MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS

K021560 · Ameriwater · FIP · Aug 14, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K021560
• Device Name: MODIFICATION TO AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS
• Applicant: Ameriwater
• Product Code: FIP · Gastroenterology, Urology
• Decision Date: Aug 14, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5665
• Device Class: Class 2

Indications for Use

The AmeriWater Purification System for Hemodialysis is used 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 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

System removes organic, inorganic, and microbial contaminants from city tap water for hemodialysis applications. Components include pretreatment (chemical feed, multimedia filters, softeners, carbon filtration), reverse osmosis (RO), deionization, and distribution systems. Chemical feed system adjusts water pH or mitigates contaminants. System includes monitors and audible/visible alarms with remote activation to notify staff of operational issues. Used in clinical hemodialysis settings; operated by trained facility staff. Output is purified water used to prepare dialysate or rinse dialyzers. Benefits include consistent water quality for dialysis procedures, reducing risk of patient exposure to contaminants.

Clinical Evidence

No clinical data. Bench testing and system design based on customer requirements and chemical analysis of source water.

Technological Characteristics

System components: tempering valve, float/pressure control, temperature gauge, return flow diffuser, backflow preventor, booster pumps, multimedia filter, water softener, carbon filtration, micron prefilter, chemical feed system, reverse osmosis, storage vessel, deionization, submicron filter, distribution system, PVC piping/valves. Includes automated lockout and alarm systems. Connectivity: remote alarm activation. Energy: electrical power for pumps and monitoring systems.

Indications for Use

Indicated for use in hemodialysis facilities to purify water for the preparation and dilution of dialysate concentrate and for rinsing multiple-use dialyzers.

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 Purification Systems for Hemodialysis (K991519)
• Osmonics 23G Reverse Osmosis Equipment for Water Purification (K931595)
• Zyzatech Reverse Osmosis Systems (K964539)
• G.E.M. Water Systems Reverse Osmosis System (K944493)
• Serv-A-Pure Co. H2Only Reverse Osmosis System (K993520)
• Isopure MD Series Reverse Osmosis Systems (K993200)
• U.S. Filter M Series Reverse Osmosis Systems (980182)

Submission Summary (Full Text)

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AUG 1 4 2003

August 12, 2003

Image /page/0/Picture/3 description: The image shows the logo for AmeriWater. The logo consists of the word "AmeriWater" in a serif font, with a registered trademark symbol to the right of the word. Below the word is a curved line made up of a series of black squares.

Dayton, OH 45404 1257 Stanlev Avenue Phone: [phone] Phone: [phone] Fax: [phone] www.ameriwater.com

Subiect: 510 (K) SUMMARY 510 (K) Number: K021560

AmeriWater Contact: Brian R. Bowman, Quality Manager

| Proprietary Name: | AMERIWATER PURIFICATION SYSTEM FOR HEMODIALYSIS |
|----------------------|-------------------------------------------------|
| Common Name: | Water Purification System for Hemodialysis |
| Classification Name: | Water Purification System for Hemodialysis |
| Classification: | Class II Medical Device under §876.5665 |

Device Description / Intended Use: The AmeriWater Purification System for Hemodialysis is used 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 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. Please note that Federal Law restricts this device to sale by or on the order of a physician for use as a water treatment device for hemodialysis.

The AmeriWater Purification System for Hemodialysis may include pretreatment components, reverse osmosis and/or deionization, post-treatment components, and a distribution system. All or some of the following components may be included in an AmeriWater Purification System for Hemodialysis based on the customer's needs: Tempering Valve, Float and Pressure Control, Temperature Gauge, Return Flow Diffuser, Backflow Preventor, Booster Pump(s), Multimedia Filter, Water Softener, Carbon Filtration, Micron Prefilter, Chemical Feed System, Reverse Osmosis, Pressure Gauges, Storage Vessel, Deionization, Submicron Filter, Distribution System, Distribution Pump(s), PVC Pipe and Fittings, PVC Ball Valves, PVC Labcock Valves, Automatic Lockout, and System Alarms.

System design is determined by the customer's needs and the water conditions at their facility. Components for the water system are selected based on a survey of the customer's requirements and a complete chemical analysis of the water to be treated. The system is complete with monitors and audible/visible alarms with remote activation in the area of patient care to notify staff of problems if they occur. AmeriWater provides direction and

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quidance for monitoring and maintenance of the system to each purchasing facility and 24 hour. 7 days a week, phone support to all owner facilities for the life of the equipment.

AmeriWater has received clearance to market the AmeriWater Purification Systems for Hemodialysis (K991519) containing some or all of the following components: Tempering Valve, Float and Pressure Control, Temperature Gauge, Return Flow Diffuser, Backflow Preventor, Booster Pump(s), Multimedia Filter, Water Softener, Carbon Filtration, Micron Prefilter, Reverse Osmosis, Pressure Gauges, Storage Vessel, Deionization, Submicron Filter, Distribution System, Distribution Pump(s), PVC Pipe and Fittings, PVC Ball Valves, PVC Labcock Valves, Automatic Lockout, and System Alarms.

This 510K submission (K021560) is to obtain clearance to market the AmeriWater Chemical Feed System, and the following RO units (with 510k clearance) in combination with some or all of the components listed above. The brand names of the RO units with 510k clearance that AmeriWater would like to market with the AmeriWater Purification System for Hemodialysis are as follows: The Osmonics 23G Reverse Osmosis Equipment for Water Purification (K931595); the Zyzatech Reverse Osmosis Systems (K964539); the G.E.M. Water Systems Reverse Osmosis System (K944493); the Serv-A-Pure Co. H2Only Reverse Osmosis System (K993520); the Isopure MD Series Reverse Osmosis Systems (K993200); and the U.S. Filter M Series Reverse Osmosis Systems (980182).

The AmeriWater Chemical Feed System is a pretreatment device that is designed to deliver chemicals to the city tap water in order to adjust various chemistries in the water. The chemical feed system is located at the front-end of a water treatment system and may be used for pH adjustment, or to mitigate certain water contaminants to help improve the performance of the complete water system. The chemical feed system is substantially equivalent to the chemical feed in the pretreatment section of the Water Purification Systems and Components and Portable Reverse Osmosis Systems, by Zyzatech (K964539) and other chemical feed systems currently leqally marketed.

Prepared By:

Bria R. Bowman

Brian R. Bowman, 8/12/03 Quality Manager

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the shape of a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 4 2003

Mr. Brian R. Bowman Quality Manager AmeriWater 1257 Stanley Avenue DAYTON OH 45404

Re: K021560

Trade/Device Name: AmeriWater® Purification System for Hemodialysis Regulation Number: 21 CFR §876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: 78 FIP Dated: May 15, 2003 Received: May 16, 2003

Dear Mr. Bowman:

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 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); 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.

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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for AmeriWater. The logo consists of the word "AmeriWater" in a serif font. Below the word is a curved line made up of black squares that decrease in size from left to right.

Dayton, Ohio 45404 1257 Stanley Avenue Phone: [phone] Phone: [phone] Fax: [phone] www.ameriwater.com

510 (K) Number: K021560

Device Name: The AmeriWater Purification System For Hemodialysis

## STATEMENT OF INTENDED USE

The AmeriWater Purification System for Hemodialysis is used 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 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.

*Prescription Use*

David A. Sarnoff

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510K, K021560, Statement of Intended Use, 8-22-02.doc brb