(90 days)
Hemodialysis with Xenium dialyzers is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs.
Xenium dialyzers are polyethersulfone fiber dialyzers and will be labeled for single use only. The dialyzers are available in six sizes, which differentiate by membrane surface area. The polyethersulfone hollow fiber membrane is the same as that contained in NxStage System One cleared under NxStage Medical's premarket notification K050525. All other components in Xenium are the same as those contained in the Exeltra dialyzer cleared under Baxter's premarket notification K030974.
Here's an analysis of the provided text regarding the Xenium Dialyzer, focusing on the acceptance criteria and the study performed:
This document is a 510(k) premarket notification for a medical device (Xenium Dialyzer), and as such, it primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study with acceptance criteria and device performance metrics in the way a clinical trial report would.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication methods, MRMC study, training set details) are explicitly listed as "Not Applicable" or are not present in this type of submission.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (Baxter's Exeltra dialyzer, K030974 & NxStage Medical's NxStage System One, K050525) based on: | The general design and materials of the Xenium dialyzer are the same as Exeltra dialyzer cleared under K030974 and NxStage System One dialyzer cleared under K050525. |
| No new types of safety and effectiveness issues compared to predicate devices. | The polyethersulfone hollow fiber membrane is the same as that contained in NxStage System One (K050525). All other components in Xenium are the same as those contained in the Exeltra dialyzer (K030974). |
| Performance testing in accordance with EN 1283 "Haemodialysers, Haemodiafilters, Haemofilters, Haemoconcentrators and their Extracorporeal Circuits," consistent with FDA guidance. | Performance testing for Xenium dialyzers has been conducted in accordance with EN 1283. (Specific numerical results are not provided in this summary). |
| Indicated uses are the same as predicate devices. | Hemodialysis with Xenium dialyzers is indicated for patients with renal failure when conservative therapy is judged to be inadequate. It also may be indicated in the treatment of patients intoxicated with poisons or drugs. |
2. 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 Applicable. This submission relies on demonstrating substantial equivalence through design, materials, and in vitro performance testing according to standards. A separate "test set" in the context of clinical data for performance metrics is not detailed in this submission summary as the device is not expected to produce new safety and effectiveness issues.
- Data Provenance: The in vitro performance testing mentioned follows EN 1283, an international standard. No specific country of origin for in vitro test data is stated, nor is it categorized as retrospective or prospective in this summary.
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. This type of regulatory submission for a dialyzer does not typically involve human expert interpretation of a clinical test set to establish ground truth in the way, for example, a diagnostic imaging AI would. The "ground truth" here is the established safety and performance of the predicate devices and the compliance with engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3.
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
- Not Applicable. This is a physical medical device (dialyzer), not an AI-based diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is a physical medical device. The "performance" assessment is of the device's physical and functional characteristics (e.g., membrane integrity, clearance rates, etc.) as per EN 1283, not an algorithm's output.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" in this context is the established safety and performance of the predicate devices. For the new device, the "ground truth" for demonstrating equivalence relies on:
- Material Equivalence: The use of the same polyethersulfone membrane as one predicate and the same other components as another predicate.
- Performance Standard Compliance: Adherence to EN 1283 standards for dialyzer performance.
- Intended Use Equivalence: The intended use of the Xenium dialyzer is identical to the predicate devices.
8. The sample size for the training set
- Not Applicable. There is no AI algorithm being trained in this context.
9. How the ground truth for the training set was established
- Not Applicable. There is no AI algorithm and therefore no training set.
§ 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.”