2008K@home Hemodialysis Machine: The Fresenius 2008K@home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician. bibag System: 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 2008K@home Hemodialysis Machine and is indicated for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag System is intended for extracorporeal bicarbonate hemodialysis according to a physician's prescription. Wireless Wetness Detector (Wet Alert): The Wireless Wetness Detector is indicated for use with the Fresenius 2008K@home Hemodialysis Machine and is an optional accessory to aid in the detection of blood and water leaks during hemodialysis. Home hemodialysis using the detector must be observed by a trained and qualified person as prescribed by their physician.

Device Description

The 2008K@home Hemodialysis Machine with bibag System is intended for short term (acute) and long term (chronic) dialysis treatment in a clinical facility and at home. In the home, a trained and qualified person must observe treatment as prescribed by a physician: The 2008K@home Hemodialysis Machine with bibag System allows operators the option to prepare a saturated sodium bicarbonate solution online through automated mixing of dialysis grade water and dry sodium bicarbonate powder within the bibag source disposable. The bibag System comprises: (1) the sodium bicarbonate concentrate generator (known as the bibag module); and (2) the single-use disposable bag of dry sodium bicarbonate concentrate. A specialized bibag connector with a door is used to connect the single-use bibag disposable (650g/900g) filled with USP grade dry sodium bicarbonate powder to the bibag connector. The 2008K@home 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 performed using a specially modified Fresenius 2008K@home Hemodialysis Machine with bibag System and can only be used with 45x (1:44) dilution. The bibag cannot be used with 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. Additionally, this submission includes minor hardware/software changes to the proposed device: Active pressure regulation, Acid/Heat Disinfect button; simplified Acid Clean program and alternate LCD display.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Fresenius 2008K@home Hemodialysis Machine with bibag System, based on the provided text:

Important Note: The provided document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed, novel clinical study results with specific performance metrics against an acceptance criterion in the way an AI/ML device submission might. Therefore, some of the requested information (like specific effect sizes for human readers with AI assistance) is not applicable or explicitly stated in this type of submission.

Acceptance Criteria and Reported Device Performance

The document states that "Test results demonstrated that the modified 2008K@home Hemodialysis Machine with bibag System functions as intended and met pre-determined acceptance criteria." It also lists various verification and validation tests performed. However, the specific quantitative acceptance criteria or detailed performance metrics are not explicitly presented in a table format within this 510(k) summary. Instead, the conclusion is a general statement of meeting criteria.

The device performance is generally reported as:

"functions as intended"
"met pre-determined acceptance criteria"
"did not affect the essential performance of the device"
"the device functions as intended"
"differences... do not raise any new concerns with regard to safety or effectiveness."

Without explicit quantitative criteria, a table like the one requested cannot be constructed precisely from the provided text. The document refers to "existing FMCNA procedures, protocols, declared performance standards and guidelines of the quality system regulation (21 CFR Part 820)" as the basis for evaluation, implying internal, pre-defined criteria were used for the various tests.

Study Details

Given this is a 510(k) for a medical device (hemodialysis machine), not an AI/ML-driven diagnostic, many of the typical AI/ML study parameters (like test set size, data provenance, ground truth experts, MRMC, standalone performance) are not applicable or not detailed in this type of submission. The studies performed are primarily engineering verification and validation tests.

Here's an attempt to address your points based on the provided text, with clarifications where information is absent or irrelevant to a traditional medical device 510(k):

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in a quantitative table. The document generically states that "pre-determined acceptance criteria" were met. These would typically be internal engineering specifications and regulatory standards (e.g., ISO, FDA regulations) for safety, performance, and functionality.
- Reported Device Performance: The device "functions as intended" and there are no "new concerns with regard to safety or effectiveness" compared to the predicate devices. This is a qualitative statement of successful verification and validation.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not specified. The testing described includes "Functional Verification and Software Validation," "System Performance," "Heat Disinfection Testing," "Chemical Testing," "System Safety," "Reliability" (Accelerated Life, Mechanical Life, Elevated Temperature Testing), and "Summative Usability." These are internal engineering and usability tests, and the "sample size" would relate to the number of test units, cycles, or user participants, which is not detailed.
- Data Provenance: Not applicable in the context of clinical data provenance. These are laboratory/engineering test results conducted by the manufacturer (Fresenius Medical Care North America, Waltham, MA).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of clinical ground truth. The "ground truth" for engineering and functional tests is established by documented specifications, regulatory standards, and expected operational behavior, which is assessed by engineers and technicians. For the "Summative Usability" study, "experts" would be the intended users and human factors specialists, but their number and qualifications are not specified.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as this is not a diagnostic device assessment involving human interpretation. Adjudication methods are typically used for clinical study endpoints or image interpretations. Engineering and software tests follow predefined pass/fail criteria.
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 a hemodialysis machine, not an AI-assisted diagnostic or interpretative device. This type of study is not relevant to this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device; the concept of an "algorithm only" performance study in this context is not relevant. The device has automated functions, which are verified through various tests (System Performance, Software Verification, Safety Systems Verification), but this is not an "AI algorithm" in the typical sense of a standalone diagnostic.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground truth for engineering/software performance: Established by design specifications, functional requirements, and compliance with industry standards (e.g., ISO, electrical safety standards).
- Ground truth for usability: "Summative Usability" studies typically evaluate whether users can safely and effectively operate the device according to its intended use and training, with "ground truth" being defined as successful task completion and adherence to safety protocols.
The sample size for the training set:
- Not applicable. This device is not an AI/ML device that undergoes a "training phase."
How the ground truth for the training set was established:
- Not applicable.

Summary

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K124035

pg 1 of 5

2008K@home Hemodialysis Machine with bibag™ System Traditional 510(k) Notification

510(k) Summary

JUL 0-3-2013

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:	27 December 2012
5.2 Device Name

Trade Name:	Fresenius 2008K@home Hemodialysis Machine with bibag System
Common Name:	Hemodialysis Delivery System
Classification Name:	High Permeability Hemodialysis System
Classification Number:	Class II per § 876.5860
Product Code/Classification Panel:	78 KDI/Gastroenterology/Urology Panel

Legally Marketed Predicate Devices 5.3

AEDICAL

Fresenius 2008K@home Hemodialysis Machine (K121421 – under review) and Fresenius 2008T. Hemodialysis Machine with bibag System (K121341).

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Image /page/1/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a stylized symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three chevron-like shapes stacked vertically, with the top two chevrons being more filled in and the bottom one being a simple outline. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

5.4 Device Description

The 2008K@home Hemodialysis Machine with bibag System allows operators the option to prepare a saturated sodium bicarbonate solution online through automated mixing of dialysis grade water and dry sodium bicarbonate powder within the bibag source disposable. The bibag System comprises: (1) the sodium bicarbonate concentrate generator (known as the bibag module); and (2) the single-use disposable bag of dry sodium bicarbonate concentrate. A specialized bibag connector with a door is used to connect the single-use bibag disposable (650g/900g) filled with USP grade dry sodium bicarbonate powder to the bibag connector. The 2008K@home 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 performed using a specially modified Fresenius 2008K@home Hemodialysis Machine with bibag System and can only be used with 45x (1:44) dilution. The bibag cannot be used with 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.

Additionally, this submission includes minor hardware/software changes to the proposed device: Active pressure regulation, Acid/Heat Disinfect button; simplified Acid Clean program and alternate LCD display.

5.5 Indications for Use

2008K@home Hemodialysis Machine:

The Fresenius 2008K@home is indicated for acute and chronic dialysis therapy in an acute or chronic facility. The 2008K@home is also indicated for hemodialysis in the home and must be observed by a trained and qualified person as prescribed by their physician.

bibag System:

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 2008K@home Hemodialysis Machine and is indicated for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag System is intended for extracorporeal bicarbonate hemodialysis according to a physician's prescription.

Volume 1 Page 137 of 187

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Image /page/2/Picture/2 description: The image shows the logo for Fresenius Medical Care. On the left side of the logo, there are three chevron-like shapes stacked on top of each other. The top two chevrons are pointing upwards, while the bottom chevron is pointing downwards. To the right of the chevrons, the text "FRESENIUS MEDICAL CARE" is written in bold, uppercase letters.

2008K@home Hemodialysis Machine with bibag™ System Traditional 510(k) Notification

Wireless Wetness Detector (Wet Alert):

The Wireless Wetness Detector is indicated for use with the Fresenius 2008K@home Hemodialysis Machine and is an optional accessory to aid in the detection of blood and water leaks during hemodialysis. Home hemodialysis using the detector must be observed by a trained and qualified person as prescribed by their physician.

Technological Characteristics 5.6

The technological characteristics of the proposed device are summarized in context with the named predicate devices:

2008K@home Hemodialysis Machine with Wet Alert (K121421 – under review)

The modified device has the same operating principle, fundamental scientific technology, and is comparable in key safety and effectiveness and quality assurance features.

All existing 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 predicate device:

Safety system .
System performance .
. Environmental Requirements
User Interface (except for bibag System) .
. Hardware and therapy settings
Accessories (except for bibag disposable) .
. Environmental Design
. Alarms (except for additional bibag System alarms)
. Accuracy and Controls
. Protection against Mechanical Hazard
Protection against Electrical Hazard
. Protection against excessive temperature or other hazards
Transportation and Storage conditions .
Manufacturing Location and manufacturing processes (assembly, fabrication, .
testing, shipping, installation and service).

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Image /page/3/Picture/2 description: The image shows the logo for Fresenius Medical Care. The logo consists of a stylized chevron symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The chevron symbol is made up of three chevrons stacked on top of each other, with the top two chevrons pointing upwards and the bottom chevron pointing downwards. The text is in a bold, sans-serif font.

2008K@home Hemodialysis Machine with bibag™ System Traditional 510(k) Notification

Safety and effectiveness of the 2008K@home Hemodialysis Machine with bibag System is confirmed by system verification and validation testing to verify performance specifications, and user requirements, in conformance with applicable referenced FDA regulations and. FDA-recognized industry and international standards.

A risk analysis (per ISO 14971) 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.

bibag System:

The bibag System/module proposed for use with the 2008K@home Hemodialysis Machine is the same device cleared for use with the 2008T Hemodialysis Machine (K121341).

The 2008K@home Hemodialysis Machine with bibag System has the following key similarities to the predicate device (K121341):

. Intended Use
. Operating Principle
. Fundamental Scientific Technology: configuration, hydraulics, safety features (control, monitoring, alarms)
Accessories bibag disposable .

5.7 Performance Data

The performance of the modified device described in this submission was evaluated according to existing FMCNA procedures, protocols, declared performance standards and guidelines of the quality system regulation (21 CFR Part 820). Design verification and validation tests were conducted to ensure that the modifications did not affect the essential performance of the device and the device functions as intended.

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Image /page/4/Picture/1 description: The image shows the Fresenius Medical Care logo. The logo consists of three downward-pointing chevrons stacked on top of each other on the left side. To the right of the chevrons is the text "FRESENIUS MEDICAL CARE" in bold, sans-serif font. The text is arranged in two lines, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

The following tests were conducted for the modified device:

5. System and Software Verification and Validation Testing

Functional Verification and Software Validation
- Software Verification (Functional Tests)
- Regression
- Safety Systems Verification
- Simulated Dialysis Treatment
- Production Test Procedure
- Unstructured and Static Code Verification
System Performance �
Heat Disinfection Testing
. Chemical Testing

System Safety 6.

. Equipment Safety
Electromagnetic Compatibility

7. Reliability

Accelerated Life Testing .
. Mechanical Life Testing
. Elevated Temperature Testing

8. Summative Usability

5.8 Conclusion

Test results demonstrated that the modified 2008K@home Hemodialysis Machine with bibag System functions as intended and met pre-determined acceptance criteria. Results of system/software verification/validation testing, safety testing, reliability testing, summative usability study and risk analysis indicate that differences between the 2008K@home Hemodialysis Machine with bibag System and the predicate devices do not raise any new concerns with regard to safety or effectiveness.

FMCNA concludes that, within the meaning of the Medical Device Amendments Act of 1976, the 2008K@home Hemodialysis Machine with bibag System is substantially equivalent to the predicate devices.

Volume 1 Page 140 of 187

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Image /page/5/Picture/0 description: The image shows a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle. Inside the circle is a symbol consisting of three stylized lines that resemble a person embracing another person. The seal is black and white and appears to be of an official government organization.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 3, 2013

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

Re: K124035

Trade/Device Name: 2008K@home Hemodialysis Machine with bibag System Regulation Number: 21 CFR§ 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: Class II Product Code: ONW. ODX, and KPO Dated: June 10, 2013 Received: June 11, 2013 ·

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

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Page 2 - Ms. Denise Oppermann

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 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Fisher-S

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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Image /page/7/Picture/0 description: The image contains the Fresenius Medical Care logo. The logo consists of a stylized symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three chevron-like shapes stacked vertically, with each chevron pointing downwards. The text is in bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

Indications for Use Statement

510(k) Number (if known): K124035

Device Name:

2008K@home Hemodialysis Machine with bibag™ System

Indications for Use:

2008K@home Hemodialysis Machine:

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 2008K@home Hemodialysis Machine and is indicated for use in bicarbonate hemodialysis for acute and chronic renal failure. The bibag System is intended for extracorporeal bicarbonate hemodialysis according to a physician's prescription.

Wireless Wetness Detector (Wet Alert):

X Prescription Use (Per 21 CFR 801 Subpart D) . AND/OR

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

Benjamin R. Fisher -S
2013.07.03 14:49:56 -04'00'

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices K124035 510(k) Number

Volume 1 Page 134 of 187

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.”