(240 days)
Servator P Plus SALF Solution is indicated for the flushing, cold static storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.
Servator P Plus SALF Solution is an extracellular electrolyte solution containing Dextran 40. The solution is pre-buffered with 2 mM THAM and pre-supplemented with 0.5 mM CaCl2. Servator P Plus is used for rapid cooling, perfusion, and cold static storage of lungs in connection with transplantation. Administration of the solution at the recommended temperatures will effectively cool the lung to reduce its metabolic requirements. The colloid component, Dextran 40 counteracts tissue oedema and protects the microvasculature against post-ischemic reperfusion injury. Calcium is important to maintain endothelial and epithelial cell integrity and endothelial contractility. The device is buffered with THAM to achieve a physiological ph. that enables safe preservation of lungs for up to 12 hours depending on status of the lung during retrieval. The intended patient population is adult patients in need of a lung transplantation.
The provided text describes a 510(k) submission for the Servator P Plus SALF Solution, an organ perfusion and preservation solution. The submission aims to demonstrate substantial equivalence to a predicate device, Perfadex Plus (K170826).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of acceptance criteria and the reported device performance:
The document primarily focuses on demonstrating substantial equivalence by comparing the subject device (Servator P Plus SALF Solution) to a predicate device (Perfadex Plus). The acceptance criteria are implicitly aligned with the characteristics of the predicate device and relevant industry standards.
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance (Servator P Plus SALF Solution) |
|---|---|---|
| Indications for Use | Indicated for flushing, cold static storage, and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient. | Met: "Servator P Plus SALF Solution is indicated for the flushing, cold static storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient." (Identical to predicate) |
| Intended Use | Organ perfusion and hypothermic preservation. | Met: "Used for organ perfusion and hypothermic preservation." (Identical to predicate) |
| Device Description | Extracellular electrolyte solution containing Dextran 40, pre-buffered with 2 mM THAM and pre-supplemented with 0.5 mM CaCl2. Used for rapid cooling, perfusion, and cold static storage of lungs. Protects against tissue oedema and microvasculature injury. Buffered to physiological pH. Enables preservation for up to 12 hours. Intended for adult patients. | Met: "Servator P Plus SALF Solution is an extracellular electrolyte solution containing Dextran 40. The solution is pre-buffered with 2 mM THAM and pre-supplemented with 0.5 mM CaCl2. Servator P Plus is used for rapid cold static storage of lungs in connection with transplantation... Dextran 40 counteracts tissue oedema and protects the microvasculature against post-ischemic reperfusion injury. Calcium is important to maintain endothelial and epithelial cell integrity and endothelial contractility. The device is buffered with THAM to achieve a physiological pH. Servator P Plus SALF enables safe preservation of lungs for up to 12 hours depending on status of the lung during retrieval. The intended patient population is adult patients in need of a lung transplant." (Substantially equivalent/identical to predicate in description) |
| Chemical Composition | Identical qualitative and quantitative composition to the predicate device. | Met: "The composition list is identical for the subject and predicate device, the subject and predicate devices are identical in chemical composition." Specific concentrations of Dextran 40, Glucose monohydrate, Potassium chloride, Sodium chloride, Magnesium sulphate heptahydrate, Potassium dihydrogen phosphate, Disodium phosphate dihydrate, Calcium Chloride dihydrate, THAM, and Water for injections are listed as identical. |
| Physical Properties | Osmolarity: ~295 mOsmol/l; pH: 7.2 to 7.6; Sterile non-pyrogenic; Clear, colorless, or slightly yellow. | Met: "The solution has a calculated osmolarity of about 295 mOsmol/1. pH: 7.2 to 7.6. Sterile non-pyrogenic solution for organ preservation of Class II. The solution is clear, colorless, or slightly yellow." (Identical to predicate) |
| Container | PVC free bags. | Met: "PVC free bags" (Identical to predicate). Subject device also has 3000ml bags in addition to 1000ml bags. |
| Particulate Matter | Particle Counts less than limits for Large Volume Injections per USP . | Met: "Particle Counts less than limits for Large Volume Injections per USP " (Identical to predicate). |
| Biocompatibility | Biocompatible per ISO 10993-1 battery of tests for Externally Communicating Blood Path Indirect Contact for prolonged periods >24 hours. | Met: "The tests were all performed according to the ISO 10993 series (10993-1, 10993-2, 10993-4, 10993-10, 10993-11, and 10993-12) and the subject device passed all biocompatibility test standards." (Identical to predicate requirements). |
| Sterilization | Sterilization processes validated according to ISO 17665 or USP Section . Steam sterilization method. | Met: "Validation of Sterility was performed, and the results passed according to ISO 17655-1. Steam sterilization and storage conditions are the same for the subject and predicate device." (Identical to predicate requirements). |
| Shelf Life | 2 years (24 months). | Met: "Shelf life for the subject and predicate is the same, at 24 months." |
| Storage Temperature | Store 2.0-25.0ºC. Do not freeze. Store in original container. Do not remove overwrap until immediately before use. Sterile and disposable. | Met: "Store 2.0-25.0ºC. Do not freeze. Store in its original container. Do not remove the overwrap until immediately before use. The device is sterile and disposable." (Identical to predicate). |
| Risk Management | ISO 14971 performed. | Met: "ISO 14971 was performed for risk." (No specific comparison to predicate, but indicates compliance with standard). |
| Performance Testing | Chemical comparisons and leachable performance testing. | Met: "Performance Testing... was completed as a direct comparison between the subject and predicate device. The chemical comparisons and leachable performance testing in part supported the substantial equivalence of this device to the predicate." |
2. Sample size used for the test set and the data provenance:
The document does not specify a separate "test set" in the context of clinical or image-based studies. The performance data provided is primarily non-clinical, comparing the physical, chemical, and manufacturing characteristics of the subject device to the predicate device and relevant standards.
- Test Set Sample Size: Not applicable in the context of clinical/image data. The "test" here refers to non-clinical laboratory testing (e.g., biocompatibility, sterility, chemical analysis). The sample sizes for these lab tests would be determined by the specific ISO standards followed (e.g., number of units tested for sterility validation).
- Data Provenance: The studies are non-clinical, related to the manufacturing and composition of the solution. The provenance would be the manufacturing facility in Italy (S.A.L.F. spa) and the laboratories where the testing was conducted, following international standards (ISO, USP). The studies appear to be prospective, as they are conducted to validate the new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The device is a medical solution for organ preservation, not an AI/imaging device requiring expert interpretation for ground truth establishment. The "ground truth" for this device relates to its chemical composition, sterility, biocompatibility, and physical properties, which are established through laboratory testing against predefined scientific and regulatory standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or reader studies where human interpretation of data (e.g., images) needs to be reconciled to establish a consensus ground truth. This is not relevant for the non-clinical laboratory testing performed for a medical solution.
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 is not applicable. The Servator P Plus SALF Solution is an organ preservation solution, not an AI-based diagnostic or imaging device. Therefore, MRMC studies and AI assistance are not relevant to its evaluation.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
This is not applicable. As mentioned, the device is a medical solution, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For this device, the "ground truth" is established by:
- Chemical Analysis: Direct measurement of the qualitative and quantitative composition of the solution, compared against the known composition of the predicate device and formulation targets.
- Physical Property Measurements: Laboratory tests to determine pH, osmolarity, and appearance.
- Biocompatibility Standards: Adherence to ISO 10993 series standards, which define acceptable biological responses to medical devices.
- Sterilization Validation: Demonstrated sterility according to ISO 17665-1.
- Particulate Matter Limits: Conformance to USP limits.
- Shelf Life Data: Stability studies demonstrating the maintenance of product specifications over time.
These are objective, measurable criteria established by scientific and regulatory bodies, rather than subjective expert consensus or pathology in a clinical sense.
8. The sample size for the training set:
This is not applicable. There is no concept of a "training set" for an organ preservation solution. The development of the solution is based on established biochemical principles and extensive prior knowledge from the predicate device and organ preservation research.
9. How the ground truth for the training set was established:
This is not applicable. As there is no training set for this type of device, there is no ground truth establishment for a training set. The development and validation largely rely on established scientific knowledge, comparison to the predicate, and adherence to performance standards.
§ 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).