BIOPURE PORTABLE RO SYSTEMS

{0}------------------------------------------------ K112331 PAGE 1 OF 6 Image /page/0/Picture/1 description: The image shows the logo for "arion water, inc." with the tagline "Pure Made Simple™". The text "Section 4: Page 1 of 6" is located below the logo. The logo is in a bold, stylized font. JUL 5 2012 # "Section 4: 510(k) Summary" This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990 and 21 CFR 807.92 ### Section 4.1: Contact Information: | Address: | Arion Water, Inc. | |------------|---------------------------------| | | 1 Commerce Way Bldg #1 - Unit C | | | Carver, MA 02330 | | Applicant: | Robert Livingston - President | | Telephone: | 508-465-2280 | | Fax: | 508-465-2283 | | Contact: | Robert Livingston | |----------------|-------------------------| | | Chief Technical Officer | | Telephone: | 508-465-2280 x114 | | E-mail: | bob@arionwater.com | | Date Prepared: | 08/11/2011 | Bob Livingston will respond to any requests for additional information. ### Section 4.2: Intend to Market Device Information Arion Dialysis Water System Device Name: High Purity Water System. Common Name: Trade Name (Model #): (P10BYD, P15BYD, P20BYD, RO50A, RO100A, RO300A, RO300ALP, RO500A, RO1000A, RO1000ALP, RO1500A, RO2000A, HPW125PP, HPW150PP, HPW200PP, HPW1255S, HPW150SS, HPW200SS) See Section 10: Device Description for details. Classification Name: Classification Panel: Product Code: Water System for Hemodialysis 21 CFR 876.5665 78FIP {1}------------------------------------------------ # 112331 Image /page/1/Picture/1 description: The image shows the logo for "arion water, inc." with the tagline "Pure Made Simple™". The text "Section 4: Page 2 of 6" is located below the logo. The logo is in a bold, stylized font. ### Section 4.3: Predicate Device Information ### Identification of Predicate Devices: ### Section 4.3.1: Predicate Device #1: Company: 510(k) Number: Common Name: Trade Name (Model #): Biolab Equipment Canada Limited K030348 Reverse Osmosis systems with pretreatment and product water distribution components Biopure Portable RO Systems Biopure 4400 Series RO Systems Biopure 8400 Series RO Systems Biopure Water Purification Pretreatment Componets: . Softeners: - . Biopure Performa Softener Biopure Magnum Series Water Softener Backwash Filters: - . Biopure Performa Filter - Biopure Magnum Series Carbon Filter . - Biopure Magnum Series Carbon Filter . - Biopure Magnum Series Multimedia Filter . Service Deionization: - Biopure Service DI ● - Biopure Premium Grade Service . . - Biopure Cation Bed DI . - Biopure Anion Bed DI . - Biopure Auto DI Organic Bed Service Carbon: - . Biopure Carbon Biopure Product Water Distribution Components: - Biopure CIP System . - Biopure Hot Water Sanitization System . {2}------------------------------------------------ # SOF6 Image /page/2/Picture/1 description: The image shows the logo for "arion water, inc." with the tagline "Pure Made Simple™". The text "Section 4: Page 3 of 6" is located below the logo. The logo is in a bold, sans-serif font. ### Classification Name: | <b>Product Code:</b> | | |------------------------------|--| | <b>Classification Panel:</b> | | Water Purification System for Hemodialysis Regulatory Classification - Class II 21 CFR 876.5665 78 FIP 21 CFR 876.5665 ### Section 4.3.2: Predicate Device #2: Company: 510(k) Number: Common Name: Performance Water Systems, LCC K033648 Complete Water Treatment System with pre-treatment and product water distribution. Performance Water Treatment System Trade Name (Model #): ### Classification Name: Water Purification System for Hemodialysis Regulatory Classification - Class II 21 CFR 876.5665 Class II Critical Medical Device 78 FIP Classification Panel: 21 CFR 876.5665 ### Section 4.4: Intend to Market Device Description: Product Code: The Arion Dialysis Water System is comprised of water purification equipment used to purify water for hemodialysis. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for Arion Water, Inc. The logo features the word "arion" in a stylized font, with the "o" extending into a curved line above the "n". Below the main logo, the words "water, inc." are printed in a smaller font, followed by the phrase "Pure Made Simple™". The text "Section 4: Page 4 of 6" is located at the bottom of the image. ### Section 4.5: Indications for Use: The Arion Dialysis Water System is for use in multi-patient hemodialysis. The system consists of pretreatment, reverse osmosis, post-treatment and distribution equipment. The sizing of the system is consisting with the demand of water needed for patients. The water produced will meet the minimum requirements of ANSI/AAMI American National Standard for Water Treatment Equipment for Hemodialysis Applications (RD52:2004 and RD62:2006/A1:2009) and the CMS End Stage Renal Disease (ESRD) Program Interpretive Guidance (based on 42 CFR 494) when used as directed. RO and Pretreatment design is based off of feed water quality to meet the stated specifications. This system is intended to be used in hospitals, dialysis centers, and dialysis clinics. ### Section 4.6: Comparison to Predicate Device: The Arion Dialysis Water System is substantially equivalent to many marketed devices that are used in Hemodialysis. Table 4.6.1 compares systems for the companies of Arion Water, Inc., Performance Water Systems, LCC, and Biolab Equipment Canada Limited. The system listed use RO as a primary purification method. The system design must be similar to the Arion Dialysis Water System due to the requlations of ANSI/AAMI RD62:2006. The standard states certain requirements for the design of water treatment system for Hemodialysis. The Arion Dialysis Water System provides safe mechanical and electrical operations. The electrical components are enclosed with in a NEMA enclosure in compliance with building and electrical codes. The Arion Water Dialysis system has no exposed moving parts. Chemicals being used in water treatment are often monitored with pH probes and other sensors. The Arion Dialysis Water System has no pH probe because it does not use chemicals. The only time the system would need chemicals in during sanitization. When sanitization is in progress test strips and/or metering devices are used to ensure correct amounts of chemicals are used. All chemicals used in the sanitization of the dialysis system are certified by the EPA or conform to AAMI standards. > 1 Commerce Way Bldg #1, Unit C, Carver, MA 02330 508.465.2280 www.arionwater.com {4}------------------------------------------------ · Image /page/4/Picture/1 description: The image shows the logo for "arion water, inc." with the tagline "Pure Made Simple™". Below the logo, it says "Section 4: Page 5 of 6". The logo is in black and white and has a stylized font. | Table 4.6.1: Comparison of Hemodialysis Equipment | | | |----------------------------------------------------|--|--| | | | | | Description | Arion Water, Inc. | Performance<br>Water Systems,<br>LCC | Biolab Equipment<br>Canada Limited | |--------------------------|---------------------------------------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------| | Pretreatment | Multimedia, Dual<br>Carbon, Softener | Dual Carbon | Multimedia, Dual<br>Caron, Softner | | RO | Primary Purification | Primary Purification | Available | | Distribution | Standard | Available | Standard | | Intended Use | Hemodialysis | Hemodialysis | Hemodialysis | | Indications of Use | Complete System:<br>Pretreatment, RO,<br>Distribution | Complete System:<br>Pretreatment, RO,<br>Distribution | Complete System:<br>Pretreatment, RO,<br>Distribution | | Target Population | People who use<br>Dialyzers | People who use<br>Dialyzers | People who use<br>Dialyzers | | Materials | Polypropylene<br>Distribution Loop/<br>SS Option AAMI<br>Compliant<br>Materials | AAMI Compliant<br>Materials | AAMI Compliant<br>Materials | | Location of Use | Hospitals | Hospitals | Hospitals | | Performance<br>Standards | AAMI RD62 | AAMI RD62 | AAMI RD62 | | Sterilized | Monthly | Monthly | Monthly | ### Section 4.7: Non-clinical Performance Data: A water treatment system must be tested for water quality at the time of install. If the system can't produce water quality specified in ANSI/AAMI RD52:2004, then it can't be used for hemodialysis. Each system will be tested and not be operational until it is shown that the water quality meets AAMI standards. The system will be tested for chemical containments on a quarterly basis. ### 1 Commerce Way Bldg #1, Unit C, Carver, MA 02330 508.465.2280 www.arionwater.com {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for "arion water, inc." with the tagline "Pure Made Simple™". The logo is stylized with a unique font. Below the logo, it indicates "Section 4: Page 6 of 6". ### Section 4.8: Clinical Performance Data: This system is not required to have Clinical Test performed. ### Section 4.9: Conclusion of Performance Data: The Arion Dialysis Water System is capable of meeting ANSI/AAMI standards by producing water that has chemical containments below the maximum acceptable levels. The system is designed to conform to ANSI/AAMI equipment and design requlations. If the water does not meet quality, the system will be sanifized and retested. Equipment should be shown to operating properly. If the system can still not meet quality, the system will be decommissioned. ### Section 4.10: Statement of Water Quality: --------------------------------------------- Arion Water certifies that the water produced by each customized purification system will meet or exceed current industry standards and government regulations. ROBERT LIVINGSTON Print Name Sign Name 20 JUN 12 Date --- End of Statement --- 1 Commerce Way Bldg #1, Unit C, Carver, MA 02330 508.465.2280 www.arionwater.com {6}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/6/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the top half of the circle, following its curve. The text is in a sans-serif font and is oriented to be read clockwise. ### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Mr. Robert Livingston Chief Technical Officer (CTO) Arion Water, Inc. 1 Commerce Way Bldg. 1 Unit C CARVER MA 02330 5 2012 JUL Re: K112331 Trade/Device Name: Arion Dialysis Water System Regulation Number: 21 CFR§ 876.5665 Regulation Name: Water purification system for hemodialysis Regulatory Class: II Product Code: FIP Dated: June 21, 2012 Received: July 2, 2012 Dear Mr. Livingston: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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); medical device reporting (reporting of medical {7}------------------------------------------------ Page 2 - device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, Benjamin R. Fisher, Ph.D. Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K112331 Device Name: Arion Dialysis Water System Indications For Use: The Arion Dialysis Water System is for use in multi-patient hemodialysis. The system consists of pretreatment, reverse osmosis, post-treatment and distribution equipment. The sizing of the system is consisting with the demand of water needed for patients. The water produced will meet the minimum requirements of ANSI/AAMI American National Standard for Water Treatment Equipment for Hemodialysis Applications (RD52:2004 and RD62:2006/A1:2009) and the CMS End_ Stage Renal Disease (ESRD) Program Interpretive Guidance (based on 42 CFR 494) when used as directed. RO and Pretreatment design is based off of feed water quality to meet the stated specifications. This system is intended to be used in hospitals, dialysis centers, and dialysis clinics. Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER:PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Hecht Lemur ivision Sign=Off of Reproductive, Gastro-Renal, 510(k) Numbe Section 3 Page 1 of 1