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.

Device Description

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.

AI/ML Overview

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.

Summary

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K051187 Page 101

CONFIDENTIAL

14.510 (K) SUMMARY

Asahi REXEED Series Dialyzers

Manufacturer:	Asahi KASEI Medical Company, Ltd.9-1, Kanda MitoshirochoChiyoda-ku, Tokyo 101-8482Japan
Date summary was prepared:	April, 30, 2005
Name(s) of the device:	Asahi REXEED Series Dialyzers
Identification of predicate device(s):	Asahi APS Series DialyzersFresenius OptifluxGambro Polyflux

Description of the device:

Intended Use:

The line of the REXEED Series Dialyzers is a family of high permeability hollow fiber dialyzers intended for the treatment of patient with acute or chronic renal failure. REXEED-U/S are intended for single use and REXEED-UR/R for reuse. This is the same intended use as the existing APS cleared under K001250 and K041726, with the exception of using mixture of hydrogen peroxide and peroxyacetic acid (e.g., Renaline) as reprocessing agent.

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Ko 511/87 Page 2 of 2

Special 510(k) Premarket Notification

CONFIDENTIAL

Evaluation of Design Modifications

As the basis for Asahi KASEI Medical's device evaluation studies and overall process for managing medical device risk, the company has performed a risk analysis using procedures based on ISO 14971 (2000) "Medical Devices - Application of Risk Management to Medical Devices". The risk analysis method used to assess the impact of the modification was Failure Modes and Effects Analysis (FMEA). Design verification tests based on the result of risk analysis and design input were performed to verify those modifications. All test results meet the acceptance criteria, and proved that those modifications to be appropriate.

Conclusion:

Asahi KASEI Medical made three modifications to the original APS cleared under K001250 and K041726. 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®).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes extending from its body. The words "U.S. Department of Health & Human Services" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Coffeet and Ante Administration Rockville 2006 orgate Boulevard Rockville MD 20850

APR 2 1 2009

Asahi Kasei Medical Co., Ltd. % David L. West, Ph.D. Vice President, Medical Device Development Quintiles Consulting 1801 Rockville Pike, Suite 300 ROCKVILLE MD 20852

Re: K051187

Trade/Device Name: REXEED Series Dialyzers, Models 15U, 15UR, 18U, 18UR, 21U, 21UR, 25U, 25UR, 15S, 15R, 18S, 18R, 21S, 21R, 25S, AND 25R Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI and MSF Dated: May 9, 2005 Received: May 9, 2005

Dear Dr. West:

This letter corrects our substantially equivalent letter of June 8, 2005.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	(240) 276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	(240) 276-0115
21 CFR 892.xxx	(Radiology)	(240) 276-0120
Other		(240) 276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of device adverse events under the MDR regulation (21CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please fo to http://www.fda.gov/cdrh/mdr/.

You may obtain other general information on your responsibilities under the Act form the Division of Small Manufacturers, International and Consumer Assistance at is toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.htm.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ko51187

CONFIDENTIAL

16.INDICATIONS FOR USE STATEMENT

INDICATIONS FOR USE STATEMENT

510(k) Number:
Device Name:	Asahi REXEED Series Dialyzers
Indications for Use:

REXEED Series Dialyzers is intended for use for hemodialysis treatment of patients A. who have chronic or acute renal failure.
who have chrome of acute renar land." B. REAEED Series Diary2015 mast 50 abd familiar with the conditions of the patient.
physician familiar with nemodiaryins and under single or initial use एं REAEED Series Dialyzers nave beers under reprocessing and reuse conditions for alle KEAED-ORNY Borros Diary Loresults from these evaluations, REXEED-UR/R up to 15 use cycles. Dased on the reserve on the same patient. If reprocessing Series Dialyzels may be reprocessor ter read 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.

Concurrence of CDRH, Office of Device Evaluation (ODE)

ש ロ

Prescription Use (per 21 CFR 801.109) Over-the Counter Use

Division of Reproductive, Abdominal,
and Radiological Devices
K051187

510(k) Number

REXEED Series Dialyzers Asahi KASEI Medical Company., Ltd.

37 of 113

Page 37 of 38

Regulation Number and Section

§ 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.”