MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION

{0}------------------------------------------------ K053286 Page 1 of 2 DEC 2 2 2005 ## Section 7 # 510(K) Summary of Safety Effectiveness This 510(k) summary of safety and effectiveness information is being summitted in The UTG(K) Bammary of the Safe Medical Device Act (SMDA) of 1990. The accordance with the requirements have been provided in conformance with 21 CFR \$807.92. | Date: | November 23, 2005 | |-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------| | 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-B Solutions (with bicarbonate buffer) are non-pyrogenic dialysis solutions provided in single use flexible bags. The PureFlow-B Solutions are intended for use with renal replacement therapy systems that utilize sterile premixed dialysate. The range of constituents allows the physician to prescribe different electrolyte compositions that meet the specific needs of individual patients. {1}------------------------------------------------ K053286 Poper 2012 ### Substantial Equivalence: Substantial Equivalence: This submission is a Special 510(k) Device Modification as described in FDA's guidance This Submison is a creatigm - Alternate Approaches to Demonstrating document entilliou "The Free Market Notifications." In support of this 510(k), NxStage Substantial Equivalierson of compliance to 21 CFR 820.30 Design Control requirements. nas provided cortined. For the more that the modified device that the modified device meets Design validations. The modified NxStage PureFlow-B Solution has been compared to the baseline as cleared in K042045 and found to be substantially equivalent. ### Conclusion: Oonoloon: characteristics, and design control certification, the modified NxStage PureFlow-B Solution has been shown to meet the minimum requirements that are considered Obliation The been of one and found to be substantially equivalent to the baseline device. Confidential {2}------------------------------------------------ Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 2 2 2005 Ms. Norma LeMay Manager, Regulatory Affairs NxStage Medical, Inc. 439 South Union Street Suite 501 LAWRENCE MA 01843 Re: K053286 K055260 Trade/Device Name: NxStage PureFlow-B Solution Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KPO Dated: November 23, 2005 Received: November 25, 2005 Dear Ms. LeMay: We have reviewed your Section 510(k) premarket notification of intent to maket the device for use attend in We have reviewed your Section Fronty promation in the indications for use stated in above and have determined the device is substantially equivalent (for the stated in above and nave determined the device is accessions of the state commerce prior to the enclosure) to legally marketcc predical Device Anendments, or to devices that have been May 28, 1976, the enactinent date of the Federal Food, Dugg, and Cosmetic Act (Act) that the reclassified in accordance with the provisions of application (PMA). You may, therefore, market the A do not require approval of a prematics approval approvations (The general controls provisions of the Act device, subject to the general controls provisions of devices, good manufacturing practice, labeling, metade requires against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket If your device is classified (see above) micelar existing major regulations affecting your Approval), if may be subject to such additions, Title 21, Parts 800 of 898. In addition, FDA device can be found in the Code of Federal Regulations, Title 21, Parts 800 nove device can be found in the Code of Footerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that FDA STISualles of a substances with other requirements of the Act of all FDA has made a decemmation mar your do rout we frederal agencies. You must comply with all the Federal statutes and regulations administered of other and listing (21 CFR Part 807); labeling (4) Act's requirements, including, but not mined to regultements as set forth in the quality systems (QS) (21 CFR Part 801); good manufacturing practice requirements as set forcu (21 CFR Part 801); good manufacturing practice requires. 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) . This letter will allow you to ocgn marketing your antial equivalence of your device to a legally premarket notification. The FDA finding of substantial equivals and thus, pe premarket notification. The FDA miding 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), pleased ation in the may be and the fill of the first anymbers, becad on the reg If you desire specific advice for your device on our laborating any in the regulation number at the top of this letter: | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Also, please note the regulation entitled, "Misoration on your responsibilities under the Act from the 807.97). You may obtain other general information on John September Assistance at its toll-free number (800) Division or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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}------------------------------------------------ Ko53286 ### Indications for USE 310ik) Number (if known): ිevice Name: . ... NxStage PureFlow-B Solution m.lications for User NxStage PureFlow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis. Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ANDIOR 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) David A. Legum (Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number Page 1 of 1