IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS

K991908 · Idemsa · FJI · Apr 17, 2000 · Gastroenterology, Urology

Device Facts

• Record ID: K991908
• Device Name: IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS
• Applicant: Idemsa
• Product Code: FJI · Gastroenterology, Urology
• Decision Date: Apr 17, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IDEMSA Hemophan Hollow Fiber Dialyzers are indicated for use whenever a patient is in acute or chronic renal failure and a physician prescribes hemodialysis. Therefore, use of this device should be only on the direction of a physician who has evaluated all of the aspects of the patient's illness.

Device Story

Hollow fiber hemodialyzer; utilizes Hemophan (modified cellulose) membrane to facilitate solute removal from blood. Blood pumped via roller pump from patient artery into dialyzer; travels through hollow fibers; waste products pass through membrane into circulating dialysate; blood returns to patient via venous line. Used in clinical settings for acute or chronic renal failure management. Physician-operated; provides safe/effective hemodialysis. Benefits patient by removing water and waste products from blood.

Clinical Evidence

Bench testing only. In vitro performance testing conducted for ultrafiltration coefficient, pressure drop, and clearance of urea, creatinine, phosphate, and vitamin B12. Results confirmed substantial equivalence to predicate devices. No clinical data provided.

Technological Characteristics

Hollow fiber dialyzer; Hemophan (modified cellulose) membrane; polycarbonate housing/headers; polyurethane potting; silicone O-rings; polypropylene caps. Fiber dimensions: 200-micron inner diameter, 8-micron wall thickness. Sterilization: Ethylene oxide or gamma radiation. Standalone device.

Indications for Use

Indicated for patients with acute or chronic renal failure requiring hemodialysis. Use restricted to physician prescription and direction.

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

• Haidylena Cuprophan and Hemophan Hollow Fiber (K982337)
• Cobe CentrySystem 160E
• Baxter CF25
• Terumo Clirans T175

Submission Summary (Full Text)

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APR 1 7 2000

# 510 (k) Notification Hemophan Conventional Dialyzers

## 510(k) SUMMARY

| SUBMITTED BY: | Lachman Consultant Services, Inc.<br>U.S. Agent for IDEMSA<br>Contact: Leon Lachman, Ph.D.<br>1600 Stewart Avenue<br>Westbury, New York 11550<br>Phone: [phone]<br>Fax: [phone] |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTED FOR: | Investigacion Y Desarrollo de Equipos Medicos, S.A (IDEMSA)<br>Pol. Ind. "Nicomedes Garcia"<br>40140 Valverde del Majano<br>Segovia, Spain |
| DATE PREPARED: | May 28, 1999 |
| DEVICE NAME: | IDEMSA Hemophan Dialyzer |
| COMMON NAME: | Hemodialyzer |
| CLASSIFICATION NAME: | Conventional Hemodialyzer, Capillary, Hollow Fiber |
| PREDICATE DEVICES: | Haidylena Cuprophan and Hemophan Hollow Fiber, Cobe<br>CentrySystem 160E, Baxter CF25, Terumo Clirans T175 Dialyzers |

The proposed family of dialyzers are substantially equivalent in construction, design, intended use, and function to other hemodialyzers currently marketed in the United States. The IDEMSA Hemophan Dialyzers are substantially equivalent in construction, design, intended use, and function to Haidylena Cuprophan and Hemophan Hollow Fiber, Cobe Centry System 160E, Baxter CF25, and Terumo Clirans T175 dialyzers.

## DEVICE DESCRIPTION

The IDEMSA Hemophan Dialyzers are a family of hollow fiber dialyzers that provide safe and effective hemodialysis over ranges of dialyzer patient treatment requirements. The membrane used in the device is Hemophan which is substantially equivalent to the Hemophan membranes utilized in the Haidylena Cuprophan and Hemophan Hollow Fiber dialyzers (cleared for marketing in the United States under 510(k) # K982337). The Hemophan membranes utilized in both IDEMSA Hemophan dialyzers and Haidylena Cuprophan and Hemophan Hollow Fiber dialyzers are manufactured by Membrana GmbH (formerly Akzo (Enka AG)) of Germany. Hemophan® is a modified cellulose membrane that was developed by ENKA to improve the blood compatibility of the regenerated cellulose membrane Cuprophan®. Cuprophan®

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IDEMSA 510 (k) Notification Hemophan Conventional Dialyzers

1991908

membranes utilized in both Cobe CentrySystem 160E dialyzers and Baxter CF25 are also manufactured by the former Akzo (Enka AG). The Terumo Clirans T175 series dialyzers also use a cellulose membrane.

Blood enters a blood inlet port where it is distributed to the Hemophan membrane. The fibers used in the proposed device are substantially equivalent in design to the previously cleared Haidylena and Cobe CentrySystem dialyzers. Each hollow fiber has an inner diameter of 200 microns and a wall thickness of 8 microns. The wall thickness of the Hemophan and Cuprophan fibers in the Haidylena, Cobe CentrySystem 160E, Baxter CF25, and the proposed device is 8 microns. The inner diameter of Hemophan and Cuprophan in the Haidylena, Baxter CF25 dialyzer and the proposed device is 200 microns.

Blood is pumped via a roller purno from the artery of the patient into the arterial end of the dialyzer. The blood travels down through the dialyzer fibers where water waste products pass through the membrane of the dialyzer into the dialysate, which is constantly circulating through the dialyzer on the outside of the hollow fibers. Blood then exits the venous end of the dialyzer back to the patient.

#### INTENDED USE

The IDEMSA Hemophan Hollow Fiber Dialyzers are indicated for use whenever a patient is in acute or chronic renal failure and a physician prescribes hemodialysis. Therefore, use of this device should be only on the direction of a physician who has evaluated all of the aspects of the patient's illness. The indication statement is essentially the same as the indication statement of the predicate devices.

## TECHNOLOGICAL CHARACTERISTICS

Comparing the proposed device to the predicate device, some similarities and differences are noted in the design and materials employed to accomplish the same intended use. Both the proposed and predicate device (Haidylena HL 100H dialyzers) utilize the same Hemophan, hollow fiber membrane manufactured by the former Enka AG (currently Membrana GmbH). Both the proposed device and predicate device (Haidylena HL 100H dialyzers) utilize polycarbonate for the header material and polyurethane for the potting materials. The proposed and predicate devices are sterilized by ethylene oxide gas. However, the proposed device may also be sterilized by gamma radiation. The proposed device and Terumo Clirans T-175 series dialyzers each contain a silicone rubber "O-ring." The proposed device utilizes polypropylene for the non-blood contact protector cap, a predicate material identified for use in the blood ports for the Terumo Clirans T-175 series dialyzers. A summary comparison is provided on the following page.

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K991908
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## IDEMSA 510 (k) Notification Hemophan Conventional Dialyzers

#### Materials

## Table 1: Predicate Device Comparison / Materials

| Item | IDEMSA<br>Hemophan<br>Dialyzers | Haidylena<br>HL100H<br>Dialyzers | Cobe Centry<br>System 160E | Baxter CF25 | Terumo<br>Clirans®<br>T-175 |
|----------------------|--------------------------------------|--------------------------------------|------------------------------------------|------------------------------------------|----------------------------------------|
| Potting<br>Materials | Polyurethane | Polyurethane | Polyurethane | Polyurethane | Polyurethane |
| Blood port<br>caps | Polycarbonate | Polycarbonate | Polycarbonate | Polycarbonate | Polypropylene |
| Housing | Polycarbonate | Polycarbonate | Polycarbonate | Polycarbonate | Acrylonitrile-<br>Styrene<br>copolymer |
| "O" rings | Silicone | ---------- | ---------- | ---------- | Silicone |
| Membrane | Hemophan®<br>(modified<br>cellulose) | Hemophan®<br>(modified<br>cellulose) | Cuprophan®<br>(regenerated<br>cellulose) | Cuprophan®<br>(regenerated<br>cellulose) | Cellulose |

## IN VITRO PERFORMANCE

In vitro testing was performed on the proposed device to determine the following: ultrafiltration coefficient; pressure drop across blood and dialysate side; and urea, creatinine, phosphate, and vitamin B12 clearance. Since the proposed dialyzer does not consist of a new or altered design n comparison to the predicate devices, hemocompatibility performance testing was not berformed. Bench data developed for the proposed device is provided on the following page. The results of these tests confirmed that the proposed device is substantially equivalent to the predicate devices for these parameters.

## ADDITIONAL SAFETY INFORMATION

Sterilization conditions have been validated according to the AAMI guidelines to provide a sterility assurance level (SAL) of 10 the negative sixth.

Ethylene oxide residuals will not exceed the maximum residue limits proposed for Part 821 of Title 21 in the Federal Register of June 23, 1978 (or as finalized or amended).

## CONCLUSION

The IDEMSA Hemophan hollow fiber dialyzers submitted in this 510(k) are substantially equivalent in intended use, design, technological characteristics, materials and performance to the predicate device when used in accordance with the instructions for use.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its wing, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 7 2000

IDEMSA c/o Leon Lachman. Ph.D. President Lachman Consultant Services, Inc. 1600 Stewart Avenue Westbury, NY 11590

Re: K991908

IDEMSA Hemophan Hollow Fiber Dialyzers Dated: January 21, 2000 Received: January 24, 2000 Regulatory Class: Il 21 CFR §876.5820/Procode: 78 FJI

Dear Dr. Lachman:

We have reviewed your Section 510(k) notification of intent to market the device 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 and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivation 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 regulation may result in regulatory action, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notfication submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

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

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitiled, "Misbranding by reference to premarket notification" (21CFR 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/odrh/dsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D.

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

Enclosure(s)

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K991908 Page 1 of 1

## IDEMSA 510 (k) Notification Hemophan Conventional Dialyzers

#### INDICATIONS FOR USE XIV.

The IDEMSA Hemophan Dialyzer has been designed for use in hemodialysis and associated forms of treatment for chronic or acute kidney failure.

Ionid C. Syam

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

Prescription Use
(Per 21 CFR 801.109)