(248 days)
Not Found
No
The summary describes an electromechanical hemodialysis system with software control for basic functions like fluid flow, mixing, heating, and alarms. While it includes a monitor (CLiC) that provides real-time data (hematocrit, oxygen saturation, blood volume change) to the clinician for manual intervention, there is no mention of the device itself using AI/ML algorithms to process this data or make automated decisions or recommendations. The decision-making based on the CLiC data is explicitly stated as being made by the clinician/nurse under physician direction.
Yes
The intended use statement indicates that the device is for intermittent hemodialysis treatment and related therapies for patients with renal failure, which is a therapeutic purpose.
No
The 5008X™ system is indicated for intermittent hemodialysis treatment for patients with acute and chronic renal failure. While it includes components like the Crit-Line Clip (CLiC) Monitor System that measure physiological parameters (hematocrit, oxygen saturation, blood volume), these measurements are used to guide treatment (intervene by adjusting fluid removal) rather than to diagnose a medical condition. The primary function of the device is therapeutic (hemodialysis), not diagnostic.
No
The device is a complex system including an electromechanical hemodialysis machine, filters, bloodlines, and disinfectant, with software controlling the machine's functions. It is not solely software.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
-
Definition of IVD: An In Vitro Diagnostic device is a medical device intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This typically involves testing blood, urine, tissue, etc., outside of the body to diagnose or monitor a condition.
-
Intended Use of the 5008X System: The primary intended use of the 5008X system is for intermittent hemodialysis treatment for patients with renal failure. This is a therapeutic treatment that filters the patient's blood in vivo (within the body, albeit through an external circuit).
-
Components and their functions:
- 5008X Machine: Performs the physical process of filtering blood.
- bibag System/Liquid Bicarbonate: Used to prepare dialysate, which is a fluid used in the dialysis process. This is part of the treatment fluid, not a diagnostic reagent.
- CLiC Monitor System: Non-invasively measures hematocrit, oxygen saturation, and blood volume changes in the blood flowing through the tubing. While it provides data, this data is used to adjust the treatment (fluid removal rate), not to diagnose a condition from a specimen.
- DIASAFE®plusUS Filter: Filters the water and prepares the dialysate/substitution fluid. This is part of the fluid preparation for treatment.
- 5008X Tubing Set: Carries the blood and dialysate during the treatment.
- CitraSure Disinfectant: Used to clean the machine.
None of these components or their functions involve the in vitro examination of a human specimen for diagnostic purposes. The measurements taken by the CLiC are on the blood as it flows through the extracorporeal circuit during treatment, and the data is used to optimize the treatment itself.
Therefore, the 5008X Hemodialysis System is a therapeutic medical device used for treating renal failure, not an In Vitro Diagnostic device.
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-invasure 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.”
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 2, 2024
Fresenius Medical Care Denise Oppermann Vice President, Regulatory Affairs - North America 920 Winter Street Waltham, Massachusetts 02451
Re: K231534
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: January 4, 2024 Received: January 4, 2024
Dear Denise 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 (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" (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).
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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 OS 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 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-reportingcombination-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.
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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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).
Sincerely, Maura Rooney - Digitally signed by Maura Rooney -S 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
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Enclosure
3
Indications for Use
510(k) Number (if known)
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-invasure 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 Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"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."
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Image /page/5/Picture/0 description: The image shows the Fresenius Medical Care logo. On the left is a blue symbol that looks like three chevrons stacked on top of each other, pointing downwards. To the right of the symbol is the text "FRESENIUS MEDICAL CARE", with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line. The text is also in blue.
5. 510(K) SUMMARY
This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR § 807.92.
5.1. Submitter's Information
| Name: | Fresenius Medical Care Renal Therapies Group, LLC |
|---|---|
| Address: | 920 Winter Street |
| Waltham, MA | |
| 02451-1457 | |
| Phone: | (781) 996-9103 |
| Fax: | (781) 699-9635 |
| Contact Person: | Denise Oppermann, VP RA, NA |
| Preparation Date: | 26 May 2023 |
5.2. Device Name
| Trade Name: | 5008X Hemodialysis System |
|---|---|
| Common Name: | Hemodialysis Delivery Device, including |
| the Diasafe filter, bloodlines, disinfectant | |
| and accessories | |
| 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 |
5.3. Legally Marketed Predicate Devices
None of the predicate devices listed below have been subject to any design-related recalls.
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Image /page/6/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue geometric shape on the left, resembling three downward-pointing chevrons stacked on top of each other. To the right of the shape is the text "FRESENIUS" in large, bold, blue letters, with "MEDICAL CARE" in a smaller font below it, also in blue. The background is plain white.
5.3.1. 5008X Machine Predicate Device
The predicate device for the 5008X Hemodialysis System is the 2008T BlueStar™ Hemodialysis system cleared under K222952. The legally marketed secondary predicate device, the Nephros OLpur H2H Module (K112314), is included to support additional therapy modes. The legally marketed predicate device, Aksys PHD Personal Hemodialysis Instrument (K010131), is included to support the online bolus feature.
5008X Bloodlines (also referred to as "Bloodline") Predicate Devices 5.3.2.
The legally marked predicate device is the CombiSet SMARTECH Hemodialysis Bloodlines cleared under K201207. The legally marketed secondary predicate device is the CAREline Airless Hemodialysis Bloodlines cleared under K172238.
5.3.3. DIASAFE®plusus filter Predicate Device
Two (2) DIASAFE® plusus filters cleared under K182367 are used on the 5008X hemodialysis machine to filter dialysate.
Device Description 5.4.
5.4.1. 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 Hemodialysis Bloodlines (hereinafter referred to as "5008X Bloodlines") ● are available in three (3) configurations:
- -5008X HDF Hemodialysis blood tubing set catalog number 03-5100-7 (hereinafter referred to as the "Standard Bloodline")
- -5008X HDF Hemodialysis blood tubing set with access flow reversing connector (Twister®) catalog number 03-5150-2 (hereinafter referred to as the "Twister Bloodline")
- 5008X HDF Hemodialysis blood tubing set with CLiC™ blood chamber catalog number 03-5100-7C (hereinafter referred to as the "CLiC Bloodline")
- CitraSure™ Disinfectant
5.4.2. 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 Diasafe filter is a non-sterile dialysis fluid filter that produces ultrapure dialysate and sterile, non-pyrogenic substitution fluid as defined in ANSI/AAMI/ISO 11663. The filter reduces microbial contaminants including endotoxins in the dialysate during hemodialysis treatment. The Diasafe filters are installed and exchanged on the 5008X Hemodialysis Machines using the
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Image /page/7/Picture/0 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue geometric shape on the left and the words "FRESENIUS MEDICAL CARE" in blue on the right. The geometric shape is made up of three chevrons pointing downwards. The words "FRESENIUS" and "MEDICAL CARE" are stacked on top of each other.
DIAFIX™ Lock System. The DIAFIX™ Lock System is a standard feature on 5008X Hemodialysis Machines and is installed during machine production.
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.
5.4.3. 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.
Brief Written Description of the Device 5.4.4.
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 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. Substitution fluid can also be delivered to the patient using the Bloodline if hemofiltration (HF) or hemodiafiltration (HDF) is being performed. Balancing chambers control the dialysate during treatment. 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 (K182367)
- ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Liquid bicarbonate or the bibag (K162716) concentrate system (central delivery of bicarbonate is not available on the 5008X)
- -Acid concentrates compliant with ISO 13958
- Dialyzers compliant with ISO 8637, 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 Hemodialysis Bloodlines
- -5008X Fluid Sampling Accessory
- Options
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Image /page/8/Picture/0 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right, also in blue. The symbol is made up of three downward-pointing chevron shapes stacked on top of each other.
- BTM (Blood Temperature Monitor) —
5.4.5. Materials of Use
5.4.5.1. Machine and Diasafe Filters
The 5008X Machine and Diasafe filters are classified as externally communicating, blood path, indirect, prolonged contact (> 24 hours to 30 days) duration, (Category B) devices in accordance with FDA guidance document Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (04 September 2020). A list of the hydraulic materials for the machine is provided in Table 1.
| 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 |
Table 1: Machine Hydraulic Materials
A list of Diasafe filter materials is provided in Table 2.
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Image /page/9/Picture/0 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue abstract symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons stacked on top of each other. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
| Table 2: | Diasafe Filter Materials |
|---|---|
| ---------- | -------------------------- |
| Component | Material |
|---|---|
| Filter fiber | Polysulfone and Polyvinylpyrrolidone |
| Housing | |
| Cap/Flange | Polypropylene |
| Potting resin | Polyurethane |
| O-Ring | |
| Plastic Tabs | |
| Sealing Disc Ring | Silicone |
5.4.5.2. 5008X Bloodlines
The 5008X Bloodlines are classified as externally communicating, circulating blood, prolonged contact (>24 hours to 30 days) duration, (Category B) devices in accordance with FDA guidance document Use of International Standard ISO 10993-1, Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process (04 September 2020). The materials for the bloodline components are listed in Table 3.
| Component | Material |
|---|---|
| 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 |
Table 3: Bloodline Materials
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Image /page/10/Picture/0 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue abstract symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.
| Table 3:
| Bloodline Materials |
|---|
| --------------------------------- |
| Component | Material |
|---|---|
| Integrated Crit-Line Blood Chamber | PVC |
| PE | |
| PC | |
| Bonding Solvents | TetraMEK (95% Tetrahydrofuran/5% MEK) |
| Cyclohexanone | |
| Loctite 3311 |
CitraSure Disinfectant 5.4.5.3.
CitraSure disinfectant 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, and sodium benzoate, and dialysis-quality water.
Key Performance Specifications/Characteristic 5.4.6.
The key performance specifications and characteristics for the 5008X Machine, Diasafe Filter, 5008X Bloodline, and CitraSure disinfectant are outlined in Table 4.
| Feature | Specification/Characteristic |
|---|---|
| 5008X Machine | |
| 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 (post- | |
| reaction, after mixing with the acid and purified water). | |
| Monitoring conductivity average accuracy: ± 1.5% | |
| Feature | Specification/Characteristic |
| Dialysis Fluid Temperature | Range 34℃-39℃. Fixed alarm window 33℃ (or 32℃ during |
| BTM recirculation measurement and preparation) or above 40℃. | |
| 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 |
| 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 | 70℃ |
| Minimum Contact Time | 10 minutes |
| Use Life | 90 Days |
| Feature | Specification/Characteristic |
| Shelf Life | 2 years |
Table 4: Key Performance Specifications/Characteristics
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Table 4: Key Performance Specifications/Characteristics
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Image /page/12/Picture/0 description: The image contains the logo for Fresenius Medical Care. On the left is a blue symbol that looks like three chevrons stacked on top of each other, pointing downwards. To the right of the symbol is the text "FRESENIUS MEDICAL CARE" in blue, with "FRESENIUS" on top of "MEDICAL CARE".
Table 4: Key Performance Specifications/Characteristics
ર.ડ. Intended Use
The 5008X Hemodialysis System intended for use in acute and chronic hemodialysis therapy. Therapy options include hemodialysis (HD), hemodiafiltration (HDF), hemoffitration (HF), and isolated ultrafiltration (ISO).
Indications for Use 5.6.
5.6.1. 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 svstem 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.
5.6.2. Diasafe Filter
The DIASAFE®plusys 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