(339 days)
Servator P SALF Solution with THAM is indicated for flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.
Servator P SALF Solution with THAM is a clear to light yellow, single use only, sterile (by steam sterilization) is indicated for the flushing, static cold storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into recipient. The solution is used for organ perfusion and hypothermic preservation. It is an ideal solution for the preservation of lungs.
The solution cooled to 4° to 8° C (39° to 46° F) is used to spray the organ isolated immediately after removal from the donor. The colloidal component Dextran 40 protects in particular microvessels from a possible damage caused by the post-ischemic reperfusion, since it prevents pathological leukocyte-endothelial interactions. In addition, Dextran 40 prevents edema and the formation of thrombi.
The primary containers used for the device are:
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- PVC free bags 1000ml, therefore they are free of phthalates. The solution may be used without any point of use filtration.
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- Clear glass bottles 25ml, therefore they are free of phthalates. The solution may be used without any point of use filtration.
The provided FDA 510(k) summary for "Servator P SALF Solution with THAM" does not describe an AI/ML-based medical device. Instead, it details a solution used for organ preservation (specifically lungs) during transplantation.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, MRMC studies, standalone performance, and ground truth establishment for an AI/ML device is not applicable to this submission.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Perfadex® with THAM) based on:
- Identical Indications for Use and Intended Use.
- Identical Chemical Composition: This is explicitly stated multiple times ("The composition list is identical for the subject and predicate device composition and therefore, the subject and predicate devices are identical in chemical composition.").
- Similar Technological Characteristics: Such as mode of operation (cold storage), container type, and sterilization method (steam).
- Non-Clinical Performance Data:
- Biocompatibility: Tests performed according to ISO 10993 series. The subject device passed all biocompatibility test standards.
- Sterilization and Shelf Life Validation: Sterility validated according to ISO 17655-1. Shelf life is 24 months, identical to the predicate.
- Performance Testing: Chemical comparisons and leachable performance testing were conducted to demonstrate substantial equivalence to the predicate.
In summary, this 510(k) submission establishes substantial equivalence through direct comparison of the product's attributes and non-clinical testing, rather than through a study proving an AI/ML device meets specific performance criteria.
§ 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).