FRESENIUS 2008T HEMODIALYSIS MACHINE

K120505 · Fresenius Medical Care North America, Design Cente · KDI · Mar 6, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K120505
• Device Name: FRESENIUS 2008T HEMODIALYSIS MACHINE
• Applicant: Fresenius Medical Care North America, Design Cente
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Mar 6, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Fresenius 2008T Hemodialysis Machine is indicated for acute and chronic dialysis therapy.

Device Story

The Fresenius 2008T Hemodialysis Machine is a hemodialysis delivery system used in clinical settings to treat patients with acute or chronic kidney failure, fluid overload, or toxemic conditions. The device controls and monitors extracorporeal blood circuits and dialysate circuits. Blood is circulated from the patient through a dialyzer, where toxins are removed via a semi-permeable membrane, and returned to the patient. The system monitors arterial/venous pressures and detects air/blood. It supports hemodialysis, hemofiltration, and hemo-concentration using low or high flux dialyzers. The user interface includes a keyboard, touchpad, and touchscreen, allowing clinicians to manage therapy settings and view status indicators. Modifications include visual status indicators for Heparin and Sodium Variation System (SVS), a dialysate flow button, application identification, and configuration transfer tools. A dual-band wireless adapter supports network connectivity for an optional MDDS program. The device provides clinicians with real-time monitoring and control of dialysis parameters, facilitating safe and effective treatment delivery.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including software verification (functional tests, regression, safety systems verification), simulated dialysis treatment, production test procedures, unstructured/static code verification, and summative usability testing. All tests met pre-determined acceptance criteria.

Technological Characteristics

High permeability hemodialysis system; Class II. Features extracorporeal blood circuit monitoring (pressure, air, blood detection). Connectivity via dual-band (2.5GHz/5GHz) wireless adapter (802.11a/b/g/n). Software-controlled user interface (keyboard, touchpad, touchscreen). No changes to hardware, therapy settings, or fundamental performance limits compared to predicate.

Indications for Use

Indicated for patients with acute or chronic kidney failure, fluid overload, or toxemic conditions requiring hemodialysis, hemofiltration, or hemo-concentration therapy.

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

• Fresenius 2008T Hemodialysis Machine (K113427)

Submission Summary (Full Text)

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Fresenius Medical Care

MAR - 6 2012

K120505
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2008T Hemodialysis Machine Special 510(k) Notification

# 510(k) Summary

This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR Part 807.92.

| Name: | Fresenius Medical Care North America |
|----------------------|--------------------------------------------------------------------------------------------|
| Address: | 920 Winter Street<br>Waltham, MA 02451-1457 |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Denise Oppermann, Senior Director<br>Regulatory Affairs - Devices<br>Renal Therapies Group |
| Date of Preparation: | 17 February 2012 |

# Submitters Information

## Device Name

| Trade Name: | Fresenius 2008T Hemodialysis Machine |
|------------------------------------|---------------------------------------|
| Common Name: | Hemodialysis Delivery System |
| Classification Name: | High Permeability Hemodialysis System |
| Classification Number: | Class II per § 876.5860 |
| Product Code/Classification Panel: | 78KDI/Gastroenterology/Urology Panel |

# Legally Marketed Predicate Device (Unmodified Device)

Fresenius 2008T Hemodialysis Machine (K113427).

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### Device Description

The Fresenius 2008T Hemodialysis Machine (K113427) is indicated for acute and chronic dialysis therapy. It is designed to provide hemodialysis treatment by controlling and monitoring both the dialysate and extracorporeal blood circuits. In the extracorporeal blood circuit, blood is continuously circulated from the patient through a dialyzer, where toxins are filtered out through a semi-permeable membrane, and returned to the patient. During this process, the extracorporeal blood circuit is monitored for venous and arterial blood pressures, and for the presence of air and blood.

The display screen of the 2008T Hemodialysis Machine is shared between the hemodialysis machine and the CDX PC (optional) running the third party MDDS (Medical Device Data Systems) program. The blue CDX Key located on the fold-down keyboard allows switching between the Dialysis Screen and the MDDS screen. The user interface of the 2008T machine which includes a keyboard, touchpad and touch-screen, is operational in both the dialysis mode and the CDX mode, whichever is actively displayed.

Modifications to the previously cleared 2008T Hemodialysis Machine include:

- . Heparin and Sodium Variation System (SVS) Status: Addition of visual indication (display) on the home screen and dialysate screen.
- . Dialysate Flow Button: Addition of Dialysate Flow ON-OFF button in the Dialysate Screen.
- Applications Installed Display: Addition of text identifying which applications . (Apps) have been loaded is added to the machine's opening screen.
- Configurator: Software modification to support the transfer of machine . configuration information between machines during installation or upgrade in service mode.
- . Sodium Variation System (SVS) as an Optional Feature: Addition of SVS selection in service mode to make the existing SVS feature optional.

The following modification was implemented following a regulatory assessment that the change did not affect the fundamental scientific technology or intended use of the device. Based on FDA guidance "Deciding When to Submit a 510(k) for a Change to an Existing

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Fresenius Medical Care

2008T Hemodialysis Machine Special 510(k) Notification

Device", Fresenius Medical Care North America determined that this modification did not necessitate a 510(k) submission:

- Wireless Adapter: A dual band (i.e. 2.5Ghz and 5Ghz) wireless adapter provides the . wireless network link for the CDX PC, and supports 802.11a/b/g/n. This new wireless adapter replaces the obsolete wireless adapter (unmodified device) and maintains the latest wireless technology.
Additionally, this submission includes minor maintenance modifications made to the Functional Board Software (V.2.34) of the 2008T Hemodialysis Machine since the last clearance (K113427).

Treatment modalities for the modified Fresenius 2008T Hemodialysis Machine remain identical to those for the unmodified 2008T (K113427):

The 2008T Hemodialysis Machine is a hemodialysis system used for the treatment of patients with acute or chronic kidney failure, fluid overload or toxemic conditions. Therapies include hemodialysis, hemofiltration and hemo-concentration. The 2008T Hemodialysis Machine will accommodate the use of both low flux and high permeability, high flux dialyzers.

## Indications for Use

Fresenius 2008T Hemodialysis Machine is indicated for acute and chronic dialysis therapy.

## Technological Characteristics

There are no changes to the technological characteristics of the unmodified Fresenius 2008T Hemodialysis Machine. The modified Fresenius 2008T Hemodialysis Machine that is the subject of this submission incorporates software modifications to address user preferences and provide additional user convenience (ease of use).

These modifications do not impact the safety and effectiveness of the device. These software modifications do not expand the capability or change the performance of the 2008T Hemodialysis Machine (K113427) and its intended use/indications for use. The

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Image /page/3/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a stylized image of a funnel or inverted pyramid above the text "Fresenius Medical Care". The funnel is made up of several horizontal lines that decrease in size as they go down, creating a three-dimensional effect.

modified device is equivalent to the un-modified device in terms of water requirements, module options, functional options, performance limits, control parameters, compatible bloodlines, and language options.

The following technical specifications of the modified device remain the same as the unmodified device:

- Safety system .
- System performance .
- Environmental Requirements .
- Transportation and Storage condition ●
- User Interface (except proposed modifications) .
- Hardware and therapy settings .
- Accessories .
- Environmental Design �
- . Alarms
- Accuracy and Controls ●
- Protection against Mechanical Hazard .
- . Protection against Electrical Hazard
- . Protection against excessive temperature or other hazards
- Manufacturing location and manufacturing processes (assembly, fabrication, testing, . shipping, installation and service).

A risk analysis has been completed and potential hazards associated with the modifications are identified and mitigated. Mitigations are verified wherever applicable. All potential risks were deemed acceptable after mitigation. Performance and safety tests were conducted to ensure the safety and effectiveness of the device after the proposed modifications.

### Performance Data

The performance of the modified device was evaluated according to existing FMCNA procedures, protocols, declared performance standards and guidelines of the quality system regulation (21 CFR 820). Design verification and validation tests were conducted to

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K120505
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ensure that the modifications described in this submission did not affect the essential performance of the device and the device functions as intended.

The following tests were conducted:

#### Software Verification and Validation Testing

- . Software Verification (Functional Tests)
- . Regression
- Safety Systems Verification
- Simulated Dialysis Treatment ●
- . Production Test Procedure
- Unstructured and Static Code Verification .

#### Summative Usability Testing

# Conclusion

Test results demonstrated that the modified 2008T Hemodialysis Machine functions as intended and met pre-determined acceptance criteria. Results of functional validation, summative usability testing and risk analysis indicate that the modified Fresenius 2008T Hemodialysis Machine is substantially equivalent to the named predicate device and remains safe and effective for its intended use.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

Ms. Denise Oppermann Senior Director, Regulatory Affairs Devices Fresenius Medical Care, North America 920 Winter Street WALTHAM MA 22451

MAR - 6 2012

Re: K120505

Trade/Device Name: Fresenius 2008T Hemodialysis Machine Regulation Number: 21 CFR§ 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: February 17, 2012 Received: February 21, 2012

Dear Ms. Oppermann:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass surfal 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). and Oosmeter Fror (110) has the device, subject to the general controls provisions of the Act. The r ou may, merelove, manel of the Act include requirements for annual registration, listing of general controls proficiting practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adunction. Ticase note: UDTC: 00101 2014 16:00 abeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your device is elassinod por ols. 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 round in the South of receivents concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc advised that I Dris blocking or our device complies with other requirements of the Act that I Dri has made a actuations administered by other Federal agencies. You must or any I ouch statules undersgaements, including, but not limited to: registration and listing Configry with an the Not 1-og (21 CFR Part 801); medical device reporting (reporting of medical

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device-related 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.

Sincerély yours,

Sincerely yours,

Benjamin K. Evanko

Benjamin R. Fisher, Ph.D. Director 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 Statement

510(k) Number (if known):

Device Name: Fresenius 2008T Hemodialysis Machine

Indications for Use:

Fresenius 2008T Hemodialysis Machine is indicated for acute and chronic dialysis therapy.

20505

XPrescription Use (Per 21 CFR 801 Subpart D)

AND/OR

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

Harles Henry

ision Sign-Off) of Reproductive, Gastro-Renal, and 20.505