PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION)

K994279 · Pure Water Solutions, Inc. · FIP · Dec 22, 2000 · Gastroenterology, Urology

Device Facts

• Record ID: K994279
• Device Name: PURE WATER-CDS (CENTRAL DIALYSIS SOLUTION)
• Applicant: Pure Water Solutions, Inc.
• Product Code: FIP · Gastroenterology, Urology
• Decision Date: Dec 22, 2000
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Intended Use

This device is intended to remove organic and inorganic substances and microbial contaminants from water that is used to dilute dialysis concentrate to form dialysate, and to produce purified water for dialyzer reprocessing and equipment rinse and disinfection.

Device Story

PURE WATER-CDS is a water purification system for hemodialysis clinics. It processes influent water through multi-media filtration, water softening, and granular activated carbon to remove suspended solids, hardness, chlorine, and chloramines. The purifier phase utilizes reverse osmosis (RO) and/or portable-exchange deionization (DI). Post-treatment circulation includes storage tanks, stainless steel repressurization pumps, ultraviolet sterilization, and absolute final filters (0.05-0.2 micron). Auxiliary components include booster pumps, blending valves, and remote alarms. The system is operated and maintained by clinic technicians. Output is purified water meeting AAMI standards for hemodialysis. The system ensures water quality via temperature-compensated conductivity monitoring. Clean-in-place functionality uses paracetic acid for RO membranes and ozone for the circulation phase. The device benefits patients by providing high-quality, contaminant-free water for dialysis procedures.

Clinical Evidence

bench testing only

Technological Characteristics

Materials: stainless steel, polypropylene, FDA 21 CFR 173.25 compliant resins. Components: multi-media filters, water softeners, granular activated carbon, RO units, DI exchange, UV sterilization, absolute filters (0.05-0.2 micron). Monitoring: temperature-compensated conductivity instrument. Disinfection: paracetic acid (RO), ozone (circulation). System is modular, assembled from existing cleared technologies.

Indications for Use

Indicated for use in hemodialysis clinics to provide purified water for diluting dialysis concentrate, dialyzer reprocessing, and equipment rinsing/disinfection by removing organic, inorganic, and microbial contaminants.

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

• Mar Cor Services, Inc. (K945559)

Submission Summary (Full Text)

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DEC 22 2000

## 510 (k) Summary

| Submitter: | PURE WATER Solutions, Inc.<br>14550 East Easter Avenue, Suite 800<br>Englewood, Colorado 80112<br>Phone [phone], Fax [phone]<br>Contact Name: Dean S. Lewis | |
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| Classification Name: | Water Purification System for Hemodialysis | |
| Device Name: | PURE WATER-CDS (Central Dialysis Solution) | |
| Predicate Device: | Mar Cor Services, Inc. #K945559 | |

The PURE WATER Solutions' Water Purification System for Description of System: Hemodialysis is designed to provide water of the required quality to meet AAMI standards for riohodialysto is actigate will remove organic, inorganic and microbial contaminants from the influent water supplied to Hemodialysis clinics. This system comes in various sizes to provide the proper volume of water for each individual clinic. It is easily used and maintained by clinic technicians.

The water treatment phase or pretreatment includes multi-media filtration to reduce suspended solids, water softening to reduce hardness and granular activated carbon filters to remove chlorine and chloramines. If finer filtration is required, cartridges with appropriate housings may be used.

The purifier phase includes reverse osmosis (RO) and or portable-exchange deionization (DI). The primary method will be reverse osmosis using an existing FDA cleared device. DI may be selected for use either independently or in conjunction with RO depending upon the influent water analysis, the available space and the demand required. If DI is selected, then 0.1 micron, absolute, final filters will be installed downstream of the DI and a temperaturecompensated, conductivity instrument will be used to monitor the quality.

The circulation phase or post treatment may consist of an RO storage tank with an appropriate 0.2 micron, absolute, vent filter, a stainless steel repressurization pump, ultraviolet sterilization, and 0.05 micron, absolute, final filter.

Auxiliary devices such as booster pumps, temperature blending valves, pressure gauges, sample ports, fittings, piping, level control switches and remote alarms are used as needed throughout the system.

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A clean-in-place system consisting of an inert plastic or stainless steel pump and a solution tank is used to clean RO membranes. A paracetic acid disinfection product may be used to chemically disinfect the RO while ozone is used to disinfect the circulation phase.

All components used in the system are components with Safety and Effectiveness: existing safety records. Materials of construction consist of stainless steel, polypropylene, existing survey records. Water treatment resins are standard resins used in potable and high poryonifications and conform to FDA standards 21 CFR 173.25 and filters are validated for low media migration and with demonstrated microbial retentiveness. All of these materials 10 i meet and do not contribute contaminants to treated water systems. The PURE WATERare mere and is assembled using existing technologies, an RO unit with existing FDA marketing clearance and personnel with certification to Water Quality Association, Lisle, Illinois, standards of system design, maintenance and treatment.

Conclusion: PURE WATER Solutions, Inc. has designed a water treatment system for Hemodialysis. We believe this system is equivalent to an FDA approved system currently on the market, namely, the predicate device from Mar Cor Service, Inc. 510(k) #K945559. The the mailed, amazerials that are safe and effective and methods of design, construction and installation sanctioned by current standards in industry. We therefore request that PURE WATER Solutions' PURE WATER-CDS be granted substantial equivalence.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES * USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, facing to the right.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 22 2000

Mr. Dean S. Lewis President Pure Water Solutions, Inc. 14550 East Easter Avenue Suite 800 ENGLEWOOD CO 80112 Re: K994279

Pure Water - CDS (Central Dialysis Solution) Dated: October 1, 2000 Received: October 6, 2000 Regulatory Class: II 21 CFR §876.5665/Procode: 78 FIP

Dear Mr. Lewis:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21.CFR Part 820) and that, through periodic QS inspections, the Food and Drug, Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D.

Captain, USPHS Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure (s)

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K994279 510(k) Number

PURE WATER-CDS Device Name

Indications For Use:

This device is intended to remove organic and inorganic substances and microbial contaminants from water that is used to dilute dialysis concentrate to form dialysate, and to produce purified water for dialyzer reprocessing and equipment rinse and disinfection.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Sezman

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

(Optional Format 3-10-98)

Prescription Use (Per 21 CFR 801.109)

000452