AQUADEX SYSTEM 100, MODEL A1100

K040489 · Chf Solutions, Inc. · KDI · Apr 27, 2004 · Gastroenterology, Urology

Device Facts

• Record ID: K040489
• Device Name: AQUADEX SYSTEM 100, MODEL A1100
• Applicant: Chf Solutions, Inc.
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Apr 27, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The System 100 is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload.

Device Story

Aquadex System 100 removes excess fluid from patients with fluid overload via ultrafiltration. System consists of console on cart, proprietary software, and accessories including venous access catheters, extensions, and blood pump circuit. Patient access via peripheral or central veins. Clinician selects ultrafiltration rate; system performs ultrafiltration of blood across hollow-fiber hemofilter. Used in clinical settings; operated by clinicians. Output allows clinicians to manage patient fluid status; benefits patients by reducing fluid overload.

Clinical Evidence

Bench testing only. Data generated to validate software changes and catheter compatibility chart per ISO 14971:2000.

Technological Characteristics

High permeability hemodialysis system. Components: console, cart, blood pump circuit, venous access catheters, extensions. Hollow-fiber hemofilter. Software-controlled ultrafiltration rate. ISO 14971:2000 risk management applied.

Indications for Use

Indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.

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

• System 100 (K013733)
• PRISMA ™ CFM Systems (K981681)

Submission Summary (Full Text)

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Aquadex System 100 Adjustable Blood Flow Rate

APR 2 7 2004

## Attachment C

K04-0489

## 510(k) Summary

Prepared on February 25, 2004

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

| Trade Names: | Aquadex™ System 100 (trademark pending) | |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Manufacturer: | CHF Solutions, Inc., Suite 170 - 7601 Northland Drive, Brooklyn Park, MN<br>55428 | |
| Official<br>Contact: | Amy Peterson<br>Vice President, RA/QA/CR | Telephone: [phone]<br>Fax: [phone] |
| Device<br>Generic Name: | Aquadex™ System 100 | |
| Classification: | High permeability dialysis systems - classified as Class II | |
| Predicate<br>Devices: | System 100 (K013733) | PRISMA ™ CFM Systems (K981681) |
| Device<br>Description: | The Aquadex System 100 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<br>a 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: | System 100 is indicated for temporary (up to 8 hours) ultrafiltration<br>treatment of patients with fluid overload. | |
| Safety &<br>Performance: | Bench testing was performed to validate the software change and to<br>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 System 100 continues to be safe and<br>effective. | |
| Conclusion: | Based on the similar intended use, patient population, technology<br>characteristics, and performance as assessed with bench testing the<br>software revision has been shown to be safe and effective for its intended<br>use. This product is substantially equivalent7 and considered acceptable for<br>the intended use. | |

⁷ 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 and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 7 2004

Ms. Amy Peterson Vice-President RA/QA/CR CHF Solutions, Inc. Suite 170-7601 Northland Drive BROOKLYN PARK MN 55428

Re: K040489

Trade/Device Name: Aquadex System 100 and System 100 Ultrafiltration Catheter Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: 78 KDI Dated: April 1, 2004 Received: April 2, 2004

Dear Ms. Peterson:

We have reviewed your Scction 510(k) prematket 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 cither class II (Spccial 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 sct 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will and wyou've FDA finding of substantial equivalence of your device to a legally prematication. " www.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 If you desko specific of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Addition of Compliance at [phone]. 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 may be obtained from the Division of Small mioritactor on 300 consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/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

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

510(k) Number (if know): ___K04 04 8 9

Device Name: System 100 and System 100 Ultrafiltration Catheter

## FDA's Statement of the Indication For Use for Device:

The System 100 is indicated for temporary (up to eight hours) ultrafiltration treatment of patients with fluid overload.

(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)

Over-The-Counter Use

David R. Segerson

OR

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

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