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.

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.

AI/ML Overview

The provided document describes the Fresenius 2008T Hemodialysis Machine with bibag™ system. The primary goal of the submission is to demonstrate that the modified hemodialysis machine, incorporating the bibag system, is substantially equivalent to predicate devices and functions as intended.

Here's an analysis of the acceptance criteria and the study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
System Functionality & Software	Ensure all modifications function as intended.	"The results from the testing demonstrated that all modifications functioned as intended and met pre-determined acceptance criteria."
	Essential performance of the 2008T is not impacted.	"The essential performance of the hemodialysis machine has not been impacted by the modifications."
	Software validation & regression testing passed.	"Software validation and regression testing" were performed, implying they passed based on the overall conclusion that "all modifications functioned as intended and met pre-determined acceptance criteria."
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2 (2007) Class A.	"The modified 2008T hemodialysis machine with bibag system met the requirements of IEC 60601-1-2 (2007)."
Electrical Safety	Compliance with UL 60601-1 (1st Ed., 2006-04-26).	"The modified 2008T hemodialysis machine with was found to comply with the above standards."
	Compliance with CAN/CSA-C22.2 No. 601.1-M90 (2005).	"The modified 2008T hemodialysis machine with was found to comply with the above standards."
bibag Disposable Testing (Dry Sodium Bicarbonate)	Dissolution testing per USP requirements.	"Dissolution testing per USP requirements" was performed, indicating compliance as part of the overall conclusion that the bibag system functioned as intended and met acceptance criteria.
	Bioburden & Endotoxin testing per USP & AAMI RD61:2006.	"Bioburden & Endotoxin testing per USP & AAMI RD61:2006" was performed, indicating compliance as part of the overall conclusion that the bibag system functioned as intended and met acceptance criteria.
	Biocompatibility testing per USP 32-NF26 biological tests <88>.	"Biocompatibility testing of the bibag materials per USP 32-NF26 biological tests <88>" was performed, indicating compliance as part of the overall conclusion that the bibag system functioned as intended and met acceptance criteria.
System Performance (with bibag dry bicarbonate)	Ensure proper function with dry bicarbonate concentrate.	"System performance testing using bibag dry bicarbonate concentrate" was performed, and the overall conclusion states that "the bibag system... and the modified 2008T hemodialysis machine functioned as intended and met pre-determined acceptance criteria." This implies successful performance in producing a saturated solution.

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

The document does not specify sample sizes for any of the individual tests. It states that "Verification and validation testing were performed," but details on the number of units or test cycles are not provided. The data provenance is implied to be from internal lab testing conducted by Fresenius Medical Care North America. There is no information regarding country of origin for data or whether it was retrospective or prospective. Given the nature of a 510(k) submission for device modification, the testing would typically be prospective, controlled laboratory testing.

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

This type of information is not applicable to this submission. The tests performed are objective engineering and performance validations (e.g., electrical safety, EMC, software validation, material biocompatibility, dissolution). These tests rely on predefined engineering standards and specifications, not on expert consensus or interpretation of medical images or outcomes.

4. Adjudication Method for the Test Set

This information is not applicable. The tests described are objective and pass/fail based on meeting predefined thresholds and standards. There is no mention of subjective assessments requiring adjudication.

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

A MRMC comparative effectiveness study was not performed and is not applicable to this type of device modification. This is a technical modification to a hemodialysis machine, not a diagnostic or AI-assisted interpretation tool that would benefit from such a study.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

This is not applicable as the device is a medical machine with integrated functionality, not a standalone algorithm. The "system performance testing" would be considered the standalone performance, but it refers to the entire machine and bibag system in operation.

7. Type of Ground Truth Used

The "ground truth" for the various tests was based on:

Pre-determined acceptance criteria derived from
- International and national medical device standards: IEC 60601-1-2 (EMC), UL 60601-1 (Electrical Safety), CAN/CSA-C22.2 No. 601.1-M90 (Electrical Safety).
- Pharmacopoeial standards: USP requirements for dissolution testing of materials.
- Biocompatibility standards: USP 32-NF26 biological tests <88>.
- AAMI standards: AAMI RD61:2006 for Bioburden & Endotoxin testing.
- Internal engineering specifications: For software validation, regression testing, and overall system functionality.

8. Sample Size for the Training Set

This is not applicable. This device is a modified hemodialysis machine, not an AI/ML algorithm that requires a training set. The "training" for the device refers to its design and manufacturing processes, which are validated through the testing described.

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

This is not applicable for the same reason as point 8.

Summary

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K101715
Page 1 of 4

Fresenius Medical Care

DEC 2 1 2010

A. Submitter's Information:

Name:	Fresenius Medical Care North America
Address:	920 Winter StreetWaltham MA 02451
Phone:	(781) 699-9505
Fax:	(781) 699-9635
Contact Person:	Randolph Quinn, Lead Regulatory AffairsSpecialist
Date of Preparation:	June 16, 2010

B. Date Summary Prepared: June 16, 2010

C. Device Name:

Propriety/Trade Name:	Fresenius 2008T Hemodialysis Machinewith bibag™ System
Common/Usual Name	Hemodialysis delivery system
Classification Name:	High permeability hemodialysis system
Classification Number:	Class II 876.5860
Product Code/ReviewPanel	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 (781) 699-9000

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D. Device Description:

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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K101715
Page 3 of 4

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.

1. 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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K101715
Page 4 of 4

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

1. 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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Page 2

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 (800) 638-2041 or (301) 796-7100 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:

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

Page 1 of 1
199

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.”