The Clearlink System Non-DEHP Solution Set (2R8401) consists of a spike tip protector, non-vented spike, non-DEHP drip chamber, non-DEHP tubing, slide clamp, regulating roller clamp, Clearlink Luer activated valve (LAV), two-piece male Luer lock and male Luer cap. The Clearlink System Solution Set with Duo-Vent Spike (2R8875) consists of a spike tip protector, vented spike, non-DEHP drip chamber , non-DEHP tubing, tri-layer tubing, slide clamp, on-off roller clamp, Clearlink Luer activated valve (LAV), one-piece male Luer lock and male Luer cap.

The Clearlink System Non-DEHP Continu-Flo Solution Set (2R8519, 2R8546) consists of a spike tip protector, nonvented spike, non-DEHP drip chamber , non-DEHP tubing, check valve, slide clamp, regulating roller clamp, Clearlink Luer activated valve (LAV), two-piece male Luer cap. Configurations of these sets differ in drip chamber flow rate (60 drops/mL or 10 drops/ mL).

AI/ML Overview

This document describes the non-clinical testing performed on the Clearlink System Solution Sets to demonstrate their substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Male Luer Cap/Spike Tip Protector Removal Force Test	Per Baxter Test Method	All tests met the acceptance criteria.
Male Luer Cap/Spike Tip Protector Retention Test	Per Baxter Test Method	All tests met the acceptance criteria.
Continuous Bubble Test (Pump Compatibility)	Per Baxter Test Method	All tests met the acceptance criteria.
Accumulated Bubble Test (Pump Compatibility)	Per Baxter Test Method	All tests met the acceptance criteria.
Administration Set Integrity After Maximum Delivery (Pump Compatibility)	Per Baxter Test Method	All tests met the acceptance criteria.
Upstream Occlusion (Pump Compatibility)	Per Baxter Test Method	All tests met the acceptance criteria.
Downstream Occlusion (Pump Compatibility)	Per Baxter Test Method	All tests met the acceptance criteria.
Flow Rate Accuracy (Pump Compatibility)	Per Baxter Test Method	All tests met the acceptance criteria.
Solvent Bond Tensile Strength Test	Per Baxter Test Method	All tests met the acceptance criteria.
Solvent Bond Pressure Test	Per Baxter Test Method	All tests met the acceptance criteria.
Top End Tubing Assembly Clear Passage	Per Baxter Test Method	All tests met the acceptance criteria.
Spike Assembly Visual Inspection	Per Baxter Test Method	All tests met the acceptance criteria.
Drop Volume Accuracy, 10 drops/mL	Per Baxter Test Method	All tests met the acceptance criteria.
Drop Volume Accuracy, 60 drops/mL	Per Baxter Test Method	All tests met the acceptance criteria.
Cannula Pull Out Force	Per Baxter Test Method	All tests met the acceptance criteria.
Spike Assembly Insertion Force Test	Per Baxter Test Method	All tests met the acceptance criteria.
Spike Assembly Removal Force Test	Per Baxter Test Method	All tests met the acceptance criteria.
Slide Clamp Shut Off Test (Fixtured Slide Clamp)	Per Baxter Test Method	All tests met the acceptance criteria.
Slide Clamp Shut Off Test - Post 24 hours (Fixtured Slide Clamp)	Per Baxter Test Method	All tests met the acceptance criteria.
Slide Clamp 7 Day Subsystem and Tubing Damage Test (Fixtured Slide Clamp)	Per Baxter Test Method	All tests met the acceptance criteria.
Slide Clamp Flow Stability Test (Fixtured Slide Clamp)	Per Baxter Test Method	All tests met the acceptance criteria.
Slide Clamp Tug Stability Test (Fixtured Slide Clamp)	Per Baxter Test Method	All tests met the acceptance criteria.
Slide Clamp Shut Off Test (plastic slide clamp)	Per Baxter Test Method	All tests met the acceptance criteria.
Slide Clamp 7 Day Subsystem and Tubing Damage Test (plastic slide clamp)	Per Baxter Test Method	All tests met the acceptance criteria.
Roller Clamp Control Range Test	Per Baxter Test Method	All tests met the acceptance criteria.
Roller Clamp Force Test	Per Baxter Test Method	All tests met the acceptance criteria.
Roller Clamp Shut Off Test -Post 24 hours	Per Baxter Test Method	All tests met the acceptance criteria.
Roller Clamp 7 Day Subsystem and Tubing Damage Test	Per Baxter Test Method	All tests met the acceptance criteria.
Roller Clamp Flow Stability Test	Per Baxter Test Method	All tests met the acceptance criteria.
Roller Clamp Tug Stability Test	Per Baxter Test Method	All tests met the acceptance criteria.
Roller Clamp Tubing Leak Test	Per Baxter Test Method	All tests met the acceptance criteria.
Roller Clamp Shut-Off Test	Per Baxter Test Method	All tests met the acceptance criteria.
Roller Clamp Force Test	Per Baxter Test Method	All tests met the acceptance criteria.
Check Valve Back Flow Test	Per Baxter Test Method	All tests met the acceptance criteria.
Check Valve High Pressure Test	Per Baxter Test Method	All tests met the acceptance criteria.
Clearlink Y-Site Valve Performance Post 100 Actuations	Per Baxter Test Method	All tests met the acceptance criteria.
Clearlink Y-Site Valve Performance Post 96 Hour Indwell	Per Baxter Test Method	All tests met the acceptance criteria.
Clearlink Y-Site Clear Air Passage	Per Baxter Test Method	All tests met the acceptance criteria.
Clearlink Y-Site Back Pressure Leak Test	Per Baxter Test Method	All tests met the acceptance criteria.
Clearlink Y-Site Luer Connection Leak Test	Per Baxter Test Method	All tests met the acceptance criteria.
Clearlink Y-Site Basic 10-Cycle Actuation Sequence	Per Baxter Test Method	All tests met the acceptance criteria.
ISO Luer Tests on Male Luer Connectors	ISO 594-1:1986 and 594-2:1998	All tests met the acceptance criteria.
ISO Luer Tests on Clearlink Connectors	ISO 594-2:1998	All tests met the acceptance criteria.
(Unscrewing Torque, Separation, Resistance to Overriding and Ease of Assembly Tests)	Per Baxter Test Method	All tests met the acceptance criteria.
Non-DEHP Claim Verification	Per Baxter Test Method	All tests met the acceptance criteria.
Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous (Irritation) Reactivity, Systemic Toxicity, Toxicological Assessment of Extractable Profile, Materials Mediated Pyrogen, Hemolysis, USP Physiochemical)	ISO 10993 series, USP <661>, and FDA Guidance	All tests met the acceptance criteria, showing the device to be biocompatible.
Sterility	ANSI/AAMI/ISO 11137-1, ANSI/AAMI/ISO 11137-2	Established and validated a 10⁻⁶ Sterility Assurance Level (SAL).
Shelf-Life	Not explicitly stated (likely internal Baxter standard for aging tests leading to shelf-life claim)	Supported a shelf-life claim of 2 years.
Microbial Ingress Testing	FDA's Guidance for Industry and Staff, Intravascular Administration Sets Premarket Notification Submissions [510(k)] Section 8, Baxter's test method	All test results met acceptance criteria.

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

The document does not specify the exact sample sizes used for each individual performance test. The data provenance is from Baxter Healthcare Corporation, indicating internal company testing. The document states "Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the result of these analyses."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a medical device clearance based on non-clinical performance and biocompatibility testing, not on diagnostic accuracy requiring expert interpretation of results. The "ground truth" for these tests is defined by the established acceptance criteria in the relevant standards or internal test methods.

4. Adjudication method for the test set

Not applicable. This is a medical device clearance based on non-clinical performance and biocompatibility testing. The "ground truth" is determined by meeting pre-defined acceptance criteria set by standards or internal protocols.

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

Not applicable. This device is an intravascular administration set, not an AI-powered diagnostic or assistive technology.

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

Not applicable. This device is an intravascular administration set, not an algorithm.

7. The type of ground truth used

The "ground truth" for the non-clinical tests described is based on:

Standards and Regulations: ISO 594-1:1986, ISO 594-2:1998 for luer tests; ISO 10993 series and USP <661> for biocompatibility; ANSI/AAMI/ISO 11137 series for sterility; FDA Guidance for microbial ingress.
Internal Baxter Test Methods: "Per Baxter Test Method" as explicitly stated for almost all functional performance tests. These methods would be based on engineering specifications and risk assessments to ensure the device performs as intended and is safe.

8. The sample size for the training set

Not applicable. This device is an intravascular administration set, not an AI model requiring a training set.

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

Not applicable. This device is an intravascular administration set, not an AI model.

Summary

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May 28, 2019

Baxter Healthcare Corporation % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K180739

Trade/Device Name: Clearlink System Solution Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: FPA Dated: April 4, 2019 Received: April 5, 2019

Dear Mark Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Tina Kiang, Ph.D Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K180739

Device Name Clearlink System Solution Sets

Indications for Use (Describe)

For the administration of fluids from a container into the patient's vascular system through a vascular access device.

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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axter

Section 5. 510(k) Summary

May 24, 2019

OWNER:

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

CONTACT PERSON:

Jeanette Licata Sr. Regulatory Affairs Associate, Regulatory Affairs 32650 N. Wilson Road Round Lake, IL 60073 Telephone: (224) 948 3996 Fax: (224) 270 4119

IDENTIFICATION OF THE DEVICE:

Trade/Device Name: Clearlink System Solution Sets Classification Panel: 80 General Hospital Regulation Number: 21 CFR 880.5440 Regulation Name: Set, Administration, Intravascular Regulatory Class: Class II Product Code: FPA

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Table 1. Code Numbers for Clearlink System Solution Set

Code Number	Name
2R8519	Clearlink System Non-DEHP Continu-Flo Solution Set
2R8537	Clearlink System Non-DEHP Continu-Flo Solution Set
2R8546	Clearlink System Non-DEHP Continu-Flo Solution Set
2R8401	Clearlink System Non-DEHP Solution Set
2R8875	Clearlink System Solution Set with Duo-Vent Spike

PREDICATE DEVICE:

Table 2. Predicate Device

Device	Company	Predicate 510(k)	Clearance Date
Clearlink Luer Activated Valve, Clearlink SystemNon-DEHP Catheter Extension Sets	Baxter Healthcare Corporation	K112893	October 18, 2011

REASON FOR SUBMISSION:

The changes identified as the basis of this submission apply to all the proposed devices included in this application (2R8519, 2R8537, 2R8546, 2R8401, and 2R8875). Specifically, the changes include the following:

· A change to the packaging configuration, specifically the design and materials of the male Luer cap and spike tip protector which are used to maintain the sterile fluid path. Both are non-fluid path components.
Differences in components and materials

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Inclusion of the expiry date for the new packaging configuration .
Minor rewording of the Indications for Use and Intended Use statements .
. An update to the pump compatibility statement
· Labeling updates with other clarifying information to comply with Baxter's labeling standards.

These modifications do not impact the intental scientific technology of the devices or raise different questions of safety and effectiveness.

Table 3 provides details on the design and materials of the current and proposed spike tip protector and male Luer cap.

DESCRIPTION OF THE DEVICE:

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Component	Current Design; Material	Proposed Design; Material	Assessment of Differences
Spike Tip Protector	Vented; Low DensityPolyethylene	Non-Vented; Linear Low DensityPolyethylene	Spike tip protector and male Luer cap areremoved before set use and are non-fluidpath components. Additional testing hasconfirmed the different technologicalcharacteristics of the new device do notraise different questions of safety andeffectiveness.
Male Luer Cap	Vented; Low DensityPolyethylene, Blue	Non-Vented Filtered; High DensityPolyethylene (housing), Acrylic withNon-Woven Nylon Substrate (filtermaterial)

INDICATIONS FOR USE:

For the administration of fluids from a container into the patient's vascular system through a vascular access device.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:

The proposed devices are substantially equivalent to the previously cleared under 510(k) premarket notification K112893 on October 18, 2011. The intended use and function of the proposed devices are equivalent to the predicate device.

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Table 4 is a device comparison table outlining the differences between the predicate and proposed devices.

Features	Predicate DeviceCleared under K112893	Proposed Devices (2R8519,2R8537, 2R8546, 2R8401,2R8875)	Assessment of Differences
Intended Use	For use with a vascular accessdevice for the administration ofdrugs and solutions. TheClearlink Luer Activated Valveis an in-line injection site, whichcan be connected to the standardmale Luer adapters (e.g.,syringes or sets) for continuousor intermittent fluidadministration or thewithdrawal of fluid.	For the administration of fluidsfrom a container into thepatient's vascular systemthrough a vascular accessdevice.	SameMinor rewording of the Intended Use statement hasbeen made to better align with 21 CFR 880.5440and for the purpose of streamlining the informationprovided to the user.The general purpose of the device and its functionremain unchanged.The minor rewording of the Intended Use statementdoes not raise different questions of safety andeffectiveness.
Indication for Use	For use with a vascular accessdevice for the administration ofdrugs and solutions. TheClearlink Luer Activated Valveis an in-line injection site, whichcan be connected to the standardmale Luer adapters (e.g.,syringes or sets) for continuousor intermittent fluidadministration or thewithdrawal of fluid.	For the administration of fluidsfrom a container into thepatient's vascular systemthrough a vascular accessdevice.	SameMinor rewording of the Indications for Usestatement has been made to better align with 21CFR 880.5440 and for the purpose of streamliningthe information provided to the user.This minor modification does not alter the diseaseor condition the device will diagnose, treat, prevent,cure/mitigate, or the patient population for whichthe device is intended to be used. In addition, theminor rewording does not reflect a differentanatomical site from which a disease state orpopulation may be inferred.
Features	Predicate DeviceCleared under K112893	Proposed Devices (2R8519,2R8537, 2R8546, 2R8401,2R8875)	Assessment of Differences
Sterile	Yes	Same	The minor rewording of the Intended Use statementdoes not raise different questions of safety andeffectiveness.
Non-Pyrogenic	Yes	Same	N/A
Single Use	Yes	Same	N/A
Pump Compatibility	Yes, compatible with Flo-Gardand Colleague	Yes, compatible with SigmaSpectrum and other Baxterinfusion pumps	Compatible pumps reference has been updated toalign with Baxter's marketed infusion pumps.Testing has been performed to confirm pumpcompatibility with Sigma Spectrum infusion pumps.
Components/Materials
Non-Vented Spike(2R8519, 2R8537,2R8546 and 2R8401)	Acrylonitrile Butadiene Styrene	Same	N/A
Non-DEHP DripChamber	Polyvinyl Chloride	Same	N/A
Non-DEHP Set Tubing(2R8537, 2R8546)	Material: Polyvinyl ChloridePlasticizer:Tris (2-Ethylhexyl) Trimellitate	Same	N/A
Clearlink Luer ActivatedValve	Polycarbonate [Inlet/OutletHousing]Silicone (Gland)	Same	N/A
Features	Predicate DeviceCleared under K112893	Proposed Devices (2R8519,2R8537, 2R8546, 2R8401,2R8875)	Assessment of Differences
Two-Piece Male LuerLock(2R8519, 2R8537,2R8546 and 2R8401)	Acrylonitrile Butadiene StyrenePolycarbonate [Center Post]	Same	N/A
Vented Spike(2R8875)	Acrylonitrile Butadiene Styrene	Same	N/A
Capped Vent Filter(Vented Spike)(2R8875)	Acrylic copolymer with nylonsubstrate (filter material)High density polyethylene(housing)	SameSame	N/A
Spike Tip Protector(2R8519, 2R8537,2R8546, 2R8401 and2R8875)	Low Density Polyethylene	Linear Low DensityPolyethylene	The spike tip protector has passed functional testingfor its intended use and is a non-fluid pathcomponent. Additional testing has confirmedmaintenance of the sterile fluid path. The differenttechnological characteristics of the new device donot raise different questions of safety andeffectiveness.a
Male Luer Cap(2R8519, 2R8537,2R8546, 2R8401 and2R8875)	Low Density Polyethylene	Acrylic with non-woven NylonSubstrate (Filter material)High Density Polyethylene(Luer cap)	The filter and male Luer cap have passed functionaltesting for their intended uses and are non-fluidpath. Additional testing has confirmed maintenanceof the sterile fluid path. The different technologicalcharacteristics of the new device do not raisedifferent questions of safety and effectiveness.a
Features	Predicate DeviceCleared under K112893	Proposed Devices (2R8519,2R8537, 2R8546, 2R8401,2R8875)	Assessment of Differences
Non-DEHP Pump Tubing(2R8519, 2R8537,2R8546, 2R8401 and2R8875)	Material: Polyvinyl ChloridePlasticizer:Tris (2-Ethylhexyl) Trimellitate	Material: Polyvinyl ChloridePlasticizer:Di (2-Ethylhexyl) terephthalate	Both the predicate and proposed device containPVC tubing. The proposed device's tubing uses adifferent plasticizer. Design control activities havebeen conducted and have confirmed that thedifferent technological characteristics of the newdevice do not raise different questions of safety andeffectiveness.
Non-DEHP Set Tubing(2R8519, 2R8537,2R8646, 2R8401)	Material: Polyvinyl ChloridePlasticizer:Tris (2-Ethylhexyl) Trimellitate	Material: Polyvinyl ChloridePlasticizer:Di (2-Ethylhexyl) terephthalate	Both the predicate and proposed device containPVC tubing. The proposed device's tubing uses adifferent plasticizer. Design control activities havebeen conducted and have confirmed that thedifferent technological characteristics of the newdevice do not raise different questions of safety andeffectiveness.
Set Tubing(2R8875)	Material: Polyvinyl ChloridePlasticizer:Tris (2-Ethylhexyl) Trimellitate	Tri-Layer:Linear low density polyethylene(inner layer)Polyolefin (middle layer)Polyvinyl Chloride (outer layer)	Both the predicate and proposed device containtubing. The proposed device contains tri-layertubing. Design control activities have beenconducted and have confirmed that the differenttechnological characteristics of the new device donot raise different questions of safety andeffectiveness.
Check Valve(2R8519, 2R8537 and2R8546)	Not Applicable	Polymethyl methacrylate(Acrylic) [Inlet and Outlet]Silicone Rubber [Disk]	The predicate device does not have a check valve.Design control activities have been conducted andhave confirmed that the different technologicalcharacteristics of the new device do not raisedifferent questions of safety and effectiveness.b
Features	Predicate DeviceCleared under K112893	Proposed Devices (2R8519,2R8537, 2R8546, 2R8401,2R8875)	Assessment of Differences
Minidrip Adapter(2R8546)	Not Applicable	Rubber (SyntheticPolyisoprene) [Blue Plug]Stainless Steel [Cannula]	The predicate device does not have a minidripadapter. Design control activities have beenconducted and have confirmed that the differenttechnological characteristics of the new device donot raise different questions of safety andeffectiveness.b
Non-DEHP BushingTubing(2R8875)	Not Applicable	Material: Polyvinyl ChloridePlasticizer:Tris (2-Ethylhexyl) Trimellitate	The predicate device does not have Non-DEHPbushing tubing. Design control activities have beenconducted and have confirmed that the differenttechnological characteristics of the new device donot raise different questions of safety andeffectiveness.
One-Piece Male LuerLock(2R8875)	Acrylonitrile Butadiene Styrene	Acrylonitrile Butadiene Styrene	Both the predicate and proposed devices contain anABS One-Piece male Luer lock. The proposeddevice's component has a slightly different design.Design control activities have been conducted andhave confirmed that the different technologicalcharacteristics of the new device do not raisedifferent questions of safety and effectiveness.

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Baxter

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Baxter

Table 4. Device Comparison

ª Although this component is non-fluid path, it's used to maintain sterility of the fluid path and has been included as it is the basis of this premarket application.

b Due to the use of a singular predicate for this submission table identifies that this is a new component from the predicate device. However, the proposed set configuration with this component was originally cleared in K961225. Additionally, this component has since been replaced with another version which has the same functional purpose, same/similar intended use and duration of contact.

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DISCUSSION OF NONCLINICAL TESTS:

Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the result of these analyses. All test results meet their acceptance criteria and support that the proposed devices are appropriately designed for their intended use.

Performance Data:

The following bench tests (Table 5) were conducted to evaluate the functional performance of the Clearlink System Solution Sets. We have included testing information supporting all of the specific changes which are the basis of submission but have also included all testing information in this application to provide a comprehensive package of testing information applicable to the proposed devices.

Test	Acceptance Criteria
Male Luer Cap/Spike Tip Protector Removal Force Test	Per Baxter Test Method
Male Luer Cap/Spike Tip Protector Retention Test	Per Baxter Test Method
Continuous Bubble Test (Pump Compatibility)a	Per Baxter Test Method
Accumulated Bubble Test (Pump Compatibility) a	Per Baxter Test Method
Administration Set Integrity After Maximum Delivery (PumpCompatibility) a	Per Baxter Test Method
Upstream Occlusion (Pump Compatibility) a	Per Baxter Test Method
Downstream Occlusion (Pump Compatibility) a	Per Baxter Test Method
Flow Rate Accuracy (Pump Compatibility) a	Per Baxter Test Method
Solvent Bond Tensile Strength Test	Per Baxter Test Method
Solvent Bond Pressure Test	Per Baxter Test Method
Top End Tubing Assembly Clear Passage	Per Baxter Test Method
Spike Assembly Visual Inspection	Per Baxter Test Method
Drop Volume Accuracy, 10 drops/mL	Per Baxter Test Method
Drop Volume Accuracy, 60 drops/mL	Per Baxter Test Method
Cannula Pull Out Force	Per Baxter Test Method
Spike Assembly Insertion Force Test	Per Baxter Test Method
Spike Assembly Removal Force Test	Per Baxter Test Method
Slide Clamp Shut Off Test (Fixtured Slide Clamp)	Per Baxter Test Method
Slide Clamp Shut Off Test - Post 24 hours (Fixtured Slide Clamp)	Per Baxter Test Method

Table 5. Performance Data

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		Table 5. Performance Data
--	--	---------------------------	--

Slide Clamp 7 Day Subsystem and Tubing Damage Test (Fixtured SlideClamp)	Per Baxter Test Method
Slide Clamp Flow Stability Test (Fixtured Slide Clamp)	Per Baxter Test Method
Slide Clamp Tug Stability Test (Fixtured Slide Clamp)	Per Baxter Test Method
Slide Clamp Shut Off Test (plastic slide clamp)	Per Baxter Test Method
Slide Clamp 7 Day Subsystem and Tubing Damage Test (plastic slideclamp)	Per Baxter Test Method
Roller Clamp Control Range Test	Per Baxter Test Method
Roller Clamp Force Test	Per Baxter Test Method
Roller Clamp Shut Off Test -Post 24 hours	Per Baxter Test Method
Roller Clamp 7 Day Subsystem and Tubing Damage Test	Per Baxter Test Method
Roller Clamp Flow Stability Test	Per Baxter Test Method
Roller Clamp Tug Stability Test	Per Baxter Test Method
Roller Clamp Tubing Leak Test	Per Baxter Test Method
Roller Clamp Shut-Off Test	Per Baxter Test Method
Roller Clamp Force Test	Per Baxter Test Method
Check Valve Back Flow Test	Per Baxter Test Method
Check Valve High Pressure Test	Per Baxter Test Method
Clearlink Y-Site Valve Performance Post 100 Actuations	Per Baxter Test Method
Clearlink Y-Site Valve Performance Post 96 Hour Indwell	Per Baxter Test Method
Clearlink Y-Site Clear Air Passage	Per Baxter Test Method
Clearlink Y-Site Back Pressure Leak Test	Per Baxter Test Method
Clearlink Y-Site Luer Connection Leak Test	Per Baxter Test Method
Clearlink Y-Site Basic 10-Cycle Actuation Sequence	Per Baxter Test Method
ISO Luer Tests on Male Luer Connectors	ISO 594-1:1986 and 594-2:1998
ISO Luer Tests on Clearlink Connectors	ISO 594-2:1998
(Unscrewing Torque, Separation, Resistance to Overriding and Ease ofAssembly Tests)	Per Baxter Test Method
Non-DEHP Claim Verification	Per Baxter Test Method

ª All pump compatibility testing was performed with the Sigma Spectrum infusion pump.

All tests met the acceptance criteria.

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Biocompatibility:

The spike tip protector and male Luer cap components are not considered part of the fluid path of the sets. The fluid path materials in these sets have been used in similar Baxter cleared devices with the same/similar intended use and with the same type and duration of contact.

For the device fluid path, biocompatibility assessments were conducted based on ISO-10993-1, Biological Evaluation of Medical Devices for prolonged duration, external communicating device, indirect blood path and Blue Book Memorandum G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,''' as recommended in the IV Administration Sets guidance, "Guidance for Industry and FDA Staff: Intravascular Administration Sets Premarket Notification Submissions [510(k)]." Biocompatibility assessments were conducted on a worst case/representative final, finished device for all materials of Clearlink System Solution Sets. The following tests were conducted as part of the biocompatibility testing for the device fluid path of the Clearlink System Solution Sets:

Cytotoxicity ISO 10993-5
Sensitization ISO 10993-10
Intracutaneous (Irritation) Reactivity ISO 10993-10
Systemic Toxicity (acute and repeat dose) ISO 10993-11 ●
Toxicological Assessment of Extractable Profile ISO 10993-17
Materials Mediated Pyrogen ISO 10993-11
Hemolysis ISO 10993-4
USP Physiochemical USP <661> (Buffering capacity, Heavy metals, Non-Volatile Residue)

Based upon the results of this prolonged duration, external communicating, indirect blood path testing, the Clearlink System Solution Sets have been shown to be biocompatible and appropriate for their intended use.

Sterility:

The Clearlink System Solution Sets are sterilized with radiation. The Minimum Sterilizing Dose (MSD) required to provide a 106 Sterility Assurance Level (SAL) for this (sub) category was established and validated at the manufacturing facility as described in ANSI/AAMI/ISO 11137-2, "Sterilization of health care products -

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Radiation-Part 2: Establishing the Sterilization Dose." The sterilization process for the proposed devices is also compliant to ANSI/AAMI/ISO 11137-1, Sterilization of health care products-Radiation-Part 1; Requirements for Development, Validation and Routine Control of a Sterilization process for Medical Devices.

Shelf-Life:

Baxter has performed aging testing to support a shelf-life claim of 2 (two) years.

Microbial Ingress Testing:

Baxter has conducted testing on all potential points of microbial entry into the sterile fluid pathway of the Clearlink Intravascular Administration sets subject to this premarket notification. Microbial ingress testing was conducted on the Clearlink Luer Activated Device (LAD) following section 8 of FDA's Guidance for Industry and Staff, Intravascular Administration Sets Premarket Notification Submissions [510(k)], issued July, 11, 2008. The Spike Area and the Luer Connector Site were tested following Baxter's test method. All test results meet their acceptance criteria and support that the proposed devices are appropriately designed for their intended use.

CONCLUSION:

The non-clinical data demonstrate that the subject devices are substantially equivalent and perform comparably to the predicate device that is legally marketed for the same intended use.

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.