(63 days)
Hemodialysis with Xenium XPH cialyzers is indicated for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. Will some of class may be indicated in the treatment of patients intoxicated with poisons or drugs.
Xenium XPH dialyzers are Polyethersulfone fiber dialyzers and will be labeled for single use only. The dialyzers are available in six (6) sizes, which differentiate by membrane surface area.
The provided text is a 510(k) summary for the Xenium XPH dialyzer a medical device. The document states that the device is "substantially equivalent" to a predicate device and that "All test results meet the acceptance criteria". However, it does not provide a table of specific acceptance criteria or detailed device performance results.
Specifically, the document states: "Baxter Healthcare Corporation conducts risk analyses, per ISO 14971, and design verification tests based on the result of these analyses. All test results meet the acceptance criteria, and support that the devices are appropriately designed for their intended use." This is a general statement and does not include the detailed information requested in the prompt.
Therefore, for the requested information, the following can be reported based solely on the provided text:
Acceptance Criteria and Study Details for Xenium XPH Dialyzer
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided text. | "All test results meet the acceptance criteria, and support that the devices are appropriately designed for their intended use." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective). The testing appears to be internal "design verification tests" conducted by Baxter Healthcare Corporation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/Not specified, as the testing described is "design verification tests" rather than clinical studies requiring expert ground truth establishment in the traditional sense.
- Qualifications of Experts: Not applicable/Not specified.
4. Adjudication method for the test set
- Not applicable/Not specified. The document describes "design verification tests," not a study requiring adjudication of interpretations.
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
- No, a MRMC comparative effectiveness study was not done. The device is a dialyzer, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a physical dialyzer, not an algorithm.
7. The type of ground truth used
- Not applicable in the context of expert consensus or pathology. The "ground truth" for a dialyzer would relate to its physical and functional performance specifications (e.g., clearance rates, ultrafiltration rates, safety parameters) as measured in design verification tests. The specific "type" is not detailed beyond "design verification tests."
8. The sample size for the training set
- Not applicable. The device is a physical dialyzer, not a machine learning algorithm that requires a training set.
9. 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.”