FRESENIUS NATURALYTE SODIUM BICARBONATE LIQUID CONCENTRATE, MODEL 08-4000-LB

{0}------------------------------------------------ K071387 Page 1 of 3 Image /page/0/Picture/1 description: The image shows a geometric design that resembles an inverted pyramid. The pyramid is constructed from a series of stacked, truncated inverted pyramids, each smaller than the one above it. The lines forming the shapes are thick and black, creating a bold contrast against the white background. The design is symmetrical and minimalist, with a focus on geometric precision. JUN 1 5 2007 # Fresenius Medical Care # Fresenius Naturalyte® Sodium Bicarbonate Liquid Concentrate "Special" 510(k) Premarket Notification # 510(k) Summary #### A. Submitter's Information: Fresenius Medical Care North America Name: Address: 920 Winter Street Waltham, MA 02451 (781)699-4475 Phone: Fax: (781) 699-9635 Contact Person: Janet C. Kay, Manager Regulatory Affairs Date of Preparation: June 14, 2007 ### B. Device Name: | Trade Name: | Naturalyte® Sodium Bicarbonate Liquid<br>Concentrate | |----------------------|------------------------------------------------------| | Common/Usual Name: | Dialysate Concentrate for Hemodialysis (liquid) | | Classification Name: | Hemodialysis systems and accessories | {1}------------------------------------------------ Ko71387 Page 2 of Image /page/1/Picture/1 description: The image shows a geometric design that resembles a stylized, inverted pyramid or cone. The design is composed of four horizontal lines that create three distinct layers or sections within the overall shape. Each layer is defined by a pair of parallel lines, with the space between the lines filled in to create a solid, dark band. The layers decrease in size from top to bottom, giving the impression of depth or perspective. # Fresenius Medical Care # Fresenius Naturalyte® Sodium Bicarbonate Liquid Concentrate "Special" 510(k) Premarket Notification ## 510(k) Summary #### C. Predicate Device Name: The Fresenius Naturalyte® Sodium Bicarbonate Liquid Concentrate is a modified version of the Fresenius Biosol Powder Bicarbonate Concentrate - #K981043 (5/26/1998) . #### D. Device Description/Indications for Use: The intended use for the modified device is equivalent to that of the unmodified device: #### Intended Use This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates #### E. Substantial Equivalence: #### Substantial Equivalence Decision Making Process #### 1. Is the product a device? YES - The Fresenius Naturalyte® Sodium Bicarbonate Liquid Concentrate is a device pursuant to 21 CFR §201 [321] (h). #### 2. Does the new device have the same intended use? - YES The intended use for the modified device is equivalent to the unmodified device. #### Fresenius modified Fresenius Naturalyte® Sodium Bicarbonate Liquid Concentrates - Intended Use This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates #### Fresenius unmodified Biosol Powder Bicarbonate Concentrate -Intended Use This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates {2}------------------------------------------------ K07L387 Page 3 of 3 JUN 15 2007 # Fresenius Medical Care ## Fresenius Naturalyte® Sodium Bicarbonate Liquid Concentrate "Special" 510(k) Premarket Notification ## 510(k) Summary #### 3. Does the device have technological characteristics that raise new types of safety or effectiveness questions? NO -- The Fresenius Naturalyte® Sodium Bicarbonate Liquid Concentrates is a modified versions of the Biosol Powder Bicarbonate Concentrates. The technological characteristics of the modified devices are equivalent to those of the unmodified devices and raise no new types of safety or effectiveness questions. #### 4. Does descriptive or performance information demonstrate equivalence? YES - Fresenius Medical Care North America believes that the information provided in this submission clearly describes the modified Fresenius Naturalyte® Sodium Bicarbonate Liquid Concentrate and demonstrates that it is substantially equivalent to the unmodified devices. #### F. Safety Summary The Fresenius modified Naturalyte® Sodium Bicarbonate Liquid Concentrate is substantially equivalent in chemical formulation, chemical composition, and intended use to the commercially available Biosol Powder Bicarbonate Concentrates currently distributed as Fresenius Naturalyte® Dry Pack Bicarbonate Concentrates. In addition, testing of the modified device indicates that the formulations are safe and effective for its intended use. #### G. General Safety and Effectiveness Concerns The Fresenius modified Naturalyte® Sodium Bicarbonate Liquid Concentrates are to be used with a three-stream proportioning systems when calibrated to specified proportions depending on the series and mixed with water that meet ANSI/AAMI RD 62.. Use with other equipment or without associated bicarbonate concentrate may cause patient injury or death. Not for Parenteral Use. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle head in profile, facing right, composed of three curved lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the eagle head. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850 Ms. Janet C. Kay Manager of Regulatory Affairs Fresenius Medical Care North America 920 Winter Street WALTHAM MA 02451 **JUN 15 2007** Re: K071387 Trade/Device Name: Fresenius Naturalyte® Sodium Bicarbonate Liquid Concentrates, (4000 Series) Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KPO Dated: May 16, 2007 Received: May 18, 2007 Dear Ms. Kay: 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. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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. Image /page/3/Picture/10 description: The image shows a circular logo with the text "FDA Centennial 1906-2006" in the center. The letters "FDA" are prominently displayed in a bold font. The word "Centennial" is written below the letters "FDA". The logo is surrounded by a ring of text and stars. Protesting and Promoting Public Health {4}------------------------------------------------ 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for 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 eontact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: > 21 CFR 876.xxxx 21 CFR 884.xxxx 21 CFR 892.xxxxx Other (Gastroenterology/Renal/Urology) 240-276-0115 (Obstetrics/Gynecology) 240-276-0115 (Radiology); 240-276-0120 240-276-0100 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html <http://www.fda.gov/oc/industry/support/index.html> Sincerely vours. 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 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of an inverted triangle shape with horizontal lines inside, above the text "Fresenius Medical Care". The text is in a simple, sans-serif font and is horizontally aligned. #### Indications for Use 510(k) Number (if known): Device Name: Fresenius Naturalyte® Sodium Bicarbonate Liquid Concentrates, 4000 Series. Indications for Use: This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates Prescription Use 4 (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 OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdomina and Radiological Device 510(k) Number K071387 (Posted November 13, 2003) Page of Fresenius Medical Care North America Corporate Headquarters: 920 Winter Street Waltham, MA 02451 (781) 699-9000