MODIFICATION TO AQUADEX FLEXFLOW SYSTEM

{0}------------------------------------------------ OF 1 PAGE | | K062922 | |--|---------| |--|---------| 510(k) Summary (Prepared on September 26th, 2006) 10(k) Summary is submitted in accordance with 21 CFR 807.92. | | DEC 1 3 2006 | |--|--------------| |--|--------------| Aquadex FlexFlow™ System (trademark pending) CHF Solutions, Inc., Suite 170 - 7601 Northland Drive, Brooklyn Park, MN 55428 | Chris Scavotto | Telephone: 763-463-4621 | |----------------|-------------------------| | QA Director | Fax: 763-463-4606 | Ultrafiltration (Aquapheresis) System High permeability dialysis systems - classified as Class II Aquadex FlexFlow System (K060008) | Predicate<br>Devices: | Aquadex FlexFlow System<br>(K060008) | |--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device<br>Description: | The Aquadex FlexFlow System removes excess fluid from the patient in fluid<br>overload by ultrafiltration of blood across a hollow-fiber hemofilter at the<br>clinician selected rate. The system is comprised on a console mounted on a<br>cart, proprietary software and accessories (venous access catheters,<br>extensions and a blood pump circuit). Patient access is obtained via either<br>peripheral or central venous veins. | | Indication<br>for Use: | The Aquadex FlexFlowTM System is indicated for:<br>• Temporary (up to 8 hours) ultrafiltration treatment of patients with fluid<br>overload who have failed diuretic therapy, and<br>• Extended (longer than 8 hours) ultrafiltration treatment of patients with<br>fluid overload who have failed diuretic therapy and require hospitalization.<br>All treatments must be administered by a health care provider, under<br>physician prescription, both of whom having received training in<br>extracorporeal therapies. | | Safety &<br>Performance: | Regression testing was performed to verify and validate the software change<br>and to generate data in support of the labeling change which incorporates a<br>catheter compatibility chart using the principles of ISO 14971:2000 "Medical<br>devices - Application of risk management to medical devices. Data<br>generated demonstrated the Aquadex FlexFlow System continues to be safe<br>and effective. | | Conclusion: | Based on the similar intended use, patient population, technology<br>characteristics, and performance as assessed | This 510( Trade Names: Manufacturer: Generic Name: Classification: Official Contact: Device CHF Solutions, Inc. Aquadex FlexFlow Rev. K Software Update {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three swooping lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850 Mr. Chris Scavotto Director of Quality Assurance CHF Solutions, Inc. 7601 Northland Dr., Ste. 170 BROOKLYN PARK MN 55428 ## DEC 1 3 2006 Re: K062922 Trade/Device Name: Aquadex™ FlexFlow™ System Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: October 30, 2006 Received: November 13, 2006 Dear Mr. Scavotto: 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/1/Picture/10 description: The image is a black and white circular logo. The logo has the letters "FDA" in a stylized font in the center. Above the letters, the numbers "1906-2006" are printed. Below the letters, the word "Centennial" is printed. The logo is surrounded by a circular border with text. oling and Promoting Public Health {2}------------------------------------------------ Page 2 - 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 contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |----------------|----------------------------------|--------------| | 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 894.xxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrlv/industry/support/index.html. Sincerely yours, Nancy Cbrogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## INDICATIONS FOR USE STATEMENT (Page 1 of 1) 510(k) Number (if known): K06 2G 22 Device Name: Aquadex FlexFlow™ System ## FDA's Statement of the Indication For Use for Device: The Aquadex FlexFlow™ System is indicated for: - Temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload . who have failed diuretic therapy, and - Extended (longer than 8 hours) ultrafiltration treatment of patients with fluid . overload who have failed diuretic therapy and require hospitalization. All treatments must be administered by a health care provider, under physician prescription, both of whom having received training in extracorporeal therapies. (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) 辅导服务员服务服务员员会长谢谢谢谢谢谢谢谢谢谢谢何将导师来来自己是非常用发展的家庭家庭和新闻发展的新闻发展的新闻网络新闻网站地址的新闻信息和新闻信息和信息信息和信息发展的意思的网络信息 Concurrence of CDRH, Office of Device Evaluation (ODE) | Prescription Use | <div> / </div> | |----------------------|--------------------------------------------| | (Per 21 CFR 801.109) | | OR | Over-The-Counter Use | __________ | |----------------------|------------| |----------------------|------------| (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices | 510(k) Number | K062922 | |---------------|---------| |---------------|---------| CHF Solutions, Inc. Aquadex FlexFlow Rev. K Software Update