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.

Device Description

The line of Asahi REXEED-SX/LX Series Dialyzer is a family of high permeability hollow fiber dialyzers intended for the treatment of patients with acute or chronic renal failure. REXEED-SX/LX Series Dialyzer is designed for single use. REXEED-SX/LX Series Dialyzer is constructed of hollow fiber (polysulfone) membranes, housed within a plastic casing of styrene-butadiene block copolymer and are subjected to electron beam irradiation prior to shipment.

AI/ML Overview

The provided 510(k) summary for the Asahi REXEED-SX/LX Series Dialyzer describes modifications to an already cleared device and focuses on proving that these modifications do not compromise the device's safety and effectiveness compared to the predicate device. It is not a study establishing initial device performance against specific clinical acceptance criteria.

Therefore, the requested information elements related to a study proving the device meets acceptance criteria, such as a table of performance, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance, are not applicable or available in this document. The submission is a "Special 510(k)," which typically focuses on demonstrating that modifications do not raise new questions of safety or effectiveness.

Here's an analysis of the available information:

1. A table of acceptance criteria and the reported device performance:

Not Applicable/Not Provided. This submission is for modifications to an already cleared device. The document states, "All test results meet the acceptance criteria, and proved that those modifications to be appropriate," but it does not specify what those acceptance criteria were or present a table of results against them. The focus is on demonstrating that the modifications do not negatively impact performance, rather than establishing initial performance metrics.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Not Applicable/Not Provided. The document refers to "design validation or where appropriate, design verification, and process validation" studies. However, it does not specify the sample sizes or provenance of data used in these studies. These are typically internal engineering tests rather than clinical studies.

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):

Not Applicable/Not Provided. There is no mention of expert-established ground truth for a test set, as this is not a diagnostic device involving human interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not Applicable/Not Provided. Not relevant for the type of device and submission.

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:

Not Applicable. This is a hemodialysis dialyzer, not a diagnostic device involving human readers or AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is a hardware medical device; it does not involve algorithms or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not Applicable/Not Provided. The "ground truth" for a hemodialysis dialyzer would generally relate to its physical properties, manufacturing quality, and in-vitro performance (e.g., blood compatibility, filtration rates, structural integrity, absence of leakage). The document states, "REXEED SX/LX Dialyzers have been tested in vitro under single use conditions," indicating in vitro performance data would be the primary "ground truth" equivalent.

8. The sample size for the training set:

Not Applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established:

Not Applicable. Not a machine learning or AI device.

Summary of what is provided:

Acceptance Criteria Mention: The document states that "All test results meet the acceptance criteria, and proved that those modifications to be appropriate." However, the specific acceptance criteria themselves are not detailed in this public summary. They would be part of the full submission, likely related to manufacturing quality, physical properties (e.g., leakage, hollow fiber specifications), and in vitro performance (e.g., clearance rates, ultrafiltration rates, biocompatibility).
The Study/Evaluation: The "study" is referred to as "Asahi's device evaluation studies and overall process for managing medical device risk," which includes a risk analysis (FMEA) and "Design validation or where appropriate, design verification, and process validation." These studies were performed to verify the impact of the described modifications (manufacturing process change, labeling change, and device modification related to leakage and physical properties).
Purpose of the Study: To establish that the modified Asahi REXEED-SX/LX Series Dialyzer is substantially equivalent in intended use/indications for use, design, principle of operation, technology, materials, specifications, and performance to the predicate REXEED-SX/LX Series Dialyzer. The predicate devices were previously cleared under K001250, K041726, K051187, and K082515.

Summary

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510(k) Summary of Safety and Effectiveness A.0

A.1 Submitter Information

FEB 0 6 2013

Company Name and Address:	Contact Name:
Asahi Kasei Medical Company, Ltd.	Patsy J.Trisler, JD, RAC
1-105 Kanda Jinbocho, Chiyoda-ku,	Vice President, Regulatory and Clinical
Tokyo 101-8101, Japan	Qserve America, Qserve Group B.V.
	154 Main Street, Suite #2
	Charlestown, NH 03603
	Telephone: 301-652-5344
	Fax: 509-807-7204
	Email: patsy.trisler@qservegroup.com

Date Prepared: May 9, 2012 A.2

A.3 Name of Device

3.1 Trade Name: Asahi REXEED-SX/LX Series Dialyzer
3.2 Common Name: High Flux Hemodialysis Membrane Dialyzer or High Flux Hollow Fiber Dialyzer

3.3 Classification Name, Class, Product Code and Panel

Classification Name and RegulationNumber	Class	Product Code	Panel
High Permeability HemodialysisSystems, Title 21 Code of FederalRegulations § 876.5860	II	KDI	Gastroenterologyand Urology

Substantial Equivalence Claimed to Predicate Device A.4

APS/REXEED, cleared for commercial distribution via 510(k) Premarket Notifications K001250 dated August 16, 2000; K041726 dated July 23, 2004; K051187 dated June 8, 2005; and K082515, dated October 3, 2008.

A.5 Device Description

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K121409

Page 2 of 2

This Special 510(k) describes the following modifications:

I Manufacturing Process Change: insertion of an additional step to enhance removal of manufacturing materials.
. Labeling Change: changes to the Instructions for Use to emphasize importance of following instructions for use.
I Device Modification: change in specification limit of leakage and related physical properties of hollow fibers for safer treatment and operation.

Intended Use and Indications for Use A.6

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.

A.7 Evaluation of Design Modifications

As the basis for Asahi'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(2007) "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 validation or where appropriate, design verification, and process validation 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.

A.8 Conclusion:

Asahi made modifications to the REXEED-SX/LX Series Dialyzer cleared under K001250, K041726, K051187, and K082515, resulting in the modified REXEED-SX/LX Series Dialyzer. The information and data provided in this Special 510(k) Premarket Notification establish that the modified REXEED-SX/LX Series Dialyzer is substantially equivalent in intended use/indications for use, design, principle of operation, technology, materials, specifications, and performance to the predicate REXEED-SX/LX Series Dialyzer.

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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 consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is smaller than the caduceus symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 6, 2013

Asahi Kasei Medical Co., Ltd. % Ms. Patsy J. Trisler, JD, RAC Vice President, Regulatory & Clinical Affairs Oserve Group B.V. 154 Main Street, Suite #2 CHARLESTOWN NH 03603

Re: K121409

Trade/Device Name: Asahi REXEED-SX/LX Series Dialyzer Regulation Number: 21 CFR§ 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: December 20, 2012 Received: December 27, 2012

Dear Ms. Trisler:

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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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.

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Page 2 - Ms. Patsy J. Trisler, JD, RAC

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin/R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Statement of Indications for Use

510(k) Number (if known): K121409

Device Name: Asahi REXEED-SX/LX Series Dialyzer

Indications for Use:

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.

X AND/OR Over-the-Counter Use: Prescription Use: __ (21 CFR § 801 Subpart D) (21 CFR §07 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Benjamin R. Fjisher -S 2013.02.06 1/5:06:01 -05'00'

Division Sian-Off lon of Reproductive, Gastro-Renal, and logical Device 510(k) Numbe

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.”