(260 days)
The WAVES is intended to be used for the pulsatile hypothermic machine perfusion of kidneys for preservation, transportation, and eventual transplantation into a recipient.
The WAVES is a transportable, self-contained renal preservation system, designed to support static monitoring and transportation of kidneys. The WAVES system provides controlled pulsatile kidney perfusion using oxygenated hypothermic physiologic solutions, and monitors, displays, trends, and saves important perfusion parameters, including: perfusate flow, temperature, pressure, and renal resistance. The WA VES system can be configured to signal an audio and visual alarm for user-selected limits.
The WAVES is a two-part system comprising a 'control unit' for perfusion and monitoring of a single kidney, and a sterile, single-use, disposable 'cassette module' used to contain, refrigerate, and circulate perfusate to and through the kidney.
The provided document describes a medical device called WAVES, a renal preservation system, and discusses its substantial equivalence to predicate devices for 510(k) premarket notification. However, it does not contain information about acceptance criteria, device performance metrics, or study details in the format requested, such as test set size, data provenance, expert-established ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.
The document focuses on demonstrating substantial equivalence through a comparison of intended use, principle of operation, and specific control aspects (perfusion and hypothermic) with predicate devices. It mentions that certain aspects like pump performance, cooling system performance, and software validation were evaluated. Sterilization and biomaterial testing were also conducted.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text.
The document primarily asserts substantial equivalence based on:
- Intended Use: All systems perform pulsatile hypothermic machine perfusion of kidneys for preservation, transportation, and eventual transplantation.
- Principle of Operation: Similar design and function for maintaining kidneys.
- Perfusion Control: WAVES perfusion control (perfusate parameters, pressure, automated features, cassette priming) is "substantially equivalent" and "evaluated through a pump performance testing and a software validation testing."
- Hypothermic Control: WAVES hypothermic control (cassette mounting, cooling method/duration/temperature, heat exchanger) is "substantially equivalent" and "evaluated through a cooling system performance testing and a software validation testing."
- Disposable Cassette Module: Sterilization validated per ISO 11135-1, and shelf life supported by accelerated aging testing.
- Biomaterials: ISO 10993 compliant testing for new biomaterials.
- User Interface: Software validation testing showed user interface operates as expected.
The FDA's letter explicitly states that they "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination means a comparative effectiveness study in the sense of AI performance metrics (like sensitivity, specificity, AUC) against human readers or a pathology-confirmed ground truth is not typically required or performed for such a device, as it's a renal preservation system, not a diagnostic imaging AI.
§ 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).