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The 2008T BlueStar Hemodialysis Machine is indicated for acute and chronic dialysis therapy in a healthcare facility.

Additional therapy options for patients receiving hemodialysis include: Isolated Ultrafiltration, Sustained Low Efficiency Dialysis (SLED), and low volume hemodialysis (patients weighing ≥ 20kg and ≤ 40 kg). This machine accommodates the use of both low flux and high flux dialyzers. The SLED therapy option is not to be used for patients weighing ≤ 40 kg. The 2008T BlueStar Hemodialysis Machine is not to be used for plasma replacement therapies, for patients weighing less than 20 kg, or for renal therapies using substitution fluid.

The 2008T BlueStar Hemodialysis Machine is an electromechanical device. Software controls the machine during hemodialysis treatment, including fluid flow, mixing, heating, and alarms.
The 2008T BlueStar Hemodialysis Machine provides hemodialysis treatment by controlling and monitoring both the dialysate circuit and the extracorporeal blood circuit. The machine pumps blood from the patient's body through an extracorporeal circuit, one component of which is the dialyzer. The dialyzer contains a semi-permeable membrane that uses diffusion to transfer toxins and ultrafiltration to transport excess water from the blood into the dialysate circuit. In this separate dialysate circuit, the dialysate concentrates are mixed with purified water, heated, degassed, and delivered to the dialyzer. Balancing chambers control the incoming flow and outgoing flow of the dialysate fluid during ultrafiltration. During hemodialysis, the extracorporeal blood circuit is monitored for venous and arterial blood pressures as well as for the presence of air and blood.
The 2008T BlueStar Hemodialysis Machine has automation features (independent internal conductivity testing, auto priming, auto start, CDX auto on, assisted reinfusion) to minimize user workload and improve user experience. The 2008T BlueStar Hemodialysis Machine includes SLED (Sustained Low Efficiency Dialysis), Low Volume, and Isolated Ultrafiltration therapy options. The 2008T BlueStar Hemodialysis Machine also accommodates the use of the Patient Card system, a dialysis treatment information system.

Based on the provided FDA 510(k) Clearance Letter, the device in question is the 2008T BlueStar Hemodialysis Machine. This document is a Class II Medical Device submission, which means it relies on substantial equivalence to a predicate device, rather than a clinical trial proving new efficacy. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than establishing new clinical effectiveness benchmarks through a de novo study.

The primary study type proving the device meets the "acceptance criteria" for 510(k) clearance is a comparison to a predicate device and supporting non-clinical performance and safety testing.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for a 510(k) submission are typically related to demonstrating that the new device meets the same performance specifications as the predicate and does not raise new questions of safety or effectiveness. The reported device performance is presented as its features and specifications.

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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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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 bibag is a specialized, single-use, sealed bag filled with USP grade dry sodium bicarbonate powder. The bibag attaches to a special connector incorporated into the front of the 2008T Hemodialysis Machine. The 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 prepared 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 other 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 of the previously cleared 2008T Hemodialysis Machine with bibag system includes:
5.4.1 900g bibag Disposable:
Addition of an optional disposable 900g bibag which is equivalent to 650g bibag but increased in length to accommodate an additional 250g dry sodium bicarbonate powder. The length of a treatment session is dependent upon pre-treatment set-up time (including potential delays) and physician-prescribed dialysate flow rate and sodium bicarbonate concentration. (For example: The larger bag will provide sufficient USP grade dry sodium bicarbonate powder for 8 hours when running at a dialysate flow rate (Qd) of 500 mL/min and sodium bicarbonate concentration setting of 32 mEq/L).

There were no hardware or software changes made to the 2008T Hemodialysis Machine with bibag System to accommodate the 900g bag option. The existing bibag module attached to the machine will be used to connect the new 900g bibag with the same connector used for the 650g bibag.

Additionally, this submission includes a minor software maintenance change made to the 2008T Hemodialysis Machine with bibag System since the last clearance (K101715).

5.4.2 Function (Fn) Lock Keyboard
The existing fold-down compact keyboard used on the 2008T Hemodialysis Machine (K101715) is located directly below the display screen. The keyboard folds down to allow the operator to enter treatment parameter values, chart with CDX or make selections inside the treatment screen and folds up again to prevent unintentional changes.

For added user convenience while navigating their MIS systems, FMCNA added function lock capability to the current 2008T's keyboard. The modification includes repurposing the "Fn" key to a "Fn Lock" key and adding a function lock indicator light to the immediate right of the Caps Lock indicator light. Software and hardware modifications were made to implement this feature is only available in 2008T Hemodialysis Machines with activation of the CDX option. In dialysis mode, the Fn Lock LED will be off and the function lock feature will be off. In addition, the keyboard is now equipped with a new elastomer material with higher tear resistance properties as compared to the standard silicon elastomer of the existing keyboard in the unmodified device (K101715).

Treatment modalities for the modified Fresenius 2008T Hemodialysis Machine remain identical to those for the unmodified 2008T (K101715):

The 2008T 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.

The provided text describes modifications to the Fresenius 2008T Hemodialysis Machine with bibag System. It outlines that the changes did not affect the fundamental scientific technology or intended use of the device and therefore did not necessitate a new 510(k) submission, confirming substantial equivalence to the predicate device. The document mentions performance and safety tests were conducted to ensure the safety and effectiveness of the device after modifications.

However, the text does not contain explicit details about acceptance criteria, specific device performance metrics, or a formal study comparing the device against these criteria. It indicates that "Test results demonstrated that the modified 2008T Hemodialysis Machine with bibag System functions as intended and met pre-determined acceptance criteria," but it does not list these criteria or the results.

Therefore, I cannot provide a table of acceptance criteria and reported device performance directly from the given text, nor can I answer questions about sample size, data provenance, ground truth establishment, or multi-reader multi-case studies, as these details are not present.

The document discusses "Performance Data" and lists various tests conducted for the 900g bibag disposable and the Fn Lock Keyboard. These tests served as the "study" to confirm the modifications did not compromise safety or effectiveness.

Here's a breakdown of what information can be extracted or inferred based on the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance:

• Cannot provide. The document states that "Test results demonstrated that the modified 2008T Hemodialysis Machine with bibag System functions as intended and met pre-determined acceptance criteria," but it does not list specific acceptance criteria or quantitative performance results in the provided text.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Cannot provide. The document does not specify sample sizes for any tests, nor does it mention data provenance (country of origin, retrospective/prospective nature).

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):

• Not applicable/Cannot provide. The device is a hemodialysis machine. The "ground truth" in this context would likely refer to engineering specifications, performance against established physiological parameters, or clinical outcomes. The document does not mention the involvement of "experts" in establishing ground truth in the way one might for diagnostic imaging or AI algorithms. The tests conducted were primarily engineering and quality assurance verifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable/Cannot provide. This concept typically applies to expert review processes for establishing ground truth, which is not described for this device's testing.

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. This is not an AI-assisted diagnostic device, so an MRMC study is not relevant and was not conducted. The modifications are to a hemodialysis machine (a larger bibag option and a keyboard function lock).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. The device is a medical machine with software components for control, but it's not an "algorithm only" device in the sense of a standalone AI diagnostic tool. Its performance is intrinsic to the machine's operation, not an algorithm's output intended for human interpretation or decision-making assistance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Inferred: For the 900g bibag, the ground truth would be based on established engineering specifications, quality control standards, and performance metrics for chemical stability, bioburden, endotoxin levels, and shelf life, presumably referenced against the previously cleared 650g bibag and industry standards. For the Fn Lock Keyboard, the ground truth would be based on software functional requirements, safety standards (e.g., EMC), and material performance specifications (e.g., tear resistance, lifecycle).

8. The sample size for the training set:

• Not applicable/Cannot provide. This device is not an AI/ML model that undergoes a "training set." The tests described are verification and validation activities for hardware and software modifications.

9. How the ground truth for the training set was established:

• Not applicable. As above, there is no "training set" for this type of device.

Summary of "Study" and Evidence based on the text:

The "study" consists of design verification and validation tests to ensure that the modifications did not affect the essential performance or safety of the device.

Key Tests Conducted:

• For 900g bibag disposable:
  • Functional Verification
  • Bioburden and Endotoxin testing
  • Shelf life
  • Stability
  • Unstructured testing
• For Fn Lock Keyboard:
  • Software Verification and Validation Testing:
    • Software Verification (Functional Tests)
    • Regression testing
    • Safety Systems Verification
    • Simulated Dialysis Treatment
    • Production Test Procedure
    • Unstructured and Static Code Verification
  • Safety Testing:
    • EMC Testing (ESD immunity)
  • Unit Testing (Fn Lock Keyboard)
  • Physical Testing (Fn Lock Keyboard):
    • High Tear Elastomer: Use Life (Shelf Life)
    • High Tear Elastomer: Life cycle

Conclusion from document: "Test results demonstrated that the modified 2008T Hemodialysis Machine with bibag System functions as intended and met pre-determined acceptance criteria. Results of functional validation, performance testing, biorburden assessment, risk analysis, safety testing, stability, shelf-life tests, and usability evaluation indicate that the modified Fresenius 2008T Hemodialysis Machine with bibag System is substantially equivalent to the named predicate device and remains safe and effective for its intended use."

The document focuses on demonstrating substantial equivalence to a predicate device (K101715) by showing that the modifications (larger bibag and keyboard update) do not introduce new risks or alter the device's fundamental function, and that all relevant performance and safety checks passed against "pre-determined acceptance criteria" (though these criteria are not detailed).

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