ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X

K991512 · Asahi Medical Co., Ltd. · FJI · Jul 29, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K991512
• Device Name: ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X
• Applicant: Asahi Medical Co., Ltd.
• Product Code: FJI · Gastroenterology, Urology
• Decision Date: Jul 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AM-R Series Dialyzers are indicated for use in hemodialysis treatment of patients who have chronic renal failure or acute renal failure. Asahi AM-R Dialyzers may be reprocessed for reuse on the same patient.

Device Story

Asahi AM-R Series Dialyzers are hollow fiber hemodialyzers used for the treatment of chronic or acute renal failure. The device consists of cuprammonium rayon membranes housed within a styrene butadiene block polymer casing. The device is designed for reuse on the same patient. This submission covers a modification to the dialyzer casing dimensions. The device functions by facilitating hemodialysis; it is used in a clinical setting by healthcare professionals. The modification to the casing does not alter the fundamental performance or intended use of the dialyzer.

Clinical Evidence

Bench testing only. Performance evaluation confirmed that modifications to the casing dimensions have an insignificant impact on dialyzer performance.

Technological Characteristics

Hollow fiber cuprammonium rayon membrane; styrene butadiene block polymer casing. Reusable design for single-patient use.

Indications for Use

Indicated for hemodialysis treatment in patients with chronic or acute renal failure. Suitable for reuse on the same patient.

Regulatory Classification

Identification

A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient. (2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860). (3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860). (4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.

Predicate Devices

• Asahi AM-R Series Dialyzers (K970650)

Submission Summary (Full Text)

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JUL 29 1999

K991512
Page 1 of 1

# Asahi AM-R Series Dialyzers

| Submitter: | Asahi Medical Company, Ltd.<br>9-1, Kanda Mitoshirocho<br>Chiyoda-ku, Tokyo 101-8482<br>Japan |
|----------------------------------------|-----------------------------------------------------------------------------------------------|
| Date summary was prepared: | April 2, 1999 |
| Name(s) of the device: | Asahi AM-R Series Dialyzers |
| Identification of predicate device(s): | Asahi AM-R Series Dialyzers |

### Description of the device:

Asahi AM-R Series Dialyzers cleared under 510(k) K970650 are designed as reusable, hollow fiber (cuprammonium rayon) membranes which are housed within a plastic casing of styrene butadiene block polymer.

#### Intended Use:

The AM-R Series Dialyzers are indicated for use in hemodialysis treatment of patients who have chronic renal failure or acute renal failure. Asahi AM-R Dialyzers may be reprocessed for reuse on the same patient.

#### Comparison To Predicate:

The previously cleared Asahi AM-R Series Dialzyers are being modified to update the dialyzer casings. No other changes to the dialyzers are being made.

#### Conclusion:

Revisions to the casing dimensions for the AM-R Series dialyzers are demonstrated to have an insignificant impact on the performance of the dialyzers. The indications for use remains unchanged and no new issues of safety or effectiveness are expected to be raised as a consequence of this modification. Therefore the modified AM-R series dialyzers are considered substantially equivalent to the original AM-R series dialyzers.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 29 1999

Asahi Medical Company, Ltd. c/o David L. West, Ph.D. Vice President Quintiles Consulting 15825 Shady Grove Road, Suite 130 Rockville, MD 20850-4008

Re: K991512 Asahi AM-R Series of Dialyzers Dated: April 29, 1999 Received: April 30, 1999 Requlatory Class: II 21 CFR §876.5820/Procode: 78 FJI

Dear Dr. West:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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), 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regult in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809,10 for in vitro diagnostic devices), piease contact the Office of Compliance at [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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive. Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications For Use Statement

None assigned as of this time

Device Name:

510(k) Number:

Asahi AM-R Series Dialyzers

Indications for Use:

The AM-R Series Dialyzers are indicated for use in hemodialysis treatment of patients who have chronic renal failure or acute renal failure. Asahi AM-R Dialyzers may be reprocessed for reuse on the same patient.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109)

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Over-the Counter Use

David A. Bergman

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K991512