CombiSet Hemodialysis Blood Tubing Set

K213992 · Fresenius Medical Care Renal Therapies Group, LLC · FJK · May 31, 2023 · Gastroenterology, Urology

Device Facts

• Record ID: K213992
• Device Name: CombiSet Hemodialysis Blood Tubing Set
• Applicant: Fresenius Medical Care Renal Therapies Group, LLC
• Product Code: FJK · Gastroenterology, Urology
• Decision Date: May 31, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5820
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Blood Tubing Set is a sterile, single use, disposable indicated for use with a prescribed hemodialyzer. For use with a compatible hemodialyzer, as per the labeling. The Blood Tubing Set is intended for acute and chronic hemodialysis therapy. The Blood Tubing Set is intended to be used with Fresenus Medical Care 2008® Series K, K2 and T Hemodialysis Machines.

Device Story

CombiSet Hemodialysis Blood Tubing Set is a sterile, single-use, disposable extracorporeal circuit component. It transports arterial blood from patient access (fistula/catheter) through a hemodialyzer and returns it to venous access. Used in acute and chronic hemodialysis settings. Operated by healthcare professionals in conjunction with Fresenius Medical Care 2008 Series K, K2, and T hemodialysis machines. Device includes tubing, transducer protectors, and connectors. Provides physical pathway for blood circulation; facilitates monitoring via machine-integrated sensors (e.g., level detection). No electrical or software components. Benefits include maintaining extracorporeal circuit integrity during dialysis therapy.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by bench testing, including structural integrity, pump segment performance, needle access port testing, connector leakage, tensile testing, spike performance, and biocompatibility testing (cytotoxicity, sensitization, irritation, pyrogenicity, hemocompatibility, systemic toxicity, genotoxicity).

Technological Characteristics

Single-use, EO-sterilized blood tubing set. Materials: PVC, PP, PE, MABS, polyisoprene. Transducer protectors: PP/PTFE on polyester. Bonding: Cyclohexanone, TetraMEK. Max flow: 600 mL/min. Max pressures: -300 mmHg (arterial), +500 mmHg (venous). Complies with ISO 8638:2010, ISO 10993-1:2018, and ISO 80369-7:2016. Non-electrical, no software.

Indications for Use

Indicated for patients requiring acute or chronic hemodialysis therapy. Used with compatible hemodialyzers and Fresenius Medical Care 2008 Series K, K2, and T hemodialysis machines.

Regulatory Classification

Identification

A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.(1) The extracorporeal blood system and accessories consists of tubing, pumps, pressure monitors, air foam or bubble detectors, and alarms to keep blood moving safely from the blood access device and accessories for hemodialysis (§ 876.5540) to the blood compartment of the dialyzer and back to the patient. (2) The conventional dialyzer allows a transfer of water and solutes between the blood and the dialysate through the semipermeable membrane. The semipermeable membrane of the conventional dialyzer has a sufficiently low permeability to water that an ultrafiltration controller is not required to prevent excessive loss of water from the patient's blood. This conventional dialyzer does not include hemodialyzers with the disposable inserts (Kiil type) (§ 876.5830) or dialyzers of high permeability (§ 876.5860). (3) The dialysate delivery system consists of mechanisms that monitor and control the temperature, conductivity, flow rate, and pressure of the dialysate and circulates dialysate through the dialysate compartment of the dialyzer. The dialysate delivery system includes the dialysate concentrate for hemodialysis (liquid or powder) and alarms to indicate abnormal dialysate conditions. This dialysate delivery system does not include the sorbent regenerated dialysate delivery system for hemodialysis (§ 876.5600), the dialysate delivery system of the peritoneal dialysis system and accessories (§ 876.5630), or the controlled dialysate delivery system of the high permeability hemodialysis system § 876.5860). (4) Remote accessories to the hemodialysis system include the unpowered dialysis chair without a scale, the powered dialysis chair without a scale, the dialyzer holder set, dialysis tie gun and ties, and hemodialysis start/stop tray.

Predicate Devices

• CombiSet SMARTECH Hemodialysis Blood Tubing Sets (K201207)

Submission Summary (Full Text)

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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.

May 31, 2023

Fresenius Medical Care Renal Therapies Group, LLC Denise Oppermann Senior Director, Regulatory Affairs 920 Winter Street Waltham, MA 02451

Re: K213992

> Trade/Device Name: CombiSet Hemodialysis Blood Tubing Set Regulation Number: 21 CFR§ 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: FJK Dated: April 28, 2023 Received: May 1, 2023

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 (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 located 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.

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.

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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 mediation-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,

# Gema Gonzalez -S

Gema Gonzalez, MS Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

### K213992

Device Name CombiSet Hemodialysis Blood Tubing Set

Indications for Use (Describe)

The Blood Tubing Set is a sterile, single use, disposable indicated for use with a prescribed hemodialyzer. For use with a compatible hemodialyzer, as per the labeling.

The Blood Tubing Set is intended for acute and chronic hemodialysis therapy.

The Blood Tubing Set is intended to be used with Fresenus Medical Care 2008® Series K, K2 and T Hemodialysis Machines.

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

| <div> <span> <b> Prescription Use (Part 21 CFR 801 Subpart D) </b> </span> </div> |
|-----------------------------------------------------------------------------------------------|
| <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/3/Picture/0 description: The image contains the logo for Fresenius Medical Care. On the left side of the logo is a blue symbol that consists 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 and "MEDICAL CARE" on the bottom.

#### 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, Senior Director |
| Preparation Date: | 20 December 2021 |

#### 5.2. Device Name

| Trade Name: | CombiSet Hemodialysis Blood Tubing Set |
|--------------------|---------------------------------------------------------------|
| Common Name: | Blood Tubing Set |
| Regulation Name: | Hemodialysis system and accessories |
| Regulatory Class: | Class II per 21 CFR § 876.5820 |
| Product Code: | FJK |
| Product Code Name: | Set, Tubing, Blood, With and Without Anti-regurgitation Valve |
| FDA Review Panel: | Gastroenterology/Urology |

#### 5.3. Legally Marketed Predicate Device

The legally marketed predicate device is the CombiSet SMARTECH Hemodialysis Blood Tubing Sets (hereinafter referred to as "CombiSet SMARTECH") cleared under K201207. The predicate device has not been subject to a design-related recall.

#### Device Description 5.4.

#### 5.4.1. Device Identification

The CombiSet Hemodialysis Blood Tubing Set (hereinafter referred to as "CombiSet Bloodline") is the subject of this 510(k).

#### 5.4.2. Device Characteristics

The CombiSet Bloodline is a single-use, ethylene oxide (EO) sterilized blood tubing set.

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Image /page/4/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. The symbol is made up of three downward-pointing chevrons. The text is in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

#### 5.4.3. Environment of Use

The CombiSet Bloodline is used in environments where acute and chronic hemodialysis are performed.

#### 5.4.4. Brief Written Description of the Device

The CombiSet Bloodline is part of the extracorporeal hemodialysis circuit. During hemodialysis, the extracorporeal circuit transports arterial blood from the patient's arterial access (e.g., fistula or catheter), through a hemodialyzer, and back to the patient's venous access.

#### Materials of Use 5.4.5.

The CombiSet Bloodline is classified as externally communicating, circulating blood, prolonged contact (> 24 hours to 30 days) duration. Class II (Category B) device 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" (4 September 2020).

The materials used for each component of the CombiSet Bloodline are listed in Table 1.

| Component | Material |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Tubing and Components | Polyvinylchloride (PVC)<br>Polypropylene (PP)<br>Polyethylene (PE)<br>Methylmethacrylate acrylonitrile butadiene styrene (MABS)<br>Polyisoprene |
| Transducer Protector | Polypropylene (PP)<br>Polytetrafluoroethylene (PFTE) on Polyester |
| Bonding Solvents | Cyclohexanone<br>TetraMEK (95% Tetrahydrofuran/5% MEK) |

#### Table 1: Materials of Composition

#### 5.4.6. Key Performance Specifications/Characteristic

The key performance specifications of the CombiSet Bloodline are outlined in Table 2.

#### Table 2: Key Performance Specifications/Characteristics

| Feature | Specification |
|---------------------------------------------|----------------|
| Maximum Blood Flow Rate | 600 mL/min |
| Maximum Arterial Pressure | -300 mmHg |
| Maximum Venous Pressure | +500 mmHg |
| Pump Segment [Inner/Outer Diameter (ID/OD)] | 8.0 mm/12.0 mm |

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Image /page/5/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 MEDICAL CARE" are written in blue, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

#### 5.5. Intended Use

The CombiSet Bloodline is intended for use in acute and chronic hemodialysis therapy.

#### Indications for Use 5.6.

The Blood Tubing Set is a sterile, single use, disposable indicated for use with a prescribed hemodialyzer. For use with a compatible hemodialyzer, as per the labeling.

The Blood Tubing Set is intended for acute and chronic hemodialysis therapy.

The Blood Tubing Set is intended to be used with Fresenius Medical Care 2008® Series K. K2 and T Hemodialysis Machines.

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

The following technological characteristics of the CombiSet Bloodline are equivalent to those of the predicate CombiSet SMARTECH (K201207):

- Indications for Use
- Principle of Operation
- Technological Characteristics
- Design
- Performance Requirements

#### 5.8. Sterilization Testing

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

#### EO Residual Testing 5.8.1.

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 bloodline.

#### Bacterial Endotoxin (Pyrogenicity) Testing 5.8.2.

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

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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 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. The logo is simple and modern, and the blue color gives it a sense of professionalism and trustworthiness.

K213992

#### 5.8.3. Sterile Barrier Testing

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

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

The 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

Performance testing was conducted in accordance with ISO 8638:2010 and Guidance for Industry and FDA Staff, Hemodialysis Blood Tubing Sets – Premarket Notification [510(k)] Submissions (23 April 2008). Testing conducted to support the determination of substantial equivalence is summarized in Table 3.

| Test Conducted | Test Objective |
|---------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Structural Integrity | Demonstrate that the bloodline can withstand 1.5X the labeled maximum<br>positive and negative pressures |
| Pump Segment<br>Performance | Evaluate performance characteristics of the bloodline over the range of the inlet<br>pressures (normally 0 mmHg to -250 mmHg). Flow rate settings will cover up<br>to 600 mL/min. |
| Visual Inspection<br>for Endurance and<br>Simulated Use Tests | Endurance<br>Demonstrate that bloodlines perform with no tubing failures (kinking,<br>collapsing, or disconnection) at the maximum labeled flow rate and pressures<br>for not less than 18 hr<br>Simulated Use<br>Demonstrate that bloodlines perform with no tubing failures (kinking,<br>collapsing, or disconnection) under simulated use conditions for not less than<br>4 hr |

| Table 3: | Performance Testing Summary |
|----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Test Conducted | Test Objective |
| Needle Access Port<br>Test | Demonstrate that the needle access ports can withstand 1.5X the labeled<br>pressures after being punctured with the largest gauge needle recommended in<br>the labeling (21 gauge) - 6X for maximum positive pressure, 11X for maximum<br>negative pressure per ISO 8638:2010 |
| DIN Connectors | Demonstrate that the DIN connectors do not leak when subjected to fluid<br>pressure of 300-330 kPa.<br>ISO 80369-7:2016 specifies the test method, but it does not specify<br>requirements for hemodialyzer blood compartment port connectors. However,<br>the liquid leakage test from this standard has been adopted using the reference<br>connector from ISO 8638 to test the DIN connectors for this device. |
| Male and Female<br>Luer Connectors<br>Tests | Demonstrate that the applicable components of the bloodline meet the<br>dimensional and performance requirements of ISO 80369-7 2016 (Sections 5<br>and 6) |
| Visual Inspection<br>for Packaging<br>(Shipping study) | Demonstrate that the shipping case, packaging configuration, and palletization<br>pattern maintain the product's structural integrity during manual handling and<br>motorized freight |
| Tensile Testing | Demonstrate that all bonded engagements in the bloodline between components,<br>and between components and tubing can withstand a tensile force of 15 lbf |
| Spike Flow Rate | Demonstrate that the spike, a component of the bloodline, can deliver not less<br>than 1000 mL of a sodium chloride solution in 10 min under a static head of<br>1 m |
| Spike Insertion<br>Force | Demonstrate that the spike, a component of the bloodline, is capable of piercing<br>and penetrating the closure of an infusion device without coring and with force<br>not exceeding 200 N, when inserted at a rate of 500 mm/min |
| Spike Leak Test | Demonstrate that the spike, a component of the bloodline, will not leak after<br>piercing an infusion device, remaining pierced for 5 hr, and then having an<br>applied internal pressure of 20 kPa for 15 sec |
| Spike Disconnection<br>Force | Demonstrate that the spike, a component of the bloodline, is capable of being<br>removed from the insertion point when a removal force is applied at a rate of<br>100 mm/min. Establish the removal force value. |
| Labeling Content<br>per FDA Guidance<br>(Blood Tubing Set)<br>and ISO 8638 | Verify the Instructions for Use, color coded components, unit labels, shipping<br>carton graphics, and case labels for the bloodline meet the requirements of ISO<br>8638:2010 and Guidance for Industry and FDA Staff: Hemodialysis Blood<br>Tubing Test - Premarket Notification [510(k)] Submissions (April 2008) |
| Readability of<br>Barcode with<br>Human Readable<br>Identification Codes | Demonstrate that the barcode information on the outer container labels and unit<br>labels for the bloodlines is capable of being scanned |
| Test Conducted | Test Objective |
| Level Detector Test | Demonstrate that the venous chamber of the bloodline interfaces correctly with<br>the hemodialysis machine (2008 series) such that the venous clamp will activate<br>(close) when the fluid level inside the venous chamber falls below the sensor<br>heads |
| Air-Capture<br>Chamber Fill Level | Demonstrate that the recommended fill level of the air-capture chambers is<br>marked |
| Blood Filter<br>Retention Test | Demonstrate that the blood filter of the bloodline remains in the assembly<br>position after tests at 1.5X the maximum recommended positive pressure, with a<br>flow rate of 600 mL/min for not less than 18 hr |
| Transparency of<br>Transducer<br>Protectors | Demonstrate that the machine side of the TPs is clear to allow for visual<br>inspection of blood contamination during use |
| Transducer<br>Protector Leak Test | Demonstrate that the TP is capable of maintaining a secure and leak-free<br>connection to the hemodialysis machine |
| Structural Integrity<br>(Vented Caps) | Demonstrate that the vented caps can withstand 1.5X the labeled maximum<br>positive and negative pressures |
| Viral Retentiveness<br>Test for Transducer<br>Protectors | Demonstrate that the membrane inside the transducer protector prevents can<br>prevent the passage of bacteriophage (Φ X174) from the patient side to the<br>machine side up to a pressure of 750 mmHg for 1 hr |
| Tubing Compliance<br>Test | Demonstrate that tubing is capable of being occlusively clamped by the venous<br>line clamp of the dialysis machine |
| Clamp Occlusion<br>Test | Demonstrate that tubing is capable of being occlusively clamped by the<br>bloodline clamps |

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Image /page/7/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. To the right of the symbol is the text "FRESENIUS MEDICAL CARE" in blue, with "FRESENIUS" on top of "MEDICAL CARE".

#### Table 3: Performance Testing Summary

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Image /page/8/Picture/0 description: The image contains the logo for Fresenius Medical Care. On the left side of the logo is a blue symbol that consists of 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 the top line and "MEDICAL CARE" on the bottom line.

#### Table 3: Performance Testing Summary

All testing met predetermined acceptance criteria. Results of the proposed device's design verification tests met the requirements and demonstrated that, like the predicate device, the CombiSet Bloodline is safe and effective for its intended use.

#### 5.9.1. Biocompatibility Testing

Biocompatibility testing 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" (4 September 2020). The following tests were conducted to support the biological safety of the CombiSet Bloodline:

- Cytotoxicity, Neutral Red Uptake ●
- Sensitization, Guinea Pig Maximization
- Intracutaneous Irritation ●

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Image /page/9/Picture/0 description: The image contains 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. 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.

- Material-Mediated Pyrogenicity
- Hemocompatibility, ASTM Hemolysis (Direct and Indirect) .
- Hemocompatibility, Dynamic (Mechanical) Hemolysis ●
- Hemocompatibility, Complement Activation, SC5b-9 ●
- Hemocompatibility, Partial Thromboplastin Time (PTT)
- Hemocompatibility, Platelet and Leukocyte Count ●
- Systemic Toxicity
- Genotoxicity, Ames Assay ●
- Genotoxicity, in vitro Mouse Lymphoma
- Semi-quantitative Leachable Chemical Evaluation, 20% Ethanol (Volatiles, Semi-● Volatiles, Non-Volatiles, Metals)
- Semi-quantitative Extractable Chemical Evaluation, Water, Isooctane, 100% Ethanol ● (Volatiles, Semi-Volatiles, Non-Volatiles, Metals)

A Toxicological Risk Assessment was also performed.

#### 5.9.2. Human Factors Validation Testing

A Human Factors assessment was conducted for the CombiSet Bloodline to demonstrate its safe and effective use in accordance with FDA guidance document Applying Human Factors and Usability Engineering to Medical Devices (03 February 2016).

#### Electrical Safety and Electromagnetic Compatibility (EMC) 5.9.3.

Not applicable. The CombiSet Bloodline is not an electrical mechanical device.

#### 5.9.4. Software Verification and Validation Testing

Not applicable. The CombiSet Bloodline does not contain software.

#### 5.9.5. Animal Studies

No animal studies were performed.

#### 5.9.6. Clinical Studies

No clinical studies were performed.

#### 5.10. Conclusion

The information provided in this submission demonstrates that the CombiSet Bloodline functions as intended and the differences between the proposed and the predicate devices do not raise any new concerns with regard to safety or effectiveness.

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Image /page/10/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 the top line and "MEDICAL CARE" on the bottom line.

The intended use, indications for Use, principle of operation, design characteristics, sterilization method and materials of the CombiSet Bloodline are substantially equivalent to that of the predicate device. FMCRTG concludes that within the meaning of the Medical Device Amendments Act of 1976, the CombiSet Bloodline is safe and effective for its intended use.