POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR

K043342 · Gambro Renal Products · FJI · May 27, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K043342
• Device Name: POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR
• Applicant: Gambro Renal Products
• Product Code: FJI · Gastroenterology, Urology
• Decision Date: May 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The capillary dialyzer is intended for use in hemodialysis and associated modalities for the treatment of chronic and acute renal failure.

Device Story

Capillary dialyzer/filter; utilizes hollow fiber membrane technology. Blood enters inlet port, flows through hollow fibers; dialysate flows countercurrently in outer compartment. Hydrostatic/transmembrane pressure drives plasma water, uremic toxins, and waste products across membrane via diffusion and convection. Used in clinical hemodialysis settings; operated by trained healthcare professionals. Output is purified blood returned to patient; dialysate/filtrate waste removed. Benefits include removal of toxins and excess fluid in renal failure patients.

Clinical Evidence

Clinical studies demonstrated that the proposed Polyflux Dialyzers/Filters meet the same acceptance criteria as the predicate devices. In vitro testing was also conducted to compare performance.

Technological Characteristics

Capillary dialyzer/filter. Membrane material: blend of polyarylethersulfone (PAES), PVP, and Polyamide. Principle: diffusion and convection across semi-permeable hollow fiber membrane. Configuration: hollow fiber bundle with blood and dialysate compartments. Connectivity: standalone component of hemodialysis system.

Indications for Use

Indicated for patients with chronic or acute renal failure requiring hemodialysis or associated modalities. May also be used for acute fluid overload to remove plasma water.

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

• Polyflux 14L, 17L, 21L (K040255)
• Polyflux 140H, 170H, 210H (K030592)
• Polyflux 6LR, 8LR, 10LR (K023615)
• Polyflux 6L, 8L, 10 L (K010985)
• Polyflux 24S, 24R (K010667)
• Polyflux 17R, 21R (K994390)
• Polyflux 11S, 14S, 17S, 21S (K982414)

Submission Summary (Full Text)

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K34.3342 page 1 of 2

Traditional 510(k) Modification Gambro Polyflux Family Labeled for Single and Multiple Use December 3, 2004

## 510(k) Summary

| Submitter: | Gambro Renal Products<br>10810 West Collins Avenue<br>Lakewood, Colorado 80215 | MAY 27 2005 |
|----------------------|------------------------------------------------------------------------------------------------|-------------|
| Contact: | Thomas Dowell, Project Manager, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone] | |
| Date prepared: | November 19, 2004, revised 4/26/2005 | |
| Device name: | Gambro Polyflux Capillary Dialyzer labeled for Single and Multiple Use | |
| Common name: | Hemodialyzer / Filter | |
| Classification name: | High Permeability Hemodialysis System Accessory (876.5860) | |

#### Predicate Devices:

| Polyflux 14L, 17L, 21L | Hemodialyzer / Filter | K040255 Cleared 5/24/2004 |
|-----------------------------|-----------------------|----------------------------|
| Polyflux 140H, 170H, 210H | Hemodialyzer / Filter | K030592 Cleared 5/23/2003 |
| Polyflux 6LR, 8LR, 10LR | Hemodialyzer / Filter | K023615 Cleared 5/6/2003 |
| Polyflux 6L, 8L, 10 L | Hemodialyzer / Filter | K010985 Cleared 10/10/2001 |
| Polyflux 24S, 24R | Hemodialyzer / Filter | K010667 Cleared 6/4/2001 |
| Polyflux 17R, 21R | Hemodialyzer / Filter | K994390 Cleared 10/26/2000 |
| Polyflux 11S, 14S, 17S, 21S | Hemodialyzer / Filter | K982414 Cleared 3/26/1999 |

# Device Description:

The Gambro Polyflux family Capillary Dialyzers/Filters, labeled for single and multiple use, have the same design, materials, intended use and function as other hemodialyzers / filters currently marketed in the United States.

These devices are intended for use in hemodialysis for the treatment of acute and chronic renal failure. They may also be used in cases of acute fluid overload for the removal of plasma water.

The membrane used in this device is a blend of polyarylethersulfone (PAES), PVP, and Polyamide, which is identical to the membrane used in the Gambro Polyflux H single use hemodialyzers cleared under 510K Notification (K030592) and the Polyflux L dialyzers cleared under 510(k) Notification (K010985).

Blood enters a blood inlet port where it is distributed to the hollow fibers. The patient's blood traverses the inside of the hollow fibers and exits the device via a blood exit port. By means of a hydrostatic pressure or transmembrane pressure which is created by a combination of positive and negative pressures across the membrane, plasma water along with certain lower and middle molecular weight solutes pass through the membrane and into the dialysate or filtrate compartment of the device. Uremic toxins and waste products are removed from the patient's blood in this device by means of both diffusion and convection through the membrane and into

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the countercurrent flowing dialysis solution during hemodialysis. The dialysate exits the devices via a dialysate outlet port.

## Indications For Use:

The capillary dialyzer is intended for use in hemodialysis and associated modalities for the treatment of chronic and acute renal failure.

## Technological Characteristics:

The proposed device configurations have the same technological characteristics and are similar in design, function, composition, and operation, to the currently marketed configurations.

# Summary of Non-Clinical Tests:

In vitro testing was conducted to compare the performance of the proposed device configurations to the predicate configurations.

#### Summary of Clinical Tests:

Clinical studies demonstrated that the proposed Polyflux Dialyzers / Filters meet the same acceptance criteria as the predicate devices.

#### Conclusion:

Testing performed on the Gambro Polyflux Dialyzers / Filters indicates that they are safe, effective and perform as well as the predicate devices, when used in accordance with the instructions for use.

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MAY 2 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Thomas B. Dowell Regulatory Project Manager Gambro® Renal Products 10810 W. Collins Avenue LAKEWOOD CO 80215

Re: K043342

Trade/Device Name: Gambro Polyflux Hemodialyzer / Filters Polyflux H, L, and S Dialyzers (Single Use) Polyflux R and LR Dialyzers (Multiple Use) Regulation Number: 21 CFR § 876.5820 21 CFR § 876.5860 Regulation Name: Hemodialysis system and accessories High permeability hemodialysis system Regulatory Class: II Product Code: FJI, KDI, and MSF Dated: May 3, 2005 Received: May 4, 2005

Dear Mr. Dowell:

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 do inc. subject to the general controls provisions of the Act. The general controls provisions of the Act action, saojoer le no go and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket A poroval), it may be subject to such additional controls. Existing major regulations affecting your I to read be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I rease of 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 r carderes and registration 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) (2) 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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This letter will allow you to begin marketing your device as described in your Section 5 f 0(k) This letter will anow you to ocgin manceing of substantial equivalence of your device to a legally premarket notification. The FDA miding of Sacsantal equi
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 If you desire specific advice for your device on our laceming organization number at the top of this letter:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) 240-276-0115 |
|-----------------|-----------------------------------------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) - 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) 240-276-0120 |
| Other | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification the Act free the Also, please note the regulation chilited, "Wissemians of your responsibilities under the Act from the 190 807.97). You may obtain other general miornation on your I ssistance at its toll-free number (800).
Division of Small Manufacturers, International and Consumer (800). Drvision of Small Manufacturers, International and Concernet address http://www.fda.gov/cdrh/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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Traditional 510(k) Modification Gambro Polyflux Family Labeled for Single and Multiple Use December 3, 2004

# Indications for Use Statement

| 510(k) number: (if known) | K043342 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Polyflux Family Hemodialyzer / Filters |
| | Polyflux H, L, and S Dialyzers (Single Use) |
| | Polyflux R and LR Dialyzers (Multiple Use) |
| Indications for Use: | The capillary dialyzer is intended for use in hemodialysis and associated modalities for the treatment of chronic and acute renal failure. |
| Prescription Use | X |
| | AND/OR |
| | Over-The-Counter Use |

Prescription Use_ _X (Per 21 CFR 801 Subpart D) APD / UN

Counter (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Syverson

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number K043342

Gambro Renal Products Confidential

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