PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPY

{0}------------------------------------------------ K120333 page 1 of 2 MAY 2 5 2012 ## 510(k) SUMMARY Submitted by: Gambro Renal Products Inc. 1845 Mason Avenue Daytona Beach, FL 32117 > Phone: (386) 481-1121 > > (386) 274-2833 Fax: Contact: Fei Law Date Prepared: 05/21/2012 Trade Name: PrismaSATE > Dialysis Solutions for Continuous Renal Replacement Therapy (CRRT) Common Name: Ready to Use Sterile Dialysate Classification Dialysate Concentrate for Hemodialysis (Liquid or Powder) per Name: 21 CFR 876.5820. The Product/Classification Code is KPO. PrismaSATE Dialysis Solutions for Continuous Renal Replacement Therapy (CRRT) Equivalent Predicate: Gambro Renal Products, K013448 > PrismaSATE Dialysis Solutions for Continuous Renal Replacement Therapy (CRRT) Gambro Renal Products, K072908 B. Braun Modified Bicarbonate Dialysate B. Braun, K052393 Device Description: Gambro PrismaSATE solutions are sterile dialysate solutions for use in Continuous Renal Replacement Therapy (CRRT) for the treatment of acute renal failure and in other cases necessitating fluid or solute removal, such as in the case of drug poisoning with dialyzable or filterable substances. The solutions are intended to be used in commercially available continuous renal replacement therapy machines as dialysate. A physician prescribes the chemical composition of the solution to be used. The solutions are sterile, and packaged in flexible bags. Testing, and Recognized Standards: Expiration Dating: Stability studies for expiration dating are performed for Gambro PrismaSATE at controlled conditions, per an approved protocol and results have been provided. Sterilization: Gambro PrismaSATE solutions are terminally sterilized using steam. The validation methods used follow ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO 11138-3. Blocompatibility: The primary packaging material for PrismaSATE solution was tested per Gambro's procedure for physico-chemical and biological evaluation and qualification of materials for medical devices and drug containers. Tests performed included selected physico-chemical tests and biological tests, and have been provided. Intended Use: Gambro PrismaSATE solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy. CRRT is used for the treatment of acute renal failure and in other cases necessitating fluid or solute removal, such as in the case of drug poisoning with dialyzable or filterable substances. The solutions are perfused through the dialysis fluid {1}------------------------------------------------ 120333 page 2 of 2 Page 9 of 9 compartment of hemofilters/dialyzers. The dialysate is separated from the patient's blood by means of a semi-permeable membrane. Excess waste products, fluids and toxins found in the blood of a patient with acute renal failure pass through the membrane into the dialysate and eventually go to waste. The therapy is aimed at normalizing the blood. Predicate Device Comparison: The modified PrismaSATE Dialysis Solutions for CRRT has the same intended use, indication for use, chemical concentration range, and packaging characteristics as the predicate devices. There are no significant technological changes. Based on the above, the device is substantially equivalent to the stated predicates. {2}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES 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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. ## Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Ms. Fei Law Quality and Regulatory Manager, US Solutions Gambro Renal Products Inc. · 1845 Mason Avenue DAYTONA BEACH FL 32117 MAY 2 5 2012 Re: K120333 > Trade/Device Name: PrismaSATE TM Regulation Number: 21 CFR§ 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KPO Dated: May 8, 2012 Received: May 10, 2012 Dear Ms. Law: 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 {3}------------------------------------------------ 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, Dayane K-tuxhe 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}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "GAMBRO" in bold, black letters. To the left of the word is a circular logo with a white "G" inside of it. The logo is also in bold, black letters. The word "GAMBRO" appears to be the name of a company or organization. 510(k) Premarket Notification Page 11 of 62 ## 4.0 Indications for Use Statement Indications for Use 510(k) Number (if known): 20333 Device Name: PrismaSATE ™ Indications For Use: Gambro PrismaSate solutions are indicated for use as a dialysate in Continuous Renal Replacement Therapy. 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) | | |----------------------------------------------------------------|-------------| | (Division Sign-Off) | | | Division of Reproductive, Gastro-Renal, and Urological Devices | Page 1 of 1 | | 510(k) Number | K120333 |