The Fresenius bibag system is used with Fresenius three stream proportioning hemodialysis systems equipped with the bibag 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.

Device Description

The Fresenius 2008T Hemodialysis Machine with bibag System is indicated for use in bicarbonate hemodialysis for acute and chronic renal failure.

The bibag is a specialized, single-use, sealed bag filled with USP grade dry sodium bicarbonate powder. The bibag attaches to a special connector incorporated into the front of the 2008T Hemodialysis Machine. The hemodialysis machine draws dialysis grade water into the bibag to produce a saturated solution of sodium bicarbonate online. This online generation of sodium bicarbonate can only be prepared using a specially modified Fresenius 2008T Hemodialysis Machine with bibag System and can only be used with 45x (1:44) dilution. The bibag cannot be used with other non-Fresenius hemodialysis machines capable of using cartridge type dry sodium bicarbonate because of the unique connection between the bibag disposable, the bibag connector, and the hemodialysis machine.

Modifications of the previously cleared 2008T Hemodialysis Machine with bibag system includes:
5.4.1 900g bibag Disposable:
Addition of an optional disposable 900g bibag which is equivalent to 650g bibag but increased in length to accommodate an additional 250g dry sodium bicarbonate powder. The length of a treatment session is dependent upon pre-treatment set-up time (including potential delays) and physician-prescribed dialysate flow rate and sodium bicarbonate concentration. (For example: The larger bag will provide sufficient USP grade dry sodium bicarbonate powder for 8 hours when running at a dialysate flow rate (Qd) of 500 mL/min and sodium bicarbonate concentration setting of 32 mEq/L).

There were no hardware or software changes made to the 2008T Hemodialysis Machine with bibag System to accommodate the 900g bag option. The existing bibag module attached to the machine will be used to connect the new 900g bibag with the same connector used for the 650g bibag.

Additionally, this submission includes a minor software maintenance change made to the 2008T Hemodialysis Machine with bibag System since the last clearance (K101715).

5.4.2 Function (Fn) Lock Keyboard
The existing fold-down compact keyboard used on the 2008T Hemodialysis Machine (K101715) is located directly below the display screen. The keyboard folds down to allow the operator to enter treatment parameter values, chart with CDX or make selections inside the treatment screen and folds up again to prevent unintentional changes.

For added user convenience while navigating their MIS systems, FMCNA added function lock capability to the current 2008T's keyboard. The modification includes repurposing the "Fn" key to a "Fn Lock" key and adding a function lock indicator light to the immediate right of the Caps Lock indicator light. Software and hardware modifications were made to implement this feature is only available in 2008T Hemodialysis Machines with activation of the CDX option. In dialysis mode, the Fn Lock LED will be off and the function lock feature will be off. In addition, the keyboard is now equipped with a new elastomer material with higher tear resistance properties as compared to the standard silicon elastomer of the existing keyboard in the unmodified device (K101715).

Treatment modalities for the modified Fresenius 2008T Hemodialysis Machine remain identical to those for the unmodified 2008T (K101715):

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

AI/ML Overview

The provided text describes modifications to the Fresenius 2008T Hemodialysis Machine with bibag System. It outlines that the changes did not affect the fundamental scientific technology or intended use of the device and therefore did not necessitate a new 510(k) submission, confirming substantial equivalence to the predicate device. The document mentions performance and safety tests were conducted to ensure the safety and effectiveness of the device after modifications.

However, the text does not contain explicit details about acceptance criteria, specific device performance metrics, or a formal study comparing the device against these criteria. It indicates that "Test results demonstrated that the modified 2008T Hemodialysis Machine with bibag System functions as intended and met pre-determined acceptance criteria," but it does not list these criteria or the results.

Therefore, I cannot provide a table of acceptance criteria and reported device performance directly from the given text, nor can I answer questions about sample size, data provenance, ground truth establishment, or multi-reader multi-case studies, as these details are not present.

The document discusses "Performance Data" and lists various tests conducted for the 900g bibag disposable and the Fn Lock Keyboard. These tests served as the "study" to confirm the modifications did not compromise safety or effectiveness.

Here's a breakdown of what information can be extracted or inferred based on the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance:

Cannot provide. The document states that "Test results demonstrated that the modified 2008T Hemodialysis Machine with bibag System functions as intended and met pre-determined acceptance criteria," but it does not list specific acceptance criteria or quantitative performance results in the provided text.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Cannot provide. The document does not specify sample sizes for any tests, nor does it mention data provenance (country of origin, retrospective/prospective nature).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable/Cannot provide. The device is a hemodialysis machine. The "ground truth" in this context would likely refer to engineering specifications, performance against established physiological parameters, or clinical outcomes. The document does not mention the involvement of "experts" in establishing ground truth in the way one might for diagnostic imaging or AI algorithms. The tests conducted were primarily engineering and quality assurance verifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/Cannot provide. This concept typically applies to expert review processes for establishing ground truth, which is not described for this device's testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is not an AI-assisted diagnostic device, so an MRMC study is not relevant and was not conducted. The modifications are to a hemodialysis machine (a larger bibag option and a keyboard function lock).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. The device is a medical machine with software components for control, but it's not an "algorithm only" device in the sense of a standalone AI diagnostic tool. Its performance is intrinsic to the machine's operation, not an algorithm's output intended for human interpretation or decision-making assistance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Inferred: For the 900g bibag, the ground truth would be based on established engineering specifications, quality control standards, and performance metrics for chemical stability, bioburden, endotoxin levels, and shelf life, presumably referenced against the previously cleared 650g bibag and industry standards. For the Fn Lock Keyboard, the ground truth would be based on software functional requirements, safety standards (e.g., EMC), and material performance specifications (e.g., tear resistance, lifecycle).

8. The sample size for the training set:

Not applicable/Cannot provide. This device is not an AI/ML model that undergoes a "training set." The tests described are verification and validation activities for hardware and software modifications.

9. How the ground truth for the training set was established:

Not applicable. As above, there is no "training set" for this type of device.

Summary of "Study" and Evidence based on the text:

The "study" consists of design verification and validation tests to ensure that the modifications did not affect the essential performance or safety of the device.

Key Tests Conducted:

For 900g bibag disposable:
- Functional Verification
- Bioburden and Endotoxin testing
- Shelf life
- Stability
- Unstructured testing
For Fn Lock Keyboard:
- Software Verification and Validation Testing:
  - Software Verification (Functional Tests)
  - Regression testing
  - Safety Systems Verification
  - Simulated Dialysis Treatment
  - Production Test Procedure
  - Unstructured and Static Code Verification
- Safety Testing:
  - EMC Testing (ESD immunity)
- Unit Testing (Fn Lock Keyboard)
- Physical Testing (Fn Lock Keyboard):
  - High Tear Elastomer: Use Life (Shelf Life)
  - High Tear Elastomer: Life cycle

Conclusion from document: "Test results demonstrated that the modified 2008T Hemodialysis Machine with bibag System functions as intended and met pre-determined acceptance criteria. Results of functional validation, performance testing, biorburden assessment, risk analysis, safety testing, stability, shelf-life tests, and usability evaluation indicate that the modified Fresenius 2008T Hemodialysis Machine with bibag System is substantially equivalent to the named predicate device and remains safe and effective for its intended use."

The document focuses on demonstrating substantial equivalence to a predicate device (K101715) by showing that the modifications (larger bibag and keyboard update) do not introduce new risks or alter the device's fundamental function, and that all relevant performance and safety checks passed against "pre-determined acceptance criteria" (though these criteria are not detailed).

Summary

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Section 5 510(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.

5.1 Submitter's Information

Name:	Fresenius Medical Care North America
Address:	920 Winter StreetWaltham, MA 02451-1457
Phone:	(781) 699-4479
Fax:	(781) 699-9635
Contact Person:	Denise Oppermann, Senior DirectorRegulatory Affairs - DevicesRenal Therapies Group
Date of Preparation:	30 December 2011

5.2 Device Name

Trade Name:	Fresenius 2008T Hemodialysis Machine withbibag System
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

5.3 Legally Marketed Predicate Device (unmodified device)

Fresenius 2008T Hemodialysis Machine with bibag System (K101715).

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K120017
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5.4 Device Description

The Fresenius 2008T Hemodialysis Machine with bibag System is indicated for use in bicarbonate hemodialysis for acute and chronic renal failure.

Modifications of the previously cleared 2008T Hemodialysis Machine with bibag system includes:

5.4.1 900g bibag Disposable:

Addition of an optional disposable 900g bibag which is equivalent to 650g bibag but increased in length to accommodate an additional 250g dry sodium bicarbonate powder. The length of a treatment session is dependent upon pre-treatment set-up time (including potential delays) and physician-prescribed dialysate flow rate and sodium bicarbonate concentration. (For example: The larger bag will provide sufficient USP grade dry sodium bicarbonate powder for 8 hours when running at a dialysate flow rate (Qd) of 500 mL/min and sodium bicarbonate concentration setting of 32 mEq/L).

Additionally, this submission includes a minor software maintenance change made to the 2008T Hemodialysis Machine with bibag System since the last clearance (K101715).

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K120017
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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", FMCNA determined that these modifications did not necessitate a 510(k) submission:

5.4.2 Function (Fn) Lock Keyboard

The existing fold-down compact keyboard used on the 2008T Hemodialysis Machine (K101715) is located directly below the display screen. The keyboard folds down to allow the operator to enter treatment parameter values, chart with CDX or make selections inside the treatment screen and folds up again to prevent unintentional changes.

Treatment modalities for the modified Fresenius 2008T Hemodialysis Machine remain identical to those for the unmodified 2008T (K101715):

5.5 Indications for Use

The modified Fresenius 2008T Hemodialysis Machine with bibag System has the same indications for use as the unmodified device. The Fresenius Medical Care bibag System is used with Fresenius Medical Care three stream proportioning hemodialysis systems equipped with the bibag module such as the 2008T Hemodialysis Machine and is intended

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K120017
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for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag system is extracorporeal bicarbonate hemodialysis according to a physician's intended for prescription.

5.6 Technological Characteristics

There are no changes in the technological characteristics of the previously cleared Fresenius 2008T Hemodialysis Machine with bibag System (K101715). The Fresenius 2008T Hemodialysis Machine with bibag system incorporates changes pertaining only to the size of the bibag disposable with 900g USP grade dry bicarbonate powder as an additional option to the previously cleared 650g bibag. There are no hardware or software changes made in the machine to accommodate this modification. The 900g bibag is designed and developed using dimensionally and functionally equivalent product specifications, construction and manufacturing methods as in the previously cleared 650g bibag (K101715). All water requirements, module options, functional options, performance limits, control parameters, compatible bloodlines, and language options remain unchanged from the predicate device. 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 for the Fn Lock feature and touchscreen)
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

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were deemed acceptable after mitigation. Performance and safety tests were conducted to ensure the safety and effectiveness of the device after the proposed modifications.

5.7 Performance Data

The performance of the modified device (900g bibag disposable and all other modifications discussed in this submission) 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 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 for the 900g bibag disposable:

Functional Verification
. Bioburden and Endotoxin
Shelf life
. Stability
. Unstructured testing

The following tests were conducted for the Fn Lock Keyboard:

1. Software Verification and Validation Testing:

Software Verification (Functional Tests) .
. Regression
. Safety Systems Verification
Simulated Dialysis Treatment .
Production Test Procedure
. Unstructured and Static Code Verification
1. Safety Testing
- EMC Testing (ESD immunity)
1. Unit Testing (Fn Lock Keyboard)
1. Physical Testing (Fn Lock Keyboard)
- . High Tear Elastomer: Use Life (Shelf Life)
- . High Tear Elastomer: Life cycle

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K120017
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5.8 Conclusion

Test results demonstrated that the modified 2008T Hemodialysis Machine with bibag System functions as intended and met pre-determined acceptance criteria. Results of functional validation, performance testing, biorburden assessment, risk analysis, safety testing, stability, shelf-life tests, and usability evaluation indicate that the modified Fresenius 2008T Hemodialysis Machine with bibag System 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 -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

FEB - 2 2012

Re: K120017

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 Code: KDI, KPO Dated: December 30, 2011 Received: January 3, 2012

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 (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 (OS) 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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher

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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Fresenius Medical Care

2008T Hemodialysis Machine with bibag™ System Special 510(k) Notification

Indications for Use Statement

510(k) Number (if known): KIQ()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()()(

Device Name:

2008T Hemodialysis Machine with bibag™ System

Indications for Use:

Prescription Use (Per 21 CFR 801 Subpart D)

AND/OR

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

forn m2ha
Division Sign-Off

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.”