BIPRO MODEL SDS-CB200

{0}------------------------------------------------ KC33/18 Page 1 of 2 JUN 2 8 2004 # 510(k) Summary ### Date: 9/26/03 ### Submitter: Jack Dillon Medical Solutions International, Inc 11522 West 90th St. Overland Park, KS 66214 Ph: 913-438-9700 Fx: 913-438-9701 medsolinc@sbcglobal.net ### Contact Person: Jarvis Stirn 938 Tennessee St. Lawrence, KS 66044 Ph: 785-843-0144 wildhawk@hotmail.com ### Device Identification: Trade Name/Proprietary Name: BiPro Model SDS-CB200 Device: Mixing and distribution system of bicarbonate for dialysis. Common Name: ### Classification Name and Reference: | Classification Names: | TANK, HOLDING, DIALYSIS AND<br>ACCESSORIES | |--------------------------------|------------------------------------------------------------------------------| | Classification: | Class II, 21 CFR 876.5820<br>Panel: Gastroenterology<br>Product Code: 78 FIN | | Premarket Notification Number: | No Prior Related Premarket Notification<br>Submissions. | {1}------------------------------------------------ ### Indications for Use: Indications for Ose. Dirro Model BDS - OD Sodium bicarbonate (bicarb) to remote points of use. The bicarb is then distribution of southin cleared and to create the dialysate solution used in hemodialysis. ### Device Description: The Medical Solutions BiPro Models provide semi-automatic mixing of bicarb I he Medical Donations as a hemodialysis patient stations. A mix tank is used for the mixing of bicarb concentrates and RO water. After mixing the bicarb solution, it is transferred to a loop (day) tank, via the mix pump, where the bicarb solution is distributed to the dialysis machine. ### Statement of Substantial Equivalence: Statement of Substantially Equivalentially equivalent in intended use, features, functions, and technological characteristics to the Mar Cor Services, Inc Bicarb System (K003560) ### Performance: Safety and Effectiveness Information: Medical Solutions BiPro Systems have been voluntarily tested to meet the safety requirements ANSI/AAMI RD62: 2001 Water Treatment Equipment for Hemodialysis Applications. The ANSI/AAMI RD62: 2001 Water Treatment Equipment for Hemodialysis Applications is a revision of the ANSI/AAMI RD5: 1992 Hemodialysis Systems. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 2 8 2004 Mr. Jack Dillon Medical Solutions International, Inc. 11522 West 90th Street SHAWNEE MISSION KS 66215 Re: K033118 Trade/Device Name: BiPro Model SDS-CB200 Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 FIN Dated: April 29, 2004 Received: April 29, 2004 Dear Mr. Dillon: We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section I ro(x) prematically equivalent (for the indications referenced above and have determined the device and seriese merketed in interstate referenced above and nave decimined the actroed predicate devices marketed in interstate for use stated in the enclosure) to regally manced producal Device Ameridaents, or to commerce prior to May 28, 1976, the enactment as a securiers of the Federal Food. Drug commerce prior to May 26, 1970, the chacultence with the provisions of the Federal Food, Drug, devices that have been reclassified in accordance with the provisions of PMA) devices that have been reclassined in accordance while approval applioation (PMA). and Cosmetic Act (Act) that do not require approval of a providens of the Act. The and Cosmetic Act (Act) that do not require approvate or are startest provisions of the Act. The Act. The Act. The Act. The You may, therefore, market the device, subject or the gentles for annual registration, listing of general controls provisions of the Act include requirements michrending and general controls provisions of the Act Herado requirement misbranding 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 critics case in the major regulations affecting your device can be it may be subject to additional controls. Exist. if may be subject to additional controls. Extraing magos In addition, FDA may found in the Code of Federal Regulations, Title 21, Parts Register Tound in the Code of Pederal Regatements, and the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA stisualite of a sudominer equirements of the Act that FDA has made a determination that your device for accepcies. You must that IDA has made a decemination ina your arres by other Federal agencies. You must or any Federal Statutes and regulations annines of of not limited to: registration and listing comply with all the Act sTequirenchis; metalling practice requirements as set (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the electronic (2) CFR Part 807); labeling (21 CFR Patr 800); government 820); and if applicable, the electronic forth in the quality systems (QS) regulation (21 CFR 1000 1050 forth in the quanty Systems (QS) regulation (21 -542 of the Act); 21 CFR 1000-1050. product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) The are and the comment of the of Substantial equivalence of your device to a le This letter will allow you to begin market in a beautes of your device of your device to a legally premarket notification. The FDA including of substantial course and thus, premarket notification. The FDA tinding of substantial call of 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 s and the many of the former of the following numbers, based on the regula If you desire specific advice for your device on our laooling regulario ( contact the Office of Compliance at one of the following numbers, based on the regulation 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 advertising of your device, please contact the Additionally, for questions on the promotion and as a seculture cataliation ontitled, "Misbranding Office of Compliance at (301) 594-4639. Association entitled, "Misoraneral Office of Compliance at (301) Sylands in Art 807.97 you may obtain. Other general by reference to premarket notification" (21CFR Part be obtived from the Division of Small by reference to premarket nothication (21C. Act may be obtained from the Division of Small information on your responsibilities under the Act may be obtained from the Univers information on your responsibilities three Asstance at its toll-free number (800) 638-2041 or Manufacturers, International and Consumer Assistance at its today, http:// Manufacturers, International and Colisumier Assistance at to con 2011 (301) 443-6597 or at its Internet address http://www.fda.gov/odrh/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 {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K033118 Device Name: BiPro Bicarb Mixing/Distribution System (BiPro SDS-CB200) Indications For Use: BiPro Model SDS-CB200 is intended for use in a hemodialysis facility for mixing and Dirro Model DDB ODDood ande (bicarb) to remote points of use. The bicarb is then mixed with purified water and acid to create the dialysate solution used in hemodialysis. Prescription Use __ X (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) Nancy C Brogdon (Division Sign-C Division of Reproduct ive, A Division of Radiological Devices 510(k) Number Page 1 of ____________________________________________________________________________________________________________________________________________________________________