(32 days)
The PERF-GEN Pulsatile Perfusion 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.
Institut Georges Lopez manufactures the PERF-GEN Pulsatile Perfusion Solution according to the solution pioneered at the University of Wisconsin by Dr Folkert O. Belzer, often referred to as "Belzer-MPS solution" used as kidney flushing and perfusion storage solution. 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). The PERF-GEN Pulsatile Perfusion Solution is a clear to light yellow, sterile, non-pyrogenic solution for the in-vitro flushing and temporary continuous perfusion of explanted kidneys. PERF-GEN Pulsatile Perfusion Solution has an osmolality of 300 mOsm/kg, a total sodium concentration of 100 mmol/L, a total potassium concentration of 25 mmol/L and a pH of 7.4 at room temperature. The solution is packaged in 1-liter bags with a shelf life of 18 months. The PERF-GEN Pulsatile Perfusion Solution is used at hospital by health professionals. The PERF-GEN Pulsatile Perfusion Solution must be cooled to +2°C and +8°C (35.6-46.5°F) prior to use. The colution is used for the in-vitro flushing and temporary continuous perfusion of explanted kidneys.
The provided text describes the 510(k) summary for the PERF-GEN Pulsatile Perfusion Solution. This document is a premarket notification for a medical device and focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical study demonstrating device performance against specific acceptance criteria for AI/diagnostic devices.
Therefore, many of the requested categories related to AI/diagnostic device performance, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to this submission.
The "acceptance criteria" in this context refer to the successful completion of non-clinical tests to demonstrate that the expanded shelf life and storage conditions do not raise new questions of safety or effectiveness compared to the predicate.
Here's the information that could be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Demonstrated by Non-Clinical Testing) | Reported Device Performance (Summary of Test Results) |
|---|---|
| Sterility | Validation of sterilizing filtration and aseptic filling process according to ISO 13408-1 and ISO 13408-2 was performed. |
| Non-pyrogenicity | Validation for non-pyrogenicity was carried out. |
| Biomaterial Safety | Evaluated through ISO 10993 compliant testing, including cytotoxicity, skin sensitization (guinea pigs), primary skin irritation, hemolysis, and acute systemic toxicity (mice). |
| Product Specifications over Shelf Life (18 months) | Stability testing showed that aging of test articles at recommended storage conditions of 2-25°C (35.6° - 77°F) does not affect the product specifications for the 18 months shelf life. |
| Substantial Equivalence | The results of these tests indicate that PERF-GEN Pulsatile Perfusion is substantially equivalent to the predicate device due to no new questions of safety or effectiveness regarding the extended shelf life and storage conditions. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This submission details non-clinical testing (sterility, biocompatibility, stability) on the perfusion solution itself, not a diagnostic or AI device tested on patient data. There isn't a "test set" in the context of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. Ground truth for clinical data is not relevant to this type of device submission. The 'ground truth' for non-clinical tests would be defined by validated laboratory methods and standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are for clinical data interpretation, not for objective non-clinical laboratory tests.
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
- Not Applicable. This is not an AI or diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI or diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable (in the clinical sense). For the non-clinical tests, the "ground truth" would be established by the adherence to ISO standards (e.g., ISO 13408 for sterility, ISO 10993 for biocompatibility) and accepted laboratory methodologies for stability testing.
8. The sample size for the training set
- Not Applicable. There is no AI model or "training set" for this device.
9. How the ground truth for the training set was established
- Not Applicable. There is no AI model or "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).