CITRISOL ACID CONCENTRATE

{0}------------------------------------------------ K130211 Page 1 of 2 DIASOL., INC. ## 510(k) Summary ട്. SUBMITTER: FEB 1 0 2014 7 CONTACT: DATE SUMMARY WAS PREPARED: CLASSIFICATION: REGULATION NUMBER: CLASSIFICATION PRODUCT CODE: NAME OF DEVICE: COMMON NAME: CLASSIFICATION NAME: PREDICATE DEVICE: DIASOL. INC 1110 Arroyo St San Fernando, CA 91340 Tel: 818-838-7077 Fax: 818-838-7007 MONICA ABELES December 6. 2012 GASTROENTEROLOGY/UROLOGY 21 CFR 876.5820 Hemodialysis system and accessories KPO CITRISOL ACID CONCENTRATE ACID CONCENTRATE FOR HEMODIALYSIS USE 21 CFR 876.5820 Hemodialysis system and accessories CLASS II ACID CONCENTRATE FOR HEMODIALYSIS USE 21 CFR 876.5820 Hemodialysis system and accessories CLASS II Diasol Acid concentrate K854391 Dryasol Concentrate K993212 Citrapure K062399 Citrasate K000792 SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL --EQUIVALENCE DETERMINATION {1}------------------------------------------------ CitriSol is manufactured following strict cGMP's and in accordance with the AAMI/ANSI/ISO 13958:2009 concentrates for hemodialysis and AAMI/ISCHANSI 13959:2009 Water for Hemodialysis. Our product codes are casy to understand. The electrolytes present in each solution. Preceded by CS representing the Citric Acid part. In the 45x proportioning formulations the first three numbers -100 stand for the Na. followed by K (ex 2). Ca (25). -Mg (75) This example stands for CS 100225-75 a 2K 2.5 Ca product. CitriSol acid concentrate comes in Iiquid and dry powder form. The product is available in all 3 different proportioning, as shown in the table below: | 45X LIQUID | 36.83X LIQUID | 35X LIQUID | POWDER | |------------------|-----------------|-----------------|--------------| | CITRISOL | CITRISOL | CITRISOL | CITRISOL | | FORMULATIONS | FORMULATIONS | FORMULATIONS | FORMULATIONS | | 100020-75-DEX100 | 80020-75-DEX100 | 78020-75-DEX100 | | | 100120-75-DEX100 | 80120-75-DEX100 | 78120-75-DEX100 | | | 100220-75-DEX100 | 80220-75-DEX100 | 78220-75-DEX100 | | | 100320-75-DEX100 | 80320-75-DEX100 | 78320-75-DEX100 | | | 100420-75-DEX100 | 80420-75-DEX100 | 78420-75-DEX100 | ALL | | 100025-75-DEX100 | 80025-75-DEX100 | 78025-75-DEX100 | FORMULATIONS | | 100125-75-DEX100 | 80125-75-DEX100 | 78125-75-DEX100 | AVAILABLE | | 100225-75-DEX100 | 80225-75-DEX100 | 78225-75-DEX100 | IN | | 100325-75-DEX100 | 80325-75-DEX100 | 78325-75-DEX100 | POWDER FORM | | 100425-75-DEX100 | 80425-75-DEX100 | 78425-75-DEX100 | ALSO | | 100030-75-DEX100 | 80030-75-DEX100 | 78030-75-DEX100 | | | 100130-75-DEX100 | 80130-75-DEX100 | 78130-75-DEX100 | | | 100230-75-DEX100 | 80230-75-DEX100 | 78230-75-DEX100 | | | 100330-75-DEX100 | 80330-75-DEX100 | 78330-75-DEX100 | | | 100430-75-DEX100 | 80430-75-DEX100 | 78430-75-DEX100 | | | 100035-75-DEX100 | 80035-75-DEX100 | 78035-75-DEX100 | | | 100135-75-DEX100 | 80135-75-DEX100 | 78135-75-DEX100 | | | 100235-75-DEX100 | 80235-75-DEX100 | 78235-75-DEX100 | | | 100335-75-DEX100 | 80335-75-DEX100 | 78335-75-DEX100 | | | 100435-75-DEX100 | 80435-75-DEX100 | 78435-75-DEX100 | | CitriSol acid concentrate dry powder or liquid is indicated for use in the acute and chronic Hemodialysis. It is an accessory to be used with the appropriate Hemodialysis machine in a 3 stream mis in the exact preserthed proportion with ANSI/AAMI/ISO standard water for hemodialysis and Sodium Bicarbonate Mix. CitriSol, contains all the same electrolytes as Diasol Concentrate and 2.4mEq of Citric Acid. CitriSol, when mixed with ANSEAAMI/ISO standard water for hemodialysis, has the same chemical equivalenev as the predicates. {2}------------------------------------------------ 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 stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 10, 2014 Diasol, Inc. Monica Abeles President 1110 Arroyo Street San Fernando, CA 91340 Re: K130211 > Trade/Device Name: CitriSol acid concentrate Regulation Number: 21 CFR§ 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KPO Dated: December 9, 2013 Received: December 11, 2013 Dear Monica Abeles, 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. {3}------------------------------------------------ Page 2 - Monica Abeles 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 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/ResourcesforYou/Industry/default.htm. Sincerely yours, Benjamin DBA Fisher -S 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 {4}------------------------------------------------ ## Indications for Use 510tk) Number (if known): k1305 // Device Name: Citrisol Acid Concentrate Indications For Use: CitriSol acid concentrate dry powder or liquid is indicated for use in the acute and chronic Hemodialysis. It is an accessory to be used with the appropriate Hemodialysis machine in a 3 stream mix in the exact prescribed proportion with ANSE/AAMI/ISO standard water for hemodialysis and Sodium Bicarbonate Mix. Preseription Use (Part 21 CFR 801 Subpart 1)) AND:OK ()ver-The-Counter I Isc (2) CFR 807 Subpart C) <PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Benjamin-R.Fisher-S 2014.02.11 15:57:42 -05'00' Page 1 of _ 1 б