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The Fresenius bibag system is used with Fresenius three stream proportioning hemodialysis systems equipped with the bibag module such as the 2008T Hemodialysis Machine and is intended for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag is intended for extracorporeal bicarbonate hemodialysis according to a physician's prescription.

The Fresenius 2008T Hemodialysis Machine with bibag System is indicated for use in bicarbonate hemodialysis for acute and chronic renal failure.

The 2008T Hemodialysis Machine with bibag System allows operators the option to prepare a saturated sodium bicarbonate solution online through automated mixing of dialysis grade water and dry sodium bicarbonate powder within the bibag source disposable. The bibag System comprises: (1) the sodium bicarbonate concentrate generator (known as the bibag module); (2) the bag of dry sodium bicarbonate concentrate. A specialized bibag connector with a door is used to connect the single-use bibag disposable (650g/900g) filled with USP grade dry sodium bicarbonate powder to the bibag connector. The 2008T Hemodialysis Machine draws dialysis grade water into the bibag to produce a saturated solution of sodium bicarbonate online. This online generation of sodium bicarbonate can only be performed using a specially modified Fresenius 2008T Hemodialysis Machine with bibag System and can only be used with 45x (1:44) dilution. The bibag cannot be used with non-Fresenius hemodialysis machines capable of using cartridge type dry sodium bicarbonate because of the unique connection between the bibag disposable, the bibag connector, and the hemodialysis machine.

Modifications to the previously cleared 2008T Hemodialysis Machine with bibag System include:

• Active Pressure Regulation Feature: Increases the maximum acid/bicarbonate . concentrate inlet pressure specification from 2 psi to 10 psi. Provides an integrated process for regulating concentrate supply (inlet) pressures from central delivery systems.
• Active Venting Feature: Replaces the existing venting process requiring dialysate . flow bypass.
• . In-line Particulate Filter: Addition of an inline particulate filter between the bibag concentrate outlet and bicarbonate pump to eliminate the possibility of particulates from the disposable bag from entering the hydraulics.
• . Mute Once Feature: Users may elect to mute all conductivity and temperature audible alarms for up to 6 minutes (maximum) to allow a newly installed bibag disposable to reach operating temperature and conductivity.
• Acid Clean/Heat disinfection button: Allows users to initiate the acid/heat disinfect process with a single screen selection.

This submission also includes a description of software modifications to implement user interface changes. Modifications include: Heparin/SVS status. Dialysate On/Off button. Configurator, SVS Option and are intended to address user preferences and to provide additional user convenience. These changes were also described in K120505 (submitted 17 February 2012; cleared 6 March 2012).

Additionally, this submission includes minor software maintenance changes made to the 2008T Hemodialysis Machine with bibag System since the last clearance (K120017).

Treatment modalities for the modified Fresenius 2008T Hemodialysis Machine with bibag System remain identical to those for the unmodified device (K120017):

The 2008T Hemodialysis Machine with bibag System is a high permeability hemodialysis system used for the treatment of patients with acute or chronic kidney failure, fluid overload or toxemic conditions. Therapies include hemodialysis. hemofiltration and hemoconcentration. The 2008T will accommodate the use of both low flux and high flux dialyzers.

{"1. A table of acceptance criteria and the reported device performance": "The document primarily describes modifications to an existing device and verifies that these modifications do not compromise the device's safety and effectiveness. It states that "Test results demonstrated that the modified 2008T Hemodialysis Machine with bibag System functions as intended and met pre-determined acceptance criteria." However, specific quantifiable acceptance criteria (e.g., conductivity deviation must be less than X%) and their corresponding performance values are not detailed in the provided text. The performance data section broadly lists the types of tests conducted.\n\nGeneral Acceptance Criteria (Implied by Study Types):\n\n* Functional Verification and Software Validation: The device's new and existing functions operate as designed, and software changes do not introduce errors or unintended behavior.\n* System Performance: The overall system maintains its intended performance specifications (e.g., precise mixing of bicarbonate solution, delivery of dialysate).\n* Heat Disinfection Testing: The device's disinfection capabilities remain effective.\n* Chemical Testing: The device's chemical processes (e.g., concentrate preparation) meet specifications.\n* Equipment Safety: The device meets applicable safety standards.\n* Electromagnetic Compatibility: The device operates without undue electromagnetic interference.\n* Reliability: The device exhibits acceptable operational lifespan and robustness under various conditions.\n* Biocompatibility: Materials in contact with patients meet biocompatibility standards.\n* Summative Usability: The device is safe and effective for users, and the user interface changes are intuitive and do not lead to errors.\n* Risk Analysis (ISO 14971): Identified potential hazards are acceptably mitigated, and residual risks are within acceptable limits.", "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The document does not specify the sample sizes for the test sets used in verification and validation activities. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.", "3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": "This information is not applicable to the provided document. The device is a hemodialysis machine, and the "ground truth" for its performance is established through engineering and systems testing against predefined specifications and safety standards, rather than expert interpretation of medical images or data from a human subject perspective.", "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "This concept is not applicable to the type of device and study described. Adjudication methods are typically used in clinical studies involving interpretation (e.g., by radiologists) where consensus or a tie-breaking mechanism is needed for ambiguous cases. The verification and validation testing for a medical device like a hemodialysis machine relies on objective measurements against engineering specifications.", "5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance": "No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for AI-powered diagnostic tools where human interpretation is involved. The Fresenius 2008T Hemodialysis Machine is a therapeutic device, not a diagnostic AI system.", "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "This question is not applicable. The device is a hemodialysis machine, which is an integrated system of hardware and software designed for a specific medical therapy. It does not operate as an algorithm only; it is a physical device performing a medical function. The performance studies focused on the integrated system's safety and effectiveness after modifications.", "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "The "ground truth" in this context refers to established engineering specifications, performance standards, regulatory requirements (e.g., 21 CFR 820, ISO 14971), and the intended function of the device. The device's performance was evaluated against these predetermined criteria through various tests (functional, safety, reliability, etc.). There is no mention of ground truth established by expert consensus (in a clinical interpretation sense), pathology, or outcomes data for the described studies, as these are typically associated with diagnostic or clinical effectiveness studies in human subjects.", "8. The sample size for the training set": "This question is not applicable to the provided document. The device is a hemodialysis machine, and the studies described are verification and validation of hardware and software modifications, not the training of a machine learning algorithm. Therefore, there is no "training set" in the AI/ML sense.", "9. How the ground truth for the training set was established": "This question is not applicable to the provided document, as there is no mention of a training set or machine learning components in the context of the device's modifications and testing."}

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