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LungProtect 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.

LungProtect is an organ preservation solution used for flushing, static cold storage, and the perfusion and preservation of lungs intended for transplantation. LungProtect is a clear, sterile, non-pyrogenic, colloid based, lightly buffered extracellular low potassium dextran solution. During use, the solution is cooled to 4-8°C and is used to perfuse the isolated organ immediately before its removal from the donor and/ or immediately after its removal. The solution is then left in the organ vasculature during storage and transportation. The solution is slightly acidic (pH 5.4) to permit long shelf life and is adjusted shortly before use to pH 7.4 by the addition of THAM solution. The solution is packaged in one-liter (1000 ml) or two-liter (2000 ml) EVA bags, permanently and integrally connected to one (for 1L) or two (for 2L) PVC bags each containing 25 ml (1 mmol) THAM.

The provided text does not contain information about acceptance criteria or a study proving that the device meets those criteria. The document is an FDA 510(k) clearance letter and a 510(k) Summary for the LungProtect device. It discusses the device's indications for use, technological characteristics, and non-clinical tests performed to demonstrate substantial equivalence to a predicate device, PERFADEX AND PERFADEX WITH THAM.

Specifically, the document states:

• Non-Clinical and/or Clinical Tests Summary & Conclusions: "Non clinical tests submitted to demonstrate biological safety are: 1) Cytotoxicity, 2) Sensitization, 3) Intracutaneous Irritation, 4) Acute Systemic & Pyrogenicity, 5) Hemolysis. Packaging validation tests submitted demonstrates that the packaging of solution is safe. The following tests were performed on realtime aged samples: 1) Shipping and Distribution tests, 2) Environmental conditioning, 3) Compression testing. Compositional analysis and microbiological testing (sterility and endotoxin) were performed to verify the stability of the solution over the defined shelf life. The physical and chemical analysis of the LungProtect solution was completed to demonstrate that the LungProtect is substantially equivalent to its predicate. Nor-clinical testing was sufficient to demonstrate substantial equivalence to the non-clinical data supports the safety and effectiveness of the LungProtect."

However, it does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for a test set, data provenance, or details about retrospective/prospective studies.
3. Information on experts used to establish ground truth or their qualifications.
4. Adjudication methods.
5. Details on a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
6. Information on standalone (algorithm-only) performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. Sample size for a training set.
9. How ground truth for a training set was established.

The document focuses on non-clinical testing to demonstrate biological safety, packaging integrity, and compositional equivalence to a predicate device, as required for 510(k) clearance for this type of medical device (an organ preservation solution). It does not describe a clinical performance study with defined acceptance criteria for a diagnostic or AI-driven device.

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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:

• 1. PVC free bags 1000ml, therefore they are free of phthalates. The solution may be used without any point of use filtration.
• 2. 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.

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