(211 days)
Servator C SALF Solution is intended for flushing and cold storage of hearts at the time of their removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient.
Servator C SALF Solution is a clear to light yellow, single use only, sterile (by steam sterilization) and non-pyrogenic for hypothermic cardiac flushing and storage in preparation for transportation and eventual transplantation of the recipient. The solution is slightly alkaline (pH 7.3 ± 0.2 at 20°C), slightly hypertonic (approximate calculated osmolarity 242-368 mOsmol/L) with low viscosity (1.15 cSt), and has a high buffering capacity (acidic approximately 11 mmol, alkaline approximately 7 mmol). After removal from refrigerated storage (2°-8°C or 36°-46°F), the cold solution is used to flush the heart immediately before removal from the donor and/or immediately after removal from the donor. The solution is left in the organ vasculature during hypothermic storage and transportation. The primary containers used for the device are PVC free bags in 1000ml, therefore they are free of phthalates. The containers are in accordance with the reference European Pharmacopoeia and USP Pharmacopeia.
This document describes the Servator C SALF Solution, an organ perfusion and preservation solution, and its substantial equivalence to a predicate device (Celsior Cold Flush, Storage and Transport Solution for Hearts). The information provided focuses on non-clinical performance data to support this equivalence.
Here's the breakdown of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Servator C SALF Solution are not explicitly stated as numerical targets in the same way one might see for an AI algorithm's sensitivity or specificity. Instead, the acceptance criteria are demonstrated by proving substantial equivalence to the predicate device across various technological characteristics and performance tests. The "reported device performance" is essentially that the Servator C SALF Solution matches or passes the same standards as the predicate or relevant ISO standards.
| Feature / Acceptance Criteria | Reported Device Performance (Servator C SALF Solution) | Comparison to Predicate |
|---|---|---|
| Indications for Use | Flushing and cold storage of hearts at the time of their removal from the donor in preparation for storage, transportation, and eventual transplantation into a recipient. | Identical |
| Intended Use | Organ storage and preservation for transplantation. | Identical |
| Device Description (Color, sterility, pyrogenicity, hypothermic cardiac flushing/storage, pH, osmolarity, viscosity, buffering capacity) | Clear to light yellow, single use, sterile, non-pyrogenic, slightly alkaline (pH 7.3 ± 0.2 at 20°C), slightly hypertonic (242-368 mOsmol/L), low viscosity (1.15 cSt), high buffering capacity (acidic approx. 11 mmol, alkaline approx. 7 mmol). Used for flushing before/after removal and left in organ during storage/transport. | Identical |
| Container (Material) | PVC free bags, free of phthalates, in compliance with European and USP Pharmacopeia. | Identical |
| Packaging | Bags with overbags for single use. | Identical |
| Quantitative Composition (Mannitol, Lactobionic Acid, Glutamic Acid, Histidine, Calcium Chloride, Potassium Chloride, Magnesium Chloride, Sodium Hydroxide, Reduced Glutathione, Water for Injection) | Identical to predicate device formulation. | Identical |
| pH | 7.3 ± 0.2 at 20°C | Identical |
| Osmolality | 242-368 mOsm/Kg | Identical |
| Bag Material | PVC free material | Identical |
| Particulate Matter | Particle Counts less than limits for Large Volume Injections per USP . | Same |
| Biocompatibility | Biocompatible per ISO 10993-1 battery of tests for Externally Communicating Blood Path Indirect Contact for prolonged periods >24 hours. | Same |
| Protecting Overwrap Bag | Yes, contains an oxygen absorber. | Identical |
| Bag Connections | 1 flip off, 1 needle point. | Identical |
| Single Use Only | Yes | Identical |
| Shelf Life | 24 months | Identical |
| Storage Temperature | Refrigerated Storage between 2℃ to 8℃, without freezing (36° - 46° F). | Identical |
| Sterilization Method | Steam | Different (predicate uses ethylene oxide for bag, aseptic processing for solution). Both validated to ISO standards. |
| Device Standards of Conformity | ISO 10993-1, -2, -4, -5, -10, -11; ISO 11607-1, -2; ISO 11737-1; ISO 14971; ISO 15223-1; ISO 17025; ISO 17665-1; USP 39 , ; USP 41 . | Subject device passed according to ISO Standards (predicate's exact test series unknown, but states ISO 17665, ISO 10993 Series, USP , USP ). |
| Chemical Comparisons and Leachables Performance Testing | Demonstrated substantial equivalence to the predicate. | Demonstrated equivalence |
The overall acceptance criterion is based on demonstrating that the Servator C SALF Solution is substantially equivalent to the predicate device (Celsior Cold Flush, Storage and Transport Solution for Hearts) in terms of safety and effectiveness, despite a minor difference in sterilization method.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly mention a "test set" in the context of clinical trials with human subjects for efficacy. The studies performed are primarily non-clinical performance data focusing on chemical, physical, and biological properties of the solution and its packaging materials.
- Sample Size: Not specified in terms of number of organs or human subjects. The tests mentioned (e.g., biocompatibility guidance per ISO standards, particulate count per USP ) involve samples of the device components/solution itself. For instance, biocompatibility testing would involve a certain number of test specimens of the device material in contact with various biological environments.
- Data Provenance: The document does not specify country of origin for the non-clinical test data, but the manufacturer is SALF S.p.A., Italy. The studies are by nature prospective in the sense that they are designed and conducted specifically to test the new device's compliance with standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable as the studies are non-clinical, comparing the device's characteristics against established standards and a predicate device, rather than against a ground truth established by medical experts for a diagnostic or AI performance study. Compliance with standards like ISO 10993 and USP is determined by accredited laboratories and their qualified technical staff.
4. Adjudication Method for the Test Set
Not applicable. The performance is assessed against predefined scientific standards and direct comparison with the predicate device's known characteristics, rather than through adjudication of medical decisions.
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 device is an organ preservation solution, not an AI-assisted diagnostic or imaging system. Therefore, MRMC studies involving human readers and AI are irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this submission is established by:
- Established scientific and regulatory standards: Such as ISO 10993 series for biocompatibility, ISO 17665-1 for sterilization, and USP for particulate matter.
- The chemical and physical properties of the legally marketed predicate device: The Servator C SALF Solution's composition, pH, osmolarity, etc., are directly compared to the Celsior solution, aiming for identical or equivalent characteristics.
8. The Sample Size for the Training Set
Not applicable. This is not an AI or machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI algorithm.
§ 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).