(155 days)
The Baxter Meridian Hemodialysis Machine is part of a high permeability hemodialysis system, which consists of a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient's blood, an extracorporeal blood set and a high permeability dialyzer. The standard features of the Meridian machine include high blood flow rate capacity (for shortened hemodialysis treatment time), automatic ultrafiltration control, standard and variable bicarbonate and sodium capabilities and automated chemical disinfection. The Meridian machine will operate in either the bicarbonate or acetate mode for concentrates. The Meridian machine is designed to operate in the chronic and acute dialysis environment.
The Baxter Meridian is a single patient hemodialysis instrument that prepares dialysis solution, circulates blood through an extracorporeal circuit of blood tubing and hemodialyzer, and monitors the system for safe operating conditions. Its features include high blood flow rates, automatic ultrafiltration control, variable sodium and bicarbonate dialysis capabilities, and patient prescription entry through a patient data card. Optional features include automated patient blood pressure monitoring, a heparin pump and a sodium administration button.
The provided document is a 510(k) summary for the Baxter Meridian Hemodialysis Machine, which is a medical device. This type of regulatory submission establishes substantial equivalence to a predicate device and does not typically include detailed studies proving performance against acceptance criteria in the manner of an AI/ML medical device or diagnostic test.
The core of a 510(k) for a device like a hemodialysis machine relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is primarily done through comparison of technological characteristics, rather than extensive clinical performance studies with specific statistical metrics.
Therefore, the requested information elements related to AI/ML performance studies, ground truth establishment, sample sizes for training/test sets, expert adjudication, or MRMC studies are not applicable to this type of device and submission.
Here's a breakdown based on the provided text, highlighting what is available and explaining why other elements are not:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|
| Substantial Equivalence: Conformance to the safety and efficacy of the predicate device (Baxter Meridian Hemodialysis Machine - K992894) in terms of technological characteristics and intended use. | The submission states: "The Baxter Meridian Hemodialysis Machine is technologically the same as the predicate device." This is the core "performance" claim for a 510(k) of this nature – that it performs equivalently to the predicate and thus meets the safety and effectiveness standards already established by the predicate. |
| Functional Features: Ability to prepare dialysis solution, circulate blood, monitor safe operating conditions, provide high blood flow rates, automatic ultrafiltration control, variable sodium and bicarbonate dialysis, and patient prescription entry. (These are features described as standard or optional on the device and presumably meet or exceed those of the predicate). | The device's description outlines these features: "Its features include high blood flow rates, automatic ultrafiltration control, variable sodium and bicarbonate dialysis capabilities, and patient prescription entry through a patient data card. Optional features include automated patient blood pressure monitoring, a heparin pump and a sodium administration button." The implicit performance is that these features function as intended and comparably to the predicate device. The intended use statement further elaborates on the system's capabilities. |
| Intended Use Achievement: Designed for chronic and acute dialysis environments, operating in bicarbonate or acetate mode for concentrates, and preventing excessive water loss. | The intended use explicitly states: "The Baxter Meridian Hemodialysis machine is part of a high permeability hemodialysis system, which consists of a controlled dialysate delivery system that incorporates an ultrafiltration controller to prevent excessive loss of water from the patient's blood... The Meridian machine is designed to operate in the chronic and acute dialysis environment." This implies the device successfully achieves these stated functionalities within its intended environment. |
Non-Applicable Information for this 510(k) Submission:
The following information points are typically associated with performance studies for software/AI devices or clinical trials, which are not detailed in this 510(k) summary for a hemodialysis machine where substantial equivalence is based on technological characteristics.
- Sample size used for the test set and the data provenance: Not applicable. Performance is demonstrated through comparison of engineering and functional specifications to the predicate, rather than a clinical "test set" in the diagnostic sense.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This refers to ground truth for diagnostic accuracy, which is not the focus here.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This device is a treatment machine, not an interpretive diagnostic tool that assists human readers.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" for this device would relate to engineering validation and verification that the machine performs its mechanical and electronic functions correctly and safely, rather than a diagnostic 'truth'.
- The sample size for the training set: Not applicable. There is no mention of an "algorithm" or "training set" in the context of this device.
- How the ground truth for the training set was established: Not applicable.
Summary Rationale:
The provided document is a 510(k) summary for a hemodialysis machine. This type of device is classified as a physical medical device (Class II) that performs a therapeutic function. The regulatory pathway for such a device, a 510(k), focuses heavily on demonstrating substantial equivalence to an already legally marketed predicate device. In this case, the Baxter Meridian Hemodialysis Machine is stated to be "technologically the same" as its predicate (K992894).
This means the submission relies on comparing design specifications, materials, operational principles, and intended use to the predicate. It is not an AI/ML-driven diagnostic device that would require extensive performance studies involving test sets, training sets, ground truth established by experts, or MRMC studies to evaluate algorithmic performance or human-AI interaction. The "acceptance criteria" are implicitly met by demonstrating that the device functions as intended and is as safe and effective as the predicate device.
§ 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.”