Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical and fluid dynamics of an administration set, with no mention of AI or ML components or functionalities.

Therapeutic

No.
This device is an administration set, which is used for delivering fluids, not for treating a disease or condition itself. It facilitates a therapeutic action but is not therapeutic on its own.

Diagnostic

No

The device is an administration set for fluid delivery into a patient's vascular system, not for diagnosing conditions. Its intended use is therapeutic (fluid administration), not diagnostic.

SaMD (Software as a Medical Device)

No

The device description clearly outlines multiple physical components (spike tip protector, tubing, clamps, valves, etc.) and the performance studies focus on the mechanical and functional performance of these hardware elements. There is no mention of software as part of the device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is "For the administration of fluids from a container into the patient's vascular system through a vascular access device." This describes a device used for delivering substances into the body, not for testing samples from the body to diagnose conditions.
Device Description: The description details components of an infusion set (spikes, tubing, clamps, valves, Luer locks), which are used for fluid administration.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any diagnostic purpose.

Therefore, this device is an infusion set, which is a medical device used for therapeutic purposes, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

FPA

Device Description

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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

patient's vascular system

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The following bench tests were conducted to evaluate the functional performance of the Clearlink System Solution Sets:

Male Luer Cap/Spike Tip Protector Removal Force Test
Male Luer Cap/Spike Tip Protector Retention Test
Continuous Bubble Test (Pump Compatibility)
Accumulated Bubble Test (Pump Compatibility)
Administration Set Integrity After Maximum Delivery (Pump Compatibility)
Upstream Occlusion (Pump Compatibility)
Downstream Occlusion (Pump Compatibility)
Flow Rate Accuracy (Pump Compatibility)
Solvent Bond Tensile Strength Test
Solvent Bond Pressure Test
Top End Tubing Assembly Clear Passage
Spike Assembly Visual Inspection
Drop Volume Accuracy, 10 drops/mL
Drop Volume Accuracy, 60 drops/mL
Cannula Pull Out Force
Spike Assembly Insertion Force Test
Spike Assembly Removal Force Test
Slide Clamp Shut Off Test (Fixtured Slide Clamp)
Slide Clamp Shut Off Test - Post 24 hours (Fixtured Slide Clamp)
Slide Clamp 7 Day Subsystem and Tubing Damage Test (Fixtured Slide Clamp)
Slide Clamp Flow Stability Test (Fixtured Slide Clamp)
Slide Clamp Tug Stability Test (Fixtured Slide Clamp)
Slide Clamp Shut Off Test (plastic slide clamp)
Slide Clamp 7 Day Subsystem and Tubing Damage Test (plastic slide clamp)
Roller Clamp Control Range Test
Roller Clamp Force Test
Roller Clamp Shut Off Test -Post 24 hours
Roller Clamp 7 Day Subsystem and Tubing Damage Test
Roller Clamp Flow Stability Test
Roller Clamp Tug Stability Test
Roller Clamp Tubing Leak Test
Roller Clamp Shut-Off Test
Roller Clamp Force Test
Check Valve Back Flow Test
Check Valve High Pressure Test
Clearlink Y-Site Valve Performance Post 100 Actuations
Clearlink Y-Site Valve Performance Post 96 Hour Indwell
Clearlink Y-Site Clear Air Passage
Clearlink Y-Site Back Pressure Leak Test
Clearlink Y-Site Luer Connection Leak Test
Clearlink Y-Site Basic 10-Cycle Actuation Sequence
ISO Luer Tests on Male Luer Connectors
ISO Luer Tests on Clearlink Connectors
(Unscrewing Torque, Separation, Resistance to Overriding and Ease of Assembly Tests)
Non-DEHP Claim Verification

All tests met the acceptance criteria.

Biocompatibility: Assessments were conducted based on ISO-10993-1, ISO-10993-10, ISO-10993-11, ISO-10993-17, ISO-10993-4, and USP . The Clearlink System Solution Sets have been shown to be biocompatible and appropriate for their intended use.

Sterility: The devices are sterilized with radiation, compliant to ANSI/AAMI/ISO 11137-2 and ANSI/AAMI/ISO 11137-1.

Shelf-Life: Aging testing supports a shelf-life claim of 2 years.

Microbial Ingress Testing: Testing was conducted on the Clearlink Luer Activated Device (LAD) and the Spike Area and the Luer Connector Site. All test results met acceptance criteria.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K112893

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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

May 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.

1

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

2

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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3

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 System
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

5

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
Polyethylene	Non-Vented; Linear Low Density
Polyethylene	Spike tip protector and male Luer cap are
removed before set use and are non-fluid
path components. Additional testing has
confirmed the different technological
characteristics of the new device do not
raise different questions of safety and
effectiveness.
Male Luer Cap	Vented; Low Density
Polyethylene, Blue	Non-Vented Filtered; High Density
Polyethylene (housing), Acrylic with
Non-Woven Nylon Substrate (filter
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
Cleared under K112893 | Proposed Devices (2R8519,
2R8537, 2R8546, 2R8401,
2R8875) | Assessment of Differences |
|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For use with a vascular access
device for the administration of
drugs and solutions. The
Clearlink Luer Activated Valve
is an in-line injection site, which
can be connected to the standard
male Luer adapters (e.g.,
syringes or sets) for continuous
or intermittent fluid
administration or the
withdrawal of fluid. | For the administration of fluids
from a container into the
patient's vascular system
through a vascular access
device. | Same
Minor rewording of the Intended Use statement has
been made to better align with 21 CFR 880.5440
and for the purpose of streamlining the information
provided to the user.
The general purpose of the device and its function
remain unchanged.
The minor rewording of the Intended Use statement
does not raise different questions of safety and
effectiveness. |
| Indication for Use | For use with a vascular access
device for the administration of
drugs and solutions. The
Clearlink Luer Activated Valve
is an in-line injection site, which
can be connected to the standard
male Luer adapters (e.g.,
syringes or sets) for continuous
or intermittent fluid
administration or the
withdrawal of fluid. | For the administration of fluids
from a container into the
patient's vascular system
through a vascular access
device. | Same
Minor rewording of the Indications for Use
statement has been made to better align with 21
CFR 880.5440 and for the purpose of streamlining
the information provided to the user.
This minor modification does not alter the disease
or condition the device will diagnose, treat, prevent,
cure/mitigate, or the patient population for which
the device is intended to be used. In addition, the
minor rewording does not reflect a different
anatomical site from which a disease state or
population may be inferred. |
| Features | Predicate Device
Cleared under K112893 | Proposed Devices (2R8519,
2R8537, 2R8546, 2R8401,
2R8875) | Assessment of Differences |
| Sterile | Yes | Same | The minor rewording of the Intended Use statement
does not raise different questions of safety and
effectiveness. |
| Non-Pyrogenic | Yes | Same | N/A |
| Single Use | Yes | Same | N/A |
| Pump Compatibility | Yes, compatible with Flo-Gard
and Colleague | Yes, compatible with Sigma
Spectrum and other Baxter
infusion pumps | Compatible pumps reference has been updated to
align with Baxter's marketed infusion pumps.
Testing has been performed to confirm pump
compatibility with Sigma Spectrum infusion pumps. |
| Components/Materials | | | |
| Non-Vented Spike
(2R8519, 2R8537,
2R8546 and 2R8401) | Acrylonitrile Butadiene Styrene | Same | N/A |
| Non-DEHP Drip
Chamber | Polyvinyl Chloride | Same | N/A |
| Non-DEHP Set Tubing
(2R8537, 2R8546) | Material: Polyvinyl Chloride
Plasticizer:
Tris (2-Ethylhexyl) Trimellitate | Same | N/A |
| Clearlink Luer Activated
Valve | Polycarbonate [Inlet/Outlet
Housing]

Silicone (Gland) | Same | N/A |
| Features | Predicate Device
Cleared under K112893 | Proposed Devices (2R8519,
2R8537, 2R8546, 2R8401,
2R8875) | Assessment of Differences |
| Two-Piece Male Luer
Lock
(2R8519, 2R8537,
2R8546 and 2R8401) | Acrylonitrile Butadiene Styrene
Polycarbonate [Center Post] | Same | N/A |
| Vented Spike
(2R8875) | Acrylonitrile Butadiene Styrene | Same | N/A |
| Capped Vent Filter
(Vented Spike)
(2R8875) | Acrylic copolymer with nylon
substrate (filter material)
High density polyethylene
(housing) | Same
Same | N/A |
| Spike Tip Protector
(2R8519, 2R8537,
2R8546, 2R8401 and
2R8875) | Low Density Polyethylene | Linear Low Density
Polyethylene | The spike tip protector has passed functional testing
for its intended use and is a non-fluid path
component. Additional testing has confirmed
maintenance of the sterile fluid path. The different
technological characteristics of the new device do
not raise different questions of safety and
effectiveness.a |
| Male Luer Cap
(2R8519, 2R8537,
2R8546, 2R8401 and
2R8875) | Low Density Polyethylene | Acrylic with non-woven Nylon
Substrate (Filter material)
High Density Polyethylene
(Luer cap) | The filter and male Luer cap have passed functional
testing for their intended uses and are non-fluid
path. Additional testing has confirmed maintenance
of the sterile fluid path. The different technological
characteristics of the new device do not raise
different questions of safety and effectiveness.a |
| Features | Predicate Device
Cleared under K112893 | Proposed Devices (2R8519,
2R8537, 2R8546, 2R8401,
2R8875) | Assessment of Differences |
| Non-DEHP Pump Tubing
(2R8519, 2R8537,
2R8546, 2R8401 and
2R8875) | Material: Polyvinyl Chloride
Plasticizer:
Tris (2-Ethylhexyl) Trimellitate | Material: Polyvinyl Chloride
Plasticizer:
Di (2-Ethylhexyl) terephthalate | Both the predicate and proposed device contain
PVC tubing. The proposed device's tubing uses a
different plasticizer. Design control activities have
been conducted and have confirmed that the
different technological characteristics of the new
device do not raise different questions of safety and
effectiveness. |
| Non-DEHP Set Tubing
(2R8519, 2R8537,
2R8646, 2R8401) | Material: Polyvinyl Chloride
Plasticizer:
Tris (2-Ethylhexyl) Trimellitate | Material: Polyvinyl Chloride
Plasticizer:
Di (2-Ethylhexyl) terephthalate | Both the predicate and proposed device contain
PVC tubing. The proposed device's tubing uses a
different plasticizer. Design control activities have
been conducted and have confirmed that the
different technological characteristics of the new
device do not raise different questions of safety and
effectiveness. |
| Set Tubing
(2R8875) | Material: Polyvinyl Chloride
Plasticizer:
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 contain
tubing. The proposed device contains tri-layer
tubing. Design control activities have been
conducted and have confirmed that the different
technological characteristics of the new device do
not raise different questions of safety and
effectiveness. |
| Check Valve
(2R8519, 2R8537 and
2R8546) | 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 and
have confirmed that the different technological
characteristics of the new device do not raise
different questions of safety and effectiveness.b |
| Features | Predicate Device
Cleared under K112893 | Proposed Devices (2R8519,
2R8537, 2R8546, 2R8401,
2R8875) | Assessment of Differences |
| Minidrip Adapter
(2R8546) | Not Applicable | Rubber (Synthetic
Polyisoprene) [Blue Plug]
Stainless Steel [Cannula] | The predicate device does not have a minidrip
adapter. Design control activities have been
conducted and have confirmed that the different
technological characteristics of the new device do
not raise different questions of safety and
effectiveness.b |
| Non-DEHP Bushing
Tubing
(2R8875) | Not Applicable | Material: Polyvinyl Chloride
Plasticizer:
Tris (2-Ethylhexyl) Trimellitate | The predicate device does not have Non-DEHP
bushing tubing. Design control activities have been
conducted and have confirmed that the different
technological characteristics of the new device do
not raise different questions of safety and
effectiveness. |
| One-Piece Male Luer
Lock
(2R8875) | Acrylonitrile Butadiene Styrene | Acrylonitrile Butadiene Styrene | Both the predicate and proposed devices contain an
ABS One-Piece male Luer lock. The proposed
device's component has a slightly different design.
Design control activities have been conducted and
have confirmed that the different technological
characteristics of the new device do not raise
different questions of safety and effectiveness. |

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10

Baxter

11

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
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

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
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-
2:1998
ISO Luer Tests on Clearlink Connectors	ISO 594-2:1998
(Unscrewing Torque, Separation, Resistance to Overriding and Ease of
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 (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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Image /page/15/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be sans-serif and slightly italicized. The word is presented against a white background, making the blue text stand out prominently. The overall impression is a clean and professional logo or branding element.

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.