(30 days)
REXEED Series Dialyzers is intended for use for hemodialysis treatment of patients who have chronic or acute renal failure. REXEED Series Dialyzers must be used by a physician familiar with hemodialysis and under single or initial use conditions. REXEED Series Dialyzers have been evaluated under reprocessing and reuse conditions for all REXEED-UR/R Series Dialyzers. Based on the results from these evaluations, REXEED-UR/R Series Dialyzers may be reprocessed for reuse on the same patient. If reprocessing Series Dialyzers may be reprocessed for reuse on the same patient. If reprocessing is elected, it is recommended that the reuse be done under the conditions as existed in the in vitro and confirmatory clinical studies as conditions as "Existed" in "the "in "the "ht" "ht" "hat REXEED-UR/R Series Dialyzers recommisinced inimediately corrent reprocessed with agents and/or processes other than these, and the performance of the dialyzers under other conditions are not known and cannot be recommended. Accordingly:
(1) The reprocessed dialyzer may be used only if the residual Total Cell Volume The reprocessed that 20% of the original TCV and if such dialyzer otherwise meets (TCV) is at least 60% of these instruction for use and the instruction of the the acceptance officilized. Furthermore, the policies, instructions, and criteria reprocessing system annized. Furthernore, mag dialyzer performance, residual of the ind/or dialyzer leakage or damage) should be followed.
(2) The reprocessing agent may mixture of hydrogen peroxide and peroxyacetic The reprocessing agent may intinues of the Renatron® Dialyzer Reprocessing System (RS 8300), manufactured by Renal Systems, Inc.
(3) The instructions provided by the manufacturer of the chosen reprocessing agent must be followed in reprocessing the dialyzer.
(4) The reprocessed dialyzer may be used only on dialysis systems equipped with volumetric ultrafiltration controllers.
The line of Asahi REXEED Series Dialyzers (hereinafter called REXEED) is a family of high permeability hollow fiber dialyzers intended for the treatment of patients with acute or chronic renal failure. REXEED-U/S are designed for single use and REXEED-UR/R are designed for reuse. The REXEED dialyers are constructed of reusable hollow fiber (polysulfone) membranes, housed within a plastic casing of styrene butadiene block copolymer and are gamma sterilized prior to shipment.
Modifications made in this 510(k) including the followings. (1) The shape modification of polysulfone hollow fibers to the crimped was implemented. The REXEED dialyzers with crimped hollow fibers is added to the existing APS Series Dialyzers (hereafter called APS) cleared under K001250 and; (2) the REXEED dialyzers membrane surface area ranges from 1.5m² to 2.5m², while that of APS ranges from 0.8 m² to 2.1 m² and; (3) mixture of hydrogen peroxide and peroxyacetic acid (e.g., Renalin®) is used as reprocessing agent) and; (4) accordingly, change in the Instruction For Use (IFU) in regard to reprocessing agent.
The provided text describes modifications to the Asahi REXEED Series Dialyzers and their substantial equivalence to predicate devices, but it does not contain a detailed study report with specific acceptance criteria and performance data in a table format, nor does it include information on sample sizes for test and training sets, expert qualifications, or MRMC studies.
Based on the available information, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text. The document states:
"All test results meet the acceptance criteria, and proved that those modifications to be appropriate."
and
"All design verification tests based on the result of risk analysis and design input proved that the REXEED dialyzers are substantially equivalent in intended use, design, principle of operation, technology, materials, specifications, and performance to the existing APS cleared under K001250 and K041726, Fresenius Optiflux F200A cleared under K003498, and Gambro Polyflux 24S and Polyflux 24R cleared under K010667, with the exception of using mixture of hydrogen peroxide and peroxyacetic acid (e.g., Renalin®)."
This indicates that acceptance criteria were met, but the specific criteria and quantitative performance results are not detailed.
2. Sample Size Used for the Test Set and Data Provenance
Not available in the provided text. The document mentions "Design verification tests," but does not specify the sample size or the nature of the data (e.g., in vitro, animal, human; country of origin; retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The document describes a device modification verification, not a study involving expert-established ground truth for a diagnostic AI device.
4. Adjudication Method for the Test Set
Not applicable, as there's no mention of a test set requiring adjudication in the context of expert consensus.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This type of study is typically for evaluating diagnostic performance of an AI system with human readers, which is not the context of this device modification submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a medical device (dialyzer) modification, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to the established performance and safety parameters of the predicate devices. The modifications were evaluated against "design verification tests based on the result of risk analysis and design input" to prove substantial equivalence to these predicate devices.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/machine learning device.
Summary of available and missing information:
| Information Requested | Availability in Text | Details/Explanation |
|---|---|---|
| 1. Table of Acceptance Criteria and Reported Device Performance | Not Available (details missing) | States "All test results meet the acceptance criteria" and "proved that the REXEED dialyzers are substantially equivalent", but no specific table or data. |
| 2. Sample Size for Test Set & Data Provenance | Not Available | Mentions "Design verification tests" but no sample size, origin, or type of data. |
| 3. Number & Qualifications of Experts for Ground Truth (Test Set) | Not Applicable | Not an AI/diagnostic device study requiring expert ground truth. |
| 4. Adjudication Method (Test Set) | Not Applicable | Not an AI/diagnostic device study. |
| 5. MRMC Comparative Effectiveness Study | No | Not relevant for this type of device modification. |
| 6. Standalone Algorithm Performance Study | Not Applicable | Not an algorithm. |
| 7. Type of Ground Truth Used | Predicate Device Performance | Evaluation against established performance and safety of predicate devices and risk analysis. |
| 8. Sample Size for Training Set | Not Applicable | Not an AI/machine learning device. |
| 9. How Ground Truth for Training Set Was Established | Not Applicable | Not an AI/machine learning 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.”