The modified Fresenius 2008T Hemodialysis Machine has the same indications for use as the unmodified device. It is indicated for acute and chronic dialysis therapy.

Device Description

The Fresenius 2008T Hemodialysis Machine (K093902) 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, the blood is continuously circulated from the patient through a dialyzer, where toxins are filtered out through a semi-permeable membrane before being 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. In the dialysate circuit, the dialysate acid and bicarbonate concentrates are mixed with purified water in predefined ratios, heated, degassed, and delivered to the dialyzer. Balancing chambers ensure that the incoming flow of the dialysate is volumetrically equal to the outgoing flow in order to control ultrafiltration from the patient.

AI/ML Overview

The provided application describes the integration of several modifications to the Fresenius 2008T Hemodialysis Machine (K093902), focusing on ergonomic enhancements and reliability for the user/operator interface. These modifications include a touch screen user interface (activation of existing functionality), a dialysate sample port, a modified shunt interlock system and Hansen connectors, a larger wheel lock pedal, and a reset board.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly list quantitative acceptance criteria in a dedicated table. Instead, it describes various tests conducted to ensure the safety and effectiveness of the modified device and confirms that the device "met pre-determined acceptance criteria." For each modification, a set of tests was performed to verify its functionality, safety, and compatibility with the existing system. The "performance" column below summarizes the type of testing described.

Component Modified	Acceptance Criteria	Reported Device Performance
Touch Screen	Ensure functional accuracy, software reliability, and user-friendliness of the activated touch screen interface.	Functional Verification: Performed to confirm the touch screen operates as intended. Software Validation: Conducted to ensure the software driving the touch interface is reliable and correct. Usability Testing: Performed to assess user interaction and ease of use.
Dialysate Sample Port	Verify chemical compatibility, structural integrity under pressure, absence of residual chemicals, and biocompatibility.	Fluid Path Chemical Testing: Ensured no adverse chemical interactions with the dialysate. Surface Disinfect Chemical Testing: Verified compatibility with disinfectants. Pressure Holding Testing: Confirmed the port maintains integrity under pressure. Residual Chemical Testing: Demonstrated no harmful residues. Aging Test: Assessed long-term durability. Biocompatibility: Confirmed material safety for patient contact. Usability Testing: Assessed ease of sample collection.
Modified Shunt Interlock System & Hansen Connectors	Ensure chemical compatibility, structural integrity, cycle durability, shipping resilience, electrical safety, and biocompatibility.	Fluid Path Chemical Testing: Ensured no adverse chemical interactions. Surface Disinfect Chemical Testing: Verified compatibility with disinfectants. Cycle Testing: Evaluated durability over repeated connections/disconnections. Strength Testing: Assessed mechanical robustness. Shipping Testing: Verified integrity after transportation. Safety Testing: Ensured overall safe operation. Pressure Holding Testing: Confirmed integrity under pressure. Residual Chemical Testing: Demonstrated no harmful residues. Shunt Electrical Testing: Verified proper electrical function. Aging Test: Assessed long-term durability. Biocompatibility: Confirmed material safety. Usability Testing: Assessed ease of use and connection.
Wheel Lock Pedal	Verify durability, mechanical strength, and user-friendliness of the enlarged pedal.	Cycle Testing: Evaluated durability over repeated locking/unlocking. Strength Testing: Assessed mechanical robustness. Usability Testing: Performed to assess ease of use for locking/unlocking. Safety Testing: Ensured reliable and safe operation.
Reset Board	Ensure functional correctness, reliable communication, and mitigation of static discharge issues.	Functional Validation: Confirmed the board performs its intended reset function. Simulated Dialysis Treatment: Tested the board's function during a typical treatment. Unstructured Testing (foreseeable misuse): Evaluated behavior under non-standard conditions. Production Testing: Ensured quality in manufacturing. Regression Testing: Confirmed existing functionalities were not negatively impacted. ESD (Electrostatic Discharge) Testing: Verified protection against static discharge to mitigate the "missing cursor" error.

Summary Conclusion on Performance: "Test results demonstrated that the modified 2008T Hemodialysis Machine functioned as intended and met pre-determined acceptance criteria."

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify exact sample sizes for the test sets used for each of the performance tests. It broadly mentions "Design verification and validation testing" and lists the types of tests conducted.

The provenance of the data is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) submission for device modifications, these tests would typically be performed internally by the manufacturer (Fresenius Medical Care North America, located in Waltham, MA, USA), likely in a controlled, prospective manner using newly manufactured or modified device components.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not explicitly state the number of experts used or their specific qualifications for establishing ground truth. Usability testing is mentioned for several components (Touch Screen, Dialysate Sample Port, Modified Shunt Interlock System & Hansen Connectors, Wheel Lock Pedal), which implies user feedback was gathered to assess ease of use and functional design from the perspective of intended users (e.g., nurses, technicians operating the machine). However, the details of these "experts" (users) are not provided. Other tests, such as chemical testing, strength testing, and electrical testing, would have been conducted by engineers and laboratory personnel with relevant expertise.

4. Adjudication Method for the Test Set:

The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The nature of the tests (functional, chemical, mechanical, electrical, software validation) suggests that results were determined by objective measurement and verification against predetermined specifications, rather than subjective interpretation requiring multi-expert adjudication. Usability testing would involve collecting feedback, but the method for resolving conflicting feedback or formal adjudication is not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The modifications are primarily ergonomic and reliability-focused for device operation, not related to interpretive diagnostic tasks that would typically involve human readers and require such a study (e.g., medical imaging AI). Therefore, there is no information about the effect size of human readers improving with or without AI assistance.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

The device is a hemodialysis machine, which is a life-support system with direct physical interaction and monitoring by human operators. The changes described are enhancements to the user interface and mechanical components. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" as typically applied to AI-driven diagnostic tools is not directly relevant here. The device's operation inherently involves human interaction for setup, monitoring, and intervention. Software validation and functional verification were performed on the embedded software for the touch screen and reset board, which can be considered "standalone" in verifying the code's function, but this is within the context of hardware interaction rather than an independent diagnostic algorithm.

7. Type of Ground Truth Used:

The ground truth for the various tests would be based on:

Engineering specifications and design requirements: For functional, mechanical, and electrical tests (e.g., pressure holding, cycle testing, strength, electrical testing for the shunt, software validation).
Chemical and biological standards: For fluid path chemical testing, surface disinfectant chemical testing, residual chemical testing, and biocompatibility.
User expectations/standards: For usability testing (e.g., ease of use, intuitive navigation).
Industry standards: Such as ISO 8637;2004 mentioned for the Hansen connector.
Regulatory requirements: For safety testing and risk analysis.

Ultimately, the goal was to ensure the modified device maintained "essential performance" and "functioned as intended," aligning with the predicate device's established performance and safety profile.

8. Sample Size for the Training Set:

The document does not describe any machine learning or AI components that would require a distinct "training set" in the conventional sense. The "software validation" and "functional verification" tests are for embedded software that controls the device's operation, not for adaptive learning algorithms. Therefore, there is no mention of a training set sample size.

9. How the Ground Truth for the Training Set Was Established:

As there is no mention of a "training set" in the context of machine learning, this question is not applicable. The software was validated against pre-defined functional specifications and performance requirements established through engineering design, risk analysis, and regulatory standards.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows a date, "OCT 21 2011". The month is October, the day is the 21st, and the year is 2011. The text is in a bold, sans-serif font.

K111639
page 1 of 5

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

Submitter's Information I. Fresenius Medical Care North America Name: 920 Winter Street Address: Waltham, MA 02451-1457 (781) 699-4479 Phone: Fax: (781) 699-9635 Denise Oppermann, Senior Director Regulatory Affairs - Devices Contact Person: Renal Therapies Group 10 June 2011 Date of Preparation:

J. Device Name
Fresenius Medical Care

Trade Name:	Fresenius 2008T Hemodialysis Machine
Common Name:	Hemodialysis Machine
Product Code/Classification Panel:	78 KDI/Gastroenterology/Urology Panel
Classification Name:	Class II per § 876.5860

K. Legally Marketed Predicate Device (unmodified device)

Fresenius 2008T Hemodialysis Machine (K093902).

Device Description L.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a stylized funnel shape above the text "Fresenius Medical Care". The funnel is made up of several horizontal lines that decrease in width as they approach the bottom of the funnel.

Modifications to the previously cleared 2008T Hemodialysis Machine include:

4) Touch screen user interface:

The display screen is a component of the control panel located at the top front section of the 2008T Hemodialysis machine. It provides a means of setting treatment parameters and monitoring the treatment and patient status during dialysis. The navigation system software for the touch screen user interface was embedded in the 2008T Hemodialysis Machine since the last 510(k) clearance (K093902). FMCNA intends to activate the use of touch screen functionality for enhanced navigation and user interface. There is no change in the functions of the any of the components of the control panel except the use of touch screen. There are no hardware or software changes required to activate the use of the touch screen navigation. The 15-inch LCD, touch-capable display screen is the same as that previously cleared with the 2008T Hemodialysis Machine (K093902).

The following modifications were implemented following a regulatory assessment that the changes 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 Device", Fresenius Medical Care North America determined that the modifications described below did not necessitate a 510(k) submission.

ર) Dialysate Sample Port:

The dialysate sample port is a special connector designed to mount on the dialyzer supply line. It allows the operator/nursing staff to conveniently draw a dialysate sample to test for conductivity, pH, and residual disinfectant before each dialysis treatment.

Shunt Interlock System and modified Hansen Connector: 6)

The dialyzer supply line (blue) and the dialyzer return line (red) connect to the hydraulics of 2008T hemodialysis machine through a shunt interlock during disinfection and between dialysis treatments. The Hansen connector is a part of the dialysate line. It is a standard connector, specified in ISO 8637;2004, for connecting a dialysate line to the dialysate port of the dialyzer. The Hansen connectors are modified with new "trigger" style easy grip handles, facilitating one-handed operation. This makes the shunt interlock system easier to use. The design features all-plastic construction with a recessed profile and plastic cover. The shunt interlock is located away from IV Pole (lower and rearward) on the side of machine. This change necessitated a modification to the IV support pole

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the text "K111639 page 3 of 5" in a handwritten style. The text appears to be a page number or document identifier. The numbers are written in a clear and legible manner.

Fresenius Medical Care

2008T Hemodialysis Machine Special 510(k) Notification

location on the machine. There is no change in the electronic circuitry from the previously cleared 2008T hemodialysis machine.

4) Wheel Lock Pedal

The surface area of the wheel lock pedal was made larger for ease of use.

Reset Board 5)

The reset board was added to the current 2008T UI-MICS (User Interface) board. The board maintains communication between 2008T touchpad and the UI-MICS board by sending a reset signal to the touchpad after every 5 seconds of inactivity (i.e., no activity on the touchpad surface, CONFIRM key or Escape key). This modification was implemented to mitigate the "missing cursor" error in the event of static discharge on the touchpad circuitry (Reference Class II recall 1225714-0126/11-001C).

M. Indications for Use

The modified Fresenius 2008T Hemodialysis Machine has the same indications for use as the unmodified device. It is indicated for acute and chronic dialysis therapy.

N. Technological Characteristics

There are no changes in the technological characteristics of the previously cleared Fresenius 2008T Hemodialysis Machine. The modified Fresenius 2008T hemodialysis machine incorporates changes pertaining only to ergonomic enhancements and reliability for the user/operator interface. All water requirements, module options, functional options. performance limits, control parameters, compatible bloodlines, and language options remain unchanged from the predicate device.

A Risk Analysis has been completed and potential hazards associated with the modifications have been identified and mitigated. Mitigations have been verified wherever applicable. All potential risks were deemed acceptable after mitigation.

Performance and safety testing were conducted to ensure the safety and effectiveness of the device after the proposed modifications.

0. Performance Data

Design verification and validation testing were conducted to ensure that the modifications described in this submission did not/will not impact the essential performance of the device and function as intended.

The following tests were conducted:

{3}------------------------------------------------

K111639
page 4 of 5

Fresenius Medical Care

1. Touch Screen
- . Functional Verification
- Software Validation .
- . Usability Testing

7. Dialysate Sample Port

Fluid Path Chemical Testing .
. Surface Disinfect Chemical Testing
Pressure Holding Testing .
Residual Chemical Testing .
Aging Test .
. Biocompatibility
. Usability Testing

8. Modified Shunt Interlock System and modified Hansen connectors

Fluid Path Chemical Testing .
. Surface Disinfect Chemical Testing
. Cycle Testing
. Strength Testing
. Shipping Testing
Safety Testing .
. Pressure Holding Testing
. Residual Chemical Testing
Shunt Electrical Testing
. Aging Test
Biocompatibility .
. Usability Testing

9. Wheel Lock Pedal

Cycle Testing ●
Strength Testing .
Usability Testing .
. Safety Testing

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the text "K111639 page 5 of 5". The text appears to be handwritten in black ink on a white background. The text is arranged in two lines, with the first line containing the alphanumeric string "K111639" and the second line indicating the page number as "page 5 of 5".

Fresenius Medical Care

10. Reset board

Functional validation .
Simulated dialysis treatment
Unstructured Testing (foreseeable misuse) .
. Production Testing
Regression Testing .
. ESD

P. Conclusion

Test results demonstrated that the modified 2008T Hemodialysis Machine functioned as intended and met pre-determined acceptance criteria. Results of functional and software validation, performance testing, biocompatibility testing, risk analysis, and usability testing 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.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

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

Ms. Denise Oppermann Senior Director, Regulatory Affairs - Devices Fresenius Medical Care North America 920 Winter Street WALTHAM MA 02451

OCT 2 1 2011

Re: K111639

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: September 21, 2011 Received: September 22, 2011

Dear Ms. Oppermann:

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

{6}------------------------------------------------

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 Parl 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/ReportaProblem/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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Hubert Lemming

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

{7}------------------------------------------------

Indications for Use

510(k) Number (if known): |< | | | | 6 3 9

Device Name:

Fresenius 2008T Hemodialysis Machine

Indications for Use:

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

Prescription Use (Per 21 CFR 801 Subpart D)

AND/OR

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jules Reum

Page lof/
Page 109

Regulation Number and Section

§ 876.5860 High permeability hemodialysis system.

(a)
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).
(b)
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.”