(126 days)
Servator B SALF Solution is intended for the flushing and cold 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.
Servator B SALF Solution is a clear to light yellow, single use only, sterile (by steam sterilization) and non-pyrogenic for hypothermic flushing and preservation of organs.
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 primary containers used for the device are PVC free bags 1000ml and 2000ml; therefore, they are free of phthalates. The bags must be chilled to between 2° and 6° C (36° to 43° F) prior to use. The solution may be used without any point of use filtration.
The Servator B SALF Solution is intended for perfusion and flushing donor kidneys, liver and pancreas immediately before or immediately after removal from a dead donor or immediately after removal from a living donor. The solution remains in the organ vessels during hypothermic storage and transportation. Servator B SALF Solution is meant for the cold storage of the organ and is not indicated for hypothermic preservation with continuous mechanical perfusion.
The provided text describes the "Servator B SALF Solution," an organ preservation solution, and its substantial equivalence to a predicate device, CoStorSol® (Belzer UW). The document is a 510(k) summary for FDA clearance.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document does not present a formal table of "acceptance criteria" in the typical sense of numerical thresholds for clinical performance metrics (e.g., sensitivity, specificity for a diagnostic device). Instead, the acceptance criteria are implicitly the demonstration of substantial equivalence to the predicate device, CoStorSol®, across various technological characteristics and non-clinical performance aspects. The "reported device performance" is the result of tests confirming this equivalence.
Here's a table based on the provided "Table of Comparison" and "Non-Clinical Performance Data" section, framed as a comparison to achieve substantial equivalence:
| Characteristic/Test | Acceptance Criterion (Implicit: Substantial Equivalence to Predicate) | Reported Servator B SALF Solution Performance |
|---|---|---|
| Indications for Use | Same as predicate | Same as predicate (flushing and cold storage of kidney, liver and pancreas) |
| Intended Use | Same as predicate | Same as predicate (Organ storage and preservation for transplantation) |
| Composition (Key Chemicals) | Identical to predicate formulation | Same chemical composition as predicate |
| Material Container/Bag | PVC Free / Bags | PVC Free / Bags |
| Protecting Overwrap Bag | Yes | Yes |
| Single Use Only | Yes | Yes |
| Bag Connections | 1 flip off, 1 needle point | 1 flip off, 1 needle point |
| Sodium Concentration | 29 mEq/L | 29 mEq/L |
| Potassium Concentration | 125 mEq/L | 125 mEq/L |
| pH | 7.4 at 20°C | 7.4 at 20°C |
| Osmolality | 320 mOsm/Kg | 320 mOsm/Kg |
| Sterilization Method | Validated according to ISO standards | Steam (ISO 17665-1 compliant) |
| Shelf Life | 24 Months | 24 Months |
| Biocompatibility | Meet ISO 10993 series standards | Passed Cytotoxicity, Irritation, System Toxicity, and Haemocompatibility (ISO 10993 series) |
| Sterility Validation | Meet ISO 17665-1 and ASTM F1980-16 | Passed according to ISO 17655-1 and ASTM F1980-16 |
| Chemical Comparisons | Demonstrate equivalence to predicate | Demonstrated substantial equivalence |
| Leachables Performance | Demonstrate equivalence to predicate | Demonstrated substantial equivalence |
2. Sample size used for the test set and the data provenance
The document explicitly states: "Performance Testing...was completed as a direct comparison between the subject and predicate device. The chemical comparisons and leachables performance testing demonstrated the substantial equivalence of this device to the predicate."
However, it does not specify the sample size for these tests (e.g., how many batches were tested for chemical composition, how many samples for leachables) nor the data provenance (e.g., country of origin, retrospective or prospective). Given the nature of the device (a solution), the "test set" would refer to specific batches or formulations tested in a laboratory setting, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For a 510(k) submission concerning a medical solution, ground truth is typically established through analytical chemical testing and standardized biological assays, not human expert consensus on interpretations of complex data like medical images.
4. Adjudication method for the test set
This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers interpreting data, especially in diagnostic imaging. For a chemical solution, the assessment relies on objective measurements and established scientific protocols.
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
No MRMC study was done or is relevant for this device. This is a medical solution for organ preservation, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a solution, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for demonstrating substantial equivalence for this device relies on:
- Analytical Chemistry and Physicochemical Properties: Direct measurement of concentrations (Na+, K+), pH, osmolality, and confirmation of chemical composition.
- Sterility Testing: Conformance to ISO and ASTM standards.
- Biocompatibility Testing: Conformance to ISO 10993 series standards.
- Leachables Testing: To ensure no harmful substances migrate from the packaging into the solution.
- Functional Equivalence: Implicitly, the solution's performance in preserving organs is assumed to be equivalent to the predicate due to identical composition and physical properties.
8. The sample size for the training set
Not applicable. This device is a medical solution, not based on an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. 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).