The 5008X Hemodialysis System is intended for use in acute and chronic hemodialysis therapy. Therapy options include hemodialysis (HD), hemodiafiltration (HDF), hemofiltration (HF), and isolated ultrafiltration (ISO).

The 5008X™ system is indicated for intermittent hemodialysis treatment for patients with acute and chronic renal failure in a healthcare facility. Therapy options for patients weighing more than 40 kg include: Hemodiafiltration (HDF), Hemodialysis (HD), Hemofiltration (HF) and Isolated Ultrafiltration.

The 5008X™ Machine is equipped with a bibag system, but it may also be used with liquid bicarbonate using the connector included with the machine. The bibag system is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. The bibag system is intended to be used as one component in the preparation of dialysate according to a physician's prescription in a 3-stream proportioning hemodialysis machine equipped with the bibag module.

The 5008X™ Machine is available equipped with a Crit-Line Clip (CLiC) Monitor System.

The optional CLiC system is used to non-invasively measure hematocrit, oxygen saturation and percent change in blood volume in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the dialysis technician. Based on the data that the monitor provides, the clinician/nurse, under physician direction, intervenes (i.e. increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common symptoms of dialysis which include nausea, cramping and vomiting.

The DIASAFE®plusUS is intended for the preparation of ultrapure dialysate and sterile, nonpyrogenic substitution fluid from pretreated water and is not intended to provide primary purification. Attention must still be given to the chemical and microbiological quality of water and concentrates and the maintenance of supply systems (e.g. RO system, central delivery system).

The microbiological quality (microbial count [CFU/mL] and endotoxin measurement [EU/mL]) of the incoming water should be < 200 CFU/mL and < 2 EU/mL, respectively.

The DIASAFE®plusUS can only be used with Fresenius Medical Care dialysis machines fitted for use with DIASAFE®plusUS.

The blood tubing sets are intended to be used only with the Fresenius Medical Care 5008X Hemodialysis Device, which is indicated for intermittent hemodialysis treatment for patients with acute kidney injury or chronic kidney disease in a healthcare facility. Therapy options include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration.

The HDF blood tubing sets are indicated for use with a prescribed dialyzer. For use with a compatible dialyzer, as per the labeling.

The Fresenius Twister Access Flow Reversing Connector (AFRC) is indicated for use during hemodialysis to reverse the blood flow to and from the arterial and venous vascular access devices in order to obtain an access flow measurement.

The blood tubing set is intended to be used with the Crit-Line Clip Monitor System (CLiC) on the 5008X Hemodialysis Device.

The CLiC is used to non-invasively measure hematocrit, oxygen saturation, and percent change in blood volume in real time for application in the treatment of dialysis patients with the intended purpose of providing a more effective treatment for both the dialysis patient and the dialysis technician. Based on the data that the monitor provides, the clinician/nurse, under physician direction, intervenes (i.e., increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common symptoms of dialysis which include nausea, cramping and vomiting.

CitraSure is intended for thermal disinfection of the Fresenius Medical Care 5008X Hemodialysis System when delivered and diluted per the 5008X heat disinfection program.

Device Description

The 5008X Hemodialysis System consists of the following:

The 5008X Hemodialysis Machine
Two (2) DIASAFE®plusUS Filters (hereinafter referred to as the "Diasafe filter(s)")
The 5008X Bloodlines are available in five (5) configurations:
- 5008X HD/HDF – Standard Blood Tubing Set (hereinafter referred to as the "HD/HDF Standard Bloodline")
- 5008X HD/HDF – With Twister Blood Tubing Set (hereinafter referred to as the "HD/HDF Twister Bloodline")
- 5008X HD/HDF – With CLiC Blood Tubing Set (hereinafter referred to as the "HD/HDF CLiC Bloodline")
- 5008X HD Pre-Flush – Standard Blood Tubing Set (hereinafter referred to as the "HD Standard Bloodline")
- 5008X HD Pre-Flush – With Twister Blood Tubing Set (hereinafter HD Twister Bloodline")
CitraSure™ Disinfectant

The 5008X Hemodialysis Machine is an electromechanical device. Software controls the machine during hemodialysis treatment, including fluid flow, mixing, heating, and alarms.

The Diasafe filter is a non-sterile dialysis fluid filter that produces ultrapure dialysate and sterile, non-pyrogenic substitution fluid as defined in ISO 23500-5. The filter reduces microbial contaminants including endotoxins in the dialysate during hemodialysis treatment.

The 5008X Bloodlines are single-use, ethylene oxide (EO) sterilized bloodlines.

CitraSure™ disinfectant is a liquid chemical disinfectant for chemical heat disinfection of the 5008X Hemodialysis Machine.

AI/ML Overview

The provided FDA 510(k) clearance letter and summary for the 5008X Hemodialysis System pertains to a medical device for renal treatment. The document does not describe an AI/ML device, a comparative effectiveness study (MRMC), or a standalone AI algorithm performance study. Therefore, sections of your request related to those topics (e.g., sample size for test/training sets, data provenance, number of experts, adjudication methods, ground truth types, human reader improvement with AI) are not applicable and cannot be extracted from this document.

However, I can provide the acceptance criteria and a summary of the performance testing conducted to prove the device meets these criteria based on the provided text for the various components of the 5008X Hemodialysis System.

Acceptance Criteria and Device Performance Summary for 5008X Hemodialysis System

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document lists "Key Performance Specifications/Characteristics" which serve as the acceptance criteria for each component. The "Reported Device Performance" column summarizes the claims made in the document regarding the device meeting these specifications through various tests.

Feature/Test Objective	Acceptance Criteria (Specification/Characteristic)	Reported Device Performance (Summary of Test Results)
5008X Machine
Maximum Blood Flow Rate	600 mL/min	System Level Performance Testing and Functional Design Verification conducted. Results support substantial equivalence, safety, and efficacy.
Maximum Dialysate Flow Rate	1000 mL/min	System Level Performance Testing and Functional Design Verification conducted. Results support substantial equivalence, safety, and efficacy.
Maximum Substitution Flow Rate	AutoSub plus: 400 mL/min; Manual substitution: 600 mL/min	System Level Performance Testing and Functional Design Verification conducted. Results support substantial equivalence, safety, and efficacy.
Net Fluid Removal	0–4000 mL/hr; Accuracy: ± (1%UF + 0.15% of balanced fluid volume)	System Level Performance Testing and Functional Design Verification conducted. Results support substantial equivalence, safety, and efficacy.
Dialysis Time	Intermittent, typical time 4 hours	System Level Performance Testing and Functional Design Verification conducted. Results support substantial equivalence, safety, and efficacy.
Dialysis Fluid Composition	Volumetric, selectable: Acid 125–151 mEq/L Na+; Bicarbonate 25–40 mEq/L; Monitoring conductivity average accuracy: ± 1.5%	System Level Performance Testing and Functional Design Verification conducted. Results support substantial equivalence, safety, and efficacy.
Dialysis Fluid Temperature	Range 34°C–39°C. Fixed alarm window 33°C (or 32°C during BTM recirculation measurement and preparation) or above 40°C.	System Level Performance Testing and Functional Design Verification conducted. Results support substantial equivalence, safety, and efficacy.
Heparin Administration Rate	0.1 to 9.9 mL/hr; Accuracy: ± 0.5mL or ± 6%	System Level Performance Testing and Functional Design Verification conducted. Results support substantial equivalence, safety, and efficacy.
Electrical Safety and EMC	IEC 60601-1-2 Edition 4.1 2020-09 compliance	EMC testing conducted in accordance with IEC 60601-1-2.
Software Verification & Validation	Functional and Performance Verification, Regression Testing, Code Reviews	Unit, integration, and system level software verification testing performed to demonstrate efficacy and confirm operation.
Human Factors Validation	Safe and effective use (per FDA guidance)	Human Factors Validation Testing conducted.
Diasafe Filter
Bacterial and Endotoxin Filtration	Produces sterile, non-pyrogenic substitution fluid from dialysis fluid with max incoming water quality < 200 CFU/mL (bacteria) and < 2 EU/mL (endotoxin)	Performance testing conducted. Results support substantial equivalence, safety, and efficacy.
Maximum Number Disinfection Cycles	100 CitraSure cycles; 13 Pure Bright Bleach cycles	Performance testing conducted. Results support substantial equivalence, safety, and efficacy.
Use Life	90 days maximum or if max disinfection cycles reached	Performance testing conducted. Results support substantial equivalence, safety, and efficacy.
5008X Bloodlines
Maximum Blood Flow Rate	600 mL/min	Blood Pump Endurance test performed. Results support substantial equivalence, safety, and efficacy.
Minimum Labeled Arterial Pressure	−300 mmHg	Structural Integrity and Positive/Negative Leak Test performed. Results show the bloodlines can withstand 1.5X labeled max positive/negative pressures and pressures from faulty conditions.
Maximum Labeled Venous Pressure	+500 mmHg	Structural Integrity and Positive/Negative Leak Test performed. Results show the bloodlines can withstand 1.5X labeled max positive/negative pressures and pressures from faulty conditions.
Arterial Pump Segment	8.0 mm/12.0 mm (ID/OD)	Pump Segment Performance test evaluated characteristics over range of inlet pressures and flow rates.
Twister Component	Facilitates measurement of access flow by reversing blood flow while maintaining closed circuit	Twister Rotation Test (180° ± 1°) and Twister Torque Test (≤ 7 inch-pound) performed.
CLiC Chamber (Optional) – Hematocrit (HCT)	Standard deviation X2 ≤ 3%, average bias ≤ 1% (of average HCT) on control blood chambers; measurement range 10–60 HCT	Functional CLiC Chamber Test (Hematocrit) performed.
CLiC Chamber (Optional) – Oxygen Saturation (O2 Sat)	Standard deviation X2 ≤ 3%, average bias ≤ 2% (of average O2 Sat) on control blood chambers; measurement range 30%–100% (when HCT ≥ 10)	Functional CLiC Chamber Test (O2 Sat) performed.
Structural Integrity (Bloodlines & Accessories)	Withstand 1.5X max positive/negative pressures; Withstand pressures from faulty machine conditions	Testing performed.
Pump Segment Performance	Evaluate characteristics over range of inlet pressures (0 to -250 mmHg), flow rates, and treatment time	Testing performed.
Blood Pump Endurance	No break or detachment at max blood flow rates & pressures for 12 hours	Testing performed.
Simulated Use	No tubing failures (kinking, collapsing, disconnection) under simulated use for ≥ 4 hours; components removable without external leaks	Testing performed.
Needle Access Port	Withstand 1.5X recommended max positive/negative pressures after multiple accesses	Testing performed.
Luer Connectors (Performance)	Meet ISO 80369-7 2021, Section 6	Testing performed.
Luer Connectors (Dimensions)	Meet ISO 80369-7: 2021, Section 5	Testing performed.
Luer Connectors (Raw Material)	Nominal modulus of elasticity > 700 MPa	Testing performed.
Transparency of Transducer Protector	Clear to allow visual inspection of blood contamination	Testing performed.
Transducer Protector Leak Test	Maintain secure and leak-free connection when subjected to 2X max labeled pressure	Testing performed.
Arterial Pressure Dome Leak Test	Maintain secure and leak-free connection when subjected to 2X max labeled pressure	Testing performed.
CLiC Blood Chamber Lens Gap	0.078 ± 0.005 in.	Testing performed to verify optical property.
Tubing Compliance Test	Capable of being occlusively clamped by venous line clamp of 5008X machine	Testing performed.
Clamp Occlusion Test	Air and liquid tightness occlusion at desired pressure and time	Testing performed.
Check Valve Cracking Pressure	Lower than 400 mbar	Testing performed.
Check Valve Pressure Drop	Specific range when substitution fluid pumped at certain flow rate	Testing performed.
Tube Transparency	Observe interface of air and liquid during passage of air bubbles	Testing performed.
Tube Resistance to Kinking	No kinking at worst-case bend radius when packaged (evaluate % flow reduction)	Testing performed.
Tube Clamping	Resist clamp occlusions by subjecting to desired pressure and cycles	Testing performed.
Tube Patency	Maintain patency after clamping and reopening (measure flow reduction)	Testing performed.
Air Bubble Trapping (Venous Chamber)	Able to trap incoming air bubbles larger than 20 µL	Testing performed.
Recirculation Connector Packaging	Burst strength, peel strength, dye penetration, microbial resistance	Testing performed.
Viral Retentiveness (Transducer Protector)	Prevent passage of bacteriophage (PhiX174) from patient to machine side up to 600 mmHg for 1 hr	Testing performed.
Sterility (Bloodlines)	Sterility assurance level (SAL) 10-6	Sterilized by 100% ethylene oxide (EO).
EO Residuals (Bloodlines)	< 4.6 mg/device for EO and ECh	Tested per AAMI/ANSI/ISO 10993-7:2008/(R)2012.
Bacterial Endotoxin (Pyrogenicity) (Bloodlines)	Non-pyrogenic (< 20 EU/device)	Tested per ANSI/AAMI/ST72:2019.
Sterile Barrier Testing (Bloodlines)	Maintain sterility of fluid path	Structural integrity test adapted from ISO 8637-2:2018 performed on samples after aging and distribution.
CitraSure Disinfectant
Minimum Disinfection Temperature	70ºC	Performance testing conducted. Results support substantial equivalence, safety, and efficacy.
Minimum Contact Time	10 minutes	Performance testing conducted. Results support substantial equivalence, safety, and efficacy.
Use Life	90 Days	Performance testing conducted. Results support substantial equivalence, safety, and efficacy.
Shelf Life	2 years	Performance testing conducted. Results support substantial equivalence, safety, and efficacy.

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

As this is not an AI/ML device, the concept of "test set" in the context of diagnostic AI algorithms (e.g., patient images or clinical data) is not directly applicable. The performance data presented refers to engineering and quality assurance tests on the physical devices/systems.

Sample Size for Physical Device Testing: The document does not specify exact sample sizes for each individual engineering performance test (e.g., how many bloodlines were tested for structural integrity, how many machines for fluid flow accuracy). It generally states "Testing performed" or "Testing conducted."
Data Provenance: Not applicable in the context of patient data provenance (e.g., country of origin, retrospective/prospective). These are laboratory and simulated use tests on hardware components.

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

Not applicable. The "ground truth" for the performance of a hemodialysis system is based on direct physical measurements against defined engineering specifications and regulatory standards (e.g., flow rates, pressure tolerances, material properties, sterility levels), not expert interpretation of complex data like medical images.

4. Adjudication Method for the Test Set

Not applicable for a medical device's engineering performance testing. Adjudication methods like 2+1 or 3+1 typically refer to resolving discrepancies in expert interpretations (e.g., radiologists reviewing medical images for ground truth labeling in AI studies).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. The document explicitly states: "No clinical studies were performed for the 5008X Hemodialysis System." MRMC studies inherently involve human readers (clinicians) assessing cases, often with or without AI assistance, to measure diagnostic performance and comparative effectiveness. This type of study was not conducted as this is not an AI-assisted diagnostic device.

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

No. The device described is a physical hemodialysis system, not a standalone AI algorithm. While it contains software, the performance evaluation is for the integrated system, and there is no mention of a standalone AI algorithm being assessed.

7. The Type of Ground Truth Used

For the various performance tests, the "ground truth" is defined by:

Engineering Specifications and Standards: Numeric values for flow rates, pressures, temperatures, accuracies, dimensions, and material properties derived from established engineering principles and relevant international standards (e.g., ISO 8637-2:2018 for bloodlines, ISO 23500-5 for dialysate quality, IEC 60601-1-2 for EMC).
Regulatory Requirements: Compliance with FDA guidance documents and regulations (e.g., for biocompatibility, sterility, software verification and validation, human factors).
Absence of Failure: Demonstrating that components do not break, kink, leak, or fail under specified conditions (e.g., blood pump endurance, simulated use).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. The software for the 5008X Hemodialysis Machine would have undergone development, verification, and validation, but this is distinct from AI model training.

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

Not applicable. As there is no AI training set, there is no ground truth established in this context.

Summary

FDA 510(k) Clearance Letter - 5008X Hemodialysis System

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

May 30, 2025

Fresenius Medical Care Renal Therapies Group, LLC
Laura Reed
Director, Submissions Management & RA In-Center
920 Winter Street
Waltham, Massachusetts 02451

Re: K243505
Trade/Device Name: 5008X Hemodialysis System
Regulation Number: 21 CFR 876.5860
Regulation Name: High Permeability Hemodialysis System
Regulatory Class: Class II
Product Code: KDI, KOC, FJK, FIP, NII
Dated: November 12, 2024
Received: May 2, 2025

Dear Laura Reed:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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K243505 - Laura Reed Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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K243505 - Laura Reed Page 3

Sincerely,

Maura Rooney -S

Maura Rooney
Assistant Director
DHT3A: Division of Renal, Gastrointestinal,
Obesity, and Transplant Devices
OHT3: Office of Gastrorenal, ObGyn,
General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026

Indications for Use

See PRA Statement below.

510(k) Number (if known)
K243505

Device Name
5008X Hemodialysis System

Indications for Use (Describe)

Machine:
The 5008X™ system is indicated for intermittent hemodialysis treatment for patients with acute and chronic renal failure in a healthcare facility. Therapy options for patients weighing more than 40 kg include: Hemodiafiltration (HDF), Hemodialysis (HD), Hemofiltration (HF) and Isolated Ultrafiltration.

The 5008X Machine is equipped with a bibag system, but it may also be used with liquid bicarbonate using the connector included with the machine.

The bibag System is indicated for use in patients undergoing extracorporeal bicarbonate hemodialysis for acute and chronic renal failure. The bibag System is intended to be used as one component in the preparation of dialysate according to a physician's prescription in a 3-stream proportioning hemodialysis machine equipped with the bibag module.

The 5008X Machine is available equipped with a Crit-Line Clip (CLiC) Monitor System.

DIASAFEPlusUS Filter:
The DIASAFE®plusUS is intended for the preparation of ultrapure dialysate and sterile, non- pyrogenic substitution fluid from pretreated water and is not intended to provide primary purification. Attention must still be given to the chemical and microbiological quality of water and concentrates and the maintenance of supply systems (e.g. RO system, central delivery system).

The microbiological quality (microbial count [CFU/mL] and endotoxin measurement [EU/mL]) of the incoming water should be < 200 CFU/mL and < 2 EU/mL, respectively.

The DIASAFE®plusUS can only be used with Fresenius Medical Care dialysis machines fitted for use with DIASAFE®plusUS.

5008X Tubing Set:
The blood tubing sets are intended to be used only with the Fresenius Medical Care 5008X Hemodialysis Device, which is indicated for intermittent hemodialysis treatment for patients with acute kidney injury or chronic kidney disease in a healthcare facility. Therapy options include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration.

The HDF blood tubing sets are indicated for use with a prescribed dialyzer. For use with a compatible dialyzer, as per the labeling.

Additional Indications for Use for the blood tubing set equipped with Twister AFRC
The Fresenius Twister Access Flow Reversing Connector (AFRC) is indicated for use during hemodialysis to reverse the blood flow to and from the arterial and venous vascular access devices in order to obtain an access flow measurement.

Additional Indications for Use for the blood tubing set equipped with CLiC
The blood tubing set is intended to be used with the Crit-Line Clip Monitor System (CLiC) on the 5008X Hemodialysis Device.

FORM FDA 3881 (8/23) Page 1 of 2 PSC Publishing Services (301) 443-6740 EF

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under physician direction, intervenes (i.e., increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common symptoms of dialysis which include nausea, cramping and vomiting.

CitraSure Disinfectant:
CitraSure is intended for thermal disinfection of the Fresenius Medical Care 5008X Hemodialysis System when delivered and diluted per the 5008X heat disinfection program.

Type of Use (Select one or both, as applicable)

☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/23) Page 2 of 2 PSC Publishing Services (301) 443-6740 EF

Page 6

510(k) Summary

5008X Hemodialysis System Traditional 510(k)

K243505
Page 1 of 15

1. 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 § 807.92.

1.1. Submitter's Information

Name: Fresenius Medical Care Renal Therapies Group, LLC
Address: 920 Winter Street
Waltham, MA 02451-1457
Contact Person: Laura Reed, Regulatory Affairs Director
Phone: (781) 491-7581
Alternate Contact: Denise Oppermann, Vice President Regulatory Affairs – North America
Phone: (781) 996-9103
Preparation Date: 12 November 2024

1.2. Device Name

Trade Name: 5008X Hemodialysis System
Common Name: Hemodialysis Delivery Device
Regulation Name: High Permeability Hemodialysis System
Regulatory Class: Class II per 21 CFR §876.5860
Product Code: KDI, KOC, FJK, FIP, NII
Product Code Name: Dialyzer, high permeability with or without sealed dialysate system
Accessories, blood circuit, hemodialysis
Set, tubing, blood, with and without anti-regurgitation valve
Subsystem, water purification
Disinfectant, dialysate delivery system
FDA Review Panel: Gastroenterology/Urology

1.3. Legally Marketed Predicate Devices

None of the predicate devices have been subject to any design-related recalls.

1.3.1. 5008X Machine Predicate Device

The 5008X Machine (K231534) is the legally marketed predicate device. The 2008T BlueStar Hemodialysis Machine (K231125) is the legally marketed secondary predicate device.

1.3.2. 5008X Bloodlines Predicate Device

The 5008X Bloodlines (K231534) are the legally marketed predicate devices. The Combiset SMARTECH Hemodialysis Bloodlines (K201207) are the legally marketed secondary predicate devices.

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1.4. Device Description

1.4.1. Device Identification

The 5008X Hemodialysis System consists of the following:

The 5008X Hemodialysis Machine
Two (2) DIASAFE®plusUS Filters (hereinafter referred to as the "Diasafe filter(s)")
The 5008X Bloodlines are available in five (5) configurations:
- 5008X HD/HDF – Standard Blood Tubing Set (hereinafter referred to as the "HD/HDF Standard Bloodline")
- 5008X HD/HDF – With Twister Blood Tubing Set (hereinafter referred to as the "HD/HDF Twister Bloodline")
- 5008X HD/HDF – With CLiC Blood Tubing Set (hereinafter referred to as the "HD/HDF CLiC Bloodline")
- 5008X HD Pre-Flush – Standard Blood Tubing Set (hereinafter referred to as the "HD Standard Bloodline")
- 5008X HD Pre-Flush – With Twister Blood Tubing Set (hereinafter referred to as the "HD Twister Bloodline")
CitraSure™ Disinfectant

1.4.2. Device Characteristics

The 5008X Hemodialysis Machine is an electromechanical device. Software controls the machine during hemodialysis treatment, including fluid flow, mixing, heating, and alarms.

The 5008X Bloodlines are single-use, ethylene oxide (EO) sterilized bloodlines.

CitraSure™ disinfectant is a liquid chemical disinfectant for chemical heat disinfection of the 5008X Hemodialysis Machine.

1.4.3. Environment of Use

The 5008X Hemodialysis System including its components (Diasafe filters, bloodlines, disinfectant, and accessories) is intended for use in healthcare facilities, such as hospitals and dialysis clinics where intermittent dialysis treatment is performed.

1.4.4. Brief Written Description of the Device

The 5008X Hemodialysis Machine provides hemodialysis treatment by controlling and monitoring both the dialysate circuit and the extracorporeal blood circuit. The machine pumps blood from the patient's body through an extracorporeal circuit, one component of which is the

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dialyzer. The dialyzer contains a semi-permeable membrane that uses diffusion to transfer toxins and ultrafiltration to transport excess water from the blood into the dialysate circuit. In this separate dialysate circuit, the dialysate concentrates are mixed with purified water, heated, degassed, filtered (Diasafe filters), and delivered to the dialyzer. Balancing chambers control the dialysate during treatment. Substitution fluid can also be delivered to the patient using the Bloodline if hemofiltration (HF) or hemodiafiltration (HDF) is being performed. During treatment, the extracorporeal blood circuit is monitored for venous and arterial blood pressures as well as for the presence of air and blood. The 5008X Hemodialysis Machine accommodates the following accessory devices and options:

Accessory Devices
- Diasafe Filter (K231534)
- Liquid bicarbonate or the bibag (K162716) concentrate system (central delivery of bicarbonate is not available on the 5008X)
- Acid concentrates compliant with ISO 13958:2014 or ISO 23500-4:2019
- Dialyzers compliant with ISO 8637-1 may be used for HD. Fresenius Medical Care dialyzers indicated for HDF and HF must be used if HDF or HF is being performed.
- 5008X Bloodlines
- 5008X Fluid Sampling Accessory
- 5008X Venous Pressure Replacement with Transducer Protector
- 5008X HD/HDF Medication Line
Options
- CLiC (Crit-Line in a Clip Monitor): K121599 (Stand-alone CLiC)
- BTM (Blood Temperature Monitor)
- CDX (Clinical Data Exchange) – K231125 (CDX cleared with 2008T HD Machine)
- Access Flow Monitor

1.4.5. Materials of Use

1.4.5.1. 5008X Machine and Diasafe Filters

The 5008X Machine and Diasafe filters are classified as externally communicating, blood path, indirect, long-term contact (> 30 days) duration, (Category C) devices in accordance with FDA guidance Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (08 September 2023). A list of the hydraulic materials for the machine is provided in Table 1.

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Table 1: Machine Hydraulic Materials

Component	Material	Material Type
Plastic/Rubber		PPE+PS (Polyphenylene ether + polystyrene)EPDM (Ethylene Propylene Diene Monomer Rubber)PP (Polypropylene)PVDF (Polyvinylidene fluoride)PVC (Polyvinyl chloride)PPSU (Polyphenylsulfone)PESU (Polyethersulfone)PPS (Polyphenylene Sulfide)PTFE (Polytetrafluoroethylene)PEEK (Polyetheretherketone)PAEK (Polyaryletherketone)FKM (Fluorinated, carbon-based synthetic rubber)Platinum Cross-linked Silicone
Metals		TitaniumStainless Steel
Other		Borosilicate GlassGraphiteCeramic

A list of Diasafe filter materials is provided in Table 2.

Table 2: Diasafe Filter Materials

Component	Material Type
Filter fiber	Polysulfone and Polyvinylpyrrolidone
HousingCap/Flange	Polypropylene
Potting resin	Polyurethane
O-RingPlastic TabsSealing Disc Ring	Silicone

1.4.5.2. 5008X Bloodlines

The 5008X Bloodlines are classified as externally communicating, circulating blood, long-term contact (> 30 days) duration, (Category C) devices in accordance with FDA guidance Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1:

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Evaluation and testing within a risk management process (08 September 2023). The materials for the bloodline components are listed in Table 3.

Table 3: 5008X Bloodline Materials

Component	Material Type
Tubing and Components	Polyvinylchloride (PVC)Polycarbonate (PC)Polypropylene (PP)Polyethylene (PE)Acrylonitrile Butadiene Styrene (ABS)PolyisopreneSiliconeTPEStyrene/Butadiene CopolymerPolystyrene
Transducer Protector	Polyester Polybutylene Terephthalate (PBT)Polytetrafluoroethylene (PTFE)PC
Twister	Acrylic and XTPolyisopreneSilicone
Integrated Crit-Line Blood Chamber	PVCPEPC
Bonding Solvents	TetraMEK (95% Tetrahydrofuran/5% MEK)CyclohexanoneLoctite 3311

1.4.5.3. CitraSure Disinfectant

CitraSure has no direct or indirect contact with the patient and is rinsed from the 5008X Machine after the disinfection cycle is complete. CitraSure is comprised of citric acid, lactic acid, malic acid, potassium sorbate, sodium benzoate, and dialysis-quality water.

1.4.6. Key Performance Specifications/Characteristics

The key performance specifications and characteristics for the 5008X Machine, Diasafe Filter, 5008X Bloodline, and CitraSure disinfectant are outlined in Table 4.

Table 4: Key Performance Characteristics

Feature	Specification/Characteristic
5008X Machine

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Table 4: Key Performance Characteristics

Feature	Specification/Characteristic
Maximum Blood Flow Rate	600 mL/min
Maximum Dialysate Flow Rate	1000 mL/min
Maximum Substitution Flow Rate	With AutoSub plus (automatic substitution): 400 mL/minWith manual substitution: 600 mL/min
Net Fluid Removal	0–4000 mL/hrAccuracy: ± (1%UF + 0.15% of balanced fluid volume)Balanced fluid volume = substitution fluid flow + dialysate flow
Dialysis Time	Intermittent, typical time 4 hours
Dialysis Fluid Composition	Volumetric, selectable: (Maximum ranges)Acid adjustment range: 125–151 mEq/L Na+Bicarbonate adjustment range: 25–40 mEq/L Bicarbonate (postreaction, after mixing with the acid and purified water).Monitoring conductivity average accuracy: ± 1.5%
Dialysis Fluid Temperature	Range 34°C–39°C. Fixed alarm window 33°C (or 32°C during BTM recirculation measurement and preparation) or above 40°C.
Heparin Administration Rate	0.1 to 9.9 mL/hrAccuracy: ± 0.5mL or ± 6%
Diasafe Filter
Bacterial and Endotoxin Filtration	Produces sterile, non-pyrogenic substitution fluid from dialysis fluid with a maximum incoming water quality of 200 CFU/mL (bacteria) and 2 EU/mL (endotoxin)
Maximum Number Disinfection Cycles	100 CitraSure cycles13 Pure Bright Bleach cycles
Use Life	90 days maximum or if maximum disinfection cycles have been reached
5008X Bloodline
Maximum Blood Flow Rate	600 mL/min
Minimum Labeled Arterial Pressure	−300 mmHg
Maximum Labeled Venous Pressure	+500 mmHg
Arterial Pump Segment [Inner/Outer Diameter (ID/OD)]	8.0 mm/12.0 mm

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Table 4: Key Performance Characteristics

Feature	Specification/Characteristic
Twister Component	The Twister component facilitates measurement of a patient's access flow by reversing blood flow to and from the arterial and venous vascular access sites while maintaining a closed extracorporeal circuit
CLiC Chamber (Optional) – Hematocrit (HCT)	The measured HCT using the CLiC Bloodline has a standard deviation X2 of ≤ 3%, and an average bias of ≤ 1% (of the average HCT) as measured on control blood chambers
CLiC Chamber (Optional) – Oxygen Saturation (O2 Sat)	The measured O2 Sat using the CLiC Bloodline has a standard deviation X2 of ≤ 3%, and an average bias of ≤ 2% (of the average O2 Sat) as measured on control blood chambers
CitraSure Disinfectant
Minimum Disinfection Temperature	70ºC
Minimum Contact Time	10 minutes
Use Life	90 Days
Shelf Life	2 years

1.5. Intended Use

1.6. Indications for Use

1.6.1. 5008X Machine

The 5008X™ Machine is available equipped with a Crit-Line Clip (CLiC) Monitor System.

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and the dialysis technician. Based on the data that the monitor provides, the clinician/nurse, under physician direction, intervenes (i.e. increases or decreases the rate at which fluid is removed from the blood) in order to remove the maximum amount of fluid from the dialysis patient without the patient experiencing the common symptoms of dialysis which include nausea, cramping and vomiting.

1.6.2. Diasafe Filter

The microbiological quality (microbial count [CFU/mL] and endotoxin measurement [EU/mL]) of the incoming water should be < 200 CFU/mL and < 2 EU/mL, respectively.

The DIASAFE®plusUS can only be used with Fresenius Medical Care dialysis machines fitted for use with DIASAFE®plusUS.

1.6.3. 5008X Tubing Set

The HDF blood tubing sets are indicated for use with a prescribed dialyzer. For use with a compatible dialyzer, as per the labeling.

Additional Indications for Use for the blood tubing set equipped with Twister AFRC

Additional Indications for Use for the blood tubing set equipped with CLiC

The blood tubing set is intended to be used with the Crit-Line Clip Monitor System (CLiC) on the 5008X Hemodialysis Device.

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1.6.4. CitraSure Disinfectant

CitraSure is intended for thermal disinfection of the Fresenius Medical Care 5008X Hemodialysis System when delivered and diluted per the 5008X heat disinfection program.

1.7. Comparison of Technological Characteristics with the Predicate Device

The following technological characteristics of the 5008X Hemodialysis System are substantially equivalent to those of the predicate 5008X Hemodialysis System (K231534):

Intended Use
Indications for Use
Design Specifications
Technological Characteristics
Principle of Operation
Performance Requirements

The following technological characteristics of the 5008X Hemodialysis Machine are substantially equivalent to the 2008T BlueStar Hemodialysis Machine (K231125):

Clinical Data Exchange (CDX)
Heparin Administration
Access Flow Monitor (AFM)

The following technological characteristics of the 5008X Bloodlines are substantially equivalent to the Combiset SMARTECH Hemodialysis Bloodlines (K201207):

Heparin Line
Saline Line

1.8. Sterilization Testing

1.8.1. 5008X Bloodline

The 5008X Bloodlines are sterilized by exposure to 100% ethylene oxide (EO). The sterility assurance level (SAL) is 10-6. Sterility and non-pyrogenicity are claimed for the fluid pathway of the bloodline.

1.8.2. 5008X Bloodline EO Residual Testing

Residual testing for EO and ethylene chlorohydrin (ECh) was performed in accordance with AAMI/ANSI/ISO 10993-7:2008/(R)2012 Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals. Acceptable results (i.e., < 4.6 mg/device for EO and ECh) were obtained for the subject bloodlines.

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1.8.3. 5008X Bloodline Bacterial Endotoxin (Pyrogenicity) Testing

The subject bloodlines were tested for bacterial endotoxin (pyrogenicity) with Limulus Amebocyte Lysate (LAL) and determined to be non-pyrogenic (< 20 EU/device) in accordance with ANSI/AAMI/ST72:2019 Bacterial Endotoxins – Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing.

1.8.4. 5008X Bloodline Sterile Barrier Testing

Sterility of the blood pathway is maintained by the sterile fluid path of the device itself which includes the following components:

Vented Caps
Transducer Protectors (TPs)
Tubing and all other components that make up the structural integrity of the bloodline's fluid path

The tubing and other components were qualified as part of the sterile barrier through the structural integrity test adapted from ISO 8637-2:2018. Testing was performed on samples after aging and distribution simulation.

1.9. Performance Data

Performance testing was conducted for the 5008X Hemodialysis System. Results of performance testing support substantial equivalence, safety, and efficacy of the 5008X Hemodialysis System.

1.9.1. 5008X Hemodialysis Machine

The following performance tests were conducted on the 5008X Hemodialysis Machine to support the determination of substantial equivalence:

System Level Performance Testing
Functional Design Verification
Electrical Safety and Electromagnetic Compatibility (EMC)
Simulated Shipping and Distribution
Software Verification and Validation

1.9.2. 5008X Bloodline

Testing conducted to support the determination of substantial equivalence for the 5008X Bloodlines and accessories is summarized in Table 5.

Table 5: 5008X Bloodline Performance Testing Summary

Test Performed	Test Objective
Structural Integrity	Demonstrate that the bloodlines and accessories can withstand 1.5X the labeled maximum positive and negative pressures.
Positive and Negative	Demonstrate that the portions of the bloodline and accessories can withstand

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Table 5: 5008X Bloodline Performance Testing Summary

Test Performed	Test Objective
Leak Test	pressures resulting from faulty conditions of the dialysis machine.
Pump Segment Performance	Evaluate performance characteristics of the bloodline pump segment over the range of inlet pressures (normally 0 mmHg to -250 mmHg), flow rates, and treatment time.
Blood Pump Endurance	Demonstrate that the blood pump segment does not break or detach at maximum blood flow rates and pressures for 12 hours.
Simulated Use	Demonstrate that bloodlines perform with no tubing failures (kinking, collapsing, or disconnection) under simulated use conditions for not less than 4 hours, and those bloodline components which interface with hemodialysis machine are removable after treatment is complete without resulting in external leaks.
Needle Access Port Test	Demonstrate that the needle access ports, including the medication line accessory with access port, can withstand 1.5X the manufacturer's recommended maximum positive and negative pressures after multiple accesses.
Male and Female Luer Connectors Tests (Performance)	Demonstrate that the components of the bloodlines and accessories meet the performance requirements of ISO 80369-7 2021, Section 6.
Male and Female Luer Connectors Tests (Dimensions)	Demonstrate that all the Luer components of the bloodlines and accessories, meet the dimensional requirements of ISO 80369-7: 2021, Section 5.
Male and Female Luer Connectors (Raw Material)	Demonstrate that all the Luer components of the bloodlines and accessories, including new or changed, are manufactured with a raw material with a nominal modulus of elasticity either in flexure or in tension greater than 700 MPa.
Visual Inspection After Simulation of Transportation	Demonstrate that shipping case, packaging configuration, and palletization pattern maintain the product's structural integrity during manual handling and motorized freight.
Tensile Testing	Demonstrate that all bonded and glued engagements in the bloodline between components, and between components and tubing can withstand a specific tensile force based on the tubing type and position in the bloodline.
Labeling Content	Demonstrate that the Instructions for Use, unit labels, case labels, and shipping carton artwork for the bloodlines and accessories meet the requirements of ISO 8637-2:2018 and Guidance for Industry and FDA Staff: Hemodialysis Blood Tubing Sets – Premarket Notification [510(k)] Submissions.
Labeling Content – Color Coding	Verify that the color-coded components meet the requirements of ISO 8637-2:2018 and Guidance for Industry and FDA Staff: Hemodialysis Blood Tubing Sets – Premarket Notification [510(k)] Submissions
Readability of Barcode with Human Readable Identification Codes	Demonstrate that the barcode information on the outer container labels and unit labels for the bloodlines is capable of being scanned.

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Table 5: 5008X Bloodline Performance Testing Summary

Test Performed	Test Objective
Transparency of Transducer Protector	Demonstrate that the machine side of the transducer protector (TP) is clear to allow for visual inspection of blood contamination during use.
Transducer Protector Leak Test	The TP will be capable of maintaining a secure and leak-free connection to the hemodialysis machine when subjected to 2X the maximum labeled pressure.
Arterial Pressure Dome Leak Test	The pressure dome will be capable of maintaining a secure and leak-free connection to the hemodialysis machine when subjected to 2X the maximum labeled pressure.
Measure Gap between Lenses	Demonstrate that the distance between the lenses from the CLiC Blood Chamber is 0.078 ± 0.005 in. to verify the optical property.
Functional CLiC Chamber Test (Hematocrit)	Demonstrate that the CLiC integrated blood chamber optical properties enable the measurement of Hematocrit in the range of 10–60 HCT.
Functional CLiC Chamber Test (O2 Sat)	Demonstrate that the CLiC integrated blood chamber optical properties enable the measurement of Saturated Oxygen in the range of 30%–100% where the HCT ≥ 10.
Tubing Compliance Test	Demonstrate that 5008X bloodline tubing is capable of being occlusively clamped by the venous line clamp of the 5008X hemodialysis machine.
Clamp Occlusion Test	Demonstrate that the performance of the manual clamp to guarantee air and liquid tightness occlusion at the desired pressure and time by pressurizing a tube with the clamp under test closed on it.
Twister Rotation Test	Demonstrate that the Twister component can twist 180° ± 1° to reverse the blood flow.
Twister Torque Test	Demonstrate that the torque needed to rotate the Twister component from 0° to 180° and back is ≤ 7 inch-pound.
Check Valve Cracking Pressure	Demonstrate that the opening pressure (cracking pressure) of the Antisiphon valve is lower than 400 mbar.
Check Valve Pressure Drop	Demonstrate that the antisiphon valve presents a pressure drop in a specific range when substitution fluid is pumped through the valve at a certain flow rate.
Tube Transparency	Evaluate the transparency of the tube by observing the interface of air and liquid during the passage of air bubbles.
Tube Resistance to Kinking	Demonstrate that the tubing does not kink at the worst-case bend radius when packaged. The kinking of a tube at the maximum expected bend radius is evaluated measuring the percentage of flow reduction against the tube curved.
Tube Clamping	Demonstrate that the performance of the tube to resist clamp occlusions by subjecting the sample to a desired pressure and alternatively occluding with a clamp for a defined number of cycles.
Tube Patency	Demonstrate that the performance of the tube to maintain its patency after being clamped and then reopened by measuring the flow reduction of the re-

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Table 5: 5008X Bloodline Performance Testing Summary

Test Performed	Test Objective
	opened tube compared to tube not clamped.
Air Bubble Trapping	Demonstrate that the Venous Chamber is able to trap incoming air bubbles larger than 20 µL.
Recirculation Connector Packaging Burst Strength	Demonstrate that the minimum burst strength of the perimeter seal around the recirculation connector flexible package as it is internally pressurized and enclosed within restraining plates.
Recirculation Connector Packaging Peel Strength	Demonstrate that the seal strength of the seal joint around recirculation connector flexible package.
Recirculation Connector Packaging Dye Penetration Test	Demonstrate that the seal of the recirculation connector flexible package does not contain micro channels. Micro channel is defined as one that forms a 50 μm (0.002") wide channel in the edge seals of a porous or nonporous packaging and presents a leak.
Recirculation Connector Packaging Microbial Resistance	Demonstrate that the ability of the recirculation connector flexible package material to resist passage of the challenge organism.
Viral Retentiveness Test for Transducer Protector	Demonstrate that the membrane inside the TP can prevent passage of bacteriophage (PhiX174) from the patient side to the machine side up to a pressure of 600 mmHg for 1 hr.

1.9.3. Biocompatibility Testing

Biocompatibility testing for the 5008X Machine and 5008X Bloodlines patient contacting components was conducted in accordance with ISO 10993-1:2018 and FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" (08 September 2023). The following endpoints were evaluated to support the biological safety of the 5008X Hemodialysis Machine:

5008X Machine
- Cytotoxicity
- Sensitization
- Intracutaneous Irritation
- Pyrogenicity (Material Mediated)
- Hemocompatibility, ASTM Hemolysis (Direct)
- Subchronic Toxicity
- Genotoxicity
- Chemical Characterization
- Toxicological Risk Assessment
5008X Bloodlines

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Cytotoxicity
Sensitization
Intracutaneous Irritation
Systemic Toxicity
Pyrogenicity (Material Mediated)
Hemocompatibility, ASTM Hemolysis (Direct and Indirect)
Hemocompatibility, Dynamic (Mechanical) Hemolysis
Hemocompatibility, Complement Activation
Hemocompatibility, Platelet and Leukocyte Count
Hemocompatibility, Partial Thromboplastin Time
Chemical Characterization
Toxicological Risk Assessment

1.9.4. Human Factors Validation Testing

The 5008X Hemodialysis System was validated for safe and effective use in accordance with FDA guidance Applying Human Factors and Usability Engineering to Medical Devices (03 February 2016).

1.9.5. Electrical Safety and Electromagnetic Compatibility (EMC)

Electromagnetic compatibility (EMC) testing was conducted on the 5008X Hemodialysis Machine in accordance with IEC 60601-1-2 Edition 4.1 2020-09, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic disturbances - Requirements and tests.

1.9.6. Software Verification and Validation Testing

Unit, integration, and system level software verification testing were performed to demonstrate the efficacy of the software and to confirm operation of the machine. The following testing was performed:

Functional and Performance Verification
Regression Testing
Code Reviews

Software verification information within this submission is provided in accordance with the following FDA guidance documents:

Content of Premarket Submissions for Device Software Functions (14 June 2023)
Off-The-Shelf Software Use in Medical Devices (11 August 2023)

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Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (27 September 2023)
Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act (13 March 2024)
Applying Human Factors and Usability Engineering to Medical Devices (3 February 2016)

1.9.7. Animal Studies

No animal studies were performed for the 5008X Hemodialysis System.

1.9.8. Clinical Studies

No clinical studies were performed for the 5008X Hemodialysis System.

1.10. Conclusion

The indications for use, design, principle of operation, and technological characteristics of the 5008X Hemodialysis System and its components are substantially equivalent to those of the predicate and secondary predicate devices. Test results demonstrate that the differences between the 5008X Hemodialysis System, the predicate, and secondary predicate devices do not raise new concerns with regard to safety or efficacy. FMCRTG concludes that within the meaning of the Medical Device Amendments Act of 1976, the 5008X Hemodialysis System is safe and effective for its intended use.

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.”