NXSTAGE PUREFLOW-B SOLUTION

{0}------------------------------------------------ Ko42045 R275/ of. AUG 27 2004 # Section 7 510(K) Summary of Safety Effectiveness This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The contents of this 510(k) summary have been provided in conformance with 21 CFR 807.92. | Date: | July 29, 2004 | |-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------| | Common/Usual Name: | Premixed Dialysate for Hemodialysis | | Trade/Proprietary Name: | NxStage PureFlow-B Solution | | Classification Name: | Hemodialysis systems and accessories<br>(21 CFR 876.5820) | | Device Classification: | Class II | | Product Code: | 78 KPO - Dialysate Concentrate for Hemodialysis<br>(Liquid or Powder) | | Device Panel: | Gastroenterology-Urology (GU)/Gastro-Renal<br>(GRDB) | | 510(k) Sponsor &<br>Owner/Operator: | NxStage Medical, Inc<br>439 South Union St, Suite 501<br>Lawrence, MA 01843<br>Owner/Operator No. 9045797<br>Establishment Registration #3003464075 | | Contact Person: | Norma LeMay<br>Manager, Regulatory Affairs | #### Device Description: The NxStage PureFlow Solution with bicarbonate (NxStage PureFlow-B Solution) is a non-pyrogenic dialysis solution provided in single use flexible bags. The PureFlow-B Solution is intended for use with renal replacement therapy systems that utilize sterile premixed dialysate. Special 510(k) Premarket Notification Device Modification NxStage Medical, Inc. NxStage PureFlow-B Solution {1}------------------------------------------------ ## Substantial Equivalence: This submission is a Special 510(k) Device Modification as described in FDA's guidance document entitled "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Pre-Market Notifications." In support of this 510(k), NxStage has provided certification of compliance to 21 CFR 820.30 Design Control requirements. Design validation testing has been performed to ensure that the modified device meets design specifications. The modified NxStage PureFlow Solution has been compared to the baseline as cleared in K033386 and found to be substantially equivalent. ### Conclusion: Based on the device indications for use, comparison of descriptive and technological characteristics, and design control certification, the modified NxStage PureFlow Solution has been shown to meet the minimum requirements that are considered acceptable for its intended use. {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 depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all caps and appears to be in a sans-serif font. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 27 2004 Ms. Norma LeMay Manager, Regulatory Affairs NxStage Medical, Inc. 439 South Union Street 5th Floor LAWRENCE MA 01843 Re: K042045 KU42045 Trade/Device Name: NxStage PureFlow Solution with Bicarbonate (PureFlow-B) Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: 78 KPO Dated: July 29, 2004 Received: July 30, 2004 Dear Ms. LeMay: We have reviewed your Section 510(k) premarket notification of intent to market the device w o forrowed your and have determined the device is substantially equivalent (for the indications forchenood above and harsure) to legally marketed predicate devices marketed in interstate for associated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conimores that have been reclassified in accordance with the provisions of the Federal Food, Drug, de Hoos that have been 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 r ou may, dicrerere, mains of the Act include requirements for annual registration, listing of general controls provision practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your device is easonivals. 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 round in 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 that I Drines interves and regulations administered by other Federal agencies. You must or any Federal statuter and and ing, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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. {3}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) The same and the same of the first of Substantial equivalence of your device to This letter will allow you to begin marketing your actives of your device of your device to a legally premarket notification The FDA indines of substantial equivalence of y premarket notification - The FDA linding of substantial or 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 many of the fellouing numbers, hased on the regulat If you desire specific advice for your device on our laboling toge. contact the Office of Compliance at one of the following numbers, based on the regulation in number at the top of the letter: | 8xx. Ixxx | (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 advectising of your device, please contact the Additionally, for questions on the production and the regulation entitled, "Maintanding Office of Compliance at (301) 594-4639 - Association may obtain - Other oceecal Office of Compliance at (301) 394-4057. Also, posts and obtain. Other general by reference to premarket notification (210, 10, 10, 10, 10, 2011, 10:11 the Division of Small information on your responsibilities under the Act may be obtained from the Div information on your responsibilities and its its tall-free number (800) -638-2041 or Manufacturers, International and Consumer Assistance at its toll-free maman huml Manufacturers, International and Collisumer Assistantoo at le 18.1.2017 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/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): NxStage PureFlow-B Solution Device Name: Indications for Use: NxStage PureFlow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate. Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use_ (21 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) Daniel R. Larson (Division Sign-Off) Division of Reproductive, A and Radiological Devices 51()(k) Number _ Page 1 of 1 .