REXEED SERIES DIALYZERS

K051187 · Asahi Kasei Medical Co., Ltd. · KDI · Jun 8, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K051187
• Device Name: REXEED SERIES DIALYZERS
• Applicant: Asahi Kasei Medical Co., Ltd.
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Jun 8, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

REXEED Series Dialyzers are high-permeability hollow fiber dialyzers for acute or chronic renal failure treatment. Input: blood and dialysate fluids. Operation: blood flows through crimped polysulfone hollow fibers; solutes/water removed via diffusion/convection. Output: filtered blood returned to patient. Used in clinical settings by physicians/trained staff. Models REXEED-U/S are single-use; REXEED-UR/R are reusable up to 15 cycles. Reprocessing requires hydrogen peroxide/peroxyacetic acid mixtures and volumetric ultrafiltration controllers. Benefits: effective waste removal and fluid management for renal patients.

Clinical Evidence

Bench testing and in vitro studies were conducted to verify design modifications, including fiber crimping and reprocessing agent compatibility. Clinical studies were performed to confirm performance under reuse conditions. All test results met acceptance criteria.

Technological Characteristics

High permeability hollow fiber dialyzer. Materials: polysulfone hollow fiber membranes, styrene butadiene block copolymer casing. Geometry: crimped hollow fibers. Surface area: 1.5m² to 2.5m². Sterilization: gamma radiation. Operation: hemodialysis via volumetric ultrafiltration controllers.

Indications for Use

Indicated for hemodialysis treatment of patients with acute or chronic renal failure. Must be used by a physician familiar with hemodialysis. REXEED-UR/R models are indicated for reuse up to 15 cycles on the same patient when reprocessed using hydrogen peroxide and peroxyacetic acid mixtures (e.g., Renalin) in systems with volumetric ultrafiltration controllers, provided residual Total Cell Volume (TCV) is at least 80% of original.

Regulatory Classification

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).

Special Controls

*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.”

Predicate Devices

• Asahi APS Series Dialyzers (K001250)
• Fresenius Optiflux (K003498)
• Gambro Polyflux (K010667)

Reference Devices

• Asahi APS Series Dialyzers (K041726)

Submission Summary (Full Text)

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K051187 Page 101

CONFIDENTIAL

# 14.510 (K) SUMMARY

Asahi REXEED Series Dialyzers

| Manufacturer: | Asahi KASEI Medical Company, Ltd.<br>9-1, Kanda Mitoshirocho<br>Chiyoda-ku, Tokyo 101-8482<br>Japan |
|----------------------------------------|-----------------------------------------------------------------------------------------------------|
| Date summary was prepared: | April, 30, 2005 |
| Name(s) of the device: | Asahi REXEED Series Dialyzers |
| Identification of predicate device(s): | Asahi APS Series Dialyzers<br>Fresenius Optiflux<br>Gambro Polyflux |

### Description of the device:

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.

### 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.

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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) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

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 [phone] or [phone] 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.

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