(31 days)
A. REXEED-SX/LX Dialyzers is intended for use for hemodialysis treatment of patients who have chronic or acute renal failure.
B. REXEED SX/LX Dialyzers must be used in accordance with the instructions for a physician familiar with hemodialysis and familiar with the conditions of the patient.
C. REXEED SX/LX Dialyzers have been tested in vitro under single use conditions.
The line of Asahi REXEED-SX/LX Dialyzers is a family of high permeability hollow fiber dialyzers intended for the treatment of patients with acute or chronic renal failure. REXEED-SX/LX Dialyzers are designed for single use. REXEED-SX/LX Dialyzers are constructed of hollow fiber (polysulfone) membranes, housed within a plastic casing of styrene-butadiene block copolymer and are subject to electron beam irradiation prior to shipment.
This Special 510(k) describes the following modifications:
- Change in wall thickness of the polysulfone REXEED-SX/LX hollow fibers to 35 um, compared to 45 um for the existing predicate APS/REXEED
- Change in priming procedure to REXEED-SX/LX priming procedure (drytype) from APS/REXEED priming procedure (wet-type)
- Change in sterilization type to electron beam irradiation REXEED-SX/LX Dialyzers, compared to gamma radiation for the existing predicate APS/REXEED
- Change in use to REXEED-SX/LX is available for single use from APS/REXEED which is available for single use and reuse.
This document describes a 510(k) premarket notification for the Asahi REXEED-SX/LX Dialyzers. The focus of the information provided is on demonstrating substantial equivalence to pre-existing predicate devices following certain modifications, rather than a study proving the device meets specific acceptance criteria in a clinical setting with human subjects.
Therefore, many of the requested categories related to clinical study design, ground truth establishment, expert adjudication, and comparative effectiveness with AI assistance are not applicable based on the provided text. The document primarily outlines the engineering and risk management aspects of the device modifications.
Here's an attempt to extract relevant information for the applicable categories:
1. A table of acceptance criteria and the reported device performance
The document states: "All test results meet the acceptance criteria, and proved that those modifications to be appropriate."
However, it does not explicitly list specific acceptance criteria values or detailed performance metrics for the REXEED-SX/LX Dialyzers in a table format within the provided text. It generally refers to "design verification tests based on the result of risk analysis and design input" and that these tests met acceptance criteria.
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 specified.
- Data Provenance: The studies are described as "in vitro" ("REXEED SX/LX Dialyzers have been tested in vitro under single use conditions."). The company is based in Japan, so it's likely the tests were conducted there or at facilities contracted by the company. Retrospective or prospective nature is not indicated, but given it's a device modification verification, it would be prospective testing of the modified device.
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)
- Number of Experts: Not applicable. The "ground truth" here relates to engineering and performance specifications validated through testing, not clinical diagnosis.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This concept is for clinical assessments, not for engineering verification tests.
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
- MRMC Study: No. This is not an AI/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: The "ground truth" for this device modification review is based on engineering specifications, risk analysis (FMEA), and benchmark performance against the predicate device as demonstrated through "design verification tests." These tests would likely involve measuring physical and functional properties of the dialyzers according to established standards for hemodialysis systems.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established
- How Ground Truth for 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.”