance of the predicate device (Belzer MPS™), to which KPS-I™ is being compared for substantial equivalence. The claim is that KPS-I™'s characteristics are identical or sufficiently similar to those of the predicate.
8. Sample Size for the Training Set
This is Not Applicable (N/A). There is no machine learning model or algorithm being trained here.
9. How the Ground Truth for the Training Set Was Established
This is Not Applicable (N/A) for the same reason as #8.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" in this context is the 510(k) submission process itself, which aims to demonstrate substantial equivalence to a previously cleared predicate device, Belzer MPS™ (UW Kidney Preservation Solution, K972066). The core of the evidence presented is a comparison table and descriptive text highlighting the identical indications for use, identical solution formulation, similar technological characteristics (e.g., clarity, sterility, pH, osmolarity, presence of key components), and identical packaging system between KPS-I™ and Belzer MPS™.
The argument for meeting "acceptance criteria" (which in this case are defined by the predicate device's characteristics and intended use) is that KPS-I™ is fundamentally the same product as the predicate device. The submission states directly: "Data contained in the 510(k) demonstrates that KPS-I™, The Kidney Perfusion Solution is substantially equivalent to Belzer MPS." The FDA's clearance letter confirms this finding of substantial equivalence based on the provided information.
§ 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).