(276 days)
The Servator H SALF solution is indicated for perfusion and flushing donor kidneys, liver, pancreas, and heart prior to removal from the donor or immediately after removal from the donor. The solution is left in the organ vasculature during hypothermic storage and transportation (not for continuous perfusion) to the recipient.
The Servator H SALF solution is intended for perfusion and flushing donor kidneys, liver, pancreas, and heart prior to removal form the donor or immediately after removal from the donor. The solutions is left in the organ vasculature during hypotermic storage and transportation (not for continuous perfusion) to the recipient. Servator H SALF solution is based on the principle of inactivating organ function by withdrawal of extracellular sodium and calcium, together with intensive duffering of the extrcellular space by means of histidine/histidine HCI, so as to prolong the period for which organs will tolerate interruption of blood and oxygen supply. Only a small portion of the osmolality of the Servator H SALF solution is due to the sodium and potassium. The composition of the Servator H SALF is similar to that of extracellular fluid. All of the components of the Servator H SALF solution occur naturally in the body.
The provided document is a 510(k) summary for the Servator H SALF Solution, which is an organ perfusion and preservation solution. It primarily focuses on demonstrating substantial equivalence to a predicate device (Custodiol HTK) rather than presenting a standalone study with specific acceptance criteria and detailed performance metrics of the device as an AI or diagnostic tool.
Therefore, many of the requested details about acceptance criteria, study design, ground truth establishment, sample sizes for training/test sets, expert involvement, and MRMC studies are not applicable or not explicitly detailed in this type of regulatory submission.
However, based on the non-clinical performance data section, we can infer some "acceptance criteria" through the tests conducted.
Here's a breakdown of the information that can be extracted or inferred:
1. A table of acceptance criteria and the reported device performance
Since this is a substantial equivalence claim for a physical solution and not an AI/diagnostic device, acceptance criteria are generally related to safety, sterility, biocompatibility, and chemical composition matching the predicate.
| Acceptance Criteria Category | Specific Test/Characteristic | Reported Device Performance (Servator H SALF) | Conclusion against Predicate |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | Passed Biocompatibility Test Standards | Equivalent to predicate (implied) |
| Irritation | Passed Biocompatibility Test Standards | Equivalent to predicate (implied) | |
| System Toxicity | Passed Biocompatibility Test Standards | Equivalent to predicate (implied) | |
| Haemocompatibility | Passed Biocompatibility Test Standards | Equivalent to predicate (implied) | |
| Sterilization & Shelf Life | Validation of Sterility | Passed all test standards | Same as predicate (Steam Sterilization) |
| Validation Method LAL Turbidimetric | Passed all test standards | Same as predicate (implied) | |
| Stability | Passed all test standards | Shelf life of 12 months (same as predicate) | |
| Physical Properties | pH (at 25°C) | 7.02 - 7.20 | Same as predicate |
| pH (at 4°C) | 7.40 - 7.45 | Same as predicate | |
| Osmolality | 310 mOsm/Kg | Same as predicate | |
| Chemical Analysis | (Between subject and predicate device) | Proved to be substantially equivalent | Substantially Equivalent |
| Safety and Effectiveness | New Questions of Safety and Effectiveness | Does not raise any new questions | Equivalent to predicate |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "performance data" and "test standards" but does not detail sample sizes for any specific tests or the provenance of the data beyond the manufacturer being S.A.L.F. S.p.A. (Italy).
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 information is not applicable as the device is a chemical solution for organ preservation, not a diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reason as above.
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
This information is not applicable as the device is not an AI-assisted diagnostic tool or an imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as the device is a chemical solution, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For this type of device (organ preservation solution), "ground truth" is established through:
- Chemical composition analysis: Comparing the exact chemical constituents and their concentrations to the predicate device.
- Biocompatibility testing: Standardized in-vitro and in-vivo tests to assess toxicity, irritation, etc.
- Sterility testing: Confirmation of absence of microbial contamination.
- Stability testing: Confirmation that the solution maintains its properties over its shelf life.
The document states that a "direct comparison between the subject and predicate device" was completed for performance testing including chemical analysis, and that "performance reports are included in the submission." This implies that the ground truth for chemical and physical properties was the established characteristics of the predicate device.
8. The sample size for the training set
This information is not applicable as the device is a chemical solution, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as above.
§ 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).