HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX

K041726 · Asahi Medical Co., Ltd. · KDI · Jul 23, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K041726
• Device Name: HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX
• Applicant: Asahi Medical Co., Ltd.
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Jul 23, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The line of APS Series Dialyzers is a family of high permeability hollow fiber dialyzers intended for the treatment of patient with acute or chronic renal failure. The APS Series Dialyzers are intended for both single use or for reuse with a maximum of 15 reprocessing reuse cycles per patient. This is the same intended use as the predicate device - APS Series Dialyzers cleared under K001250.

Device Story

Asahi APS Series Dialyzers are high-permeability hollow fiber dialyzers for hemodialysis treatment of acute or chronic renal failure. Device consists of polysulfone hollow fiber membranes within a styrene butadiene block polymer casing. Available in 'wet' (factory-primed) or 'dry' models. Used in clinical settings by physicians/trained staff. Modifications include revised pre-cleaning labeling, housing design to improve flow diffusion, and updated shipping carton materials. Device supports single use or reuse (up to 15 cycles) when reprocessed with specific agents and systems. Output is the filtered blood/dialysate exchange; healthcare providers monitor performance via standard dialysis system metrics. Benefits include effective solute removal and fluid management for renal patients.

Clinical Evidence

Confirmatory clinical studies and in vitro testing were conducted to validate performance under single use and reuse conditions (up to 15 cycles). Results demonstrated that modified dialyzers meet acceptance criteria for performance, residual blood, and leakage.

Technological Characteristics

High permeability hollow fiber dialyzer. Materials: Polysulfone membrane, styrene butadiene block polymer casing. Sterilization: Gamma radiation. Connectivity: None (mechanical component of dialysis system). Operation: Passive filtration/diffusion. Design: Wet or dry models.

Indications for Use

Indicated for hemodialysis treatment of patients with acute or chronic renal failure. Must be used by a physician familiar with hemodialysis and patient conditions. May be reused up to 15 cycles on the same patient if reprocessed using specified agents (4% formaldehyde or Renalin) and systems (Seratronics DRS4/DPS4 or Renatron RS 8300), provided residual Total Cell Volume is at least 80% and dialysis system uses volumetric ultrafiltration controllers.

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)

Submission Summary (Full Text)

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JUL 2 3 2004

Special 510(k) Premarket Notification

CONFIDENTIAL

ﮯ

## 510 (K) SUMMARY

#### APS Series Dialyzers

Manufacturer:

Asahi Medical Company, Ltd. 9-1, Kanda Mitoshirocho Chiyoda-ku, Tokyo 101-8482 Japan

Date summary was prepared:

June 24, 2004

Name(s) of the device:

Asahi APS Series Dialyzers

Identification of predicate device(s):

Asahi APS Series Dialyzers

Description of the device:

The line of Asahi Polysulfone (APS) Series Dialyzers is a family of high permeability hollow fiber dialyzers intended for the treatment of patients with acute or chronic renal failure. The Asahi APS Series Dialyzers are designed for both single use or for reuse with a maximum of 15 reprocessing reuse cycles per patient. They are constructed of reusable, hollow fiber (polysulfone) membranes, housed within a plastic casing of styrene butadiene block polymer and are gamma sterilized prior to shipment.

The Asahi APS Series Dialyzers are offered for sale in both a "wet" and a "dry" model. The wet and dry dialyzers are identical to each other except that the wet models filled at the factory with a fluid to facilitate priming by the user and the dry models are not filled. The use of a wet or dry dialyzer is a matter of user preference.

Modifications made to the Asahi APS Series Dialyzers subject of this 510(k) include (1) labeling revised to provide additional information concerning pre-cleaning; (2) modification of the dialyzer housing to diffuse the flow water used in pre-cleaning; and, (3) modification of the shipping carton partition materials and mold.

APS Series Dialyzers Asahi Medical Company., Ltd.

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## Intended Use:

The line of APS Series Dialyzers is a family of high permeability hollow fiber dialyzers intended for the treatment of patient with acute or chronic renal failure. The APS Series Dialyzers are intended for both single use or for reuse with a maximum of 15 reprocessing reuse cycles per patient. This is the same intended use as the predicate device - APS Series Dialyzers cleared under K001250.

## Evaluation of Design Modifications

As the basis for Asahi 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 were performed to verify those modifications. All test results meet the acceptance criteria, and proved that those modifications to be appropriate.

### Conclusion:

Asahi Medical made three modifications to the original APS Series Dialyzers cleared under K001250. All design verification tests based on the result of risk analysis proved that modified APS Series Dialyzers are substantially equivalent in intended use, design, principle of operation/technology, materials, specifications and performance to the original APS Series Dialyzers.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 3 2004

Asahi Medical Company, Ltd. c/o Mr. David L. West, Ph.D. Vice President Quintiles Consulting 1801 Rockville Pike ROCKVILLE MD 20852

Re: K041726

Trade/Device Name: High Flux Hemodialysis Membrane Dialyzer or High Flux Hollow Fiber Dialyzer, Models APS-R, -M, -S, -E, and -EX Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: 78 KDI Dated: June 25, 2004 Received: June 25, 2004

Dear Dr. West:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector. 310(x) presidentially equivalent (for the indications ferenced above and nave decemined by marketed predicate devices marketed in interstate for use stated in the enclosure) to regally to regally the Medical Device Amendments, or to commerce prior to May 20, 1776, the enactines with the provisions of the Federal Food, Drug, devices that have occarred in asse approval of a premarket approval application (PMA). and Cosmette Act (rec) market the device, subject to the general controls provisions of the Act. The 1 ou may, therefore, mance the act include requirements for annual registration, listing of general controls provisions of the fiel labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), IT your device is classified (see above) and are regulations affecting your device can be it may be subject to additional controls. Extraige angest 800 to 898. In addition, FDA may round in the Code of Casterning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Picase oe advised that I Dr s issuation of one device complies with other requirements of the Act that I DA has made a decemmanen administered by other Federal agencies. You must of any I ederal statutes and regulations including, but not limited to: registration and listing comply with an the Act s requirements, metaling, our manufacturing practice requirements as set (21 CFR Part 807), labemig (21 CFR Part 820); and if applicable, the electronic form in the quanty 35 stems (QB) registeriors 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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 the letter.

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Înternet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

## 510(k) Number: Device Name:

## Asahi APS Series Dialyzers

Indications for Use:

- APS Series Dialyzers are intended for use for hemodialysis treatment of patients A.. who have chronic renal failure or acute renal failure.
- APS Series Dialyzers must be used in accordance with the instructions for a B. physician familiar with hemodialysis and familiar with the conditions of the patient.
- APS Series Dialyzers have been tested in vitro and in confirmatory clinical studies एं under single or initial use and under reprocessing and reuse conditions for up to 15 reuse cycles. Based on the results from these evaluations, Asahi APS Series Dialyzers may be reprocessed for reuse on the same patient. If reprocessing and reuse is practiced, it is recommended that the reuse be done under the conditions as existed in the in vitro and confirmatory clinical studies as recommended immediately below. It is noted that the Asahi APS Series Dialyzers have not been tested for reuse when 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:
- The reprocessed dialyzer may be used only if the residual Total Cell Volume (1) (TCV) is at least 80% of the original TCV and if such dialyzer otherwise meets the acceptance criteria of these instruction for use and the instruction of the reprocessing system utilized. Furthermore, the policies, instructions, and criteria of the institution for reuse (e.g., concerning dialyzer performance, residual blood, and/or dialyzer leakage or damage) should be followed.
- The reprocessing agent may be either (1) 4% formaldehyde (also known as (2) formalin) in conjunction with the Seratronics Dialyzer Reprocessing Systems Dialyzer Reprocessing and Preparation (DRS4TM and DPS4TM), for manufactured by Seratronics, Inc., or (2) Renalin ® (peroxyacetic acid) in conjunction with the Renatron @ Dialyzer Reprocessing System (RS 8300), manufactured by Renal Systems, Inc.
- The instructions provided by the manufacturer of the chosen reprocessing agent (3) must be followed in reprocessing the dialyzer.
- The reprocessed dialyzer may be used only on dialysis systems equipped with (4) volumetric ultrafiltration controllers.

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Concurence of CDRH, Office of Device Evaluation (ODE)

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Prescription Use (per 21 CFR 801.109)

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Over-the Counter Use

APS Series Dialyzers Asahi Medical Company., Ltd.

David b. Layman

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devic 510(k) Number.