WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS

K042797 · Gambro Renal Products · FIP · Mar 9, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K042797
• Device Name: WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
• Applicant: Gambro Renal Products
• Product Code: FIP · Gastroenterology, Urology
• Decision Date: Mar 9, 2005
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Intended Use

The Gambro WRO 300 Water Purification System is intended to be used as a dialysis accessory device in conjunction with one dialysis machine to produce water used to prepare and dilute dialysis concentrate to form dialysis fluid by using the reverse osmosis concept.

Device Story

The Gambro WRO 300 is a water purification system utilizing reverse osmosis technology to produce water for hemodialysis. It functions as an accessory to a single dialysis machine, preparing and diluting dialysis concentrate to form dialysis fluid. The device is operated in clinical settings to support hemodialysis procedures. It ensures the water meets the necessary quality standards for dialysis fluid preparation. The system is designed to integrate with the flow and pressure demands of a single dialysis machine.

Clinical Evidence

Bench testing only. Testing verified that the reverse osmosis method used in the WRO 300 produces purified water suitable for use in dialysis.

Technological Characteristics

Reverse osmosis water purification system; designed for single dialysis machine integration; operates based on reverse osmosis principle to produce purified water for dialysis fluid preparation.

Indications for Use

Indicated for use as a dialysis accessory to produce purified water for the preparation and dilution of dialysis concentrate in hemodialysis procedures. Intended for use with a single dialysis machine, provided input flow and pressure requirements are met.

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

• Gambro WRO 10-01 (K811678)

Submission Summary (Full Text)

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# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS CAMBRO WRO 300(K) SUMMAN OF SHE ATION SYSTEM FOR HEMODIALYSIS 510(k) Number: __ K 042797_

MAR 9 - 2005

# A. Submitter's Information

| Name: | Gambro Renal Products |
|----------|------------------------------------------------------------------------------------------------|
| Address: | 10810 West Collins Avenue<br>Lakewood, Colorado 80215<br>USA |
| Phone: | 303-542-5075 |
| Fax: | 303-542-5138 |
| Contact: | Rod J. Rylands<br>Quality and Regulatory Director<br>Gambro Renal Products International Sales |

### B. Device Information

| Classification name: | Water Purification System For<br>Hemodialysis [21 CFR 876.5665] |
|------------------------------------|-----------------------------------------------------------------|
| Common or usual name: | Water Purification System For<br>Hemodialysis |
| Proprietary Name(s): | WRO 300 Water Purification System<br>For Hemodialysis |
| Product Code Classification Panel: | FIP/Gastroenterology-Urology |
| Device Classification: | Class II per 21 CFR 876.5665 |
| C. Predicate Device Information | |

| Predicate Device Name: | Gambro WRO 10-01 |
|------------------------|------------------|
| FDA Clearance: | K811678 |

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### 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS GAMBRO WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS 510(k) Number: _ Ko42797

#### D. Substantial Equivalence

The proposed Gambro WRO 300 Water Purification System is substantially Fire proposed Gambro WRO 10-01 Water Purification System. The current Cambro WRO 10-01 Water Purification System has been cleared for marketing / sale in the United States under 510K Notification – K811678.

#### E. Device Description

The Gambro WRO 300 water purification unit is designed to be used as a dialysis The Gallerice to produce water used to prepare and dilute dialysis concentrate aooosory arried to proving the reverse osmosis concept. It is intended for use in conjunction with one dialysis machine, provided that the input flow and pressure demands correspond to the output of the WRO 300 unit.

#### F. Indications For Use

The Gambro WRO 300 Water Purification System is intended to be used as a dialysis accessory device in conjunction with one dialysis machine to produce water used to prepare and dilute dialysis concentrate to form dialysis fluid by using the reverse osmosis concept.

#### G. Summary of Non-Clinical Tests Submitted

The Gambro WRO 300 water purification unit is designed to be used as a dialysis accessory device to produce water used to prepare and dilute dialysis concentrate to form dialysis fluid by using the reverse osmosis concept. It is intended for use in conjunction with one dialysis machine, provided that the input flow and pressure demands correspond to the output of the WRO 300 unit. Testing verified that the reverse osmosis method used in the WRO 300 produces purified water for use in Dialysis.

### H. Summary of Clinical Tests Submitted - Not Applicable

signature

7 October 2004

Rod J. Rylands Quality and Regulatory Director Gambro Renal Products International Sales

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MAR 9 - 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: K042797

Trade/Device Name: Gambro WRO 300 Water Purification System for Hemodialysis Regulation Number: 21 CFR §876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: 78 FIP Dated: March 2, 2005 Received: March 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 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) 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.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 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/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Higdon

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 Statement

| 510(k) Number (if known) | K042797 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Gambro WRO 300 Water Purification System |
| Indications for Use | The Gambro WRO 300 Water Purification System is intended to be used as a dialysis accessory device in conjunction with one dialysis machine to produce water used to prepare and dilute dialysis concentrate to form dialysis fluid by using the reverse osmosis concept. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801. 109) | <div> <span>✓</span> </div> | OR | Over-The-Counter Use |
|----------------------------------------|-----------------------------|----|----------------------|
|----------------------------------------|-----------------------------|----|----------------------|

| (Division Sign-Off) | Vance C. Bragdon |
|---------------------------------------------------------------|------------------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K042797 |