FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows a geometric figure that resembles a funnel or a series of stacked, truncated pyramids. The figure is oriented with the widest section at the top and narrows down towards the bottom, ending in a sharp point. There are four distinct layers or sections, each separated by a horizontal line, creating a tiered effect. The figure is drawn in black and white, with bold lines outlining the shape and defining the different sections. KOL-3244- PAGE 1 OF 3 # Fresenius Medical Care ## Fresenius Optiflux F20NR , F18NR and F16NR Single Use Hemodialyzers "Special" 510(k) Premarket Notification Summary of Safety and Effectiveness This 510(k) Summary of Safety and Effectiveness is being submitted in accordance with the requirements of SMDA 1990. #### A. Submitter's Information: | Name: | Fresenius Medical Care North America | |----------------------|--------------------------------------------------------------| | Address: | 95 Hayden Ave<br>Two Ledgemont Center<br>Lexington, MA 02420 | | Phone: | 1-781-402-9068 | | Fax: | (781) 402-9635 | | Contact Person: | Arthur Eilinsfeld, Director of Regulatory Affairs | | Date of Preparation: | 19 November, 2004 | #### B. Device Name: | Proprietary Name: | Fresenius Optiflux F20NR e, F18NRe and<br>F16NRe Hemodialyzers | |-------------------|----------------------------------------------------------------| |-------------------|----------------------------------------------------------------| #### Common Name: | • Optiflux F20NRe and Optiflux F18NRe: | Dialyzer, High Permeability with or without Sealed Dialysate System | |-------------------------------------------|---------------------------------------------------------------------| | • Optiflux F16NRe: | Dialyzer, Capillary, Hollow Fiber | | <b>Product Code/Classification Panel:</b> | | | • Optiflux F20NRe and Optiflux F18NRe: | 78KDI/Gastroenterology-Urology | | • Optiflux F16NRe: | 78FJI/Gastroenterology-Urology | | <b>Classification:</b> | | | • Optiflux F20NRe and Optiflux F18NRe: | Class II per §876.5860 | | • Optiflux F16NRe: | Class II per §876.5820 | Image /page/0/Picture/12 description: The image shows the number 000042. The numbers are in a bold, sans-serif font. The numbers are all aligned horizontally and are evenly spaced apart. The image is black and white. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the text "KOL-3244 PAGE 2 CF 3". The text appears to be handwritten. The text "PAGE 2 CF 3" indicates that this is page 2 of 3. # Fresenius Medical Care ## Fresenius Optiflux F20NR , F18NR and F16NR Single Use Hemodialyzers "Special" 510(k) Premarket Notification Summary of Safety and Effectiveness #### C. Predicate Devices The Fresenius Optiflux F20NR , F18NR , and F16NR8 are modified versions of the Fresenius Optiflux 200NR and Fresenius Hemoflow F7NR®, which were cleared under the following premarket notifications: #### Optiflux 200NR: - K002277 (8/25/00) . #### Hemoflow F7NR® - · #K002761 (12/04/00) #### D. Indications for Use/Intended Use Optiflux F20NR®, F18NR®, and F16NR® dialyzers are designed for single use acute and chronic hemodialysis. #### E. Substantial Equivalence: #### 1. Is the product a device? YES - The Fresenius Optiflux F20NR , F18NR , and F16NR® hemodialyzers are devices pursuant to 21 CFR §201 [321] (h). #### 2. Does the new device have the same intended use? YES ~ The intended use for the Optiflux F20NR , F18NR , and F16NR , hemodialyzers is equivalent to that for the Fresenius Optiflux 200NR and is as follows: #### Optiflux F20NR®, F18NR®, and F16NR® - Intended Use Optiflux F20NR , F18NR , and F16NR dialyzers are designed for single use acute and chronic hemodialysis. #### Fresenius Optiflux 200NR - Intended Use Optiflux 200NR dialyzers are designed for acute and chronic hemodialysis and are appropriate for single and multiple use. Image /page/1/Figure/20 description: The image shows a sequence of numbers, specifically "000043". The numbers are printed in a bold, sans-serif font, and they appear to be stamped or printed with some slight imperfections, giving them a somewhat aged or vintage look. The digits are evenly spaced and aligned horizontally. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the text "K043244", followed by the text "PAGE 3 OF 3" on the line below. The text appears to be handwritten. The text is written in black ink on a white background. Image /page/2/Picture/1 description: The image shows the logo for Fresenius Medical Care. The logo consists of a geometric shape resembling an inverted pyramid with horizontal lines inside, positioned above the text "Fresenius Medical Care". The text is in a simple, sans-serif font and is the primary identifier for the brand. ## Fresenius Optiflux F20NR , F18NR and F16NR Single Use Hemodialyzers "Special" 510(k) Premarket Notification Summary of Safetv and Effectiveness #### 3. Does the device have technological characteristics that raise new types of safety or effectiveness questions? NO - The Optiflux F20NR , F18NR , and F16NR are e-beam sterilized, low-flux versions of the Optifiux 200NR. The technological characteristics of the Optiflux F20NR®, F18NR°, and F16NR° are equivalent to those of the Optiflux 200NR and Hemoflow F7NR8 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 Optiflux F20NR, and and demonstrates that they are substantially equivalent to the F16NR® Fresenius Optiflux 200NR and Hemoflow F7NR®. #### F. Safety Summary The Optiflux F20NR°, F18NR°, and F16NR° dialyzers are substantially equivalent in construction, design, materials, and intended use to the commercially available Fresenius F7NR® and Fresenius Optiflux 200NR dialyzers. In addition, testing of the Optiflux F20NR , F18NR , and F16NR indicates that they are safe and effective for their intended use. 0000-3 00004 {3}------------------------------------------------ Image /page/3/Picture/2 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 figure with flowing lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird-like figure. The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 2 0 2004 Ms. Nichole Riek Regulatory Affairs Supervisor Fresenius Medical Care North America 95 Hayden Avenue LEXINGTON MA 02420 Re: K043244 Trade/Device Name: Fresenius Optiflux 20NR, 18NR and 16NRt Hemodialyzers Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Product Code: 78 KDI Regulation Number: 21 CFR §876.5820 Regulation Name: Hemodialysis system and accessories Product Code: 78 FJI Regulatory Class: II Dated: November 19, 2004 Received: November 23, 2004 Dear Ms. Riek: 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 (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); 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. {4}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with anow you'ts begin matter of substantial equivalence of your device to a legally prematication. "The PDF machassification 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 If you debite specific acries at one of the following numbers, based on 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 807.97). You may obtain other general information on your responsibilities under the Act from the 00 : 77). " Cormal Manufacturers, International and Consumer Assistance at its toll-free number (800) D1 rison or climit in and on or at its Internet address http://www.fda.gov/cdrb/dsmaldsmamain.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 {5}------------------------------------------------ # Indications for Use 510(k) Number (if known): K043244 Device Name: Fresenius Optiflux F20NR®, F18NR®, and F16NR® Hemodialyzers Indications For Use: Optiflux F20NR , F18NR , and F16NR dialyzers are designed for single use acute and chronic hemodialysis. 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) David G. Legarra (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number . Page 1 of ____________________________________________________________________________________________________________________________________________________________________