CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER

K982337 · Haidylena Medical Egypt · FJI · Dec 29, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K982337
• Device Name: CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER
• Applicant: Haidylena Medical Egypt
• Product Code: FJI · Gastroenterology, Urology
• Decision Date: Dec 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Haidylena Cuprophan and Hemophan Hollow Fiber Dialyzer 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

Haidylena Cuprophan and Hemophan Hollow Fiber Dialyzer is a hemodialyzer for acute or chronic renal failure. Device uses hollow fiber membrane technology (Cuprophan or Hemophan) to facilitate solute removal from blood. Blood is pumped from patient artery into dialyzer; waste products pass through membrane into circulating dialysate; purified blood returns to patient via venous line. Used in clinical settings under physician direction. Device provides safe, effective hemodialysis across various patient treatment requirements. Benefits include removal of waste products (urea, creatinine, phosphate, Vitamin B12) and fluid management via ultrafiltration.

Clinical Evidence

Bench testing only. In vitro performance evaluated for Urea, Creatinine, Phosphate, and Vitamin B12 clearance, and ultrafiltration coefficient. Results compared against Terumo Clirans T175, Baxter CF25, and Cobe Centry System 160E. Data confirms performance metrics are substantially equivalent to predicate devices.

Technological Characteristics

Hollow fiber hemodialyzer. Materials: Polycarbonate housing/caps, Akzo (Enka) Cuprophan/Hemophan membrane, polyurethane potting, polyethylene vented caps. Fiber dimensions: 200 micron inner diameter, 8 micron wall thickness. Sterilization: Ethylene oxide gas per BS EN 550 and AAMI guidelines. Connectivity: None (standalone).

Indications for Use

Indicated for patients with acute or chronic renal failure requiring hemodialysis as prescribed by a physician.

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

• Cobe Centry System 160E (K864831)
• Baxter CF25
• Terumo Clirans T175

Submission Summary (Full Text)

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DEC 2 9 1998

HAIDYLENA MEDICAL

## 510(k) SUMMARY

## Submitter

Haidylena Medical 26, Makrame Ebeid St., Nasr City, Cairo. EGYPT Telephone: [phone] Facsimile: 002-02-2750552

#### Date summary was prepared

June 15, 1998

#### Name of the device

Haidylena Cuprophan and Hemophan Hollow Fiber Dialyzer

#### ldentification of predicate device

The Haidylena Cuprophan and Hemophan Hollow Fiber Dialyzer are substantially equivalence in construction, design, intended use, and function to other hemodialyzers currently marketed in the United States. The Haidylena Cuprophan and Hemophan Hollow Fiber Dialyzer are substantially equivalence in function, design and operation to the Cobe Centry Syatem 160E, Baxter CF25, and Terumo Clirans T175 Dialyzers, which have been previously approved for marketing in the United States.

## Description of the device

The Haidylena Cuprophan and Hemophan Hollow Fiber Dialyzer are a family of hemodialyzers developed to provide safe and effective hemodialysis over ranges of dialyzer patient treatment requirements. The membrane used in the device is Cuprophan which is substantially equivalence to the Cuprophan membranes utilized in the cobe centry System 160E and Baxter CF25 Dialyzers, which have been previously approved for marketing in the United States. The Cobe Cnetry System 160E was approved under a 510(k) Notification (K864831). The Cuprpohan membranes utilzed in both Haidylena Cuprophan and Hemophan Hollow Fiber Dialyzer and Cobe Centry System 160E Dialyzers are manufactured by Akzo (Enka) of Germany. Cuprophan membrane is also utilized in Baxter CF25 Dialyzers. Hemophan membrane is also manufactured by Akzo (Enka) and is also cellulose membrane but derivative from Cuprophan membrane.

Blood enters a blood inlet port where it is distributed to Cuprophan and Hemophan membrane. Each hollow fiber has an inner diameter of 200 microns and a wall thickness of 8 microns. The fibers used in

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this device are substantially equivalence in design to the previously approved Cobe Centry System. The wall thickness of the Cuprophan and Hemophan fibers in Cobe Centry System 160E Dialyzers, Baxter CF25 Dialyzers and the proposed device is 8 microns. The inner diameter o Cuprophan and Hemophan in both Baxter CF25 Dialyzer and the proposed device is 200 microns.

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

## Intended use

The Haidylena Cuprophan and Hemophan Hollow Fiber Dialyzer 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 are noted in the design and materials employed to accomplish the same intended use. Both the proposed device and Cope Centry Sytem 160E Dialyzers utilize the same Cupropohan hollow fiber membrane manufactured by Akzo (Enka) of Germany. Both the proposed device and Cobe Centry Syatem 160E Dialyzers utilize polycarbonate for the header material and polyurethan for membrane potting material. The proposed device and predicate devices are sterilized by ethylene oxide gas.

| Hadylena Dialyzer | Cobe Centry<br>system 160E | Baxter CF 25 | Terumo Clirance<br>T175 |
|---------------------------------------------------------------------------------------------------------|----------------------------|--------------|-------------------------|
| - with assistance of alpha plan<br>company (German company)<br>- according to international<br>standard | The same | The same | The same |

#### Design

## Materials

| Materials | Haidyelna<br>Dialyzer | Cobe Centry<br>system 160E | Baxter<br>CF 25 | Terumo<br>Clirance T175 |
|----------------------|-----------------------------|-----------------------------|-----------------------------|-----------------------------|
| Housing | Polycarbonate | Polycarbonate | Polycarbonate | Polycarbonate |
| Membrane | AkzoCuprophan<br>& Hemophan | AkzoCuprophan<br>& Hemophan | AkzoCuprophan<br>& Hemophan | AkzoCuprophan<br>& Hemophan |
| Putting<br>materials | Polyurethane | polyurethane | polyurethane | polyurethane |
| Blood caps | Polycarbonate | Polycarbonate | Polycarbonate | Polycarbonate |
| Vented caps | Polyethylene | Polyethylene | Polyethylene | Polyethylene |

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p:3/3 HAIDYLENA MEDICAL

## In Vitro Performance

In vitro testing was performed on the proposed device to determine the following: Urea, Creatinine, Phosphate, and Vitamin B12 clearance, and ultrafiltration coefficient. The results are listed on the next page with the data from the predicate device. The result indicates that the proposed device is substantially equivalent to Terumo Clirans T175 and Baxter CF25 for in vitro performance.

| | Haidylena Hollow fiber Dialyzer | | | | | | Terumo | Baxter | Cobe | |
|--------------------------------------|---------------------------------|-----------|-----------|-------------|-------------|-------------|-----------------|--------|-------------------|-----|
| Physical | Cuprophan | | | Hemophan | | | Clirans<br>T175 | CF25 | Centry<br>S. 160E | |
| | HL<br>100 | HL<br>120 | HL<br>130 | HL<br>100 H | HL<br>120 H | HL<br>130 H | HL<br>160 H | | | |
| Blood priming<br>volume (ml) | 57 | 68 | 79 | 57 | 68 | 79 | 95 | 120 | 112 | 42 |
| Effective surface<br>(S.Q.M.) | 1.0 | 1.2 | 1.3 | 1.0 | 1.2 | 1.3 | 1.6 | 1.75 | 1.6 | 0.9 |
| Wall thickness(µm) | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 9 | 8 | 8 |
| Clearance (ml/min.) | | | | | | | | | | |
| Urea | 174 | 179 | 184 | 170 | 175 | 179 | 190 | 192 | 191 | |
| Cretonne | 149 | 156 | 162 | 149 | 154 | 160 | 161 | 177 | 170 | 130 |
| Phosphate | 124 | 138 | 141 | 129 | 140 | 149 | 151 | 151 | 159 | |
| Vitamin | 48 | 55 | 58 | 46 | 55 | 60 | 61 | 97 | 62 | 35 |
| Ultrafiltration rate<br>(ml/hr/mmHg) | 4.9 | 6.0 | 6.6 | 4.9 | 6.0 | 6.0 | 8.0 | 8.8 | 6.5 | 4.3 |
| Maximum TMP | 500 | 500 | 500 | 500 | 500 | 500 | 500 | 500 | 500 | |

## Additional safety Information

Sterilization conditions have been validated according to BS EN 550: Sterilization of medical devices, Validation and remote control of Ethylene oxide sterilization, and AAMI guidelines to provide a Sterility Assurance Level of 10 to the negative sixth.

Ethylene oxide residuals will not exceed the maximum residuals limits proposed for part 821 of Tittle 21 in the Federal register of June 23, 1978 (or as finalized or amended).

## Conclusions

Testing performed on the Haidylena Cuprophan and Hemophan Hollow Fiber Dialyzer indicate it is safe, effective, and performs as well as the predicate devices, when used in accordance with instruction for use.

Signature

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of a stylized caduceus, which is a traditional symbol of medicine, with three wavy lines representing the branches of government.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 29 1998

Mr. Saneh Tamim Laboratories and Sterilization Manager, Plant Quality Coordinator, and Registration Specialist Haidylena Medical 26 Makram Ebeid St. Nasr City, Cairo, Egypt

Re: K982337 Cuprophan and Hemophan Hollow Fiber Dialyzer Received: October 23, 1998 Regulatory Class: II 21 CFR 876.5820/Procode: 78 FJI

Dear Mr. Tamim:

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 regulations 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 regulation may result 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 vitto diagnostic devices), please 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,

t Daniel G. Schultz, M.D.

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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# PREMARKET NOTIFICATION STATEMENT FOR INDICATIONS FOR USE [ As required by 510(k)]

certify that, in my capacity as a laboratories and sterilization manager, plant quality coordinator and registration specialist of Haidylena Medical company, that the device submitted in this premarket notification are intended for use whenever a patient is in acute or chronic renal failure and hemodialysis is prepared by a physician. 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.

| | Signature |
|-------------------------------------------|------------------------------------------|
| | Sameh Tamim |
| | (Typed Name) |
| | Sameh Abdel Rahman Tamim |
| | (Dated) |
| | 15/06/1998 |
| | (premarket Notification [ 510 (k) ] Numk |
| For Prescription use | |
| See Below | |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, | |
| and Radiological Devices | |
| 510(k) Number | K982337 |
| | 12/29/98 |