(264 days)
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:
- A table of acceptance criteria and reported device performance.
- Sample sizes for a test set, data provenance, or details about retrospective/prospective studies.
- Information on experts used to establish ground truth or their qualifications.
- Adjudication methods.
- Details on a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
- Information on standalone (algorithm-only) performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for a training set.
- 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.
§ 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).