The Blood Tubing Set is a sterile, single use, disposable indicated for use with a prescribed hemodialyzer. The suitability of a particular bloodline/hemodialyzer configuration is the responsibility of the physician.

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 equipped with Crit-Line hardware.

The Crit-Line Blood Chamber is an optical cuvette designed for use with the Crit-Line monitor's sensor clip during acute and chronic hemodialysis therapy to non-invasively measure hematocrit, percent change in blood volume, and oxygen saturation.

Device Description

The CombiSet SMARTECH Hemodialysis Blood Tubing Sets (hereinafter referred to as "CombiSet SMARTECH Bloodlines") are the subject of this 510(k) and are available in two (2) configurations:

CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and ● Integrated Crit-Line Technology (hereinafter referred to as the "Standard bloodline")
. CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, no Heparin Line (hereinafter referred to as the "No heparin line")

The CombiSet SMARTECH Bloodlines are single-use, ethylene oxide (EO) sterilized blood tubing sets.

The CombiSet SMARTECH Bloodlines are 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. When the CombiSet SMARTECH Bloodlines are used with the Crit-Line Sensing System (which includes the Crit-Line Sensor Clip), the proposed devices will provide a clear viewing surface for the Crit-Line Sensor Clip to transmit light through the blood.

AI/ML Overview

The provided text describes the acceptance criteria and a summary of the performance testing for the CombiSet SMARTECH Hemodialysis Blood Tubing Sets.

Here's the requested information:

1. A table of acceptance criteria and the reported device performance

Please note that for many of the tests, the document states the "objective" or "demonstrate that..." rather than specific numerical acceptance criteria and reported numerical performance. Where specific numerical criteria are given, they are included.

Feature	Acceptance Criteria (Specification)	Reported Device Performance (as summarized)
Maximum Blood Flow Rate	600 mL/min	The testing aimed to evaluate performance over a range of inlet pressures up to 600 mL/min. The results are summarized as meeting the objective.
Maximum Arterial Pressure	-300 mmHg	The document states the device can withstand 1.5X the labeled maximum positive and negative pressures, which implies meeting this specification.
Maximum Venous Pressure	+500 mmHg	The document states the device can withstand 1.5X the labeled maximum positive and negative pressures, which implies meeting this specification.
Pump Segment [Inner/Outer Diameter (ID/OD)]	8.0 mm/12.0 mm	This refers to the physical dimensions of the pump segment. The document implies these specifications are met as part of the device characteristics.
Functional CLiC Chamber Test - Hematocrit (HCT)	Standard deviation X2 of ≤ 3%, and an average bias of ≤ 1% (of the average HCT) as measured on control blood chambers	The measured HCT using the CombiSet SMARTECH Bloodline met the criteria of having a standard deviation X2 of ≤ 3% and an average bias of ≤ 1% when compared to HCT measurements from a production blood chamber (CL10041021) as control.
Functional CLiC Chamber Test - Oxygen Saturation (O2 Sat)	Standard deviation X2 of ≤ 3%, and an average bias of ≤ 2% (of the average O2 Sat) as measured on control blood chambers	The measured O2 Sat using the CombiSet SMARTECH Bloodline met the criteria of having a standard deviation X2 of ≤ 3% and an average bias of ≤ 2% when compared to O2 Sat measurements from a production blood chamber (CL10041021) as control.
Structural Integrity	Withstand 1.5X the labeled maximum positive and negative pressures	Testing demonstrated that the bloodlines could withstand 1.5X the labeled maximum positive and negative pressures.
Pump Segment Performance	Evaluate performance over the range of inlet pressures (normally 0 mmHg to -250 mmHg) and flow rates up to 600 mL/min	Performance characteristics were evaluated over the specified range, and results are summarized as meeting the objective.
Endurance	No tubing failures (kinking, collapsing, or disconnection) at maximum labeled flow rate and pressures for not less than 18 hr	Bloodlines performed with no tubing failures for not less than 18 hours, meeting the objective. -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Simulated Use	No tubing failures (kinking, collapsing, or disconnection) under simulated use conditions for not less than 4 hr	Bloodlines performed with no tubing failures under simulated use conditions for not less than 4 hours, meeting the objective. -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Needle Access Port Test	Withstand 1.5X labeled pressures after 21 gauge needle punctures (6X for max positive, 11X for max negative per ISO 8638:2010)	Testing confirmed that the needle access ports could withstand the specified pressures after repeated punctures. -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
DIN Connectors	Not leak when subjected to fluid pressure of 300-330 kPa (adapted from ISO 80369-7:2016 using ISO 8638:2010 reference connector)	The DIN connectors met the objective of not leaking under the specified pressure. -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Male and Female Luer Connectors Tests	Meet dimensional and performance requirements of ISO 80369-7:2016 (Sections 5 and 6)	The applicable components met the specified dimensional and performance requirements. -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Visual Inspection for Packaging (Shipping study)	Maintain product's structural integrity during manual handling and motorized freight	The shipping case, packaging configuration, and palletization pattern maintained the product's structural integrity. -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Tensile Testing	All bonded engagements withstand a tensile force of 15 lbf	Testing showed that all bonded engagements could withstand a tensile force of 15 lbf. -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Spike Flow Rate	Deliver not less than 1000 mL of a sodium chloride solution in 10 min under a static head of 1 m	The spike met the performance objective. -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Spike Insertion Force	Piercing and penetrating closure without coring and with force not exceeding 200 N, when inserted at a rate of 500 mm/min	The spike demonstrated capability to pierce and penetrate without coring and within the force limit. -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Spike Leak Test	Not leak after piercing an infusion device, remaining pierced for 5 hr, and then having an applied internal pressure of 20 kPa for 15 sec	The spike did not leak under the specified conditions. -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Spike Disconnection Force	Capable of being removed from insertion point when removal force is applied at a rate of 100 mm/min. Establish the removal force value.	The spike's removal force value was established, demonstrating its capability to be removed as specified. -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Level Detector Test	Venous chamber interfaces correctly with hemodialysis machine (2008 series) such that venous clamp activates (closes) when fluid level falls below sensor heads	The venous chamber correctly interfaced with the hemodialysis machine, and the venous clamp activated as specified. -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Air-Capture Chamber Fill Level	Recommended fill level of air-capture chambers is marked	The recommended fill level for the air-capture chambers was confirmed to be marked. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Blood Filter Retention Test	Remains in assembly position after tests at 1.5X maximum recommended positive pressure, with a flow rate of 600 mL/min for not less than 18 hr	The blood filter remained in the assembly position under the specified testing conditions. -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Transparency of Transducer Protectors	Machine side of TPs is clear to allow for visual inspection of blood contamination during use	The machine side of the transducer protectors was confirmed to be clear for visual inspection. -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Transducer Protector Leak Test	Capable of maintaining a secure and leak-free connection to the hemodialysis machine	The TP demonstrated capability of maintaining a secure and leak-free connection. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Viral Retentiveness Test for Transducer Protectors	Membrane prevents passage of bacteriophage (Φ Χ174) from patient side to machine side up to a pressure of 600 mmHg for 1 hr	The membrane inside the transducer protector prevented the passage of bacteriophage as specified. -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Torque Test (Connection of Blood Chamber to Dialyzer Connector)	Bond connection between Arterial DIN connector and CLiC Blood Chamber withstands an applied torque of not less than 14.8 in-lbs without creating a leak at 15 psi for 10 min	The bond connection met the specified torque and leak resistance criteria. -----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Measure Gap between Lenses	Distance between the lenses from the CLIC Blood Chamber is 0.078 ± 0.005 in	The distance between the lenses met the specified dimension. -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

The Study Proving Acceptance Criteria were Met:

The document describes "Performance Testing" which was conducted in accordance with ISO 8638:2010 and the FDA Guidance for Industry and FDA Staff, Hemodialysis Blood Tubing Sets – Premarket Notification [510(k)] Submissions (April 2008).

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes used for each individual test within the "Performance Testing Summary."
The document does not specify the data provenance (e.g., country of origin, retrospective or prospective) for the performance testing. It is implied these were laboratory or bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The performance tests appear to be objective measurements against established engineering and performance criteria and standards, rather than requiring expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/provided. The performance tests are quantitative or pass/fail against engineering standards and do not involve human interpretation or adjudication in the way a clinical study with subjective endpoints might.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done. This device is a blood tubing set for hemodialysis, not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical medical device (blood tubing set), not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the "Functional CLiC Chamber Test - Hematocrit (HCT)" and "Functional CLiC Chamber Test - Oxygen Saturation (O2 Sat)" was based on measurements made using a production blood chamber (CL10041021) as a control.
For other performance tests (e.g., structural integrity, flow rates, leak tests), the ground truth was based on predefined engineering specifications, international standards (ISO 8638, ISO 80369-7), and FDA guidance documents.

8. The sample size for the training set

This is not applicable/provided. This device is a physical medical device, not a machine learning or AI algorithm that requires a "training set."

9. How the ground truth for the training set was established

This is not applicable. As stated above, this device does not involve a training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 18, 2020

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

Re: K201207

Trade/Device Name: CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, no Heparin Line Regulation Number: 21 CFR 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KOC, FJK Dated: August 18, 2020 Received: August 19, 2020

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

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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. 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-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 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 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,

Carolyn Y. Neuland, Ph.D. 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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Indications for Use

510(k) Number (if known) K201207

Device Name

CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology and CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line

Indications for Use (Describe)

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 equipped with Crit-Line hardware.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/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 arrows 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".

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 StreetWaltham, MA02451-1457
Phone:	(781) 996-9103
Fax:	(781) 699-9635
Contact Person:	Denise Oppermann, Senior DirectorRegulatory Affairs – Devices
Preparation Date:	28 January 2020

5.2. Device Name

Trade Name:	CombiSet SMARTECH Hemodialysis Blood Tubing Sets
Common Name:	Blood Tubing Set
Regulation Name:	Hemodialysis system and accessories
Regulatory Class:	Class II per 21 CFR § 876.5820
Product Code:	KOC/FJK
Product Code Name:	KOC – Accessories, Blood Circuit, HemodialysisFJK - Set, Tubing, Blood, With and Without Anti-regurgitationValve
FDA Review Panel:	Gastroenterology/Urology

5.3. Legally Marketed Predicate Device

The legally marketed primary predicate device is the CAREline Hemodialysis Blood Tubing Sets cleared under K172238. The legally marketed secondary predicate device is the Crit-Line Clip (CLiC) Blood Chamber cleared under K152953. These devices have not been subject to a designrelated recall.

The Blood Volume Monitor (BVM) Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors (K120823) is being used as a reference device.

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Image /page/4/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 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.

Device Description 5.4.

5.4.1. Device Identification:

The CombiSet SMARTECH Hemodialysis Blood Tubing Sets (hereinafter referred to as "CombiSet SMARTECH Bloodlines") are the subject of this 510(k) and are available in two (2) configurations:

CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and ● Integrated Crit-Line Technology (hereinafter referred to as the "Standard bloodline")
. CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, no Heparin Line (hereinafter referred to as the "No heparin line")

5.4.2. Device Characteristics

The CombiSet SMARTECH Bloodlines are single-use, ethylene oxide (EO) sterilized blood tubing sets.

5.4.3. Environment of Use

The CombiSet SMARTECH Bloodlines are used in environments where acute and chronic hemodialysis are performed.

5.4.4. Brief Written Description of the Device

5.4.5. Materials of Use

The CombiSet SMARTECH Bloodlines are classified as externally communicating, circulating blood, prolonged contact (> 24 hours to 30 days) duration, Class II (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" (16 June 2016).

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

Component	Material
Tubing and Components	Polyvinylchloride (PVC)Polycarbonate (PC)

Table 1: Materials of Composition

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Image /page/5/Picture/0 description: The image shows the logo for Fresenius Medical Care. The logo consists of a blue stylized "F" on the left and the text "FRESENIUS MEDICAL CARE" on the right. The text is also in blue, and the two words are stacked on top of each other.

K201207

Component	Material
	Polypropylene (PP)
	Polyethylene (PE)
	Acrylonitrile Butadiene Styrene (ABS)
	Polyisoprene
Transducer Protector	Polyester Polybutylene Terephthalate (PBT)
	Polytetrafluoroethylene (PFTE)
	PC
Integrated Crit-Line BloodChamber	PVC
	PE
	PC
Bonding Solvents	Cyclohexanone
	50% Methyl Ethyl Ketone (MEK)/50% Cyclohexanone
	TetraMEK (95% Tetrahydrofuran/5% MEK)

Table 1: Materials of Composition

5.4.6. Key Performance Specifications/Characteristics

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

Table 2: Key Performance Specifications

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
Functional CLiC Chamber Test - Hematocrit(HCT)	The measured HCT using the CombiSetSMARTECH Bloodline has a standarddeviation X2 of ≤ 3%, and an average bias of≤ 1% (of the average HCT) as measured oncontrol blood chambers
Functional CLiC Chamber Test - OxygenSaturation (O2 Sat)	The measured O2 Sat using the CombiSetSMARTECH Bloodline has a standarddeviation X2 of ≤ 3%, and an average bias of≤ 2% (of the average O2 Sat) as measured oncontrol blood chambers

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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 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.

5.5. Intended Use

The CombiSet SMARTECH Bloodlines are intended for use in acute and chronic hemodialysis therapy.

5.6. Indications for Use

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. K-and T Hemodialysis Machines equipped with Crit-Line hardware.

5.7. Comparison of Technological Characteristics with the Predicate Device

The following technological characteristics of the CombiSet SMARTECH Bloodlines are substantially equivalent to those of the primary predicate CAREline Bloodlines (K172237) and secondary predicate CLiC Blood Chamber (K152953):

Indications for Use
Technological Characteristics
. Design
Performance Requirements

5.8. Sterilization Testing

The CombiSet SMARTECH 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.

5.8.1. 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.

5.8.2. Bacterial Endotoxin (Pyrogenicity) Testing

The subject bloodlines were tested for bacterial endotoxin (pyrogenicity) with Limulus Amebocyte Lysate (LAL) and determined to be non-pyrogenic (< 20 EU/device) in accordance with

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Image /page/7/Picture/0 description: The image contains the logo for Fresenius Medical Care. The logo consists of a blue emblem on the left and the company name on the right. The emblem is made up of three downward-pointing chevron shapes stacked on top of each other. The text "FRESENIUS MEDICAL CARE" is written in a bold, sans-serif font, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

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

Sterile Barrier Testing 5.8.3.

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

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 bloodlines can withstand 1.5X the labeledmaximum positive and negative pressures
Pump SegmentPerformance	Evaluate performance characteristics of the bloodlines over the range ofthe inlet pressures (normally 0 mmHg to -250 mmHg). Flow ratesettings will cover up to 600 mL/min.
Test Conducted	Test Objective
Visual Inspection forEndurance and SimulatedUse Tests	EnduranceDemonstrate that bloodlines perform with no tubing failures (kinking,collapsing, or disconnection) at the maximum labeled flow rate andpressures for not less than 18 hrSimulated UseDemonstrate that bloodlines perform with no tubing failures (kinking,collapsing, or disconnection) under simulated use conditions for notless than 4 hr
Needle Access Port Test	Demonstrate that the needle access ports can withstand 1.5X thelabeled pressures after being punctured with the largest gauge needlerecommended in the labeling (21 gauge) – 6X for maximum positivepressure, 11X for maximum negative pressure per ISO 8638:2010
DIN Connectors	Demonstrate that the DIN connectors do not leak when subjected tofluid pressure of 300-330 kPaISO 80369-7:2016 specifies the test method, but it does not specifyrequirements for hemodialyzer blood compartment port connectors.However, the liquid leakage test from this standard has been adoptedusing the reference connector from ISO 8638:2010 to test the DINconnectors for this device.
Male and Female LuerConnectors Tests	Demonstrate that the applicable components of the bloodlines meet thedimensional and performance requirements of ISO 80369-7:2016(Sections 5 and 6)
Visual Inspection forPackaging (Shippingstudy)	Demonstrate that shipping case, packaging configuration, andpalletization pattern maintain the product's structural integrity duringmanual handling and motorized freight
Tensile Testing	Demonstrate that all bonded engagements in the bloodlines betweencomponents, and between components and tubing can withstand atensile force of 15 lbf
Spike Flow Rate	Demonstrate that the spike, a component of the bloodlines, can delivernot less than 1000 mL of a sodium chloride solution in 10 min under astatic head of 1 m
Spike Insertion Force	Demonstrate that the spike, a component of the bloodlines, is capableof piercing and penetrating the closure of an infusion device withoutcoring and with force not exceeding 200 N, when inserted at a rate of500 mm/min
Test Conducted	Test Objective
Spike Leak Test	Demonstrate that the spike, a component of the bloodlines, will not leakafter piercing an infusion device, remaining pierced for 5 hr, and thenhaving an applied internal pressure of 20 kPa for 15 sec
Spike DisconnectionForce	Demonstrate that the spike, a component of the bloodlines, is capableof being removed from the insertion point when a removal force isapplied at a rate of 100 mm/min. Establish the removal force value.
Labeling Content perFDA Guidance (BloodTubing Set) and ISO8638	Verify the Instructions for Use, color coded components, unit labels,shipping carton graphics, and case labels for the bloodlines meet therequirements of ISO 8638:2010 and Guidance for Industry and FDAStaff: Hemodialysis Blood Tubing Test – Premarket Notification[510(k)] Submissions (April 2008)
Readability of Barcodewith Human ReadableIdentification Codes	Demonstrate that the barcode information on the outer container labelsand unit labels for the bloodlines is capable of being scanned
Level Detector Test	Demonstrate that the venous chamber of the bloodline interfacescorrectly with the hemodialysis machine (2008 series) such that thevenous clamp will activate (close) when the fluid level inside thevenous chamber falls below the sensor heads
Air-Capture ChamberFill Level	Demonstrate that the recommended fill level of the air-capturechambers is marked
Blood Filter RetentionTest	Demonstrate that the blood filter of the bloodlines remains in theassembly position after tests at 1.5X the maximum recommendedpositive pressure, with a flow rate of 600 mL/min for not less than18 hr
Transparency ofTransducer Protectors	Demonstrate that the machine side of the transducer protectors (TPs) isclear to allow for visual inspection of blood contamination during use
Transducer ProtectorLeak Test	Demonstrate that the TP is capable of maintaining a secure and leak-free connection to the hemodialysis machine
Viral Retentiveness Testfor Transducer Protectors	Demonstrate that the membrane inside the transducer protectorprevents can prevent the passage of bacteriophage (Φ Χ174) from thepatient side to the machine side up to a pressure of 600 mmHg for 1 hr
Torque Test (Connectionof Blood Chamber toDialyzer Connector)	Demonstrate that the bond connection between the Arterial DINconnector and the CLiC Blood Chamber can withstand an appliedtorque of not less than 14.8 in-lbs without creating a leak at 15 psi for10 min
Test Conducted	Test Objective
Measure Gap betweenLenses	Demonstrate that the distance between the lenses from the CLIC BloodChamber is 0.078 ± 0.005 in
Functional CLICChamber Test(Hematocrit)	Demonstrate that the measurement of HCT of the integrated CLICBlood Chamber has a standard deviation X2 of ≤ 3%, and an averagebias of ≤ 1%, when compared to the HCT measurements made using aproduction blood chamber (CL10041021) as control
Functional CLICChamber Test (O2 Sat)	Demonstrate that the measurement of O2 Sat using the IBC bloodchamber will have a standard deviation X2 of ≤ 3%, and an averagebias of ≤ 2%, when compared to the O2 Sat measurements made usinga production blood chamber (CL10041021) as control
Tubing Compliance Test	Demonstrate that tubing is capable of being occlusively clamped by thevenous line clamp of the dialysis machine
Clamp Occlusion Test	Demonstrate that tubing is capable of being occlusively clamped by thebloodline clamps

Table 3: Performance Testing Summary

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Table 3: Performance Testing Summary

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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, also in blue. The abstract symbol appears to be three downward-pointing chevrons stacked on top of each other.

Table 3: Performance Testing Summary

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Image /page/10/Picture/0 description: The image contains the logo for Fresenius Medical Care. On the left side of the logo, there 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 MEDICAL CARE" are written in blue, with "FRESENIUS" on the top line and "MEDICAL CARE" on the bottom line.

Performance Testing Summary Table 3:

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" (16 June 2016). The following testing was conducted to support the biological safety of the CombiSet SMARTECH Bloodlines:

Cytotoxicity, Neutral Red Uptake
Sensitization, Guinea Pig Maximization ●
Intracutaneous Irritation ●
Material-Mediated Pyrogenicity
Hemocompatibility, ASTM Hemolysis (Direct and Indirect)
Hemocompatibility, Dynamic (Mechanical) Hemolysis
Complement Activation, SC5b-9
Platelet and Leukocyte Count
Partial Thromboplastin Time (PTT)
Semi-quantitative Leachable Chemical Evaluation, 20% Ethanol (Volatiles, Semi-. Volatiles, Non-Volatiles, Metals)
Semi-quantitative Extractable Chemical Evaluation, Water, Hexane, 95% Ethanol ● (Volatiles, Semi-Volatiles, Non-Volatiles, Metals)

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K201207

5.9.2. Human Factors Validation Testing

The CombiSet SMARTECH Bloodlines were validated for safe and effective use in accordance with FDA guidance document Applying Human Factors and Usability Engineering to Medical Devices (03 February 2016).

5.9.3. Electrical Safety and Electromagnetic Compatibility (EMC)

Not applicable. The CombiSet SMARTECH Bloodlines are not electrical mechanical devices.

5.9.4. Software Verification and Validation Testing

Not applicable. The CombiSet SMARTECH Bloodlines do not contain software.

5.9.5. Animal Studies

No animal studies were performed.

Clinical Studies 5.9.6.

No clinical studies were performed.

5.10. Conclusion

The Indications for Use, technological characteristics, design, and performance requirements of the CombiSet SMARTECH Bloodlines are substantially equivalent to those of the predicate devices. FMCRTG concludes that within the meaning of the Medical Device Amendments Act of 1976, the CombiSet SMARTECH Bloodlines are safe and effective for their intended use.

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.

Regulation Number and Section

§ 876.5820 Hemodialysis system and accessories.

(a)
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.
(b)
Classification. (1) Class II (performance standards) for hemodialysis systems and all accessories directly associated with the extracorporeal blood system and the dialysate delivery system.(2) Class I for other accessories of the hemodialysis system remote from the extracorporeal blood system and the dialysate delivery system, such as the unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.