GAMBRO POSICLEAR

K061782 · Gambro Services, Inc. · FIP · Jan 4, 2007 · Gastroenterology, Urology

Device Facts

• Record ID: K061782
• Device Name: GAMBRO POSICLEAR
• Applicant: Gambro Services, Inc.
• Product Code: FIP · Gastroenterology, Urology
• Decision Date: Jan 4, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Intended Use

The Gambro Posiclear filter is intended to remove bacteria, endotoxin, and particulate matter from water used for hemodialysis. It is intended for use in dialysis water treatment systems as a final stage of filtration after RO or DI treatment to help control bacteria and endotoxin levels in purified water distribution systems. This filter is not intended as a primary means of water purification for hemodialysis

Device Story

Gambro Posiclear filter is an encapsulated, micro-porous pleated nylon membrane housed in polypropylene; designed for use in dialysis water treatment systems. Device functions as a final stage filter post-RO or DI treatment to control bacteria and endotoxin levels in purified water distribution systems. It is not a primary water purification method. Device operates via physical filtration of water inputs; output is purified water with reduced bacterial and endotoxin load. Used in clinical dialysis settings; managed by healthcare personnel. Benefits patients by reducing exposure to contaminants in hemodialysis water.

Clinical Evidence

Bench testing only. In vitro performance testing was conducted to establish and compare performance characteristics against the predicate device. No clinical data was required or provided.

Technological Characteristics

Encapsulated, micro-porous pleated nylon membrane in a polypropylene housing. Mechanical filtration principle. Standalone component for integration into dialysis water treatment systems.

Indications for Use

Indicated for removal of bacteria, endotoxin, and particulate matter from water used in hemodialysis treatment systems as a final stage of filtration following RO or DI treatment.

Regulatory Classification

Identification

A water purification system for hemodialysis is a device that is intended for use with a hemodialysis system and that is intended to remove organic and inorganic substances and microbial contaminants from water used to dilute dialysate concentrate to form dialysate. This generic type of device may include a water softener, sediment filter, carbon filter, and water distillation system.

Special Controls

*Classification.* Class II (special controls). The device, when it is a water purification subsystem disinfectant, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Predicate Devices

• MINNTECH CORP. FIBERFLOW HOLLOW FIBER CAPSULE WATER FILTER

Submission Summary (Full Text)

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#### 510K(k) SUMMARY

| SUBMITTER: | Gambro Renal Products 10810 West Collins Avenue Lakewood, CO 80215 [phone] |
|-----------------------|-----------------------------------------------------------------------------------|
| DATE PREPARED: | June 20th 2006 |
| DEVICE NAME: | Gambro Posiclear Filter |
| CLASSIFICATION NAMES: | Water Purification Subsystem |
| PREDICATE DEVICE: | MINNTECH CORP. FIBERFLOW HOLLOW FIBER CAPSULE WATER FILTER |

JAN - 4 2007#### Device Description:

The Gambro Posiclear filter consists of a encapsulated, micro porous pleated nylon membrane in a polypropylene housing designed to filter endotoxins, bacteria and particulates from water intended to be used for hemodialysis

#### Predicate Device:

### MINNTECH CORP. FIBERFLOW HOLLOW FIBER CAPSULE WATER FILTER

#### Intended Use:

The Gambro Posiclear filter is intended to remove bacteria, endotoxin, and particulate matter from water used for hemodialysis. It is intended for use in dialysis water treatment systems as a final stage of filtration after RO or DI treatment to help control bacteria and endotoxin levels in purified water distribution systems. This filter is not intended as a primary means of water purification for hemodialysis

#### Technological Characteristics:

Comparing the proposed devices to the predicate devices, they are substantially equivalent to the predicate devices. Both the proposed and predicate devices use the a micro porous membrane to remove endotoxin, bacteria and particulates from water intended for hemodialysis.

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## Summary of Non-Clinical Tests:

In vitro performance testing was performed to establish and compare performance characteristics to the predicate devices.

### Conclusions:

Testing performed on the Gambro Posiclear filters indicates that they are safe, effective, and perform as well as the predicate devices, when used in accordance with the instructions for use. In vitro performance data / specifications are included in the labeling.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized emblem resembling an eagle or bird with three wing-like shapes.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Jeffrey R. Shideman, Ph.D. Director, Therapy Group Americas Gambro Corporate Research 7307 Glouchester Drive EDINA MN 55435

JAN 0 4 2007

Re: K061782

> Trade/Device Name: Gambro Posiclear Regulation Number: 21 CFR §876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: FIP Dated: June 10, 2006 Received: October 19, 2006 .

Dear Dr. Shideman:

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.

Image /page/2/Picture/10 description: The image shows a circular logo with the text "FDA Centennial 1906-2006". The letters "FDA" are prominently displayed in the center of the logo. Three stars are located below the word "Centennial". The logo is surrounded by a dotted circle.

noting Public H.

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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,

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone]

or at its Internet address http://www.fda.gov/edrh/industry/support/index.html.

Sincerely yours,

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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# Indications for Use

510(k) Number (if known): KDløl782

Device Name: Gambro Posiclear

Indications for Use:

The Gambro Posiclear filter is intended to remove bacteria, endotoxin, and particulate matter from water used for hemodialysis. It is intended for use in dialysis water treather systems as a final stage of filtration after RO or DI treatment to help control bacteria and endotoxin levels in purified water distribution systems. This filter is not intended as a primary means of water purification for hemodialysis

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ehrich A. Strausser

(Posted November 13, 2003)

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 2061782 510(k) Number .

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