5008X Hemodialysis System

K231534 · Fresenius Medical Care · KDI · Feb 2, 2024 · Gastroenterology, Urology

Device Facts

• Record ID: K231534
• Device Name: 5008X Hemodialysis System
• Applicant: Fresenius Medical Care
• Product Code: KDI · Gastroenterology, Urology
• Decision Date: Feb 2, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

5008X Hemodialysis System is an electromechanical device for intermittent hemodialysis in healthcare facilities. System components include hemodialysis machine, DIASAFEplusUS filters, blood tubing sets, and CitraSure disinfectant. Machine pumps blood through extracorporeal circuit containing dialyzer; uses semi-permeable membrane for diffusion of toxins and ultrafiltration of excess water. Dialysate circuit mixes concentrates with purified water, heats, degasses, and filters via DIASAFEplusUS filters. Optional CLiC monitor uses optical sensors in blood chamber to measure hematocrit, oxygen saturation, and blood volume change in real-time. Clinicians use CLiC data to adjust fluid removal rates to prevent dialysis symptoms (nausea, cramping, vomiting). Twister AFRC accessory allows blood flow reversal for access flow measurement. System monitored for venous/arterial pressures, air, and blood presence. Software controls fluid flow, mixing, heating, and alarms. Benefits include effective toxin/fluid removal and real-time monitoring to optimize patient comfort during treatment.

Clinical Evidence

No clinical studies were performed. Evidence consists of bench testing, including system-level performance, interface verification, disinfection validation, biocompatibility (ISO 10993-1), electrical safety (IEC 60601-1-2), and software verification. Literature evaluation of predecessor devices was conducted.

Technological Characteristics

Electromechanical hemodialysis system. Materials: PPE+PS, EPDM, PP, PVDF, PVC, PPSU, PESU, PPS, PTFE, PEEK, PAEK, FKM, silicone, titanium, stainless steel, borosilicate glass, graphite, ceramic. Sensing: pressure, air, blood, optical (CLiC). Connectivity: standalone. Sterilization: EO (bloodlines), thermal/chemical (machine). Software: controls fluid flow, mixing, heating, alarms.

Indications for Use

Indicated for intermittent hemodialysis in patients >40 kg with acute or chronic renal failure in healthcare facilities. Therapy options: HDF, HD, HF, isolated ultrafiltration. Optional CLiC monitor indicated for real-time non-invasive measurement of hematocrit, oxygen saturation, and blood volume change to assist clinicians in fluid removal management.

Regulatory Classification

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).

Special Controls

*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.”

Predicate Devices

• 2008T BlueStar Hemodialysis system (K222952)
• Nephros OLpur H2H Module (K112314)
• Aksys PHD Personal Hemodialysis Instrument (K010131)
• CombiSet SMARTECH Hemodialysis Bloodlines (K201207)
• CAREline Airless Hemodialysis Bloodlines (K172238)
• DIASAFE plusus filters (K182367)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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

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# 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 < 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 disease in a healthcare facility. Therapy options include: hemodiafiltration (HDF), hemofiltration (HF), and isolated ultrafiltration.

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

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

The Fresenus 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.

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,

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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 experiencing the common symptoms of dialysis which include nausea, cramping and vomiting.

CitraSure Disinfectant:

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

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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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<br>Waltham, MA<br>02451-1457 |
| Phone: | [phone] |
| Fax: | [phone] |
| 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<br>the Diasafe filter, bloodlines, disinfectant<br>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<br>without sealed dialysate system;<br>Accessories, blood circuit, hemodialysis;<br>Set, tubing, blood, with and without anti-<br>regurgitation valve;<br>Subsystem, water purification;<br>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
- Patient Card and User Card —
- CLiC (Crit-Line in a Clip Monitor): K121599 (Stand-alone CLiC) and K131908 — (CLiC with 2008T HD Machine)

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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<br>Cap/Flange | Polypropylene |
| Potting resin | Polyurethane |
| O-Ring<br>Plastic Tabs<br>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)<br>Polycarbonate (PC)<br>Polypropylene (PP)<br>Polyethylene (PE)<br>Acrylonitrile Butadiene Styrene (ABS)<br>Polyisoprene<br>Silicone<br>TPE<br>Styrene/Butadiene Copolymer<br>Polystyrene |
| Transducer Protector | Polyester Polybutylene Terephthalate (PBT)<br>Polytetrafluoroethylene (PTFE)<br>PC |
| Twister | Acrylic and XT<br>Polyisoprene<br>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:<br>Bloodline Materials |
|---------------------------------|
|---------------------------------|

| Component | Material |
|------------------------------------|------------------------------------------------------------------------|
| Integrated Crit-Line Blood Chamber | PVC<br>PE<br>PC |
| Bonding Solvents | TetraMEK (95% Tetrahydrofuran/5% MEK)<br>Cyclohexanone<br>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<br>With manual substitution: 600 mL/min |
| Net Fluid Removal | 0-4000 mL/hr<br>Accuracy: ± (1% UF +0.15% of balanced fluid volume)<br>Balanced fluid volume = substitution fluid flow + dialysate flow |
| Dialysis Time | Intermittent, typical time 4 hours |
| Dialysis Fluid Composition | Volumetric, selectable: (Maximum ranges)<br>Acid adjustment range: 125–151 mEq/L Na+<br>Bicarbonate adjustment range: 25-40 mEq/L Bicarbonate (post-<br>reaction, after mixing with the acid and purified water).<br>Monitoring conductivity average accuracy: ± 1.5% |
| Feature | Specification/Characteristic |
| Dialysis Fluid Temperature | Range 34℃-39℃. Fixed alarm window 33℃ (or 32℃ during<br>BTM recirculation measurement and preparation) or above 40℃. |
| Diasafe Filter | |
| Bacterial and Endotoxin Filtration | Produces sterile, non-pyrogenic substitution fluid from dialysis<br>fluid with a maximum incoming water quality of 200 CFU/mL<br>(bacteria) and 2 EU/mL (endotoxin) |
| Maximum Number Disinfection<br>Cycles | 100 CitraSure cycles<br>13 Pure Bright Bleach cycles |
| Use Life | 90 days maximum or if maximum disinfection cycles have been<br>reached |
| 5008X Bloodline | |
| Maximum Blood Flow Rate | 600 mL/min |
| Minimum Labeled Arterial<br>Pressure | -300 mmHg |
| Maximum Labeled Venous<br>Pressure | +500 mmHg |
| Arterial Pump Segment<br>[Inner/Outer Diameter (ID/OD)] | 8.0 mm/12.0 mm |
| Twister Component | The Twister component facilitates measurement of a patient's<br>access flow by reversing blood flow to and from the arterial and<br>venous vascular access sites while maintaining a closed<br>extracorporeal circuit |
| CLiC Chamber (Optional) -<br>Hematocrit (HCT) | The measured HCT using the CLiC Bloodline has a standard<br>deviation X2 of ≤3%, and an average bias of ≤1% (of the average<br>HCT) as measured on control blood chambers |
| CLiC Chamber (Optional) -<br>Oxygen Saturation (O2 Sat) | The measured O2 Sat using the CLiC Bloodline has a standard<br>deviation X2 of ≤3%, and an average bias of ≤2% (of the average<br>O2 Sat) as measured on control blood chambers |
| CitraSure Disinfectant | |
| Minimum Disinfection<br>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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Image /page/11/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.

#### 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 < 200 CFU/mL and < 2 EU/mL, respectively.

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Image /page/13/Picture/0 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue geometric shape on the left and the text "FRESENIUS MEDICAL CARE" on the right. The geometric shape 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.

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

#### 5.6.3. 5008X Bloodlines

The bloodlines 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 blood tubing sets are indicated for use with a prescribed hemodialyzer. For use with a compatible hemodialyzer, 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.

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.

#### 5.6.4. 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.

### 5.7. Comparison of Technological Characteristics with the Predicate Device

#### 5.7.1. 5008X Hemodialysis Machine

The following technological characteristics of the 5008X Hemodialysis Machines are equivalent to the 2008T BlueStar predicate device:

- Indications for Use
- bibag
- Blood Pressure Monitor (BPM) ●

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Image /page/14/Picture/0 description: The image shows 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 a bold, blue font. The words are stacked on top of each other.

- BTM
- Online Clearance Monitor (OCM)
- Recirculation measurement ●
- CLiC Monitor System (optional) ●
- HD and ISO therapy modes ●

The following technological characteristics of the 5008X Hemodialysis Machines are equivalent to the Nephros OLpur H2H Module predicate device:

- . Intended Use
- . Filtration of dialysate to generate sterile, non-pyrogenic substitution fluid
- HDF and HF therapy modes ●

#### 5.7.2. Diasafe Filter

The following technological characteristics of the Diasafe filter are substantially equivalent to those of the predicate Diasafe filter (K182367):

- . Indications for Use
- Technological Characteristics ●
- Design
- Performance Requirements ●

#### 5.7.3. 5008X Bloodline

The following technological characteristics of the 5008X Bloodlines are substantially equivalent to those of the predicate CombiSet SMARTECH Hemodialysis Bloodlines (K201207) and secondary predicate CAREline Airless Hemodialysis Bloodlines (K172237):

- Indications for Use
- Technological Characteristics ●
- . Design
- Performance Requirements ●

#### 5.8. Sterilization Testing

#### 5008X Hemodialysis Machine and Diasafe Filters 5.8.1.

The 5008X Hemodialysis Machine and Diasafe filters are provided non-sterile. These components are disinfected with either CitraSure Disinfectant or Pure Bright Bleach using the pre-programmed machine disinfection cycle. The machine disinfection cycle has been validated to ensure an appropriate log reduction of bacteria and prevention of biofilm overgrowth in the hydraulics of the machine.

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Image /page/15/Picture/0 description: The image contains the logo for Fresenius Medical Care. On the left side of the logo, there are three downward-pointing chevrons stacked on top of each other. To the right of the chevrons, the text "FRESENIUS MEDICAL CARE" is written in a bold, sans-serif font. The logo is blue and the background is white.

#### 5.8.2. 5008X Bloodline

The 5008X Bloodlines are sterilized by exposure to 100% ethylene oxide (EO). The sterility assurance level (SAL) is 106. Sterility and non-pyrogenicity are claimed for the fluid pathway of the bloodline.

#### 5.8.2.1. 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.

#### Bloodline Bacterial Endotoxin (Pyrogenicity) Testing 5.8.2.2.

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/ST72:2011/(R)2016 Bacterial Endotoxins - Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing.

#### Bloodline Sterile Barrier Testing 5.8.2.3.

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 vented caps were qualified as part of the sterile barrier by microbial challenge tests in accordance with ANSI/AAMI/ISO 11607-1.

The TPs were qualified as part of the sterile barrier by a viral penetration test adapted from ASTM F1671-13.

The tubing and other components were qualified as part of the sterile barrier through the structural integrity test adapted from ISO 8638 and ASTM F2096-11. Testing was performed on samples after aging and distribution simulation.

#### 5.9. Performance Data

#### 5.9.1. 5008X Hemodialysis Machine

Performance testing to support the determination of substantial equivalence of the 5008X Machine is summarized in Table 5.

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Image /page/16/Picture/0 description: The image shows the logo for Fresenius Medical Care. On the left is a blue symbol that looks like three downward-pointing chevrons stacked on top of each other. To the right of the symbol is the text "FRESENIUS MEDICAL CARE" in blue, with "FRESENIUS" on top and "MEDICAL CARE" on the bottom.

| Test Conducted | Test Objective |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| System Level Performance Testing | Ensure the device performs in accordance<br>with the product requirements and design<br>inputs |
| Performance to Standards | Ensure the device conforms to the applicable<br>standards: 60601-2-16:2018, 60601-1-8,<br>60601-1-2, AIM 7351731, and 60601-1 |
| Interface Verification | Ensure the interfaces of the device function as<br>intended when connected to the components<br>and accessories of the system |
| Ship Testing | Verify that the device packaging protects the<br>device from damage during shipment and<br>storage |
| Disinfection Validation Testing | Ensure the disinfection cycles preset in the<br>machine properly reduce microorganism<br>populations |
| Material Compatibility | Ensure that the materials of the machine are<br>compatible with the chemicals that they<br>contact. |

#### Table 5: 5008X Machine Performance Testing Summary

#### 5.9.2. Diasafe Filter

Performance testing to support the determination of substantial equivalence of the Diasafe filter is summarized in Table 6.

| Test Conducted | Test Objective |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Bacteria Retention | Verify that the Diasafe filter can produce ultrapure dialysate from<br>dialysis fluid spiked with bacteria exceeding the allowable limit<br>of <200 CFU/mL (ANSI/AAMI RD52) |
| Endotoxin Retention | Verify that the Diasafe filter can produce ultrapure dialysate from<br>dialysis fluid spiked with endotoxin exceeding the allowable<br>limit of <2 EU/mL (ANSI/AAMI RD52) |
| Ultrafiltration Rate | Verify that the Diasafe filter has an acceptable aqueous<br>Ultrafiltration rate (KUF) |
| Substitution Fluid Composition | Measure the composition of substitution fluid after passing<br>through two (2) Diasafe filters |

Diasafe Filter Performance Testing Summary Table 6:

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Image /page/17/Picture/0 description: The image contains the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left, which is made up of three downward-pointing chevrons stacked on top of each other. To the right of the symbol, the words "FRESENIUS" and "MEDICAL CARE" are written in blue, with "FRESENIUS" on top of "MEDICAL CARE". The text is in a bold, sans-serif font.

| Test Conducted | Test Objective |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------|
| Chemical Contaminants | Verify that the proposed device does not contribute unacceptable<br>levels of chemical contaminants (elemental or ionic) |

#### Table 6: Diasafe Filter Performance Testing Summary

#### 5.9.3. 5008X Bloodline

Performance testing for the 5008X Bloodlines was conducted in accordance with ISO 8638:2010 and Guidance for Industry and FDA Staff, Hemodialysis Blood Bloodlines – Premarket Notification [510(k)] Submissions (23 April 2008). Testing conducted to support the determination of substantial equivalence of the 5008X Bloodline is summarized in Table 7.

| Test Conducted | Test Objective |
|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Structural Integrity | Demonstrate that the bloodlines can withstand 1.5X the labeled maximum positive and negative pressures |
| Pump Segment<br>Performance and<br>Endurance Test | 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.<br><br>There is no flow at 0 mmHg; therefore, the pump segment was not evaluated at that flow rate.<br><br>The blood pump segment does not break or detach at maximum blood flow rates of 600 mL/min and pressures (-300 mmHg inlet pressure and +760 mmHg outlet pressure) 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 hr. |
| Needle and Needleless<br>Access Port | Demonstrate that the needle and needleless access ports can withstand 1.5X the labeled maximum and minimum pressures after being punctured with the largest gauge needle (21 gauge) recommended in the labeling per ISO 8638:2010. |
| DIN Connectors | Demonstrate that the DIN connectors do not leak when subjected to fluid pressure of 300–330 kPa<br><br>ISO 80369-7:2016 specifies the test method, but it does not specify requirements for hemodialyzer blood compartment port connectors. However, the liquid leakage test from this standard has been adopted using the reference connector from ISO 8638:2010 to test the DIN connectors for this device. |
| Test Conducted | Test Objective |
| Male and Female Luer<br>connectors | Demonstrate that the Luer connectors of the bloodlines meet the<br>dimensional and performance requirements of ISO 80369-7 2016 (Sections<br>5 and 6) |
| Visual Inspection After<br>Simulation of Transport | Demonstrate that shipping case, packaging configuration, and palletization<br>pattern maintain the product's structural integrity during manual handling<br>and motorized freight. Verify that there are no detached or missing caps,<br>kinks in tubing, damages to components and/or tubing after shipping. |
| Tensile Testing | Demonstrate that all bonded engagements in the bloodlines between<br>components, and between components and tubing can withstand a tensile<br>force of 16N for main line tube connections, 152N for arterial pump tube<br>connections, 144N for substitution pump tube connections, 11N for<br>administration line tube connections, and 13N for access line tube<br>connections |
| Labeling Content per<br>FDA Blood Tubing Set<br>Guidance and ISO 8638 | Verify the Instructions for Use, color coded components, unit labels,<br>shipping carton graphics, and case labels for the bloodlines meet the<br>requirements of ISO 8638:2010 and Guidance for Industry and FDA Staff:<br>Hemodialysis Blood Tubing Test – Premarket Notification [510(k)]<br>Submissions (April 2008). |
| Readability of Barcode<br>with Human Readable<br>Identification Codes | Demonstrate that the barcode information on the outer container labels and<br>unit labels for the bloodlines is capable of being scanned. |
| Transparency of<br>Transducer Protector (TP) | Demonstrate that the machine side of the TP is clear to allow for visual<br>inspection of blood contamination during use. |
| TP and Pressure Dome<br>Leak | Demonstrate that the TP and pressure dome are capable of maintaining a<br>secure and leak-free connection to the hemodialysis machine when<br>subjected to 2x the maximum labelled pressure for 60 min as per ISO 8638<br>(with FDA recommendations). |
| Viral Retentiveness for<br>TP | Demonstrate that the membrane inside the TP can prevent the passage of<br>bacteriophage (Φ X174) from the patient side to the machine side up to a<br>pressure of 600 mmHg for 1 hr. |
| Measure Gap Between<br>Lenses | Demonstrate that the distance between the lenses from the CLiC Blood<br>Chamber is within the specification of 0.078±0.005 in. |
| Functional CLiC<br>Chamber (Hematocrit) | The measured hematocrit (HCT) using the CLiC Bloodline has a standard<br>deviation X2 of ≤ 3%, and an average bias of ≤ 1% (of the average HCT) as<br>measured on control blood chambers. |
| Test Conducted | Test Objective |
| Functional CLiC<br>Chamber (O2 Sat) | The measured O2 Sat using the CLiC Bloodline has a standard deviation X2<br>of ≤ 3%, and an average bias of ≤2% (of the average O2 Sat) as measured<br>on control blood chambers. |
| Tubing Compliance | Demonstrate that tubing is capable of being occlusively clamped by the<br>venous line clamp of the dialysis machine. |
| Clamp Occlusion | Demonstrate that tubing is capable of being occlusively clamped by the<br>bloodline clamps. |
| Twister (Rotation and<br>Torque) | Demonstrate that the Twister component can twist and lock to 180° ± 1° to<br>reverse the blood flow, and that the torque required ≤ 7 inch-pound. |
| Check Valve (Cracking<br>Pressure and Pressure<br>Drop) | Demonstrate that the opening pressure (cracking pressure) of all the check<br>valves is lower than 400 mbar. Demonstrate that the antisiphon valves<br>present a pressure drop in a specific range when the substitution fluid is<br>pumped through the valve at a certain flow rate. |
| Tube (Transparency,<br>Resistance to Kinking,<br>Clamping and Patency) | Demonstrate the transparency of the tube is evaluated observing the<br>interface of air and liquid during the passage of 0.02 mL air bubble.<br>Demonstrate no kinking of a tube at the maximum expected bend radius of<br>2.5 cm is evaluated measuring the percentage of flow reduction against the<br>tube curved. |
| | Demonstrate the performance of the tube to resist clamp occlusions is<br>evaluated subjecting the sample at a desired pressure and alternatively<br>occluded with a clamp for a defined number of cycles. |
| | Demonstrate the performance of the tube to maintain its patency after being<br>clamped and then reopened is evaluated measuring the flow reduction of the<br>re-opened tube against the tube not clamped. |
| Air Bubble Trapping | Demonstrate that the Venous Chamber is able to trap incoming air bubbles<br>larger than 20 µL. |

Table 7: 5008X Bloodline Performance Testing Summary

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Image /page/18/Picture/0 description: The image shows the logo for Fresenius Medical Care. 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 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 7: 5008X Bloodline Performance Testing Summary

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Image /page/19/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue geometric shape on the left and the text "FRESENIUS MEDICAL CARE" on the right. The geometric shape is made up of three chevrons stacked on top of each other, pointing downwards. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

#### Table 7: 5008X Bloodline Performance Testing Summary

#### Biocompatibility Testing 5.9.4.

Biocompatibility testing for the 5008X System patient contacting components was conducted in accordance with ISO 10993-1:2018 and 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 following testing was conducted to support the biological safety of the 5008X System:

- 5008X Machine .
- Cytotoxicity
- Sensitization, Guinea Pig Maximization

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- | Intracutaneous Irritation
- | Material-Mediated Pyrogenicity
- -Systemic Toxicity
- Hemocompatibility, ASTM Hemolysis (Indirect) —
- | Chemical Characterization
- Diasafe Filter ●
- | Cytotoxicity, Neutral Red Uptake
- Sensitization, Guinea Pig Maximization l
- | Intracutaneous Irritation
- Material-Mediated Pyrogenicity |
- -Hemocompatibility, ASTM Hemolysis (Indirect)
- Subchronic Toxicity -
- Genotoxicity, (bacterial reverse mutation and mouse lymphoma) -
- -Chemical Characterization
- 5008X Bloodlines:
- Cytotoxicity, Neutral Red Uptake —
- -Sensitization, Guinea Pig Maximization
- -Intracutaneous Irritation
- -Material-Mediated Pyrogenicity
- Hemocompatibility, ASTM Hemolysis (Direct and Indirect) -
- Hemocompatibility, Dynamic (Mechanical) Hemolysis |
- Hemocompatibility, Complement Activation
- Hemocompatibility, Platelet and Leukocyte Count
- Hemocompatibility, Partial Thromboplastin Time —
- | Chemical Characterization

#### Human Factors Validation Testing 5.9.5.

Human Factors validation testing performed on the 5008X System ONLINE Features found no impact on the safe and effective use of ONLINE features. FMCRTG concludes that the system is safe and effective for the intended users, uses, and use environments.

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Image /page/21/Picture/0 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue stylized 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.

#### Electrical Safety and Electromagnetic Compatibility (EMC) 5.9.6.

The 5008X Hemodialysis Machine was evaluated for electromagnetic compatibility (EMC) in accordance with IEC 60601-1-2:2014. Additional electrical testing was conducted in accordance with AIM 7351731.

#### 5.9.7. 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:

- Guidance for the Content of Premarket Submissions for Software Contained in ● Medical Devices (11 May 2005)
- Guidance for Off-The-Shelf Software Use in Medical Devices (27 September 2019) ●
- Content of Premarket Submissions for Management of Cybersecurity in Medical ● Devices (02 October 2014)

#### 5.9.8. Animal Studies

No animal studies were performed on the devices.

#### 5.9.9. Clinical Studies

Clinical studies were not performed on the devices. However, an evaluation of published literature on the use of the predecessor device that is currently available outside of the U.S. was conducted.

#### Conclusion 5.10.

The Indications for Use, technological characteristics, design, and performance requirements of the 5008X Hemodialysis System and its components are substantially equivalent to those of the predicate and secondary predicate devices. FMCRTG concludes that within the meaning of the Medical Device Amendments Act of 1976, the 5008X Hemodialysis System and all components included in this submission are safe and effective for their intended use.