The CRIT-LINE Clip (CLiC) Blood Chamber is a sterile, single use, disposable, optical cuvette designed for use with the CLiC Monitor's sensor clip during acute and chronic herapy to non-invasively measure hematocrit, percent change in blood volume, and oxygen saturation. The blood chamber is connected between the arterial bloodline and the dialyzer within the extracorporeal circuit during hemodialysis treatment.

Device Description

The CRIT LINE™ Clip (CLiC) Blood Chamber is a non-invasive, disposable, transparent optical cuvette designed as a connection between the arterial bloodline and the hemodialyzer in the extracorporeal circuit during hemodialysis treatment. The chamber's two (2) polycarbonate viewing lenses serve to secure the CLiC Monitor's sensor clip and provide a uniform cross section, allowing a clear blood passage for the CLiC Monitor to transmit light through the blood. The CLiC Monitor uses the principle of light absorption to measure oxygen saturation (O2 SAT) and hematocrit (HCT) levels in the blood.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the CRIT-LINE Clip (CLiC) Blood Chamber, structured according to your request.

Overall Device Context:
The document relates to a 510(k) premarket notification for the CRIT-LINE Clip (CLiC) Blood Chamber, a sterile, single-use, disposable optical cuvette for non-invasively measuring hematocrit, percent change in blood volume, and oxygen saturation during hemodialysis. The goal is to demonstrate substantial equivalence to a predicate device (CRIT-LINE Blood Chamber (K935958)).

Important Note: This document is a 510(k) summary, which typically provides high-level results and conclusions rather than detailed study protocols and raw data. Therefore, some of the requested information (like specific effect sizes for MRMC studies, precise sample sizes for certain tests, or depth of ground truth establishment for training) may not be explicitly present. The information provided is based only on the text given.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list numerical "acceptance criteria" alongside "reported device performance" in a separate table for each test. Instead, it states the "Test Objective" and then reports "Pass - Results within acceptance criteria" or similar conclusive statements for all tests. This indicates that the tests met predefined criteria, but the specific numerical thresholds for these criteria are not provided in this summary.

Test Method (as listed in document)	Test Objective (Acceptance Criteria Implicitly Derived)	Reported Device Performance
Mechanical Characteristics / Structural Integrity	Ensure the blood chamber is capable of withstanding extreme positive and negative pressure conditions.	Pass - Results within acceptance criteria.
Dialyzer Connectors (Female Din connector)	Ensure the connectors meet the performance requirements of ISO 594-2.	Pass - Results within acceptance criteria.
Connector to Vascular Access Device (Male Luer Connector)	Ensure the connectors meet the performance requirements of ISO 594-2.	Pass – Results within acceptance criteria.
Endurance Performance Test: Extracorporeal Circuit Evaluation	Demonstrate the product performs at various flow rates and bloodline-dialyzer combinations without resulting in any tubing failure (i.e. loosening of connections).	Pass - Results within acceptance criteria.
Endurance Performance Test: Effects of Flow Rates on the CLiC Monitor Evaluation	Demonstrate varying flow rates do not affect the CLiC Blood Chamber's ability to allow the CLiC Monitor to record accurate and consistent measurements of Hematocrit (HCT) and Percent Oxygen Saturation (O2 Sat).	Pass - Results within acceptance criteria.
Endurance Performance Test: Extracorporeal Circuit Evaluation of Maximum Flow Rate	Demonstrate the product performs at maximum flow rates without resulting in any tubing failure (i.e. loosening of connections).	Pass - Results within acceptance criteria.
Bond Strength Testing	Confirm the solvent bonding between the CLiC Blood Chamber blue polycarbonate body and the clear PVC DIN Connector.	Pass - Results within acceptance criteria.
Torque Test	Test the material properties after Gamma sterilization.	Pass - Results within acceptance criteria.
Blood Pathway Volume (Priming Volume)	Establish the blood pathway volume of the blood chamber for the information for use (IFU).	Pass - Results within acceptance criteria.
Functional CLiC Chamber Test	Evaluate the repeatability of the CLiC Blood Chamber by examining differences in hematocrit and oxygen saturation readings between individual chambers and multiple blood chamber lots.	Pass - Results within acceptance criteria.
Mechanical Hemolysis Test	Evaluate the hemolytic properties of the CLiC Blood Chamber when exposed to circulating blood flow.	Pass - Results within acceptance criteria.
Ship Testing (ISTA 1A)	Ensure the package design is robust and prevents product damage.	Pass - Results within acceptance criteria.
Bubble emission test	Ensure packaging does not yield any gross leaks.	Pass - Results within acceptance criteria.
Dye Penetration test	Ensure the porous medical packaging does not yield seal leaks.	Pass - Results within acceptance criteria.
Peel Test	Determine that the packaging meets the specification for the force required to separate the label portion of the packaging from film at the separator tab.	Pass - Results within acceptance criteria.
Film Tensile Strength	Determine that the film used on the packaging meets specification.	Pass - Results within acceptance criteria.
Microbial Barrier Aerosol Spore Challenge	Determine the passage of airborne bacteria through CLiC Blood Chamber packaging occurs at an acceptable level.	Pass - Results within acceptance criteria.
Sterilization Validation	Validate the gamma radiation sterilization process of the CLiC Blood Chamber by achieving a required sterility assurance level.	Pass – Results within acceptance criteria.
Bioburden Validation	Demonstrate the established sterilization dose maintains acceptable levels of bioburden.	Pass – Results within acceptance criteria.
Bacterial Endotoxins Test (Nonpyrogenicity)	Validate the claim of “non-pyrogenic” on the device label.	Pass – Results within acceptance criteria.
Biological Safety	Demonstrate the biological safety of the CLiC Blood Chamber.	Pass - Results support the conclusion that the CLiC Blood Chamber is biologically safe.
Human Factors (Usability Testing)	Evaluate the use of the CLiC Blood Chamber in an environment representative of its intended use. Determine if the instructions for use (IFU) allowed the intended user population to connect the CLiC Blood Chamber to the extracorporeal circuit correctly, safely, and effectively for its intended use.	Pass - Results support a conclusion that the CLiC Blood Chamber has no unacceptable residual risk and is safe and effective for use by the intended user population.
CLiC Blood Chamber Storage Temperature Test	Validate the storage temperature requirement on the device label.	Pass - Results within acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not specify exact numerical sample sizes for each test listed (e.g., number of chambers tested for mechanical characteristics, number of blood samples for functional tests). It only states that tests were performed "to support the determination of substantial equivalence."
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) submission for a physical medical device accessory (a blood chamber), the tests are typically internal, in-house laboratory and engineering tests, rather than clinical trials with patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable or not specified in the document. The tests performed are primarily engineering and laboratory performance tests, not diagnostic accuracy studies requiring expert interpretation of results for ground truth.
Qualifications of Experts: Not applicable or not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable or not specified. As mentioned, these are laboratory and engineering tests, not studies requiring expert adjudication of clinical outcomes or interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No, an MRMC comparative effectiveness study was not performed.
Effect Size: Not applicable, as no MRMC study was conducted. The device is a physical component (blood chamber) of a hemodialysis system, not a diagnostic imaging algorithm that requires human-in-the-loop performance evaluation.

6. Standalone (Algorithm Only) Performance Study

Was a standalone study done? No, a standalone (algorithm only) performance study was not done. The device itself is a blood chamber, an accessory for a monitor, not an algorithm. The "Functional CLiC Chamber Test" evaluates the repeatability of the chamber's ability to allow the monitor to read HCT and O2 Sat, not the standalone performance of an algorithm.

7. Type of Ground Truth Used

Type of Ground Truth: For the various engineering and performance tests, the "ground truth" would be established by:
- Engineering Specifications/Standards: For mechanical, connector, bond strength, torque, and material property tests. (e.g., ISO 594-2 for connectors).
- Reference Methods/Instrumentation: For tests like blood pathway volume, functional repeatability (comparison to a known standard or highly precise reference method for HCT and O2 Sat measurement), and mechanical hemolysis (e.g., a standardized hemolysis assay).
- Regulatory Requirements: For sterilization, bioburden, and pyrogenicity (e.g., sterility assurance level (SAL), non-pyrogenic limits).
- Usability Best Practices: For human factors testing, evaluating successful vs. unsuccessful completion of tasks according to predefined criteria.

8. Sample Size for the Training Set

Sample Size for Training Set: The document does not describe any "training set" in the context of machine learning or AI models. This device is a physical medical accessory, and its evaluation relies on engineering and biological performance testing, not on data-driven algorithm development that typically involves training sets.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set was Established: Not applicable, as there is no mention of a training set for an AI/ML algorithm.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure in profile, with three overlapping faces.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 14, 2014

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

Re: K141281 Trade/Device Name: CRIT-LINE Clip (CLiC) Blood Chamber Regulation Number: 21 CFR§ 876.5820 Regulation Name: Hemodialysis system and accessories Regulatory Class: II Product Code: KOC Dated: May 15, 2014 Received: May 16, 2014

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Herbert P. Lerner -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

N/A K141281

Device Name CRIT-LINE Clip (CLiC) Blood Chamber

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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510(K) SUMMARY 5.

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) 699-4479
Fax:	(781) 699-9635
Contact Person:	Denise Oppermann, Senior DirectorRegulatory Affairs – Devices
Preparation Date:	5/15/2014

5.2. Device Name

Trade Name:	CRIT-LINE Clip (CLiC) Blood Chamber
Common Name:	CLiC Blood Chamber
Product Code:	KOC
Classification Panel:	Gastroenterology-Urology
Classification Name:	Accessories, Blood Circuit, Hemodialysis
Regulation:	21 CFR 876.5820

5.3. Legally Marketed Predicate Device

CRIT-LINE Blood Chamber (K935958)

Device Description 5.4.

ર્ડ.

જિંત જિલ્લાના ગુજરાત રાજ્યના દિવસાય ખેતી ખેતી કરવામાં આવેલું એક ગામનાં લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામનાં મુખ્યત્વે ખેતી, ખેતમજૂરી તેમ જ પશ Comparison to Predicate

Table 1 contains a full description of the intended use and technological characteristics of the subject CLiC Blood Chamber as well as a comparison to the predicate CRIT-LINE Blood Chamber in each of these areas.

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	Predicate Device	Proposed Device
Feature	CRIT-LINE Blood Chamber(K935958)	CLiC Blood Chamber	Comment
ClassificationProduct Code /Regulation	KOC/876.5820	KOC/876.5820	SubstantiallyEquivalent
Indications foruse	No Indications for Use statementwas provided in K935958.	The CRIT-LINE Clip (CLiC)Blood Chamber is a sterile, singleuse, disposable, optical cuvettedesigned for use with the CLiCMonitor's sensor clip during acuteand chronic hemodialysis therapyto non-invasively measurehematocrit, percent change in bloodvolume, and oxygen saturation. Theblood chamber is connectedbetween the arterial bloodline andthe dialyzer within theextracorporeal circuit duringhemodialysis treatment.	SubstantiallyEquivalent
Configuration	A clear polycarbonate lens issonically welded to a clearpolycarbonate body. A secureconnection with the arterialbloodline is made by a male Luer-lock connector. Connection to thehemodialyzer is made by a femaleconical fitting with external threads(DIN connector) which is part of thechamber body mold. Eachconnection is capped; caps areremoved prior to treatment.	Two clear polycarbonate lenses aresonically welded to a translucent,blue polycarbonate body. A secureconnection with the arterialbloodline is made by a male Luer-lock connector. Connection to thehemodialyzer is made by apolyvinylchloride (PVC), femaleconical fitting with external threads(DIN connector). Each connectionis capped; caps are removed priorto treatment.	SubstantiallyEquivalent
Blood Pathway	The blood pathway created by theCRIT-LINE Blood Chamberexposes the blood to onlypolycarbonate.	The blood pathway created by theCLiC chamber exposes the blood tothree different materials; PVC (DINconnector), clear polycarbonate(lenses), and blue polycarbonate(chamber body).	SubstantiallyEquivalent
Connection toDialyzer	Female conical fitting with externalthreads.Part of the chamber body mold.	Female conical fitting with externalthreads.PVC component bonded to thechamber body mold with a bondingsolution.Meets ISO 594-2 performancerequirements.	SubstantiallyEquivalent

Table 1: Device Description and Comparison to the Predicate

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Image /page/5/Picture/0 description: The image contains the logo for Fresenius Medical Care. The logo consists of a blue symbol on the left and the text "FRESENIUS MEDICAL CARE" on the right. The symbol is made up of three downward-pointing chevrons stacked on top of each other, also in blue.

Feature	Predicate Device	Proposed Device	Comment
	CRIT-LINE Blood Chamber(K935958)	CLiC Blood Chamber
Connection toArterialBloodline	Male Luer-lock conical fitting withinternal threads.Part of the chamber bodypolycarbonate mold.	Male Luer-lock conical fitting withinternal threads.Part of the chamber bodypolycarbonate mold.Meets ISO 594-2 performancerequirements.	SubstantiallyEquivalent
ConnectionCaps	Caps do not come into contact withthe blood path and are discardedprior to treatment.	Caps do not come into contact withthe blood path and are discardedprior to treatment.	SubstantiallyEquivalent
Sensor Clip toLens Interface	The predicate blood chamberincludes a "Double D" patternmolded into one side of the bloodchamber. This shape matches theCRIT-LINE Monitor's sensor clip.The chamber guides the opticalparts in the clip to the properpositioning relative to the viewingarea and keeps the clip fromrotating on the chamber.	Each lens employs a uniformannular ring to interface with thecomplementary shroud design ofthe CLiC Monitor's sensor clip.The shroud fills the area betweenthe annular ring on the chamber andthe outside edge of the lens. Eachlens features an anti-rotation detentwhich interlocks withcomplementary tabs on both sidesof the CLiC Monitor's clip. Thisprevents the rotation of the clip.	SubstantiallyEquivalent
SterilizationMethod	Gamma Radiation	Gamma Radiation	SubstantiallyEquivalent
Pyrogenicity	Non-pyrogenic	Non-pyrogenic	SubstantiallyEquivalent
Sterile Barrier	Unit Packaging	Unit Packaging	SubstantiallyEquivalent
Single use orreuse	Single use only	Single use only	SubstantiallyEquivalent
Packaging	Medical grade peel pouch with labelinformation printed on the paperportion.	Blister pack made from medicalpaper with heat seal coating and ahigh performance nylon-basedforming film pouch. Labelinformation is printed on medicalpaper portion.	SubstantiallyEquivalent
BiologicalSafety	Biologically Safe	Biologically Safe	SubstantiallyEquivalent

Table 1: Device Description and Comparison to the Predicate

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Image /page/6/Picture/0 description: The image shows the logo for Fresenius Medical Care. On the left is a blue symbol that looks like three chevrons stacked on top of each other. To the right of the symbol is the text "FRESENIUS MEDICAL CARE" in blue, with "FRESENIUS" on top of "MEDICAL CARE".

5.6. Performance Data

The following tables outline testing performed on the CLiC Blood Chamber to support the determination of substantial equivalence to the predicate device.

Test Method	TestObjective	Result
MechanicalCharacteristics /Structural Integrity	Ensure the blood chamber is capable of withstandingextreme positive and negative pressure conditions.	Pass - Results withinacceptance criteria.
Dialyzer Connectors(Female Din connector)	Ensure the connectors meet the performance requirementsof ISO 594-2.	Pass - Results withinacceptance criteria.
Connector to VascularAccess Device (MaleLuer Connector)	Ensure the connectors meet the performance requirementsof ISO 594-2	Pass – Results withinacceptance criteria.
Endurance PerformanceTest:Extracorporeal CircuitEvaluation	Demonstrate the product performs at various flow ratesand bloodline-dialyzer combinations without resulting inany tubing failure (i.e. loosening of connections).	Pass - Results withinacceptance criteria.
Endurance PerformanceTest:Effects of Flow Rateson the CLiC MonitorEvaluation	Demonstrate varying flow rates do not affect the CLiCBlood Chamber 's ability to allow the CLiC Monitor torecord accurate and consistent measurements ofHematocrit (HCT) and Percent Oxygen Saturation (O2Sat).	Pass - Results withinacceptance criteria.
Endurance PerformanceTest:Extracorporeal CircuitEvaluation ofMaximum Flow Rate	Demonstrate the product performs at maximum flow rateswithout resulting in any tubing failure (i.e. loosening ofconnections).	Pass - Results withinacceptance criteria.
Bond Strength Testing	Confirm the solvent bonding between the CLiC BloodChamber blue polycarbonate body and the clear PVC DINConnector.	Pass - Results withinacceptance criteria.
Torque Test	Test the material properties after Gamma sterilization.	Pass - Results withinacceptance criteria.
Blood Pathway Volume(Priming Volume)	Establish the blood pathway volume of the blood chamberfor the information for use (IFU).	Pass - Results withinacceptance criteria.
Functional CLiCChamber Test	Evaluate the repeatability of the CLiC Blood Chamber byexamining differences in hematocrit and oxygensaturation readings between individual chambers andmultiple blood chamber lots.	Pass - Results withinacceptance criteria.
Mechanical HemolysisTest	Evaluate the hemolytic properties of the CLiC BloodChamber when exposed to circulating blood flow.	Pass - Results withinacceptance criteria.

Table 2: Performance and Functional Testing

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Image /page/7/Picture/0 description: The image shows the Fresenius Medical Care logo. On the left is a blue symbol that looks like three chevrons stacked on top of each other. To the right of the symbol is the company name, "FRESENIUS MEDICAL CARE", in blue block letters.

Test Method	Test Objective	Results
Ship Testing (ISTA1A)	Ensure the package design is robust and prevents product damage.	Pass - Results withinacceptance criteria.
Bubble emission test	Ensure packaging does not yield any gross leaks.	Pass - Results withinacceptance criteria.
Dye Penetration test	Ensure the porous medical packaging does not yield seal leaks.	Pass - Results withinacceptance criteria.
Peel Test	Determine that the packaging meets the specification for the forcerequired to separate the label portion of the packaging from film at theseparator tab.	Pass - Results withinacceptance criteria.
Film Tensile Strength	Determine that the film used on the packaging meets specification.	Pass - Results withinacceptance criteria.
Microbial BarrierAerosol SporeChallenge	Determine the passage of airborne bacteria through CLiC Blood Chamberpackaging occurs at an acceptable level.	Pass - Results withinacceptance criteria.

Table 3: Packaging Qualification and Ship Testing

Table 4: Sterilization Validation Testing

Test Method	Test Objective	Results
Sterilization Validation	Validate the gamma radiation sterilization process of the CLiC BloodChamber by achieving a required sterility assurance level.	Pass – Results withinacceptance criteria.
Bioburden Validation	Demonstrate the established sterilization dose maintains acceptablelevels of bioburden.	Pass – Results withinacceptance criteria.
Bacterial EndotoxinsTest (Nonpyrogenicity)	Validate the claim of “non-pyrogenic” on the device label.	Pass – Results withinacceptance criteria.

Table 5: Additional Performance Testing

Test Method	Test Objective	Results
Biological Safety	Demonstrate the biological safety of the CLiC Blood Chamber.	Pass - Results support theconclusion that the CLiCBlood Chamber is biologicallysafe.
Human Factors(Usability Testing)	Evaluate the use of the CLiC Blood Chamber in an environmentrepresentative of its intended use.Determine if the instructions for use (IFU) allowed the intendeduser population to connect the CLiC Blood Chamber to theextracorporeal circuit correctly, safely, and effectively for itsintended use.	Pass - Results support aconclusion that the CLiCBlood Chamber has nounacceptable residual risk andis safe and effective for use bythe intended user population.
CLiC Blood ChamberStorage TemperatureTest	Validate the storage temperature requirement on the device label.	Pass - Results withinacceptance criteria.

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Image /page/8/Picture/0 description: The image shows the Fresenius Medical Care logo. The logo consists of a blue geometric shape on the left and the text "FRESENIUS MEDICAL CARE" on the right. The geometric shape is made up of three downward-pointing chevrons stacked on top of each other.

5.7. Conclusion

Based on a cumulative review of the verification and validation testing, the function of the CLiC Blood Chamber is substantially equivalent to the predicate CRIT-LINE Blood Chamber (K935958) and is safe and effective for its intended use.

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.