PERFORMANCE WATER TREATMENT SYSTEM

{0}------------------------------------------------ K033648 Page 1 of 3 ## AUG - 9 2004 ## 510(k) Summary of Safety and Effectiveness | Submitter: | Performance Water Systems, LLC<br>13601 South Kenton Ave.<br>Crestwood, IL 60445 | | |------------------------------------|----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------| | Establishment Registration Number: | 9058752 | | | Phone: | (708) 396-0136 | | | Fax: | (708) 396-0137 | | | Date Prepared: | Oct. 31, 2003 | | | Contact Person: | Robert Downey | | | Device Names: | Trade Name: | Performance Water Treatment System | | | Common Name: | Complete Water Treatment<br>System with pre-treatment<br>and product water<br>distribution | | | Classification Name: | Water purification system for<br>Hemodialysis<br>(21 CFR 876.5665)<br>Class II Critical Medical<br>Device | | | Product Code: | 78 FIP | | Predicate Device: | | Better Water, Inc. Water Purification System<br>for Hemodialysis, K#920186/C | Device Description: The water treatment system and its components consisting of; pre-treatment, reverse osmosis machine, and the product water distribution components, are designed to remove microbiological, organic, and inorganic contaminants from the tap water to supply dialysis machines for the preparation of dialysate solutions for hemodialysis treatments. {1}------------------------------------------------ K033648 Page 2 of 3 Pretreatment components can include a tap water l retroutinem, blending valve, sediment filtration, boosting Systems, water softeners, and all the carbon roll of reconnecting plumbing. The purpose of this part of the system is to ensure that properly conditioned water is supplied to the reverse oonditionsachine to ensure its safe and trouble free operation. The blending valve ensures that the operation: The proper temperature when entering the reverse osmosis machine. The tap water booster system helps ensure that the reverse osmosis systhine has adequate water pressure and volume so it can produce the desired amount of water. The i sediment filters can be in the form of an automatic backwashing filter (such as a multi-media depth filter), or as a replaceable filter cartridge. The carbon filters are installed primarily to remove the amount of chlorine and chloramines from the water to meet the necessary water quality standards and can be in the form of automatic backwashing tanks, or portable exchange tanks. The water softener(s) are in place to remove the hardness from the tap water to both meet water quality standards, and to protect the reverse osmosis membranes from scaling and therefore not performing to specifications. After the tap water has been pre-treated, it then enters the R.O. (reverse osmosis), where total dissolved solids are removed to pertinent water quality standards. This is accomplished by utilizing a membrane separation process, whereby the incoming water is separated into a product stream, and a concentrate stream. The molecular weight cut-off determines what and how many contaminants are passed through into the product stream. R.O.s used for this application typically remove 95-99% of all total dissolved solids and bacteria. The product water distribution part of the system is in place to store, provide additional purification if needed, and deliver the purified water to wherever needed. These components can include such things as a storage tank, deionization tanks, final filters (for bacteria and endotoxins), and delivery pumps and controls. Some systems can also utilize an ultraviolet light for additional sterilization properties. {2}------------------------------------------------ K033648 Page 3 of 3 The Performance Water Treatment System is Intended Use: intended to be used to remove organic and intendou to beaminants from a tap water supply to illute a dialysate concentrate for hemodialysis treatments, as well as for use for dialyzer reprocessing and dialysis equipment disinfecting and rinsing. - Predicate Device: The Performance Water Treatment System and its components are substantially equivalent to the Better Water, Inc. Water Purification System for Hemodialysis, K#920186/C. Both the predicate device systems and the Performance Water Treatment System utilize reverse osmosis technology as the primary means of purification, and all utilize an R.O. which has 510(k) clearance from the FDA. ## Non-Clinical Performance Data: The Performance Water Treatment System produces i product water which is in compliance with the standard issued by the Association for the Advancement of Medical Instrumentation, AAMI RD62-2001. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows a logo with a bird in the center. The bird is facing left and has three lines above it, possibly representing wings or flight. The bird and lines are enclosed in a circle, and there is some text around the outside of the circle, although the text is not clear enough to read. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG - 9 2004 Mr. Robert P. Downey Manager Performance Water Systems, LLC 13601 South Kenton Avenue CRESTWOOD IL 60445 Re: K033648 Trade/Device Name: Performance Water Treatment System Regulation Number: 21 CFR §876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: 78 FIP Dated: August 1, 2004 Received: August 3, 2004 Dear Mr. Downey: We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section JTQ(x) premantially equivalent (for the indications referenced above and have determined the devices marketed in interstate referenced above and have delemined the actress to redicate devices marketed in interstate for use stated in the enclosure) it regally manced prodited Device Ameridae, or to commerce prior to May 28, 1976, the enactment date of the Foderal Food. Days commerce prior to May 28, 1970, the chacinent and select one of the Federal Food, Drug, devices that have been reclassified in accordance while approval application (PMA). and Cosmetic Act (Act) that do not require approval of a provisions of the Act. The and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The Act. The Act. The Act. The You may, therefore, market the device, subject to the greats for annual registration, listing of general controls provisions of the Act include requirements for any and general controls provisions of the Act morade requirements of the manufactures and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), ( If your device is classified (see above) into crime regulations affecting your device can be it may be subject to additional controls. Existing major regulations affectives it may be subject to additional controls. Extraing mg Solo to 898. In addition, FDA may found in the Code of Federal Regulations, Title 21, Parts of Register found in the Code of rederal Regulations, Four device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA Stssualles of a substitution with other requirements of the Act that FDA has made a determination that your device of and orders . You must that FDA has made a delemination that your cerres by other Federal agencies. You must or any Federal statutes and regulations administed to: registration and listing comply with all the Act 5 requirencents, medaling practice requirements as set (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practicable, the electronic (2) CFR Part 807); labeling (21 CFR Pair 800); good namb f forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QS) regulation (21 OFR Public of the Act); 21 CFR 1000-1050. product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-105 {4}------------------------------------------------ ## l'are ? This letter will allow you to begin marketing your device as described in your Section 10(k) 10 alers and the supportion for the finding of substantial equivalence of a leg This letter will allow you to begin marketing your device of your device of your device to a le;ally premarket notification The FDA finding of substantial equivalence and t prematication - The FDA linding of substantial Quivalence or your device and thus, permits your device marketed predicate device results in a classification for your device a to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please s and on the security of the following numbers, based on the regulation If you desire specific advice for your device on our laooling ough number at the top of the letter : | 8xx.1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion and advice, please contact the Additionally, for questions on the promotion and administration, "Misbranding Office of Compliance at (30) 594-4639. Also, please note this regulation of ther general Office of Compliance at (301) Systems (21CFR Part 807.97) you may obtain. Other general by reference to premarket notification" (21CFR Part be obtained from the Division of by reference to premarket nothication (21C/A 1 are 0077) your drom the Division of Small information on your responsibilities under the Act may be obtained from the Division information on your responsibilities under the Asstance at its toll-free number (800) 638-2041 or Manufacturers, International and Chisantes Asstance at its toll-free number Manufacturers, International and Consumer Assistance at to con and Constitutional (1978) (301) 443-6597 or at its Internet address http://www.fda.gov/odrh/dsmaldsmamin.itml. 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 {5}------------------------------------------------ K023648 Page / of / 510(k) Number (if known): المثال Hot Assigned K033648 Device Name: Performance Water Treatment System Indications for Use: The water treatment system and its components consisting of; pretreatment, reverse osmosis machine, and the product water distribution components, are designed to remove microbiological, organic, and inorganic contaminants from the tap water to supply dialysis machines for the preparation of dialysate solutions for hemodialysis treatments. 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. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ______________________________________________________________________________________________________________________________________________________________________________ Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use _V (Per 21 CFR 801.109) David A. Legum (Division Sign-Off) Division of Reproductive, and Radiological De 510(k) Number