Clearlink System Solution Set

K180739 · Baxter Healthcare Corporation · FPA · May 28, 2019 · General Hospital

Device Facts

• Record ID: K180739
• Device Name: Clearlink System Solution Set
• Applicant: Baxter Healthcare Corporation
• Product Code: FPA · General Hospital
• Decision Date: May 28, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Indications for Use

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

Device Story

Clearlink System Solution Sets are intravascular administration sets used to deliver fluids from a container to a patient's vascular system. The sets include components such as a spike (vented or non-vented), drip chamber, tubing (non-DEHP), clamps (slide/roller), and a Clearlink Luer activated valve (LAV). The device is used in clinical settings by healthcare providers to facilitate continuous or intermittent fluid administration. The system is compatible with infusion pumps, including the Sigma Spectrum. The device maintains a sterile fluid path, with some configurations including check valves or minidrip adapters. The healthcare provider connects the set to a fluid container and the patient's vascular access device; the flow is regulated via clamps or an infusion pump. The device benefits patients by providing a reliable, sterile, and biocompatible pathway for intravenous therapy.

Clinical Evidence

No clinical data. Substantial equivalence is supported by extensive bench testing, including functional performance (flow rate, occlusion, bubble tests), biocompatibility (ISO 10993-1, -4, -5, -10, -11, -17), sterility validation (ANSI/AAMI/ISO 11137), and microbial ingress testing.

Technological Characteristics

Materials include PVC (non-DEHP), ABS, polycarbonate, silicone, and polyethylene. Components include non-vented/vented spikes, drip chambers, and Luer activated valves. Connectivity is via standard Luer locks. Sterilization is via radiation (ANSI/AAMI/ISO 11137). Complies with ISO 594-1:1986 and 594-2:1998 for Luer connectors. Non-fluid path components include LLDPE/HDPE spike protectors and Luer caps.

Indications for Use

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

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Clearlink Luer Activated Valve, Clearlink System Non-DEHP Catheter Extension Sets (K112893)

Reference Devices

• K961225

Submission Summary (Full Text)

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

## 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 System<br>Non-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:

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).

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| Component | Current Design; Material | Proposed Design; Material | Assessment of Differences |
|---------------------|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Spike Tip Protector | Vented; Low Density<br>Polyethylene | Non-Vented; Linear Low Density<br>Polyethylene | Spike tip protector and male Luer cap are<br>removed before set use and are non-fluid<br>path components. Additional testing has<br>confirmed the different technological<br>characteristics of the new device do not<br>raise different questions of safety and<br>effectiveness. |
| Male Luer Cap | Vented; Low Density<br>Polyethylene, Blue | Non-Vented Filtered; High Density<br>Polyethylene (housing), Acrylic with<br>Non-Woven Nylon Substrate (filter<br>material) | |

## 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 Device<br>Cleared under K112893 | Proposed Devices (2R8519,<br>2R8537, 2R8546, 2R8401,<br>2R8875) | Assessment of Differences |
|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For use with a vascular access<br>device for the administration of<br>drugs and solutions. The<br>Clearlink Luer Activated Valve<br>is an in-line injection site, which<br>can be connected to the standard<br>male Luer adapters (e.g.,<br>syringes or sets) for continuous<br>or intermittent fluid<br>administration or the<br>withdrawal of fluid. | For the administration of fluids<br>from a container into the<br>patient's vascular system<br>through a vascular access<br>device. | Same<br>Minor rewording of the Intended Use statement has<br>been made to better align with 21 CFR 880.5440<br>and for the purpose of streamlining the information<br>provided to the user.<br>The general purpose of the device and its function<br>remain unchanged.<br>The minor rewording of the Intended Use statement<br>does not raise different questions of safety and<br>effectiveness. |
| Indication for Use | For use with a vascular access<br>device for the administration of<br>drugs and solutions. The<br>Clearlink Luer Activated Valve<br>is an in-line injection site, which<br>can be connected to the standard<br>male Luer adapters (e.g.,<br>syringes or sets) for continuous<br>or intermittent fluid<br>administration or the<br>withdrawal of fluid. | For the administration of fluids<br>from a container into the<br>patient's vascular system<br>through a vascular access<br>device. | Same<br>Minor rewording of the Indications for Use<br>statement has been made to better align with 21<br>CFR 880.5440 and for the purpose of streamlining<br>the information provided to the user.<br>This minor modification does not alter the disease<br>or condition the device will diagnose, treat, prevent,<br>cure/mitigate, or the patient population for which<br>the device is intended to be used. In addition, the<br>minor rewording does not reflect a different<br>anatomical site from which a disease state or<br>population may be inferred. |
| Features | Predicate Device<br>Cleared under K112893 | Proposed Devices (2R8519,<br>2R8537, 2R8546, 2R8401,<br>2R8875) | Assessment of Differences |
| Sterile | Yes | Same | The minor rewording of the Intended Use statement<br>does not raise different questions of safety and<br>effectiveness. |
| Non-Pyrogenic | Yes | Same | N/A |
| Single Use | Yes | Same | N/A |
| Pump Compatibility | Yes, compatible with Flo-Gard<br>and Colleague | Yes, compatible with Sigma<br>Spectrum and other Baxter<br>infusion pumps | Compatible pumps reference has been updated to<br>align with Baxter's marketed infusion pumps.<br>Testing has been performed to confirm pump<br>compatibility with Sigma Spectrum infusion pumps. |
| Components/Materials | | | |
| Non-Vented Spike<br>(2R8519, 2R8537,<br>2R8546 and 2R8401) | Acrylonitrile Butadiene Styrene | Same | N/A |
| Non-DEHP Drip<br>Chamber | Polyvinyl Chloride | Same | N/A |
| Non-DEHP Set Tubing<br>(2R8537, 2R8546) | Material: Polyvinyl Chloride<br>Plasticizer:<br>Tris (2-Ethylhexyl) Trimellitate | Same | N/A |
| Clearlink Luer Activated<br>Valve | Polycarbonate [Inlet/Outlet<br>Housing]<br><br>Silicone (Gland) | Same | N/A |
| Features | Predicate Device<br>Cleared under K112893 | Proposed Devices (2R8519,<br>2R8537, 2R8546, 2R8401,<br>2R8875) | Assessment of Differences |
| Two-Piece Male Luer<br>Lock<br>(2R8519, 2R8537,<br>2R8546 and 2R8401) | Acrylonitrile Butadiene Styrene<br>Polycarbonate [Center Post] | Same | N/A |
| Vented Spike<br>(2R8875) | Acrylonitrile Butadiene Styrene | Same | N/A |
| Capped Vent Filter<br>(Vented Spike)<br>(2R8875) | Acrylic copolymer with nylon<br>substrate (filter material)<br>High density polyethylene<br>(housing) | Same<br>Same | N/A |
| Spike Tip Protector<br>(2R8519, 2R8537,<br>2R8546, 2R8401 and<br>2R8875) | Low Density Polyethylene | Linear Low Density<br>Polyethylene | The spike tip protector has passed functional testing<br>for its intended use and is a non-fluid path<br>component. Additional testing has confirmed<br>maintenance of the sterile fluid path. The different<br>technological characteristics of the new device do<br>not raise different questions of safety and<br>effectiveness.a |
| Male Luer Cap<br>(2R8519, 2R8537,<br>2R8546, 2R8401 and<br>2R8875) | Low Density Polyethylene | Acrylic with non-woven Nylon<br>Substrate (Filter material)<br>High Density Polyethylene<br>(Luer cap) | The filter and male Luer cap have passed functional<br>testing for their intended uses and are non-fluid<br>path. Additional testing has confirmed maintenance<br>of the sterile fluid path. The different technological<br>characteristics of the new device do not raise<br>different questions of safety and effectiveness.a |
| Features | Predicate Device<br>Cleared under K112893 | Proposed Devices (2R8519,<br>2R8537, 2R8546, 2R8401,<br>2R8875) | Assessment of Differences |
| Non-DEHP Pump Tubing<br>(2R8519, 2R8537,<br>2R8546, 2R8401 and<br>2R8875) | Material: Polyvinyl Chloride<br>Plasticizer:<br>Tris (2-Ethylhexyl) Trimellitate | Material: Polyvinyl Chloride<br>Plasticizer:<br>Di (2-Ethylhexyl) terephthalate | Both the predicate and proposed device contain<br>PVC tubing. The proposed device's tubing uses a<br>different plasticizer. Design control activities have<br>been conducted and have confirmed that the<br>different technological characteristics of the new<br>device do not raise different questions of safety and<br>effectiveness. |
| Non-DEHP Set Tubing<br>(2R8519, 2R8537,<br>2R8646, 2R8401) | Material: Polyvinyl Chloride<br>Plasticizer:<br>Tris (2-Ethylhexyl) Trimellitate | Material: Polyvinyl Chloride<br>Plasticizer:<br>Di (2-Ethylhexyl) terephthalate | Both the predicate and proposed device contain<br>PVC tubing. The proposed device's tubing uses a<br>different plasticizer. Design control activities have<br>been conducted and have confirmed that the<br>different technological characteristics of the new<br>device do not raise different questions of safety and<br>effectiveness. |
| Set Tubing<br>(2R8875) | Material: Polyvinyl Chloride<br>Plasticizer:<br>Tris (2-Ethylhexyl) Trimellitate | Tri-Layer:<br>Linear low density polyethylene<br>(inner layer)<br>Polyolefin (middle layer)<br>Polyvinyl Chloride (outer layer) | Both the predicate and proposed device contain<br>tubing. The proposed device contains tri-layer<br>tubing. Design control activities have been<br>conducted and have confirmed that the different<br>technological characteristics of the new device do<br>not raise different questions of safety and<br>effectiveness. |
| Check Valve<br>(2R8519, 2R8537 and<br>2R8546) | Not Applicable | Polymethyl methacrylate<br>(Acrylic) [Inlet and Outlet]<br>Silicone Rubber [Disk] | The predicate device does not have a check valve.<br>Design control activities have been conducted and<br>have confirmed that the different technological<br>characteristics of the new device do not raise<br>different questions of safety and effectiveness.b |
| Features | Predicate Device<br>Cleared under K112893 | Proposed Devices (2R8519,<br>2R8537, 2R8546, 2R8401,<br>2R8875) | Assessment of Differences |
| Minidrip Adapter<br>(2R8546) | Not Applicable | Rubber (Synthetic<br>Polyisoprene) [Blue Plug]<br>Stainless Steel [Cannula] | The predicate device does not have a minidrip<br>adapter. Design control activities have been<br>conducted and have confirmed that the different<br>technological characteristics of the new device do<br>not raise different questions of safety and<br>effectiveness.b |
| Non-DEHP Bushing<br>Tubing<br>(2R8875) | Not Applicable | Material: Polyvinyl Chloride<br>Plasticizer:<br>Tris (2-Ethylhexyl) Trimellitate | The predicate device does not have Non-DEHP<br>bushing tubing. Design control activities have been<br>conducted and have confirmed that the different<br>technological characteristics of the new device do<br>not raise different questions of safety and<br>effectiveness. |
| One-Piece Male Luer<br>Lock<br>(2R8875) | Acrylonitrile Butadiene Styrene | Acrylonitrile Butadiene Styrene | Both the predicate and proposed devices contain an<br>ABS One-Piece male Luer lock. The proposed<br>device's component has a slightly different design.<br>Design control activities have been conducted and<br>have confirmed that the different technological<br>characteristics of the new device do not raise<br>different 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 (Pump<br>Compatibility) 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 Slide<br>Clamp) | 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 slide<br>clamp) | 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-<br>2:1998 |
| ISO Luer Tests on Clearlink Connectors | ISO 594-2:1998 |
| (Unscrewing Torque, Separation, Resistance to Overriding and Ease of<br>Assembly 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.