(30 days)
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
- Software Verification and Validation Testing:
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).
§ 876.5860 High permeability hemodialysis system.
(a)
Identification. A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K
uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.).
(3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).
(b)
Classification. Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ”
(2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,”
(3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,”
(4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and
(5) “Guidance for Hemodialyzer Reuse Labeling.”