(437 days)
Perfadex® Solution for Lung Perfusion is indicated for the flushing, storage and transportation of isolated lungs after removal from the donor in preparation for eventual transplantation into a recipient.
Perfadex® is a clear, sterile, non-pyrogenic, extracellular type solution for hypothermic flushing and storage of isolated lungs. The solution is slightly acidic (pH5.5) to permit long shelf life and is adjusted shortly before use to pH 7.4. The solution is slightly hypertonic (osmolarity 295 mOsm/L) and has a low buffering capacity. The composition of Perfadex® is thus consistent with that of an extracellular solution.
Perfadex® is filled into 1 or 2.8 liter PVC (Viaflex) bags, each of which is sealed in an outer polypropylene bag.
Manufacturing, control and sterilization is performed at an FDA inspected plant owned and operated by Fresenius Kabi Norge AS in Halden, Norway. The product is stored at room temperature.
Perfadex® is supplied with pre-filled, sterile, non-pyrogenic, syringes of THAM (tromethamine USP) for pH adjustment of the solution prior to use.
The pre-filled syringes of THAM are manufactured, packaged, labeled and controlled by Vitrolife UK Ltd., Edinburg, UK.
The provided document is a 510(k) Summary for a medical device called Perfadex® Solution for Lung Perfusion. This type of document is for regulatory clearance of a medical device and describes its intended use and its substantial equivalence to a previously marketed device. It does not contain information about studies proving the device meets specific acceptance criteria in the way described in your request (e.g., performance metrics, sample sizes, ground truth establishment, expert adjudication).
The document focuses on:
- Identification of the device: Perfadex® Solution for Lung Perfusion.
- Its intended use: flushing, storage, and transportation of isolated lungs for transplantation.
- Device description: composition, packaging, manufacturing, and sterilization.
- Predicate device: K000881, also Perfadex® Solution for Lung Perfusion.
- Claim of substantial equivalence to the predicate device, specifically noting the addition of pre-filled THAM syringes for pH adjustment as the main difference.
Therefore, I cannot provide the requested table of acceptance criteria and reported device performance or information about studies related to performance metrics, sample sizes, expert involvement, or comparative effectiveness with or without AI assistance, as this information is not present within the provided text.
This document's purpose is to demonstrate that the new version of Perfadex® is as safe and effective as the previously cleared version, primarily through demonstrating material and compositional equivalence. It is not a clinical study report describing performance against specific, quantifiable acceptance criteria for diagnostic accuracy or clinical outcomes.
§ 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).