VIRGINIA WATER SYSTEMS' WATER PURIFICATION SYSTEM FOR HEMODIALYSIS

K991916 · Virginia Water Systems, Inc. · FIP · Jan 14, 2000 · Gastroenterology, Urology

Device Facts

• Record ID: K991916
• Device Name: VIRGINIA WATER SYSTEMS' WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
• Applicant: Virginia Water Systems, Inc.
• Product Code: FIP · Gastroenterology, Urology
• Decision Date: Jan 14, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Intended Use

Virginia Water Systems' Water Purification for Hemodialysis is intended to remove organic, inorganic, and microbial contaminants from water used to make dialysate and reprocess dialyzers as well as rinsing and disinfection of the dialysis equipment. When used as a medical device, Federal law restricts this device to sale by or on the order of a physician.

Device Story

Complete water treatment system for hemodialysis facilities; produces ultrapure water. Input: municipal/source water. Process: multi-stage filtration including blend valve, inlet booster pump, multimedia filter (10 micron), softener, dual-series carbon tanks (chloramine/organic removal), reverse osmosis unit (95-98% mineral/99% organic removal), water storage tank, repressure pumps, deionizer (backup/polishing), ultraviolet light (bactericidal), submicron filter (0.2 micron), and hollow fiber filter (0.05 micron pyrogen removal). Output: purified water for dialysate and equipment maintenance. Operated by facility staff. Benefits: ensures water quality meets standards for hemodialysis, reducing patient exposure to contaminants.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Materials: FRP, PVC, SS, Polypro. Energy: 110/220V. Components: Blend valve, booster pump, multimedia filter, softener, carbon tanks, RO unit, storage tank, repressure pumps, deionizer, UV light, submicron filter, hollow fiber filter. System is a complete water treatment assembly.

Indications for Use

Indicated for use in hemodialysis facilities to purify water for dialysate preparation, dialyzer reprocessing, and rinsing/disinfection of dialysis equipment. Prescription use only.

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

• Osmonics Osmo 23G Series Reverse Osmosis (K931595B)
• MarCor Complete Water Treatment System for Kidney Dialysis (K945559)
• Gambro Central Water Treatment System CWP100-W (K974899)
• Dayton Water Systems Ultrapure Water Treatment System for Hemodialysis (K981680)

Submission Summary (Full Text)

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# SECTION 8

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

May 25, 1999

Hemodialysis

Submitted by: VIRGINIA WATER SYSTEMS, INC. 7433 Whitepine Road Richmond, VA 23237 [phone]

Contact: William G. Garrahan

Dated :

Classification Name:

Proprietary Name:

Claiming Substantial _Equivalence To:

> Osmonics Osmo 23G Series Reverse Osmosis / K931595B

Water Purification System for

Virginia Water Systems' Water Purification for Hemodialysis

MarCor Complete Water Treatment System for Kidney Dialysis / K945559

Gambro Central Water Treatment System CWP100-W / K974899

Dayton Water Systems Ultrapure Water Treatment System for Hemodialysis K981680

#### Device Description:

Virginia Water Systems' Water Purification for Hemodialysis is complete water treatment system used in the production ਰ of ultrapure water used in hemodialysis facilities. The components consist of the following:

Blend Valve - used to temper the incoming water to 77°F.

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## CHARACTERISTICS

| | Design | Material | Chemical<br>Composition | Energy<br>Source |
|-----------|--------------------|----------------------------------------|-------------------------|------------------|
| Va. Water | Complete<br>System | Pretreatment<br>RO, Post-<br>treatment | FRP, PVC, SS<br>Polypro | 110/220V |
| Osmonics | RO only | Exact RO<br>unit | Same | 110/220V |
| MarCor | Complete<br>System | Same | Same | 110/220V |
| Gambro | Complete<br>System | Same | Same | 110/220V |
| Dayton | Complete<br>System | Same | Same | 110/220V |

#### Statement of Intended Use:

Virginia Water Systems' Water Purification for Hemodialysis is intended to remove organic, inorganic, and microbial contaminants from water used to make dialysate and reprocess dialyzers as well as rinsing and disinfection of the dialysis equipment. When used as a medical device, Federal law restricts this device to sale by or on the order of a physician.

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Device Description (cont'd)

Inlet Booster Pump - increases incoming water pressure to the pre-treatment and RO unit.

Multimedia Filter - removes incoming particles to a level of ten (10) microns.

Softener - reduces hardness constituants in incoming water.

Carbon Tanks - two (2) tanks in series that remove chlorine, chloramine, and organics. Ten (10) minutes empty bed time ensures complete chloramine removal.

Reverse Osmosis Unit - removes 95-98% of incoming minerals and 99% of organics. This is the primary treatment in most instances.

Water Storage Tank - retains product water from reverse osmosis unit as well as water recirculated through dialysis loop.

Repressure Pumps - supply pressure of water out of storage tank to the post-treatment equipment and the loop.

Deionizer - removes remaining minerals in RO product water as well as functions as a back-up to the reverse osmosis unit during periods of pre-teatment or RO problems.

Ultraviolet Light - kills bacteria in product water of RO, DI, or from the recirculation loop.

Submicron Filter - removes bacteria and particles greater than .2 micron from the product water and loop.

Hollow Fiber Filter - provides pyrogen removal with .05 micron filtration.

Technological Characteristics - Virginia Water systems claims equivalence in terms of technological characteristics, including design, material, chemical composition, and energy source as the predicate devices. A summary is as follows:

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JAN 1 4 2000

Mr. William G. Garrahan Virginia Water Systems, Inc. 7433 Whitepine Road Richmond, VA 23237

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Re: K991916

Virginia Water Systems' Water Purification System for Hemodialysis Dated: October 13, 1999 Received: October 20,1999 Requiatory Class: II 21 CFR §876.5665/Procode: 78 FIP

Dear Mr. Garrahan:

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, 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 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"(21 CFR 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## SECTION 7

# INDICATION FOR USE STATEMENT

from water used to make dialysate and reprocess dialyzers as well as rinsing and disinfection of the dialysis equipment. When used as a medical device, Federal law restricts this device to sale by or on the order of a physician.

Prescription Use . (Per 21 CFR 801.109)

David A. Bergman

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