(449 days)
The xevonta dialyzer is designed for single use in acute and chronic hemodialysis.
The xevonta dialyzer is a polysulfone high flux dialyzer with the surface areas 1.2 m², 1.5 m2, 1.8 m2, 2.0 m2, 2.3 m2. It is designed for single use in acute and chronic hemodialysis. The dialyzer is gamma sterilized, with a non pyrogenic fluid path, and does not contain natural rubber latex.
The polysulfone hollow fiber (membrane) is housed within a plastic cylinder containing four ports: two ports for blood compartment access and two ports for dialysate access.
This document is a 510(k) premarket notification for the "xevonta dialyzer". It describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to previously marketed predicate devices.
Here's an analysis of the provided information concerning acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table with formal acceptance criteria against which numerical performance metrics are directly compared for the new device. Instead, it states that the testing aimed to demonstrate equivalence with the predicate devices. This implies that the performance of the xevonta dialyzer was expected to be comparable to, or within an acceptable range of, the predicate devices for each tested parameter.
Below is a table summarizing the tested parameters and the general conclusion regarding performance, as direct numerical targets for acceptance criteria are not provided.
| Performance Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Complies with ISO 10993-1 and FDA Guidance for category B device | Testing performed; results demonstrate safety. |
| In-vitro Ultrafiltration Rate | Comparable to predicate devices | Results demonstrate similar performance to predicate devices. |
| Pressure Drop (Blood Side) | Comparable to predicate devices | Results demonstrate similar performance to predicate devices. |
| Pressure Drop (Dialysate Side) | Comparable to predicate devices | Results demonstrate similar performance to predicate devices. |
| Clearances (Urea) | Comparable to predicate devices | Results demonstrate similar performance to predicate devices. |
| Clearances (Creatinine) | Comparable to predicate devices | Results demonstrate similar performance to predicate devices. |
| Clearances (Vitamin B12) | Comparable to predicate devices | Results demonstrate similar performance to predicate devices. |
| Mechanical Hemolysis | Comparable to predicate devices (acceptable levels) | Results demonstrate similar performance to predicate devices. |
| In-vitro & In-vivo Ultrafiltration Coefficient | Comparable to predicate devices | Results demonstrate similar performance to predicate devices. |
| Overall Safety and Effectiveness | As safe and effective as predicate devices | "The data provided for the new device demonstrates that xevonta dialyzers are as safe and effective as the marketed predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes used for the "test set" in any of the described studies (biocompatibility, in vitro performance, clinical testing). It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective.
Given the nature of the device (dialyzer) and the types of tests mentioned, it is highly probable that:
- Biocompatibility testing would have used standard laboratory samples according to ISO 10993.
- In vitro performance testing would involve a set number of dialyzers for each model and surface area, tested under controlled laboratory conditions.
- Clinical testing (comparison of in-vitro and in-vivo ultrafiltration coefficient) would have been performed on a cohort of human subjects undergoing hemodialysis. This would most likely be a prospective study, though its location is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the studies described. The "ground truth" concept, often used in AI/ML performance evaluation (e.g., for image interpretation), does not directly apply here. The studies involve objective measurements of physical and chemical properties of the dialyzer and their performance in a clinical setting, rather than subjective interpretations by experts.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the studies involve objective measurements, not subjective evaluations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices or AI systems that assist human readers in making diagnoses. The xevonta dialyzer is a medical device (a high permeability hemodialysis system) for which performance is assessed through biophysical and clinical parameters, not human interpretation of data.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. The xevonta dialyzer is a passive medical device, not an algorithm or AI system. Its performance is inherent in its physical and chemical properties and how it functions during hemodialysis. "Standalone performance" in this context refers to the device's function independent of human interaction beyond its setup and monitoring during use. The in-vitro tests represent this form of standalone performance.
7. Type of Ground Truth Used
The "ground truth" for the performance evaluation comes from:
- Established scientific and regulatory standards: For biocompatibility (ISO 10993-1).
- Instrumental measurements: For in-vitro performance parameters like ultrafiltration rate, pressure drop, and clearances.
- Clinical measurements: For in-vivo ultrafiltration coefficient, which would be measured directly from patients.
- Predicate device performance: The performance of the legally marketed predicate devices provided the benchmark for "substantial equivalence."
8. Sample Size for the Training Set
Not applicable. The xevonta dialyzer is a manufactured medical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of 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.”