GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H

K051520 · Gambro Renal Products · KDI · Dec 9, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K051520
• Device Name: GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H
• Applicant: Gambro Renal Products
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Dec 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Polyflux 6H is intended for chronic and acute applications in hemodialysis, hemodiafiltration and hemofiltration on small patients including pediatric indications, considering blood flow, body weight and extracorporeal blood volume.

Device Story

Polyflux 6H is a capillary dialyzer/filter for pediatric hemodialysis, hemodiafiltration, and hemofiltration. Device consists of hollow fibers made of a polyarylethersulfone (PAES), PVP, and Polyamide blend. During operation, patient blood flows through the inside of hollow fibers while dialysis solution flows countercurrently in the outer compartment. Hydrostatic/transmembrane pressure drives plasma water, uremic toxins, and waste products across the membrane via diffusion and convection. Used in clinical settings by healthcare professionals to treat acute and chronic renal failure. Output is the filtered blood returned to the patient, facilitating waste removal and fluid balance. Benefits include effective solute clearance tailored to small patient body size and extracorporeal volume constraints.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Capillary dialyzer/filter. Membrane material: blend of polyarylethersulfone (PAES), PVP, and Polyamide. Principle: diffusion and convection across a semi-permeable membrane. Single-use. No software or electronic components.

Indications for Use

Indicated for chronic and acute hemodialysis, hemodiafiltration, and hemofiltration in small patients, including pediatric populations, based on blood flow, body weight, and extracorporeal blood volume requirements.

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

• Polyflux 140H, 170H, 210H (K030592)
• 100 HG (K904566)

Reference Devices

• Polyflux L dialyzers (K010985)

Submission Summary (Full Text)

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K051520

#### DEC 9 2005

# GAMBRO Renal Products

#### 510(k) Summary

| Submitter: | Gambro Renal Products<br>10810 West Collins Avenue<br>Lakewood, Colorado 80215 | | |
|---------------------------|-------------------------------------------------------------------------------------------|-----------------------|---------|
| Contact: | Thomas B. Dowell, Manager, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone] | | |
| Date prepared: | June 6, 2005 | | |
| Device name: | Gambro Polyflux 6H Capillary Dialyzer | | |
| Common name: | Hemodialyzer / Filter | | |
| Classification name: | High Permeability Hemodialysis System Accessory (876.5860) | | |
| Predicate Devices: | | | |
| Polyflux 140H, 170H, 210H | | Hemodialyzer / Filter | K030592 |
| 100 HG | | Hemodialyzer / Filter | K904566 |

#### Device Description:

The Gambro Polyllex 6H Capillary Dialyzers/Filters, labeled for single use, have the same design, materials, intended use and function as other hemodialyzers / filters currently marketed in the United States.

These device is intended for use in hemodialysis, hemolitiration for the treatment of acute and chronic renal failure.

Considering blood flow, body weight and extracorporeal blood volume, the Polyflux 6H is intended for pediatric indication. The membrane used in this device is a blend of polyarylethersulfone (PAES), PVP, and Pobvanide, which is identical to the membranc used in the Gambro Polyflux H single use hemodialyzers cleared under 510(k) 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 the countercurrent flowing dialysis solution during hemodialysis. The dialysate exits the devices via a dialysate outlet port.

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Image /page/1/Picture/1 description: The image shows the logo for GAMBRO Renal Products. The logo consists of a stylized "G" symbol followed by the text "GAMBRO Renal Products". The text is in a simple, sans-serif font and is horizontally aligned.

### Indications For Use:

The Polyflux 6H is intended for chronic and acute applications in hemodialysis, hemodiafiltration and hemofiltration on small patients including pediatric indications, considering blood flow, body weight and extracorporeal blood volume.

## 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:

N/A

## Summary of Clinical Tests:

N/A

#### 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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Image /page/2/Picture/2 description: The image shows a circular logo with the words "DEPARTMENT of HUMAN & HEALTH SERVICES" written around the edge. In the center of the logo is a stylized image of an eagle with its wings spread. The eagle is facing to the left and has three lines representing its body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 9 2005

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

Re: K051520

> Trade/Device Name: Polyfulx 6H Capillary Dialyzer / Filter - Pediatric Labeling Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: November 29, 2005 Received: December 2, 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 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 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 FDA has made 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 Act's requirements, including, 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) regulation (21 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 510(k) I ms letter with and in Jours of substantial equivalence of your device to a legally prematice nothreadon: " Nessification 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 dearle spoorne at nee at one of the following numbers, based on the regulation 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" (21 CFR Also, produce the regulation enneral information on your responsibilities under the Act from the 601.777. I 60 may overs, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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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7GAMBRO Renal Products

#### Indications for Use Statement

| 510(k) number:<br>(if known) | K051520 |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Polyflux 6H Capillary Dialyzer / Filter – Pediatric Labeling |
| Indications for Use: | The Polyflux 6H is intended for chronic and acute applications in hemodialysis, hemodiafiltration and hemofiltration on small patients including pediatric indications, considering blood flow, body weight and extracorporeal blood volume |

Prescription Use X (Per 21 CFR 801 Subpart D) AND / OR

Over-The-Counter Use (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)

Nancy C hogdon

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