(199 days)
No
The document describes a hemodialysis system and its components. While it functions as an electromechanical device controlled by software for fluid flow, mixing, heating, and alarms, there is no mention of AI, machine learning, or deep learning models being used within the device. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is described as a "Hemodialysis System" intended for use in "acute and chronic hemodialysis therapy" for patients with "renal failure," which indicates its use in treating a medical condition.
No
This device is primarily a hemodialysis system, which is a treatment device for renal failure. While it includes components like the Crit-Line Clip (CLiC) System that measure physiological parameters (hematocrit, oxygen saturation, percent change in blood volume), these measurements are explicitly for the "application in the treatment of dialysis patients" and to "provide a more effective treatment." The information gathered is used to guide interventions during the therapy, not primarily to diagnose a condition or disease.
No
The 5008X Hemodialysis System is a complex electromechanical device consisting of a hemodialysis machine, filters, bloodlines, and disinfectant. While it includes "Software controls the machine during hemodialysis treatment," this software is embedded within and controls physical hardware components designed for hemodialysis, making it a hardware-based medical device with integrated software, not a software-only medical device. The device description and performance testing clearly outline extensive hardware components and their physical characteristics and performance.
No.
The device is a hemodialysis system, which is used for the physical filtering of blood in patients with renal failure. While some components like the Crit-Line Clip (CLiC) monitor non-invasively measure blood parameters, the primary function of the system is a therapeutic one (hemodialysis), not to provide information for diagnosis or to screen for disease. The measurements done by the CLiC are for monitoring during treatment, not for diagnosis.
N/A
Intended Use / Indications for Use
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.
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.
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
§ 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.”
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"
Page 2
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).
Page 3
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.
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.
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 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.
Page 9
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 | Titanium | |
| Stainless Steel | ||
| Other | Borosilicate Glass | |
| Graphite | ||
| Ceramic |
A list of Diasafe filter materials is provided in Table 2.
Table 2: Diasafe Filter Materials
| Component | Material Type |
|---|---|
| Filter fiber | Polysulfone and Polyvinylpyrrolidone |
| Housing | |
| Cap/Flange | Polypropylene |
| Potting resin | Polyurethane |
| O-Ring | |
| Plastic Tabs | |
| Sealing 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:
Page 10
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) | |
| Polyisoprene | |
| Silicone | |
| TPE | |
| Styrene/Butadiene Copolymer | |
| Polystyrene | |
| Transducer Protector | Polyester Polybutylene Terephthalate (PBT) |
| Polytetrafluoroethylene (PTFE) | |
| PC | |
| Twister | Acrylic and XT |
| Polyisoprene | |
| Silicone | |
| Integrated Crit-Line Blood Chamber | PVC |
| PE | |
| PC | |
| Bonding Solvents | TetraMEK (95% Tetrahydrofuran/5% MEK) |
| Cyclohexanone | |
| Loctite 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 |
Page 11
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/min |
| With manual substitution: 600 mL/min | |
| Net Fluid Removal | 0–4000 mL/hr |
| Accuracy: ± (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/hr |
| Accuracy: ± 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 cycles |
| 13 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 |
Page 12
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
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).
1.6. Indications for Use
1.6.1. 5008X 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.
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
Page 13
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 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