(429 days)
The PERF-GEN® Pulsatile 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.
The PERF-GEN® Pulsatile Perfusion (PERF-GEN Solution) is a clear, sterile, non-pyrogenic, non-toxic solution for the in-vitro flushing and temporary continuous perfusion of explanted kidneys. This solution has an approximate calculated osmolarity of 300 mOsm/kg, a sodium concentration of 100 mEq/L, a potassium concentration of 25 mEq/L, and a pH of approximately 7.4 at room temperature.
The PERF-GEN® Pulsatile Perfusion Solution is a medical device that received a 510(k) clearance based on substantial equivalence to a predicate device, the BELZER-MPS™ UW Machine Perfusion Solution. This regulatory pathway typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive clinical trials to establish new efficacy. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the demonstration of substantial equivalence through comparative testing and analysis against the predicate, rather than performance against pre-defined, quantitative clinical metrics of efficacy.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (Summary of Studies) |
|---|---|
| Identical Intended Use | Met: The PERF-GEN Solution has an identical intended use to the BELZER-MPS UW Machine Perfusion Solution: 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. |
| Identical Chemical Composition & Principle of Operation | Met: Comparison by infrared, chromatography, and conductivity measurements confirmed that the PERF-GEN Solution and the BELZER-MPS solution are chemically equivalent. They are both sterile, non-toxic, transparent solutions dispensed from a bag, with identical chemical compositions and principles of operation. |
| Biocompatibility | Met: Evaluated through ISO 10993 compliant testing, including cytotoxicity, acute systemic toxicity, hemocompatibility, skin sensitization (guinea pigs), and primary skin irritation. Results showed the PERF-GEN Solution is non-cytotoxic, non-toxic, hemocompatible, non-genotoxic, non-sensitizing, and non-irritating, ensuring safety for intended biocontact. This addresses potential differences in dispensing bag material. |
| Stability/Shelf-Life | Met: Stability studies (up to 1 year real-time aging at recommended storage and several months worst-case conditions) confirmed that aging does not affect product specifications. This supports the 1-year shelf life. This addresses potential differences in dispensing bag material. |
| No New Questions of Safety or Effectiveness | Met: The evaluations of technological differences (primarily dispensing bag material) through biocompatibility, stability, and chemical testing demonstrated that these differences do not impact the specifications of the perfusion solution itself and did not raise any new questions of safety or effectiveness when compared to the predicate device. Therefore, the PERF-GEN Solution was deemed substantially equivalent to the BELZER-MPS predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable in the traditional sense of a clinical test set for performance, as this was a substantial equivalence submission relying primarily on bench testing and comparison.
- Data Provenance: The studies performed were primarily bench testing (biocompatibility, stability, chemical comparisons) conducted by the manufacturer, Waters Medical Systems, LLC. The "data provenance" refers to the results generated from these in-house or contract laboratory tests. There is no mention of country of origin for clinical data as no clinical trials were presented for this 510(k).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. Ground truth in the context of this 510(k) submission was established through scientific and engineering principles applied to the comparative testing and analysis against the predicate device's known characteristics, rather than expert consensus on clinical outcomes. The FDA's review division (Division of Reproductive, Gastro-Renal, and Urological Devices) evaluated the submitted evidence.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set requiring adjudication in the context of expert review was conducted or reported. Adjudication in this context would refer to the FDA's regulatory review process, where they adjudicate the substantial equivalence claim based on the submitted evidence.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve with AI vs without AI Assistance
- Not applicable. This device is a pulsatile perfusion solution, a chemical and delivery system for organ preservation, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI-driven performance improvements are irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a solution used in organ preservation, not an algorithm or software. Its performance is evaluated through its physical and chemical properties, and its biological interaction with organs, not through a standalone algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this 510(k) submission was demonstrably equivalent to the predicate device regarding:
- Predicate Device Characteristics: The known, legally marketed, and accepted properties, composition, and performance of the BELZER-MPS UW Machine Perfusion Solution.
- ISO 10993 Standards: Biocompatibility testing followed established international standards, where "ground truth" is defined by the passing criteria of these validated tests.
- Chemical Equivalence: Established through analytical chemistry techniques (infrared, chromatography, conductivity), where "ground truth" is the scientific validation of similar molecular and ionic profiles.
- Stability Standards: Industry-accepted methods for shelf-life determination.
8. The Sample Size for the Training Set
- Not applicable. This medical device is not an AI/ML algorithm that requires a training set. The "training" for this product would conceptually involve its development and formulation, and the testing involved was to validate its properties against established standards and the predicate.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As the device is not an AI/ML algorithm, a "training set" and associated "ground truth" for training are not relevant concepts in this submission.
§ 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).