(187 days)
2008K@home Hemodialysis Machine: The Fresenius 2008K@home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician. bibag System: The Fresenius Medical Care bibag system is used with Fresenius Medical Care three stream proportioning hemodialysis systems equipped with the bibag module such as the 2008K@home Hemodialysis Machine and is indicated for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag System is intended for extracorporeal bicarbonate hemodialysis according to a physician's prescription. Wireless Wetness Detector (Wet Alert): The Wireless Wetness Detector is indicated for use with the Fresenius 2008K@home Hemodialysis Machine and is an optional accessory to aid in the detection of blood and water leaks during hemodialysis. Home hemodialysis using the detector must be observed by a trained and qualified person as prescribed by their physician.
The 2008K@home Hemodialysis Machine with bibag System is intended for short term (acute) and long term (chronic) dialysis treatment in a clinical facility and at home. In the home, a trained and qualified person must observe treatment as prescribed by a physician: The 2008K@home 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); and (2) the single-use disposable 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 2008K@home 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 2008K@home 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. Additionally, this submission includes minor hardware/software changes to the proposed device: Active pressure regulation, Acid/Heat Disinfect button; simplified Acid Clean program and alternate LCD display.
Here's a breakdown of the acceptance criteria and the study information for the Fresenius 2008K@home Hemodialysis Machine with bibag System, based on the provided text:
Important Note: The provided document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed, novel clinical study results with specific performance metrics against an acceptance criterion in the way an AI/ML device submission might. Therefore, some of the requested information (like specific effect sizes for human readers with AI assistance) is not applicable or explicitly stated in this type of submission.
Acceptance Criteria and Reported Device Performance
The document states that "Test results demonstrated that the modified 2008K@home Hemodialysis Machine with bibag System functions as intended and met pre-determined acceptance criteria." It also lists various verification and validation tests performed. However, the specific quantitative acceptance criteria or detailed performance metrics are not explicitly presented in a table format within this 510(k) summary. Instead, the conclusion is a general statement of meeting criteria.
The device performance is generally reported as:
- "functions as intended"
- "met pre-determined acceptance criteria"
- "did not affect the essential performance of the device"
- "the device functions as intended"
- "differences... do not raise any new concerns with regard to safety or effectiveness."
Without explicit quantitative criteria, a table like the one requested cannot be constructed precisely from the provided text. The document refers to "existing FMCNA procedures, protocols, declared performance standards and guidelines of the quality system regulation (21 CFR Part 820)" as the basis for evaluation, implying internal, pre-defined criteria were used for the various tests.
Study Details
Given this is a 510(k) for a medical device (hemodialysis machine), not an AI/ML-driven diagnostic, many of the typical AI/ML study parameters (like test set size, data provenance, ground truth experts, MRMC, standalone performance) are not applicable or not detailed in this type of submission. The studies performed are primarily engineering verification and validation tests.
Here's an attempt to address your points based on the provided text, with clarifications where information is absent or irrelevant to a traditional medical device 510(k):
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in a quantitative table. The document generically states that "pre-determined acceptance criteria" were met. These would typically be internal engineering specifications and regulatory standards (e.g., ISO, FDA regulations) for safety, performance, and functionality.
- Reported Device Performance: The device "functions as intended" and there are no "new concerns with regard to safety or effectiveness" compared to the predicate devices. This is a qualitative statement of successful verification and validation.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not specified. The testing described includes "Functional Verification and Software Validation," "System Performance," "Heat Disinfection Testing," "Chemical Testing," "System Safety," "Reliability" (Accelerated Life, Mechanical Life, Elevated Temperature Testing), and "Summative Usability." These are internal engineering and usability tests, and the "sample size" would relate to the number of test units, cycles, or user participants, which is not detailed.
- Data Provenance: Not applicable in the context of clinical data provenance. These are laboratory/engineering test results conducted by the manufacturer (Fresenius Medical Care North America, Waltham, MA).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of clinical ground truth. The "ground truth" for engineering and functional tests is established by documented specifications, regulatory standards, and expected operational behavior, which is assessed by engineers and technicians. For the "Summative Usability" study, "experts" would be the intended users and human factors specialists, but their number and qualifications are not specified.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as this is not a diagnostic device assessment involving human interpretation. Adjudication methods are typically used for clinical study endpoints or image interpretations. Engineering and software tests follow predefined pass/fail criteria.
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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 a hemodialysis machine, not an AI-assisted diagnostic or interpretative device. This type of study is not relevant to this submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device; the concept of an "algorithm only" performance study in this context is not relevant. The device has automated functions, which are verified through various tests (System Performance, Software Verification, Safety Systems Verification), but this is not an "AI algorithm" in the typical sense of a standalone diagnostic.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground truth for engineering/software performance: Established by design specifications, functional requirements, and compliance with industry standards (e.g., ISO, electrical safety standards).
- Ground truth for usability: "Summative Usability" studies typically evaluate whether users can safely and effectively operate the device according to its intended use and training, with "ground truth" being defined as successful task completion and adherence to safety protocols.
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The sample size for the training set:
- Not applicable. This device is not an AI/ML device that undergoes a "training phase."
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How the ground truth for the training set was established:
- Not applicable.
§ 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.”