For administering fluids from container to a patient's vascular system through a vascular access device. Used for the removal of particulate matter and elimination of air from infusion fluids while administering. May be used with TPN solutions containing lipid emulsions.

Device Description

The Solution Set with 1.2 Micron Air Eliminating Filter product line consists of single use disposable device for administering fluids from container to a patient's vascular system through a vascular access device. Used for the removal of particulate matter and elimination of air from infusion fluids while administering. The filter consists of a 1.2 micron filter consisting of polysulfone solution membrane and a Teflon air vent media enclosed in an acrylic housing and may be used with TPN solutions containing lipid emulsions. The 1.2 micron filter has a maximum pressure of 45 psi (2241 kPa). The Solution Set with 1.2 Micron Air Eliminating Filter was previously cleared under 510(k) premarket notification K952074 (cleared July 27, 1995).

The basis for this premarket notification is modifications to the Solution Set with 1.2 Micron Air Eliminating Filter product line. The modifications consists of the use of a Non-DEHP PVC tubing material that uses Di (2-Ethylhexyl) terephthalate as a plasticizer to provide an alternate to the current Non-DEHP PVC tubing material, conversion to sterile packaging, addition of an expiration date, and updates to the labeling.

AI/ML Overview

The provided document is a 510(k) premarket notification from Baxter Healthcare Corporation to the FDA for a "Solution Set with 1.2 Micron Air Eliminating Filter." This document is not about an AI/ML medical device. It concerns a physical medical device (an intravenous administration set) and its modifications.

Therefore, many of the requested categories related to AI/ML device studies (such as the number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details) are not applicable to this document. The document describes traditional medical device performance testing and biocompatibility assessments.

However, I can extract the acceptance criteria and performance results for the physical device as described in the document.

Here's an analysis of the provided document focusing on the acceptance criteria and study that proves the device meets them, adapted to the context of a physical medical device.

Device Name: Solution Set with 1.2 Micron Air Eliminating Filter

Purpose of the Submission:
The basis for this premarket notification is modifications to an existing device (previously cleared under K952074). The modifications include:

Use of a Non-DEHP PVC tubing material that uses Di (2-Ethylhexyl) terephthalate as a plasticizer.
Conversion to sterile packaging.
Addition of an expiration date.
Updates to the labeling.

The submission aims to demonstrate that these modifications do not impact the intended use or the fundamental technology of the devices and that the modified devices are substantially equivalent to the predicate device.

1. Table of Acceptance Criteria and the Reported Device Performance:

The document lists performance tests conducted to evaluate the effect of using the proposed Non-DEHP PVC tubing material. The acceptance criterion for all these tests is "Per Baxter Test Method." The document explicitly states the overall performance: "All tests met the acceptance criteria."

Test	Acceptance Criteria	Reported Device Performance
Solvent Bond Tensile Strength Test	Per Baxter Test Method.	Met acceptance criteria.
Solvent Bond Air Pressure Test	Per Baxter Test Method.	Met acceptance criteria.
Continuous Bubble Test (Pump Compatibility Test)	Per Baxter Test Test Method.	Met acceptance criteria.
Accumulated Bubble Test (Pump Compatibility Test)	Per Baxter Test Method.	Met acceptance criteria.
Slide Clamp Shut-Off Test	Per Baxter Test Method.	Met acceptance criteria.
Slide Clamp Shut-Off Test-Post 24 Hour	Per Baxter Test Method.	Met acceptance criteria.
Slide Clamp 7 Day Subsystem and Tubing Damage Test	Per Baxter Test Method.	Met acceptance criteria.
Slide Clamp Flow Stability Test	Per Baxter Test Method.	Met acceptance criteria.
Slide Clamp Tug Stability Test	Per Baxter Test Method.	Met acceptance criteria.
Upstream Occlusion Test (Pump Compatibility Test)	Per Baxter Test Method.	Met acceptance criteria.
Downstream Occlusion Test (Pump Compatibility Test)	Per Baxter Test Method.	Met acceptance criteria.
Roller Clamp Force Test	Per Baxter Test Method.	Met acceptance criteria.
Roller Clamp Shut-Off Test	Per Baxter Test Method.	Met acceptance criteria.
Roller Clamp 7 Day Subsystem and Tubing Damage Test	Per Baxter Test Method.	Met acceptance criteria.
Roller Clamp Flow Stability Test	Per Baxter Test Method.	Met acceptance criteria.
Roller Clamp Tug Stability Test	Per Baxter Test Method.	Met acceptance criteria.
Total Parenteral Nutrition (TPN) Resistance Test	Per Baxter Test Method.	Met acceptance criteria.
Roller Clamp Flow Control Test	Per Baxter Test Method.	Met acceptance criteria.
Administration Set Integrity Test After Maximum Fluid Delivery (Pump Compatibility Test)	Per Baxter Test Method.	Met acceptance criteria.
Flow Rate Accuracy Test (Pump Compatibility Test)	Per Baxter Test Method.	Met acceptance criteria.
ISO Luer Tests on Male Luer Lock Connectors	Per ISO Standard 594	Met acceptance criteria. (Implied, as "All tests met...")

Biocompatibility Tests:

Biocompatibility Test	Applicable Standard	Reported Device Performance
In Vitro Cytotoxicity	ISO10993-5	Biocompatible and appropriate for intended use.
Sensitization	ISO10993-10	Biocompatible and appropriate for intended use.
Intracutaneous (Irritation) Reactivity Assay	ISO10993-10	Biocompatible and appropriate for intended use.
Systemic Injection (Acute Toxicity)	ISO10993-11	Biocompatible and appropriate for intended use.
Sub-Chronic Toxicity (Repeat Dose)	ISO10993-11	Biocompatible and appropriate for intended use.
Material Mediated Pyrogen	ISO10993-11	Biocompatible and appropriate for intended use.
Hemocompatibility (In Vitro Hemolysis)	ISO10993-4	Biocompatible and appropriate for intended use.
USP Physiochemical tests	USP <661>	Biocompatible and appropriate for intended use.

Sterility & Shelf Life:

Sterilization Method: Radiation (Method No. 1 as described in ISO 11137-2).
Sterility Assessment: Minimum Sterilizing Dose (MSD) established and validated to provide a 10⁻⁶ Sterility Assurance Level (SAL).
Package Verification: Visual Inspection, ASTM F88 Seal Strength, and ASTM F2096 Bubble Leak. ("These products are labeled 'Sterile, Nonpyrogenic.'")
Shelf Life: Twenty-four (24) months, supported by aging testing.

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

Sample Size for performance tests: Not explicitly stated in terms of a numerical count for each test. The document states, "All evaluations were performed on the product code set configuration (Code: 2R8486) that is using the proposed Non-DEHP PVC tubing material." This implies that samples of this specific configuration were used for all listed tests.
Data Provenance: The studies were conducted by Baxter Healthcare Corporation. No specific country of origin for the data is mentioned, but the company is based in the US (Deerfield, Illinois). The studies are "bench tests" and "design verification tests," which implies a prospective testing approach conducted in a laboratory setting rather than retrospective analysis of clinical data.

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 physical medical device. Ground truth, in the context of AI/ML, refers to clinically relevant labels from human annotators for image or signal data. For this device, "ground truth" is typically defined by engineering specifications, industrial standards (e.g., ISO, ASTM, USP), and established test methods, verified by objective measurements. These are not established by "experts" in the clinical sense (e.g., radiologists) for performance testing.

4. Adjudication Method for the Test Set:

Not Applicable. As this is a physical medical device undergoing bench and biocompatibility testing, there is no need for human expert adjudication of results in the way it's done for AI/ML diagnostic tools. The results are quantitative measurements against predefined criteria/standards.

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 is a physical medical device, not an AI-assisted diagnostic tool or an AI/ML algorithm.

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

Not Applicable. This is a physical medical device, not an AI or algorithm. The performance tests ("bench tests") can be considered analogous to "standalone" performance for a physical device, as they assess the device's function directly without human intervention in its operation (beyond setting up the test).

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

For Performance Data: The "ground truth" is based on the device meeting the "Per Baxter Test Method" criteria and "ISO Standard 594." These are engineering and performance specifications.
For Biocompatibility Data: The "ground truth" is based on meeting the requirements of various ISO 10993 standards (e.g., ISO10993-4, ISO10993-5, ISO10993-10, ISO10993-11) and USP <661>. These are international and national standards for biological evaluation of medical devices.
For Sterility: The "ground truth" is based on meeting ISO 11137-2 for achieving a 10⁻⁶ Sterility Assurance Level (SAL).

8. The Sample Size for the Training Set:

Not Applicable. This is not an AI/ML device; therefore, there is no "training set."

9. How the Ground Truth for the Training Set was Established:

Not Applicable. This is not an AI/ML device; therefore, there is no "training set" or ground truth establishment relevant to AI/ML.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The logo is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in all caps.

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

June 21, 2017

Baxter Healthcare Corporation Mr. John Lamela Regulatory Affairs Specialist 32650 North Wilson Road Round Lake, Illinois 60073

Re: K161808

Trade/Device Name: Solution Set with 1.2 Micron Air Eliminating Filter Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: May 19, 2017 Received: May 22, 2017

Dear Mr. Lamela:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices. good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Lori A. Wiggins -S6

Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K161808

Device Name

Solution Set with 1.2 Micron Air Eliminating Filter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary - K161808

June 19, 2017

OWNER:

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

CONTACT PERSON:

John Lamela Regulatory Specialist, Regulatory Affairs 32650 N. Wilson Road Round Lake, IL 60073 Telephone: (224) 270-2850 Fax: (224) 270-4119

IDENTIFICATION OF THE DEVICE:

Common Name: Intravascular Administration Set Trade Name: Solution Set with 1.2 Micron Air Eliminating Filter Classification Panel: 80 General Hospital Regulation Number: 21 CFR 880.5440 Regulation Name: Set, Administration, Intravascular Regulatory Class: Class II Product Code: FPA

Table 1. Product Codes for Solution Sets with 1.2 Micron Air Eliminating Filter

Code Number	Name
2C1103	INTERLINK System Non-DEHP Extension Set with 1.2 Micron DownstreamFilter
2H8603	CLEARLINK System Non-DEHP Extension Set
2H8486	CLEARLINK System Non-DEHP Solution Set
2R8486	CLEARLINK System Non-DEHP Solution Set

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PREDICATE DEVICE:

Device	Company	Predicate 510(k)	Clearance Date
Solution Set with 1.2 MicronAir Eliminating Filter	Baxter HealthcareCorporation	K952074	July 27, 1995

Table 2. Predicate Device(s)

DESCRIPTION OF THE DEVICE:

Code and Description	Change Summary
2C1103 – INTERLINK System Non-DEHP Extension Setwith 1.2 Micron Downstream Filter	1. Label Changes2. Packaging Change3. Addition of Exp. Date
2H8603 - CLEARLINK System Non-DEHP Extension Set	1. Label Changes2. Packaging Change3. Addition of Exp. Date
2H8486 - CLEARLINK System Non-DEHP Solution Set	1. Label Changes2. Packaging Change3. Addition of Exp. Date
2R8486 - CLEARLINK System Non-DEHP Solution Set	1. Label Changes2. Packaging Change3. Addition of Exp. Date

Table 3. Summary of Proposed Changes per Product Code

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Code and Description	Change Summary
	4. Use of Non-DEHP PVC Tubing Materialthat uses Di (2-Ethylhexyl) terephthalate as aplasticizer

Table 3. Summary of Proposed Changes per Product Code

These modifications do not impact the intended use or the fundamental technology of the devices. The product labels are being updated to revise statements regarding latex and pump device references, add the indications for use statement that was previously cleared for this device (K952074 - cleared July 27, 1995), include expiration dating, change from "fluid path is sterile" to "sterile" (sterile packaging), and implement other modifications to comply with Baxter's labeling standards. Note: The indications for use statement from the previously cleared 510(k) was modified, per the FDAs recommendation, to include the description in 21 CFR 880.5440.

Table 4. Set Configuration Using Proposed Non-DEHP PVC Tubing Material

Device Description	Code Number
CLEARLINK System Non-DEHP Solution SetImage: CLEARLINK System Non-DEHP Solution Set	2R8486

Table 5. Set Configuration of Current Codes

Device Description	Code Number
INTERLINK System Non-DEHP Extension Set with 1.2 Micron Downstream Filter	2C1103
CLEARLINK System Non-DEHP Extension Set	2H8603

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Image /page/6/Figure/1 description: This image shows a table with two columns, "Device Description" and "Code Number". The device description is "CLEARLINK System Non-DEHP Solution Set", and there is a diagram of the device below the text. The code number for this device is "2H8486".

Table 5. Set Configuration of Current Codes

INDICATIONS FOR USE:

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:

The proposed devices have equivalent technological characteristics as Baxter's current legally marketed device cleared under 510(k) premarket notification K952074 (cleared July 27, 1995).

DEVICE COMPARISON TABLE:

The comparison table below identifies similarities and differences of the proposed devices to the current legally marketed devices to which substantial equivalency is claimed.

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	Features	Predicate Device(K952074)	Proposed Devices	Assessment ofDifferences
	Indications for use	The Baxter solutionadministration sets with1.2 micron Supor IV-3filter will be used for theremoval of particulatematter and elimination ofair from infusion fluids.The 1.2 micron filter setsmay be used with TPNsolutions containing lipidemulsions.	For administering fluidsfrom a container to apatient's vascular systemthrough a vascular accessdevice. Used for theremoval of particulatematter and elimination ofair from infusion fluidswhile administering. Maybe used with TPNsolutions containing lipidemulsions.	Alignment of languageprovided in 21 CFR880.5440.In addition, reference totrade name (Supor IV-3)filter was removed sincethis name is no longerused (filter remains thesame).These administrativechanges have no impactto safety or effectivenessof the device.
	Sterile	Yes	Same	No difference
	Non-Pyrogenic	Yes	Same	No difference
	Single Use	Yes	Same	No difference
	Materials
	SolutionMembrane	Polysulfone	Same	No difference
1.2MicronFilter	Air VentMembrane	Teflon	Same	No difference
	Housing	Acrylic(PolymethylMethacrylate)	Same	No difference
	Spike		Acrylonitrile ButadieneStyrene	Same
	Non-DEHP DripChamber	Polyvinyl Chloride	Same	No difference
Features	Predicate Device(K952074)	Proposed Devices	Assessment ofDifferences
Female Luer LockConnector	N/A	Blend of Copolyester andHytrel	The predicate device doesnot have a female luerlock connector. Designcontrol activitiesconfirmed there was noimpact to the safety oreffectiveness of thedevice due to this change.
Non-DEHP Tubing1(used on codes2H8486, 2C1103,and 2H8603)	Material: PolyvinylChloridePlasticizer: Tris (2-Ethylhexyl) Trimellitate	Same	No difference
Non-DEHP Tubing2(used on code2R8486)	N/A	Material: PolyvinylChloridePlasticizer: Di (2-Ethylhexyl) terephthalate	This is the basis of thissubmission: modificationconsisting of the use of aNon-DEHP PVC tubingmaterial that uses Di (2-Ethylhexyl) terephthalateas a plasticizer.Design control activitieshave confirmed there isno impact to the safety oreffectiveness for the newmaterial.
Interlink Y-Site	N/A	Copolyester (Housing)Synthetic polyisoprene(Septum)	The predicate device doesnot have an Interlink Y-Site. Design controlactivities confirmed therewas no impact to thesafety or effectiveness ofthe device due to thischange.
Clearlink Y-Site	N/A	Silicone Rubber (Gland)Polycarbonate (Housing,Housing Inlet, and CenterPost)	The predicate device doesnot have a Clearlink Y-Site. Design controlactivities confirmed therewas no impact to thesafety or effectiveness ofthe device due to thischange.
Features	Predicate Device(K952074)	Proposed Devices	Assessment ofDifferences
Two-Piece MaleLuer LockConnector	N/A	Acrylonitrile ButadieneStyrene	The predicate device doesnot have a Two-PieceMale Luer LockConnector. Design controlactivities confirm thedevice meets thefunctional testrequirements when usedin accordance with theinstructions for use.
One-Piece MaleLuer LockConnector	Acrylonitrile ButadieneStyrene	Same	No difference

Table 6. Device Comparison

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Table 6. Device Comparison

1 Non-DEHP tubing material for current codes (2H8486, 2C1103, and 2H8603).

2 Non-DEHP tubing material for proposed code (2R8486).

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Table 6. Device Comparison

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 7) were conducted to evaluate the effect of using a proposed Non-DEHP PVC tubing material that uses Di (2-Ethylhexyl) terephthalate as a plasticizer. All evaluations were performed on the product code set configuration (Code: 2R8486) that is using the proposed Non-DEHP PVC tubing material.

Test	Acceptance Criteria
Solvent Bond Tensile Strength Test	Per Baxter Test Method.
Solvent Bond Air Pressure Test	Per Baxter Test Method.
Continuous Bubble Test (Pump Compatibility Test)	Per Baxter Test Method.
Accumulated Bubble Test (Pump Compatibility Test)	Per Baxter Test Method.
Slide Clamp Shut-Off Test	Per Baxter Test Method.
Slide Clamp Shut-Off Test-Post 24 Hour	Per Baxter Test Method.
Slide Clamp 7 Day Subsystem and Tubing Damage Test	Per Baxter Test Method.
Slide Clamp Flow Stability Test	Per Baxter Test Method.
Slide Clamp Tug Stability Test	Per Baxter Test Method.

Table 7. Performance Testing Summary

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Test	Acceptance Criteria
Upstream Occlusion Test (Pump Compatibility Test)	Per Baxter Test Method.
Downstream Occlusion Test (Pump Compatibility Test)	Per Baxter Test Method.
Roller Clamp Force Test	Per Baxter Test Method.
Roller Clamp Shut-Off Test	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.
Total Parenteral Nutrition (TPN) Resistance Test	Per Baxter Test Method.
Roller Clamp Flow Control Test	Per Baxter Test Method.
Administration Set Integrity Test After Maximum Fluid Delivery(Pump Compatibility Test)	Per Baxter Test Method.
Flow Rate Accuracy Test (Pump Compatibility Test)	Per Baxter Test Method.
ISO Luer Tests on Male Luer Lock Connectors	Per ISO Standard 594

Table 7. Performance Testing Summary

Note: All pump testing performed with the Sigma Spectrum Pump.

All tests met the acceptance criteria.

Biocompatibility:

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, "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)]". The Biocompatibility Tests and the applicable standards are listed in Table 8.

Table 8. Biocompatibility Tests and Applicable Standards

Biocompatibility Test	Applicable Standard
In Vitro Cytotoxicity	ISO10993-5
Sensitization	ISO10993-10
Intracutaneous (Irritation) Reactivity Assay	ISO10993-10
Systemic Injection (AcuteToxicity)	ISO10993-11
Sub-Chronic Toxicity (Repeat Dose)	ISO10993-11

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Biocompatibility Test	Applicable Standard
Material Mediated Pyrogen	ISO10993-11
Hemocompatibility (In Vitro Hemolysis)	ISO10993-4
USP Physiochemical tests	USP <661>

Table 8. Biocompatibility Tests and Applicable Standards

Based upon the results of this prolonged duration, external communicating, indirect blood path testing, the Solution Sets with 1.2 Micron Air Eliminating Filter have been shown to be biocompatible and appropriate for their intended use.

Sterilitv

The Solution Set with 1.2 Micron Air Eliminating Filter product line is sterilized with radiation. The Minimum Sterilizing Dose (MSD) required to provide a 10 ° Sterility Assurance Level (SAL) for this (sub) category was established and validated at the manufacturing facility using Method No. 1 as described in ISO 11137-2, "Sterilization of health care products- Radiation-Part 2: Establishing the Sterilization Dose."

These products are labeled "Sterile, Nonpyrogenic." Package Verification testing is based on Visual Inspection, ASTM F88 Seal Strength, and ASTM F2096 Bubble Leak.

Shelf Life

Baxter has provided aging testing to support a shelf-life claim of twenty-four (24) months.

CONCLUSION:

The non-clinical data demonstrate that the subject device is substantially equivalent and performs comparably to the predicate devices that are currently marketed.

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.