(32 days)
The BEL-GEN Cold Storage Solution is intended for the flushing and the hypothermic storage of kidney, liver and pancreas organs at the time of organ removal from the donor in preparation for storage, transportation and eventual transplantation into a recipient.
Institut Georges Lopez manufactures the BEL-GEN Cold Storage Solution according to the solution pioneered at the University of Wisconsin by Dr Folkert O. Belzer, often referred to as "Belzer UW solution". The formulation includes soluble colloids, buffers, sodium and potassium salts, redox stabilizers, and phosphoric compounds to aid tissue viability by enabling regeneration of adenosine triphosphate (ATP).
The BEL-GEN Cold Storage Solution is a clear to light yellow single use, sterile and non-pyrogenic solution. BEL-GEN Cold Storage Solution has an osmolality of 320 mOsm/kg, a total sodium concentration of 29 mmol/L, a total potassium concentration of 125 mmol/L and a pH of 7.4 at room temperature. The solution is packaged in 1-liter or 2-liter bags with a shelf life of 2 years.
The BEL-GEN Cold Storage solution is used at hospital by health professionals. The BEL-GEN Cold Storage solution must be cooled to +2°C (36° and 43°F) prior to use The cold solution is used to flush the isolated organ immediately before removal from the donor and/or immediately after removal from the donor. The solution is then left in the organ vasculature during hypothermic storage and transportation to cool the organ and lower its metabolic requirements.
The provided text is a 510(k) Premarket Notification for a medical device called "BEL-GEN Cold Storage Solution." This document focuses on demonstrating that the device is substantially equivalent to existing predicate devices, rather than proving its efficacy through a clinical study with specific acceptance criteria related to a new function or performance benefit.
Therefore, many of the requested details about acceptance criteria, study design for device performance, expert involvement, and ground truth establishment are not directly applicable or present in this type of regulatory submission. The submission is primarily about proving manufacturing quality, safety, and equivalence to a known product.
Here's an analysis based on the provided document, addressing the points where information is available and indicating where it is not:
1. A table of acceptance criteria and the reported device performance
The document does not present "acceptance criteria" in the traditional sense of a clinical trial with performance metrics. Instead, it demonstrates through non-clinical testing that the device meets established safety and quality standards and retains its properties over its shelf life, showing equivalence to predicate devices.
| Acceptance Criteria (Equivalent to Performance Standards and Safety) | Reported Device Performance |
|---|---|
| Device Characteristics (for Substantial Equivalence Comparison): | |
| - Intended Use/Indications for Use: Intended for flushing and hypothermic storage of kidney, liver, and pancreas organs for transplantation. | - Same: The BEL-GEN Cold Storage Solution has the same intended use as the predicate devices. |
| - Principle of Operation: Based on the "Belzer UW solution" enabling regeneration of ATP to aid tissue viability. | - Same: Functions similarly by cooling the organ and lowering its metabolic requirements. |
| - Chemical Composition: Similar to predicate devices, based on Belzer UW solution (Pentafraction (HES), Lactobionic acid, Potassium Phosphate monobasic, Magnesium Sulfate heptahydrate, Raffinose pentahydrate, Adenosine, Allopurinol, Glutathione, Potassium Hydroxide, Sodium Hydroxide). | - Similar: Same composition as secondary predicate. Slight difference from primary predicate regarding HCl (not necessary to adjust pH 7.4 in subject device). |
| - pH at Room Temperature: 7.4 | - 7.4: Matches predicate devices. |
| - Osmolality: 320 mOsm/Kg | - 320 mOsm/Kg: Matches predicate devices. |
| - Sterility: Sterile solution. | - Sterile: Validated through sterilizing filtration and aseptic filling process according to ISO 13408-1 and ISO 13408-2. |
| - Non-Pyrogenic: Non-pyrogenic solution. | - Non-Pyrogenic: Demonstrated. |
| - Single Use: Yes. | - Yes: Matches predicate devices. |
| - Biomaterial Safety: Safe for intended biocontact. | - Safe: Evaluated through ISO 10993 compliant testing (cytotoxicity, skin sensitization, primary skin irritation, hemolysis, acute systemic toxicity) with favorable results. |
| - Shelf Life Stability: Maintain product specifications for the labeled shelf life. | - 24 months (2 years): Stability testing showed aging at recommended storage conditions (2-25°C) does not affect product specifications for a 2-year shelf life. This is an extension from the primary predicate (1 year) but matches the secondary predicate. |
| - Dispensing Bag Material and Design: EVA as fluid contact layer, with 3 tubing connections (ports). | - Same: Matches predicate devices. |
| - Format: 1-liter and 2-liter bags. | - Added 2-liter format: Primary predicate was 1-liter only. This is an addition to the existing format. |
| - Storage Condition: Room temperature (2-25°C). | - 2-25°C: Matches secondary predicate. This is an extension from the primary predicate (2-8°C). |
| - Pre-use Conditions: Cool at 2-6°C prior to use. | - Same: Matches predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This submission describes non-clinical testing (e.g., sterilization validation, biomaterial safety, stability testing) rather than a clinical study involving human or animal subjects for assessing device performance on organs. Therefore, concepts like "test set sample size" for a clinical trial are not applicable here.
- Sample Size: Not specified in terms of clinical cases, but standard testing methodologies for sterilization, biocompatibility, and stability would have defined sample sizes for their respective tests (e.g., number of bags tested for sterility, number of animals for toxicity tests, number of solution samples for stability). These specific numbers are not detailed in the summary.
- Data Provenance: The manufacturer is Institut Georges Lopez (IGL) based in Lissieu, France. The tests were performed to current industry standards (ISO). The testing is prospective for the purpose of this submission (i.e., new tests performed to support the 510(k)).
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)
This is not applicable as there is no "ground truth" established by experts in the context of clinical performance or diagnosis for this type of submission. The tests performed are laboratory-based (e.g., chemical analysis, microbiological testing, in-vitro/in-vivo biocompatibility assays, stability testing). "Ground truth" in this context refers to the defined results of these standardized tests against established parameters (e.g., a solution is sterile if no microbial growth is detected).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study assessing human reader performance or diagnostic accuracy.
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 a premarket notification for a medical solution, not an AI/CADe/CADx device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a cold storage solution, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As mentioned in point 3, the "ground truth" refers to the scientific and regulatory standards met by the physical and chemical properties of the solution and its packaging, and its biological safety. This is based on:
- Chemical composition, pH, osmolality: Verified by analytical chemistry methods to conform to the established formulation (Belzer UW solution).
- Sterility: Absence of microbial contamination, verified by microbiology testing (e.g., sterility tests).
- Non-pyrogenicity: Absence of fever-inducing substances, verified by pyrogen testing.
- Biocompatibility: Absence of toxic or adverse reactions, verified by ISO 10993 compliant in-vitro and in-vivo tests.
- Stability: Maintenance of critical parameters over time, verified by accelerated and real-time aging studies.
These are objective, laboratory-determined "truths" against scientific definitions and regulatory thresholds, not subjective expert consensus.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set. The device is a chemical solution.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of 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).