FRESENIUS ULTRAFLO HPX HEMODIALYZER

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows a geometric shape that resembles a three-tiered funnel or inverted pyramid. Each tier is defined by thick, dark lines, creating a stacked appearance. The tiers decrease in size from top to bottom, converging to a point at the bottom of the shape. The overall design is simple and graphic, with a focus on the geometric form. KO34064 ## Fresenius Medical Care Fresenius Ultraflo HPX Single Use Hemodialyzer "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>Lexington, MA 02420 | | Phone: | 1-781-402-9068 | | Fax: | (781) 402-9635 | | Contact Person: | Arthur Eilinsfeld, Director of Regulatory Affairs | | Date of Preparation: | 29 December 2003 | #### B. Device Name: | Common Name: | Dialyzer, High Permeability with or without Sealed Dialysate System | |------------------------------------|---------------------------------------------------------------------| | Product Code/Classification Panel: | 78KDI/Gastroenterology-Urology | #### C. Predicate Device The predicate devices for the Fresenius Ultraflo HPX Hemodialyzer are: - Fresenius Optiflux 200NR #K002277 (8/25/00); . - Fresenius Ultraflux #K031378 (5/30/03). . {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the Fresenius Medical Care logo. The logo consists of a stylized funnel shape above the text "Fresenius Medical Care". The funnel is made up of several horizontal lines that decrease in length from top to bottom, creating a perspective effect. K034064 #### Fresenius Ultraflo HPX Sinqle Use Hemodialyzer "Special" 510(k) Premarket Notification ## Summary of Safety and Effectiveness #### D. Indications for Use: The Fresenius Ultraflo HPX dialyzer is designed for single use acute and chronic hemodialysis. #### E. Substantial Equivalence: #### 1. Is the product a device? YES - The Ultraflo HPX dialyzers 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 Ultraflo HPX is identical to that for the Optiflux 200NR and Ultraflux and is as follows: #### Intended Use for Ultraflux The Fresenius Ultraflo HPX dialyzer is designed for single use acute and chronic hemodialysis. #### Intended Use for Optiflux 200NR Optiflux 200NR dialyzers are designed for single use acute and chronic hemodialysis. #### Intended Use for Ultraflux The Fresenius Ultraflux dialyzer is designed for single use acute and chronic hemodialysis. #### 3. Does the device have technological characteristics that raise new types of safety or effectiveness questions? NO - The Ultraflo HPX dialyzers are equivalent in materials, sterilization and indications for use to the currently manufactured Optiflux 200NR and Ultraflux dialyzers. The technological characteristics of the Ultraflo HPX dialyzers are equivalent to those of the Optiflux 200NR and Ultraflux and raise no new types of safety or effectiveness questions. {2}------------------------------------------------ KO3406A # Fresenius Medical Care ## Fresenius Ultraflo HPX Single Use Hemodialyzer "Special" 510(k) Premarket Notification ## Summary of Safety and Effectiveness #### 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 Ultraflo HPX dialyzers and demonstrates that it is substantially equivalent to the Optiflux 200NR and Ultraflux. #### F. Safety Summary The Ultraflo HPX dialyzers are substantially equivalent in construction, design, materials, and intended use to the commercially available Fresenius Optiflux and Ultraflux hemodialyzers. In addition, testing of Ultraflo HPX dialyzers indicates that they are safe and effective for their intended use. In vitro testing was performed to determine the following: priming volume, bloodside and dialysate-side pressure drops, ultrafiltration coefficient, urea clearance, creatinine clearance, Vitamin B12 clearance, phosphate and lysozyme clearance. No clinical testing was performed. #### G. General Safety and Effectiveness Concerns The device labeling contains a Package Insert, which includes indications for use, cautions and warnings, as well as the general operating instructions required for proper use of the device. This information promotes safe and effective use of the dialyzer. {3}------------------------------------------------ Image /page/3/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is black and the background is white. JAN 3 0 2004 Ms. Nichole Riek Regulatory Affairs Supervisor Frescnius Medical Care North American Two Ledgemont Center 95 Hayden Avenue LEXINGTON MA 02173 Re: K034064 Trade/Device Name: Fresenius Ultraflo HPX Single Use Hemodialyzer Regulation Number: 21 CFR 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: 78 KDI Dated: December 29, 2003 Received: December 31, 2003 Dear Ms. Riek: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becare in (a) the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encream. 776, 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, de noos that have been require approval of a premarket approval application (PMA). and Cosmote Fee (110) the device, subject to the general controls provisions of the Act. The I ou may, distore, mains of the Act include requirements for annual registration, listing of general controls provision gractice, 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 i lease of advisou that i Dr instian that your device complies with other requirements of the Act that I Dr Has Interes and regulations administered by other Federal agencies. You must of any I edetar statures and regularents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set (21 CFR Party) accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic rordline and quality by overse (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 his letter will anow you to begin mative. 3 > prematication. The PDF intellight 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 If you destle specific advice tor your do to the following numbers, based on the regulation number at the top of the letter: | 8xx. 1xxx | (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 advertising of your device, please contact the Additionally, for questions on the prosse note the regulation entitled, "Misbranding Onlice of Compliance at (501) 57 - 155 (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your responsional and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Obliess http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, Nancy C. Brogdon Nancy C. I rogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure Page 2 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a geometric shape resembling an inverted pyramid or funnel, with horizontal lines inside. Below the shape, the text "Fresenius Medical Care" is written in a clear, sans-serif font. ## Fresenius Ultraflo HPX Single Use Hemodialyzer "Special" 510(k) Premarket Notification ## Indications for Use Statement #### Device Name: Fresenius Ultraflo HPX Hemodialyzers #### Indications for Use: The Fresenius Ultraflo HPX dialyzer is designed for single use acute and chronic hemodialysis. #### PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number K034064 000035