PURE WATER INC'S ACIDIFIED STORAGE AND DISTRIBUTION SYSTEM WITH OPTIONAL REMOTE FILL

{0}------------------------------------------------ 510(k) Summary ## Submitter Information: | Company Name: | Pure Water, Inc. | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Company Address: | 305 West Market Street<br>Anderson, South Carolina | | Company Phone: | (864) 375-0105 | | Company Fax: | (864) 226-1384 | | Contact Person: | Rhonda S. McCoy | | Prepared: | September 10, 1999 | | Trade Name: | Pure Water, Inc. Acidified Storage and Distribution System with<br>Optional Remote Fill | | Classification Name: | Acidified Storage and Distribution System with optional Remote<br>Fill for Hemodialysis | | Equivalancy: | Pure Water, Inc.'s Acidified Storage and Distribution System with<br>Optional Remote Fill is substantially equivalent to Better Water's<br>Water Purification System for Hemodialysis (510(k) #: K920186)<br>and ZyzaTech Water System, Inc.'s Water Purification Systems<br>and Components and Portable Reverse Osmosis Systems (510(k)<br>#: K964539) which are currently in commercial distribution. | | Device Description: | Pure Water, Inc.'s Acidified Storage and Distribution System with<br>Optional Remote Fill uses "one-piece molded seamless tanks<br>constructed of linear polyethylene" for bulk storage of acidified<br>concentrate.<br><br>The Optional Remote Fill allows the storage tanks to be filled by<br>the vendor from outside the building.<br><br>Pure Water, Inc.'s Acidified Storage and Distribution System with<br>optional Remote Fill meets or exceeds all Association for the<br>Advancement of Medical Instrumentation (AAMI) National | Standards for Hemodialysis. {1}------------------------------------------------ Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the caduceus symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 2 4 2000 Ms. Rhonda S. McCoy Office Manager Pure Water, Inc. 305 West Market Street Anderson, South Carolina 29624 Re: K993058 Pure Water, Inc. Acidified Storage and Distribution System Dated: December 29, 1999 Received: December 30, 1999 Regulatory Class: II 21 CFR §876.5820/Procode: 78 FIN 21 CFR §876.5820/Procode: 78 KPO Dear Ms. McCoy: 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 verily such assumptions. Failure to comply with the GMP regult 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 Compilance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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 {2}------------------------------------------------ Page 1 of of 1 510(k) Number (if known): K993058 Device Name: Pure Water, Inc. Acidified Storage and Distribution System Indications For Use: The Pure Water, Inc. Acidified Storage and Distribution system with Remote Fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of hemodialysis patients. ## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Dinda H.P. Siti Aisah Dom (Division Sign Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices K993058 510(k) Number Prescription Use J (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)