FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573

K101715 · Fresenius Medical Care North America, Design Cente · KDI · Dec 21, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K101715
• Device Name: FRESENIUS 2008T HEMODIALYSIS MACHINE MODEL 190573
• Applicant: Fresenius Medical Care North America, Design Cente
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Dec 21, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fresenius bibag system is used with Fresenius three stream proportioning hemodialysis systems equipped with the bibaq module such as the 2008T Hemodialysis Machine and is intended for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibaq is intended for extracorporeal bicarbonate hemodialysis according to a physician's prescription.

Device Story

The Fresenius 2008T Hemodialysis Machine with bibag system is a modified hemodialysis delivery system. It incorporates a bibag module and a single-use, sealed bibag containing USP grade dry sodium bicarbonate powder. The system automates the mixing of AAMI grade water with the dry powder to produce a saturated sodium bicarbonate solution on-line, replacing traditional liquid bicarbonate concentrates. The bibag disposable attaches to nozzles on a specialized connector on the machine. The device performs three-stream proportioning to deliver de-aerated dialysate at controlled conductivity, temperature, and pressure. It is intended for use in clinical settings by trained operators to treat renal failure. The healthcare provider uses the machine to deliver prescribed hemodialysis therapy, benefiting the patient by providing an automated, on-line method for bicarbonate concentrate preparation.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included full system validation, software regression testing, EMC testing per IEC 60601-1-2 (2007), and electrical safety testing per UL 60601-1 and CAN/CSA-C22.2 No. 601.1-M90. Bibag disposable testing included USP dissolution, bioburden/endotoxin per USP & AAMI RD61:2006, and biocompatibility per USP 32-NF26 <88>.

Technological Characteristics

Hemodialysis delivery system with three-stream proportioning. Materials: bibag disposable materials tested per USP 32-NF26 <88>. Connectivity: Standalone hemodialysis machine. Standards: IEC 60601-1-2 (2007) for EMC; UL 60601-1 and CAN/CSA-C22.2 No. 601.1-M90 for electrical safety; AAMI RD61:2006 for bioburden/endotoxin. Features: Automated on-line bicarbonate mixing module.

Indications for Use

Indicated for patients with acute or chronic renal failure requiring extracorporeal bicarbonate hemodialysis. Use is restricted to prescription by a physician.

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

• Gambro BiCart® (K013724)
• Gambro BiCart® System (K873155)
• Fresenius 2008T hemodialysis machine (K093902)

Submission Summary (Full Text)

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# Fresenius Medical Care

DEC 2 1 2010

## A. Submitter's Information:

| Name: | Fresenius Medical Care North America |
|----------------------|-------------------------------------------------------|
| Address: | 920 Winter Street<br>Waltham MA 02451 |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Randolph Quinn, Lead Regulatory Affairs<br>Specialist |
| Date of Preparation: | June 16, 2010 |

## B. Date Summary Prepared: June 16, 2010

- C. Device Name:

| Propriety/Trade Name: | Fresenius 2008T Hemodialysis Machine<br>with bibag™ System |
|------------------------------|------------------------------------------------------------|
| Common/Usual Name | Hemodialysis delivery system |
| Classification Name: | High permeability hemodialysis system |
| Classification Number: | Class II 876.5860 |
| Product Code/Review<br>Panel | KDI/Gastroenterology/Urology Panel |

## C. Predicate Device Name:

- Gambro BiCart® (K013724, 1/8/02) .
- . Gambro BiCart® System (K873155, 10/26/87)
- . Fresenius 2008T hemodialysis machine (K093902, 5/27/2010)

## Fresenius Medical Care North America

Corporate Headquarters: 920 Winter Street Waltham, MA 02451 [phone]

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### D. Device Description:

The Fresenius 2008T Hemodialysis Machine with bibag System is the cleared 2008T Hemodialysis Machine that has been modified to enable use of a specialized, single use, sealed bag (the "bibaq") containing USP grade dry sodium bicarbonate powder to produce a saturated solution of sodium bicarbonate. The addition of the bibag system to the hemodialysis machine allows operators the option of producing a saturated sodium bicarbonate solution on-line through automated mixing of AAMI grade water and dry sodium bicarbonate powder within the bibag source disposable rather than with liquid bicarbonate concentrates. The bibag system is comprised of: (1) the bicarbonate concentrate generator (known as the bibag module); and (2) the bag of dry sodium carbonate concentrate. A specialized bibag connector (is attached? to the hemodialysis machine.] The bibag disposable hangs on two nozzles located in the bibag connector.

### E. Intended Use:

The Fresenius bibag system is used with Fresenius three stream proportioning hemodialysis systems equipped with the bibaq module such as the 2008T Hemodialysis Machine and is intended for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibaq is intended for extracorporeal bicarbonate hemodialysis according to a physician's prescription.

## F. Technological Characteristics:

The technological characteristics of the Fresenius 2008T hemodialysis machine with bibag system are equivalent to those of the BiCart, BiCart System and 2008T hemodialysis machine. Both the Fresenius 2008T hemodialysis machine with bibag system and the BiCart System prepare on-line bicarbonate from a single use dry powder container, proportion bicarbonate concentrate as part of a three stream bicarbonate proportioning system using AAMI grade water, and deliver de-aerated dialysate fluid at the desired conductivity, temperature, and specified pressure. There are no new types of safety and effectiveness questions presented by the modifications made to the 2008T hemodialysis machine to accommodate the bibag system.

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## G. Performance Testing:

Verification and validation testing were performed to ensure that the bibag system, including the bibag dry sodium bicarbonate (disposable), and the modified 2008T hemodialysis machine function as intended and that the modifications did not impact the essential performance of the 2008T hemodialysis machine. Testing included :

- 1. Full system validation and software regression testing were performed. Testing included:
- · Software validation and regression testing
- · Electromagnetic compatibility (EMC) testing
- · Electrical safety testing
- System performance testing using bibag dry bicarbonate concentrate

The results from the testing demonstrated that all modifications functioned as intended and met pre-determined acceptance criteria. The essential performance of the hemodialysis machine has not been impacted by the modifications.

- 2. Electromagnetic compatibility testing (EMC) was conducted according to the IEC 60601-1-2 (2007) Class A Testing. The modified 2008T hemodialysis machine with bibag system met the requirements of IEC 60601-1-2 (2007).
- Electrical safety testing was conducted according to the following standards: 3.
- · UL 60601-1, 1st Edition,2006-04-26, (Medical Electrical Equipment, Part 1:General Requirements for Safety)
- · CAN/CSA-C22.2 No. 601.1-M90, 2005, (Medical Equipment Electrical Equipment, Part 1: General Requirements for Safety)

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The modified 2008T hemodialysis machine with was found to comply with the above standards.

- 4. Testing of the bibag disposable included:
- a) Dissolution testing per USP requirements
- b) Bioburden & Endotoxin testing per USP & AAMI RD61:2006
- c) Biocompatibility testing of the bibag materials per USP 32-NF26 biological tests <88>

#### H. Conclusions

The results from the testing conducted demonstrated that both the bibag system, including the bibag disposable, and the modified 2008T hemodialysis machine functioned as intended and met pre-determined acceptance criteria.

The Fresenius 2008T hemodialysis machine with bibag system was validated. The results of functional and software validation, performance testing, biocompatibility testing, risk analysis, and usability testing indicate that the Fresenius 2008T hemodialysis machine with bibag system is substantially equivalent to the named predicate devices and is safe and effective for its intended use.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized image of an eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle image.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Mr. Randy Quinn Lead Regulatory Affairs Specialist Renal Therapies Group Fresenius Medical Care North American Corporate Headquarters 920 Winter Street WALTHAM MA 02451

DEC 2 1 2010

Re: K101715

Trade/Device Name: 2008T Hemodialysis Machine with bibag™ system Regulation Number: 21 CFR §876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Codes: KDI and KPO Dated: December 14, 2010 Received: December 15, 2010

Dear Mr. Quinn:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading:

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); medical device reporting of medical device-related

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adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Richard Lemon MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive. Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

@EC 2 1 2010

510(k) Number (if known): K101715

Device Name: 2008T Hemodialysis Machine with bibag™ system

Indications for Use:

The Fresenius bibag system is used with Fresenius three stream proportioning hemodialysis systems equipped with the bibaq module such as the 2008T Hemodialysis Machine and is intended for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag is intended for extracorporeal bicarbonate hemodialysis according to a physician's prescription.

Prescription Use X - AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Halus Leen

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