(247 days)
The Moda-flx Hemodialysis System™ is indicated for use in patients with acute and/or chronic renal failure, with or without ultrafiltration, in an acute, post-acute, or chronic care facility. Treatments must be administered under a physician's prescription, by a trained person who is considered competent in the use of the device.
Treatment types available include: Intermittent Hemodialysis (IHD), Sustained Low Efficiency Dialysis (SLED/ SLEDD), and Prolonged Intermittent Renal Replacement Therapy (PIRRT).
The Moda-flx Hemodialysis System™ Cartridge is a single use, disposable arterial and venous bloodline set, with dialysate tubing, intended to provide extracorporeal access during hemodialysis. The Moda-flx Hemodialysis System™ Cartridge is compatible only with the Moda-flx Hemodialysis System TM.
The Moda-flx Hemodialysis System™ is a transportable hemodialysis system that consists of three parts: Hemodialysis Delivery (HD) Device. Dialysate Generator (DG) Device, and a single use Moda-flx Hemodialysis System™ Cartridge that provides extracorporeal access during hemodialysis. The Moda-flx Hemodialysis System™ Cartridge is only compatible with the Modaflx Hemodialysis System™. The system creates purified water from tap water; from this purified water and chemical concentrates, the system creates dialysate in real time. The chemicals used to create the dialysate are standard 45X concentrates.
Ultrafiltration is achieved by controlling the dialysate going in and coming out of the dialyzer independently, using pumps on the HD Device to control fluid flow from both the inlet and outlet of the dialyzer. An external bag of saline is used to provide solution infusions to combat hypotensive episodes. Saline is also used to prime the Moda-flx Hemodialysis System™ Cartridge prior to use.
Prescribed blood flow rate is generated by a peristaltic pump, while heparin is administered to prevent blood coagulation. All fluid pathways are disposable and easily installed and replaced. Once installed, the device will check the connections of the fluid pathways and the system will automatically prepare itself for treatment.
This document is a 510(k) summary for the Moda-flx Hemodialysis System and Cartridge. It outlines the device's indications for use, its description, and a comparison to predicate devices, but does not provide the acceptance criteria or results of a study designed to prove the device meets specific acceptance criteria related to its clinical performance.
The "Performance Data" section lists various tests conducted, such as biocompatibility, electrical safety, software verification, and bench performance (including clearance, transport, and dialyzer integrity testing). It explicitly states that "no clinical studies were required to support this submission." This indicates that the FDA's substantial equivalence determination for this device was based on non-clinical performance data and comparison to predicate devices, rather than a clinical study demonstrating specific efficacy or clinical performance acceptance criteria.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them, as such a study (specifically a clinical one with performance metrics) is stated as not being required and thus not provided in this document.
However, based on the information provided, here's what can be inferred about the types of performance criteria and tests performed, even if specific numerical acceptance values aren't given:
Inferred Information from the Document:
While specific clinical acceptance criteria are not detailed (as no clinical study was required for this submission), the document does list various performance data provided in support of substantial equivalence. These imply underlying performance criteria for safety and technical functionality.
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Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the document for clinical performance. The document only lists categories of tests performed.
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Sample size used for the test set and the data provenance: This information is not provided in the document for any of the listed performance tests. The provenance (e.g., country of origin, retrospective/prospective) is also not provided.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not applicable/provided, as no clinical study with "ground truth" established by experts is mentioned. For the non-clinical tests (e.g., bench testing, software V&V), the "ground truth" would be the engineering specifications and regulatory standards.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is not applicable/provided, as no clinical study requiring adjudication is described.
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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: This information is not applicable/provided. The device is a hemodialysis system, not an AI-assisted diagnostic tool involving human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This information is not applicable/provided. The device is a medical system, not an AI algorithm in the typical sense of "standalone performance" for diagnostic or predictive tasks. Performance was likely evaluated for the integrated system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical tests mentioned (biocompatibility, electrical safety, software V&V, bench performance, etc.), the "ground truth" would be established by relevant engineering standards, regulatory requirements, and internal specifications for the device's functional performance. No clinical ground truth (like pathology or outcomes data) was used or required for this submission according to the document.
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The sample size for the training set: This information is not applicable/provided. As no clinical study requiring "training data" for an AI model is described, this question is not relevant to the provided text.
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How the ground truth for the training set was established: This information is not applicable/provided for the same reasons as point 8.
§ 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.”