WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS

K083712 · Dipure, LLC · FIP · Jul 10, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K083712
• Device Name: WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
• Applicant: Dipure, LLC
• Product Code: FIP · Gastroenterology, Urology
• Decision Date: Jul 10, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Intended Use

The DiPure Deionization Tanks are exchangeable mix bed tanks intended to remove ions from the water to a sufficient level to allow safe treatment of Hemodialysis patients. These deionization tanks are not to be used alone, but are intended to be a part of a larger water treatment system employing adequate pre-treatment and post-treatment. Upon exhaustion, these tanks will be replaced with other tanks containing newly regenerated resin, or new resin altogether. The DiPure Carbon Exchange Tanks are activated carbon tanks intended to remove chlorine and chloramines from the water to allow safe treatment of Hemodialysis patients. These carbon tanks are not to be used alone, but are intended to be a part of a larger water treatment system employing adequate pre-treatment and post-treatment. Upon exhaustion, these tanks are replaced with other tanks containing new activated carbon.

Device Story

Device consists of exchangeable tanks for hemodialysis water purification; includes mixed bed resin deionization tanks and activated carbon tanks. Input is municipal or source water; output is purified water meeting AAMI standards. Tanks feature machined PVC schedule 80 heads, stand pipes, fill ports, and distributor baskets. Used in clinical dialysis settings as part of larger water treatment systems. Healthcare providers monitor chlorine/chloramine levels before patient shifts. Upon exhaustion, tanks are replaced with regenerated or new media. Benefits include removal of dissolved solids, chlorine, and chloramines to ensure safe water for hemodialysis treatment.

Clinical Evidence

No clinical data. Bench testing only. Device relies on established water purification technology (ion exchange and activated carbon filtration) consistent with AAMI standards for hemodialysis water.

Technological Characteristics

Tanks filled with mixed bed resin or activated carbon (iodine number ≥900). Components include machined PVC schedule 80 heads, stand pipes, fill ports, and distributor baskets. Materials are NSF/FDA approved. System configuration utilizes dual carbon filters in series. Mechanical filtration/purification principle. No software or electronic components.

Indications for Use

Indicated for hemodialysis patients requiring purified water. Deionization tanks remove ions; carbon tanks remove chlorine and chloramines. Not for standalone use; must be integrated into larger water treatment systems with pre- and post-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

• AmeriWater Dialysis Deionizer and Carbon Exchange Tanks (K991519)

Submission Summary (Full Text)

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# KO83712
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JUL 1,0 2009

## Pre-Market Notification 510(K) Summary

## Water Purification Components for Hemodialysis

| Date | December 4, 2008 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Prepared/Submitted By | DiPure, LLC<br>DiPure Water Technologies<br>1919 Edwards Street<br>Houston, Texas 77007 |
| Contact | Tim Marco<br>President/General Manager<br>713.686.4049 |
| Device Name | Carbon and DI Exchange Tanks for Hemodialysis |
| Device Classification | Class II Medical Device, 21 CFR 876.5665<br>Product Code 78 FIP |
| Predicate Device | AmeriWater Dialysis Deionizer and Carbon Exchange Tanks<br>Registration Number K991519 |
| Device Description | DiPure's DI Exchange Tanks for Dialysis are approved tanks<br>filled with mixed bed resin. Connectors are used in<br>conjunction with a machined PVC schedule 80 head, stand<br>pipe, fill port, and distributor basket. Our tanks are designed<br>to supply AAMI standard water for dialysis through ion<br>exchange. The DI exchange tanks are based on the<br>Ameriwater Dialysis Deionizer Exchange Tanks.<br><br>DiPure's Carbon Exchange Tanks for Dialysis are approved<br>tanks filled with activated carbon. Connectors are used in<br>conjunction with a machined PVC schedule 80 head, stand<br>pipe, fill port, and distributor basket. These tanks are<br>designed to remove chlorine and chloramines. These tanks<br>are based on the Ameriwater Carbon Exchange Tanks. |

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# K083712 PAGE 2 OF 2

### Indications for Use

Comparison to Predicate AmeriWater Device

The DiPure Deionization Tanks are exchangeable/rechargeable mix bed tanks intended to remove ions from the water to a sufficient level to allow safe treatment of Hemodialysis patients. These deionization tanks are not to be used alone, but are intended to be a part of a larger water treatment system employing adequate pretreatment and post-treatment. Upon exhaustion, these tanks will be replaced with other tanks containing newly regenerated resin, or new resin altogether.

The DiPure Carbon Exchange Tanks are activated carbon tanks intended to remove chlorine and chloramines from the water to allow safe treatment of Hemodialysis patients. These carbon tanks are not to be used alone, but are intended to be a part of a larger water treatment system employing adequate pre-treatment and post-treatment. Upon exhaustion, these tanks are replaced with other tanks containing new activated carbon.

Deionization tanks from both DiPure and AmeriWater are utilized to remove dissolved solids from the water. Both utilize mixed bed resins, consisting of cation and anion resins to remove the charged particles in the water. Both utilize parts and materials that are NSF and/or FDA approved.

Activated carbon filtration is utilized by both DiPure and AmeriWater to filter out chlorine and chloramines from the water. DiPure uses carbon filter made from materials that are NSF and/or FDA approved. Both companies use two (2) carbon filters in a series configuration. Both DiPure and AmeriWater recommend the chlorine and chloramines are checked before each patient shift. Both companies utilize an activated carbon with an iodine number of 900 or greater. DiPure always recommends using dual carbon filters in series in every dialysis water system installed, including single patient systems.

In Summary, the DiPure water purification components and the AmeriWater predicate device components are substantially equivalent to one another. The core water purification components and technology are exactly the same.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, rendered in a stylized, minimalist design.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 1 0 2009

Mr. Tim Marco President/General Manager DiPure, LLC DiPure Water Technologies 1919 Edwards Street HOUSTON TX 77007

Re: K083712

Trade/Device Name: Carbon and Deionized Exchange Tanks for Hemodialysis Regulation Number: 21 CFR §876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: FIP Dated: June 22, 2009 Received: June 25, 2009

Dear Mr. Marco:

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 vour device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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. unu

Janine 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: K083712

### Device Name: Carbon and Deionized Exchange Tanks for Hemodialysis

#### Indications for Use:

The DiPure Deionization Tanks are exchangeable mix bed tanks intended to remove ions from the water to a sufficient level to allow safe treatment of Hemodialysis patients. These deionization tanks are not to be used alone, but are intended to be a part of a larger water treatment system employing adequate pre-treatment and post-treatment. Upon exhaustion, these tanks will be replaced with other tanks containing newly regenerated resin, or new resin altogether.

DiPure Deionization Tank Model Numbers:

DMB025 - . 25 cu ft Deionization Tank DMB05 - . 5 cu ft Deionization Tank DMB12 - 1.2 cu ft Deionization Tank DMB20 - 2.0 cu ft Deionization Tank DMB36 - 3.6 cu ft Deionization Tank

The DiPure Carbon Exchange Tanks are activated carbon tanks intended to remove chlorine and chloramines from the water to allow safe treatment of Hemodialysis patients. These carbon tanks are not to be used alone, but are intended to be a part of a larger water treatment system employing adequate pre-treatment and post-treatment. Upon exhaustion, these tanks are replaced with other tanks containing new activated carbon.

DiPure Carbon Tank Model Numbers:

DAC025 - .25 cu ft Carbon Tank DAC05 - .5 cu ft Carbon Tank DAC12 - 1.2 cu ft Carbon Tank DAC20 - 2.0 cu ft Carbon Tank DAC 36 - 3.6 cu ft Carbon Tank

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|---------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K083712 |

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