AQUADEX FLEXFLOW SYSTEM

K060008 · Chf Solutions, Inc. · KDI · Feb 2, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K060008
• Device Name: AQUADEX FLEXFLOW SYSTEM
• Applicant: Chf Solutions, Inc.
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Feb 2, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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.

Device Story

Aquadex FlexFlow System removes excess fluid from patients with fluid overload via ultrafiltration of blood across a hollow-fiber hemofilter. System includes console, cart, proprietary software, and blood pump circuit. Access via peripheral or central venous veins. Modification adds blood pump circuit with standard male/female luer adapter to allow optional integration of standalone hematocrit (Hct) monitor cuvette. Operated by trained healthcare providers in clinical settings. Output is controlled fluid removal; clinician monitors patient status and Hct levels to guide therapy. Benefits include effective fluid management for patients unresponsive to diuretics.

Clinical Evidence

Bench testing only. Testing validated the mechanical integrity and safety of the modified blood circuit (UF500) with the added luer junction for Hct monitor compatibility. No clinical data presented.

Technological Characteristics

High permeability hemodialysis system (Product Code KDI). Components include console, cart, venous access catheters, and blood pump circuit. Modification adds standard male/female luer adapter to withdrawal line. System utilizes extracorporeal ultrafiltration. Software-controlled pump system.

Indications for Use

Indicated for patients with fluid overload who have failed diuretic therapy, requiring temporary (≤8 hours) or extended (>8 hours) ultrafiltration treatment. Requires hospitalization for extended treatment. Must be administered by trained healthcare providers under physician prescription.

Regulatory Classification

Identification

A high permeability hemodialysis system is a device intended for use as an artificial kidney system for the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration, and hemodiafiltration. Using a hemodialyzer with a semipermeable membrane that is more permeable to water than the semipermeable membrane of the conventional hemodialysis system (§ 876.5820), the high permeability hemodialysis system removes toxins or excess fluid from the patient's blood using the principles of convection (via a high ultrafiltration rate) and/or diffusion (via a concentration gradient in dialysate). During treatment, blood is circulated from the patient through the hemodialyzer's blood compartment, while the dialysate solution flows countercurrent through the dialysate compartment. In this process, toxins and/or fluid are transferred across the membrane from the blood to the dialysate compartment. The hemodialysis delivery machine controls and monitors the parameters related to this processing, including the rate at which blood and dialysate are pumped through the system, and the rate at which fluid is removed from the patient. The high permeability hemodialysis system consists of the following devices:(1) The hemodialyzer consists of a semipermeable membrane with an in vitro ultrafiltration coefficient (K uf ) greater than 8 milliliters per hour per conventional millimeter of mercury, as measured with bovine or expired human blood, and is used with either an automated ultrafiltration controller or anther method of ultrafiltration control to prevent fluid imbalance.(2) The hemodialysis delivery machine is similar to the extracorporeal blood system and dialysate delivery system of the hemodialysis system and accessories (§ 876.5820), with the addition of an ultrafiltration controller and mechanisms that monitor and/or control such parameters as fluid balance, dialysate composition, and patient treatment parameters (e.g., blood pressure, hematocrit, urea, etc.). (3) The high permeability hemodialysis system accessories include, but are not limited to, tubing lines and various treatment related monitors (e.g., dialysate pH, blood pressure, hematocrit, and blood recirculation monitors).

Special Controls

*Classification.* Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Device—Part I: Evaluation and Testing,’ ” (2) “Guidance for the Content of 510(k)s for Conventional and High Permeability Hemodialyzers,” (3) “Guidance for Industry and CDRH Reviewers on the Content of Premarket Notifications for Hemodialysis Delivery Systems,” (4) “Guidance for the Content of Premarket Notifications for Water Purification Components and Systems for Hemodialysis,” and (5) “Guidance for Hemodialyzer Reuse Labeling.”

Predicate Devices

• Aquadex FlexFlow System (K050609)
• Hemametrics Blood Chamber and Blood Chamber tubing adaptor set CRIT-LINE III TQA Monitor (K982412 & K011741)

Submission Summary (Full Text)

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## 510(k) Summary (Prepared on December 30, 2005)

This 510(k) Summary is submitted in accordance with 21 CFR 807.92.

| Trade Names: | Aquadex FlexFlow™ System (trademark pending) |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | CHF Solutions, Inc., Suite 170 - 7601 Northland Drive,<br>Brooklyn Park, MN 55428 |
| Official<br>Contact: | Chris Scavotto<br>QA Manager<br>Telephone: [phone]<br>Fax: [phone] |
| Device<br>Generic Name: | Ultrafiltration (Aquapheresis) System |
| Classification: | High permeability dialysis systems - classified as Class II |
| Predicate<br>Devices: | Aquadex FlexFlow System<br>(K050609)<br><br>Hemametrics Blood Chamber and Blood<br>Chamber tubing adaptor set CRIT-LINE<br>III TQA Monitor<br>(K982412 & K011741) |
| 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. This 510(k) is to add an alternate blood<br>pump circuit which has a standard male and female luer adapter just before<br>the filter on the withdrawal line to allow the optional use of a blood chamber<br>cuvette to interface with a stand alone Hct monitor. |
| Indication<br>for Use: | The Aquadex FlexFlow™ 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: | Bench tests were performed to validate the incorporation of the blood<br>chamber placement in-line on the withdrawal line of the blood circuit. No<br>software change was required. The data demonstrated the Aquadex<br>FlexFlow System continues to be safe and effective. |
| Conclusion: | Based on the similar intended use, patient population, technology<br>characteristics, and performance as assessed with bench testing the alternate<br>UF500 blood circuit (PN A1700) has been shown to be safe and effective, is<br>substantially equivalent‡ and considered acceptable for the intended use. |

⁴ This document uses the term "substantial equivalent" as intended in 21 CFR 807.87 and not as defined in Title 36 of the U.S. Code.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing the bird's body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 2006

2006

Mr. Chris Scavotto Quality Assurance Manager CHF Solutions, Inc. 7601 Northland Drive, Suite 170 BROOKLYN PARK MN 55428

Re: K060008

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: December 30, 2005 Received: January 3, 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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.

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Page 2 - Mr. Chris Scavotto

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 (21 CFR Part 807); 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 the labeling regulation, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 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 [phone] or [phone], or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Daniel R. Lyman

Nancy C.
Director,
Abdomi

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT (Page 1 of 1)

510(k) Number (if know): __Kf85_Kolg0008

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) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Daniel C. Lynam

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

CHF Solutions, Inc. UF500 with Luer Junction & Hct Adaptor