(188 days)
Servator M SALF 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, and eventual transportation, and eventual transplantation into a recipient.
The Servator M SALF is a clear, sterile, non-pyrogenic, non-toxic solution for the in-vitro flushing and temporary continuous perfusion preservation of explained kidneys. This solution has an approximate calculated osmolarity of 300 mOsm/kg, a sodium concentration of 100 mEq/L, a potassium concentration of 25 rnEq/L, and a pH of approximately 7.4 at room temperature. The primary containers used for the device are PVC free bags 1000ml, therefore they are free of phthalates. The solution may be used without any point of use filtration. Servator M SALF 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 Servator M SALF Solution is intended for flushing and continuous hypothermic machine perfusion of kidneys, and for the preservation of these organs for eventual transplantation. The device is a clear, sterile, non-pyrogenic, non-toxic solution.
Here's a breakdown of the acceptance criteria and supporting study details:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance relies on demonstrating substantial equivalence to a predicate device (PERF-GENQ® Pulsatile Perfusion Solution, K121736). Therefore, the acceptance criteria are based on matching or providing equivalent performance/characteristics to the predicate.
| Acceptance Criteria (Based on Predicate Equivalence) | Reported Device Performance (Servator M SALF Solution) |
|---|---|
| Same Indications for Use | Servator M SALF 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, and eventual transportation, and eventual transplantation into a recipient. (Identical to predicate) |
| Same Intended Use | Organ perfusion and preservation solution. (Identical to predicate) |
| Identical Chemical Composition | The solution qualitative and quantitative composition is identical to the predicate for all listed constituents (Adenine, Calcium Chloride, Dextrose, Glutathione, HEPES, Hydroxyethyl Starch, Magnesium Gluconate, Mannitol, Potassium Phosphate, Ribose, Sodium Gluconate, Sodium Hydroxide, Sterile Water for injection). |
| Similar Device Description | A clear, sterile, non-pyrogenic, non-toxic solution for in-vitro flushing and temporary continuous perfusion preservation of explained kidneys. Approximate calculated osmolarity of 300 mOsm/kg, sodium concentration of 100 mEq/L, potassium concentration of 25 mEq/L, and pH of approximately 7.4 at room temperature. |
| Similar pH | 6.90-7.50 at 20°C |
| Similar Container/Bag | PVC free bags |
| Meets UNOS Policy | Yes |
| Particulate Matter & Biocompatibility | Particle counts less than limits for Large Volume Injections per USP ; Biocompatible per ISO 10993-1 battery of tests for Externally Communicating Blood Path Indirect Contact for prolonged periods >24 hours. (Conforms to standards) |
| Sterilization Method | Steam |
| Nominal Volume | 1000 mL bags |
| Shelf Life | 24 months |
| Storage Temperature | Indoors with temperature at 2°-25°C, without freezing. |
| Protecting Overwrap Bag | Yes |
| Bag Connections | 1 flip off, 1 needle point |
| Single Use Only | Yes |
| Safe Interaction with Other Medical Technology | Labels include warnings regarding expiration date, container damage, and visible particles/precipitates/contaminations. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly mention a "test set" in the context of a clinical trial with a defined sample size for the Servator M SALF Solution itself. Instead, the evaluation focuses on non-clinical performance data and a direct comparison to a predicate device.
- Non-Clinical Performance Data: The reported data includes:
- Biocompatibility tests (according to ISO 10993 series).
- Sterilization and Shelf Life validation (according to ISO 17655-1).
- Chemical comparisons.
- Leachables performance testing.
The document does not specify the number of samples used for each of these non-clinical tests.
- Data Provenance: The device manufacturer is SALF S.p.A. in Italy, suggesting the non-clinical testing was likely conducted in Italy or by contracted labs. The nature is retrospective in terms of comparing against the established predicate specifications and existing standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the clearance is based on substantial equivalence demonstrated through non-clinical testing and direct comparison to a predicate, rather than a clinical study requiring expert-established ground truth.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3.
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. The device is a medical solution for organ preservation, not an AI-assisted diagnostic or imaging tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance would not be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical solution and not an algorithm or software.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established safety and effectiveness profile of the predicate device (PERF-GENQ® Pulsatile Perfusion Solution) and the adherence to relevant international standards (ISO 10993, ISO 17665-1, USP , USP ) for biocompatibility, sterility, and particulate matter. The core of the submission is to demonstrate that the Servator M SALF Solution is chemically identical and performs equivalently to the predicate, meeting these established safety and performance benchmarks.
8. The Sample Size for the Training Set
This information is not applicable. This is not a machine learning or AI device that requires a training set. The "training" in this context refers to the development and manufacturing processes adhering to quality systems (e.g., good manufacturing practice).
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As mentioned above, this device does not utilize a training set in the AI/ML sense.
§ 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).