DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS

K082400 · Culligan Soft Water Service Co. · FIP · Feb 3, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K082400
• Device Name: DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS
• Applicant: Culligan Soft Water Service Co.
• Product Code: FIP · Gastroenterology, Urology
• Decision Date: Feb 3, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Intended Use

The Culligan Soft Water Service Company Deionizer and Carbon Exchange tanks are primary or temporary devices to provide water for hemodialysis applications per the requirements of ANSI/AAMI RD62. These tanks remove chlorine, chloramines, total organic carbons and total dissolved solids from water used to dilute dialysis concentrate to form dialysate, in reprocessing of hemodialyzers, as supply water to the dialysis machines and equipment rinse and disinfection. Upon exhaustion, these tanks will be replaced with other tanks containing newly regenerated resin, or with new resin altogether. These tanks are components of a larger water treatment system employing adequate pre-treatment and post-treatment sections. Culligan's tanks are not to be used alone.

Device Story

Device consists of carbon filtration and deionizer (DI) exchange tanks; removes chlorine, chloramines, total organic carbons, and total dissolved solids from water; utilizes ion exchange process to achieve AAMI quality water; used in clinical hemodialysis settings as part of a larger water treatment system; tanks are replaced upon exhaustion with regenerated or new resin; provides purified water for dialysate dilution, hemodialyzer reprocessing, and equipment disinfection; benefits patient by ensuring water meets safety standards for hemodialysis.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Carbon filtration and ion exchange resin tanks; modular form factor; components of a larger water treatment system; requires pre-treatment and post-treatment sections; compliant with ANSI/AAMI RD62.

Indications for Use

Indicated for hemodialysis patients requiring water purification for dialysate preparation, hemodialyzer reprocessing, and equipment disinfection. Used as a component in a larger water treatment system; not for standalone use.

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

• Ameriwater Dialysis Deionizer Exchange Service (K991519)

Submission Summary (Full Text)

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2/3/09

## Subject: 510 (K) SUMMARY

| 510 (K) Number: | K082400 |
|----------------------|--------------------------------------------------------------------------------------------------|
| Contact Name: | Mike Jablonski, General Manager<br>Joe Baumtrog, Project Coordinator |
| Proprietary Name: | Culligan Soft Water Service Company, Deionizer, and Carbon Exchange<br>Service for Hemodialysis |
| Common Name: | DI and Carbon Exchange Tanks for Hemodialysis |
| Classification Name: | Carbon and Deionized Dialysis Exchange Tanks for Hemodialysis |
| Classification: | Class II Medical Device under 21 CFR 876.5665<br>Panel: Gastroenterology<br>Product Code:<br>FIR |

Intended Use: The Culligan Soft Water Service Company Deionizer and Carbon Exchange tanks are primary or temporary devices to provide water for hemodialysis applications per the requirements of ANSI/AAMI RD62. These tanks remove chlorine, chloramines, total organic carbons and total dissolved solids from water used to dilute dialysis concentrate to form dialysate, in reprocessing of hemodialyzers, as supply water to the dialysis machines and equipment rinse and disinfection. Upon exhaustion, these tanks will be replaced with other tanks containing newly regenerated resin, or with new resin altogether. These tanks are components of a larger water treatment system employing adequate pre-treatment and post-treatment sections. Culligan's tanks are not to be used alone.

Device Description: The Culligan Soft Water Service Company, Deionizer and Carbon Exchange Service for Hemodialysis includes carbon filtration for the removal of chlorine and chloramines and deionizer (DI) exchange tanks for the removal of contaminants from the water through an ion exchange process to provide AAMI quality water for hemodialysis applications.

Statement of Substantial Equivalence: The Culligan Soft Water Service Company, Deionizer and Carbon Exchange Service for Hemodialysis is substantially equivalent in intended use, function, and technology to the Ameriwater Dialysis Deionizer Exchange Service (K991519).

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes representing the three branches of government. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB -3 2009

Mr. Mike Jablonski General Manager Culligan Soft Water Service Company 6030 Culligan Way MINNETONKA MN 55345-5970 -

Re: K082400

Trade/Device Name: Carbon and Deionized Dialysis Exchange Tanks for Hemodialysis

Regulation Number: 21 CFR §876.5665

Regulation Name: Water purification system for hemodialysis

Regulatory Class: II

Product Code: FIP

Dated: January 28, 2009

Received: January 30, 2009

Dear Mr. Jablonski:

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 (PMA), 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.

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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 os 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) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html.

Sincerely yours.

Janine M. Morris

anine M. Morris Acting 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: | K082400 |
|----------------|---------------------------------------------------------------|
| Device Name: | Carbon and Deionized Dialysis Exchange Tanks for Hemodialysis |

Culligan Tank Model Numbers:

| | Carbon Tanks | Mixed-Bed Tanks | Duo-Bed Tanks |
|--|--------------|-----------------|---------------|
| | DRM50 | UDM50 | DC9 |
| | DRM9 | UDM9 | DA9 |
| | DRM4 | UDM4 | DC4 |

Indications For Use: The Culligan Soft Water Service Company Deionizer and Carbon Exchange tanks are primary or icmporary devices to provide water for hemodialysis applications per the requirements of ANSI/AAMI RD62. These tanks remove chloramines, total organic carbons and total dissolved solids from water used to dilute dialysis concentrate to form dialysate, in reprocessing of hemodialyzers, as supply water to the dialysis machines and equipment rinse and disinfection. Upon exhaustion, these tanks will be replaced with other tanks containing newly regenerated resin, or with new resin altogether. These tanks are components of a larger water treatment system employing adequate pretreatment and post-treatment sections. Culligan's tanks are not to be used alone.

X Prescription Use (Pait 21 CFR 801 Subpart D)

AND/OR

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

DA4

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Helen Lew

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

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