AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS

K991519 · Ameriwater · FIP · Apr 14, 2000 · Gastroenterology, Urology

Device Facts

• Record ID: K991519
• Device Name: AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS
• Applicant: Ameriwater
• Product Code: FIP · Gastroenterology, Urology
• Decision Date: Apr 14, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Intended Use

The AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS is intended to be used in hemodialysis to remove organic and inorganic substances and microbial contaminants from water. Purified (or treated) water will then be used to prepare and dilute dialysate concentrate to form dialysate and/or rinse dialyzers for multiple use and/or to prepare and dilute solutions for reprocessing procedures in multiple-use dialyzers. AmeriWater does not recommend nor endorse any other use for water treated with AmeriWater systems. AmeriWater further does not endorse any specific hemodialysis or reprocessing procedures or equipment. NOTE* Federal Law restricts this device to sale by or on the order of a physician for use as a water treatment device for hemodialysis.

Device Story

AmeriWater Purification System for Hemodialysis removes organic/inorganic substances and microbial contaminants from water. System components include tempering valves, gauges, pumps, multi-media/carbon filtration, water softeners, reverse osmosis units, deionization, and distribution piping. Design is customized based on customer requirements and chemical analysis of source water. System includes monitors and audible/visual alarms with remote activation to notify staff of operational issues. Used in clinical hemodialysis settings; operated by facility staff. Provides purified water for dialysate preparation and dialyzer rinsing/reprocessing. Benefits patients by ensuring water quality meets AAMI standards for hemodialysis.

Clinical Evidence

No clinical data. Bench testing only; system performance is validated against AAMI standards for water used in hemodialysis.

Technological Characteristics

System utilizes multi-stage purification: tempering valves, multi-media filtration, carbon filtration, water softeners, reverse osmosis, deionization, and submicron filtration. Includes pressure/temperature gauges, booster/repressurization pumps, and PVC plumbing. Features integrated monitoring system with audible/visual alarms and remote notification capabilities. Standalone industrial-scale water treatment system.

Indications for Use

Indicated for use in hemodialysis facilities to provide purified water for dialysate preparation and dialyzer reprocessing. No specific patient age or gender restrictions stated.

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

• Reverse Osmosis Water Purification System; Continental Water Systems Corp. (K894300)

Submission Summary (Full Text)

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APR 1 4 2000

## SUMMARY STATEMENT

With regard to AmeriWater's 510(k)submission to the FDA, (ref. K991519)
The **AmeriWater Purification System for Hemodialysis** is a water purification system
designed and maintained to produce water of quality that consistently meets or exceeds
AAMI Standards for water used in Hemodialysis and/or Dialyzer reuse. It is
AmeriWater's contention that the system is substantially equivalent to the Reverse
Osmosis Water Purification System; Continental Water Systems Corp. (K894300) and
other systems currently legally marketed in the U.S. The components may include all or
some of the following:

Tempering valve Temperature Gauge Backflow Preventor Pressure Gauges Booster Pump Multi Media Filtration Carbon Filtration Water Softener Automatic Lockout 5 micron prefilter Reverse Osmosis

Float & Pressure Control Return Flow Diffuser Storage Vessel Repressurization Pump(s) Deionization Submicron Filtration Distribution System PVC Pipe & Fittings PVC ball valves PVC labcock valves System Alarms

System design is determined by the design team following collection of information from the Customer Survey of Requirements, and complete chemical analysis of the waters to be treated. The system is complete with monitors and audible & visual alarms with remote activation in the area of patient care to notify staff of problems if they occur. AmeriWater provides direction and guidance for monitoring and maintenance of the system to each purchasing facility, and 24 hour, 7 day support to all owner facilities for the life of the equipment.

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Public Health Service

APR 1 4 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Sandra E. Monsman Dialysis Specialist AmeriWater® 1257 Stanley Avenue Dayton, OH 45404

Re: K991519 AmeriWater Water Purification system for hemodialysis Dated: January 21, 2000 Received: January 24, 2000 Requlatory Class: II 21 CFR 876.5665/Procode: 78 FIP

Dear Ms. Monsman:

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 inclusive) to legally marketed predicate devices marketed in interstate commerce pror 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 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalion 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 requlation may result in requlatory 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 Radiation Control provisions, or other Federal laws or requiations.

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 requlation (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/dsma/dsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D.

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

Enclosure(s)

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STATEMENT OF INTENDED USE

## The AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS

is intended to be used in hemodialysis to remove organic and inorganic substances and microbial contaminants from water. Purified (or treated) water will then be used to prepare and dilute dialysate concentrate to form dialysate and/or rinse dialyzers for multiple use and/or to prepare and dilute solutions for reprocessing procedures in multiple-use dialyzers. AmeriWater does not recommend nor endorse any other use for water treated with AmeriWater systems. AmeriWater further does not endorse any specific hemodialysis or reprocessing procedures or equipment.

NOTE* Federal Law restricts this device to sale by or on the order of a physician for use as a water treatment device for hemodialysis.

Daniel C. Segerson
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number.

1. Prescription Use (Per 21 CFR 801.109)