Solution Set with 1.2 Micron Air Eliminating Filter

K161808 · Baxter Healthcare Corporation · FPA · Jun 21, 2017 · General Hospital

Device Facts

• Record ID: K161808
• Device Name: Solution Set with 1.2 Micron Air Eliminating Filter
• Applicant: Baxter Healthcare Corporation
• Product Code: FPA · General Hospital
• Decision Date: Jun 21, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Single-use disposable intravascular administration set; removes particulate matter and eliminates air from infusion fluids. Components include 1.2-micron polysulfone membrane filter, Teflon air vent, acrylic housing, and PVC tubing. Used in clinical settings for fluid delivery; operated by healthcare professionals. Connects fluid container to patient vascular access device. Output is filtered infusion fluid. Benefits include reduced risk of air embolism and particulate infusion. Modifications include alternative non-DEHP PVC tubing (using Di (2-Ethylhexyl) terephthalate plasticizer), sterile packaging, and updated labeling.

Clinical Evidence

Bench testing only. No clinical data. Performance testing included solvent bond strength, bubble tests, clamp shut-off/stability, occlusion tests, flow rate accuracy, and TPN resistance. Biocompatibility testing performed per ISO 10993-1, including cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, and hemocompatibility. Sterilization validated per ISO 11137-2.

Technological Characteristics

Materials: Polysulfone membrane, Teflon air vent, acrylic housing, ABS spike, PVC tubing (non-DEHP). Dimensions: 1.2-micron filter rating, 45 psi max pressure. Connectivity: Luer lock connectors. Sterilization: Radiation (SAL 10^-6). Standards: ISO 594 (Luer), ISO 10993 (Biocompatibility), ISO 11137-2 (Sterilization), USP <661> (Physiochemical).

Indications for Use

Indicated for patients requiring fluid administration from a container to the vascular system via a vascular access device, including TPN solutions with lipid emulsions. No specific age or gender contraindications stated.

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

• Solution Set with 1.2 Micron Air Eliminating Filter (K952074)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|
| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
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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: [phone] Fax: [phone]

# 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 Downstream<br>Filter |
| 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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Image /page/4/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be italicized, with the letters slanting slightly to the right. The word is the logo for the healthcare company Baxter International.

# PREDICATE DEVICE:

| Device | Company | Predicate 510(k) | Clearance Date |
|--------------------------------------------------------|----------------------------------|------------------|----------------|
| Solution Set with 1.2 Micron<br>Air Eliminating Filter | Baxter Healthcare<br>Corporation | K952074 | July 27, 1995 |

Table 2. Predicate Device(s)

## DESCRIPTION OF THE DEVICE:

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.

| Code and Description | Change Summary |
|---------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| 2C1103 – INTERLINK System Non-DEHP Extension Set<br>with 1.2 Micron Downstream Filter | 1. Label Changes<br>2. Packaging Change<br>3. Addition of Exp. Date |
| 2H8603 - CLEARLINK System Non-DEHP Extension Set | 1. Label Changes<br>2. Packaging Change<br>3. Addition of Exp. Date |
| 2H8486 - CLEARLINK System Non-DEHP Solution Set | 1. Label Changes<br>2. Packaging Change<br>3. Addition of Exp. Date |
| 2R8486 - CLEARLINK System Non-DEHP Solution Set | 1. Label Changes<br>2. Packaging Change<br>3. 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 Material<br>that uses Di (2-Ethylhexyl) terephthalate as a<br>plasticizer |

#### 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 Set<br>Image: 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/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be sans-serif. The word is slightly blurred, giving it a sense of depth. The background is white.

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:

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.

# 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<br>(K952074) | Proposed Devices | Assessment of<br>Differences |
|----------------------------------------------------------------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Indications for use | The Baxter solution<br>administration sets with<br>1.2 micron Supor IV-3<br>filter will be used for the<br>removal of particulate<br>matter and elimination of<br>air from infusion fluids.<br>The 1.2 micron filter sets<br>may be used with TPN<br>solutions containing lipid<br>emulsions. | For administering fluids<br>from a container to a<br>patient's vascular system<br>through a vascular access<br>device. Used for the<br>removal of particulate<br>matter and elimination of<br>air from infusion fluids<br>while administering. May<br>be used with TPN<br>solutions containing lipid<br>emulsions. | Alignment of language<br>provided in 21 CFR<br>880.5440.<br>In addition, reference to<br>trade name (Supor IV-3)<br>filter was removed since<br>this name is no longer<br>used (filter remains the<br>same).<br>These administrative<br>changes have no impact<br>to safety or effectiveness<br>of the device. |
| | Sterile | Yes | Same | No difference |
| | Non-Pyrogenic | Yes | Same | No difference |
| | Single Use | Yes | Same | No difference |
| | Materials | | | |
| | Solution<br>Membrane | Polysulfone | Same | No difference |
| 1.2<br>Micron<br>Filter | Air Vent<br>Membrane | Teflon | Same | No difference |
| | Housing | Acrylic<br>(Polymethyl<br>Methacrylate) | Same | No difference |
| | Spike | | Acrylonitrile Butadiene<br>Styrene | Same |
| | Non-DEHP Drip<br>Chamber | Polyvinyl Chloride | Same | No difference |
| Features | Predicate Device<br>(K952074) | Proposed Devices | Assessment of<br>Differences | |
| Female Luer Lock<br>Connector | N/A | Blend of Copolyester and<br>Hytrel | The predicate device does<br>not have a female luer<br>lock connector. Design<br>control activities<br>confirmed there was no<br>impact to the safety or<br>effectiveness of the<br>device due to this change. | |
| Non-DEHP Tubing1<br>(used on codes<br>2H8486, 2C1103,<br>and 2H8603) | Material: Polyvinyl<br>Chloride<br>Plasticizer: Tris (2-<br>Ethylhexyl) Trimellitate | Same | No difference | |
| Non-DEHP Tubing2<br>(used on code<br>2R8486) | N/A | Material: Polyvinyl<br>Chloride<br>Plasticizer: Di (2-<br>Ethylhexyl) terephthalate | This is the basis of this<br>submission: modification<br>consisting of the use of a<br>Non-DEHP PVC tubing<br>material that uses Di (2-<br>Ethylhexyl) terephthalate<br>as a plasticizer.<br>Design control activities<br>have confirmed there is<br>no impact to the safety or<br>effectiveness for the new<br>material. | |
| Interlink Y-Site | N/A | Copolyester (Housing)<br>Synthetic polyisoprene<br>(Septum) | The predicate device does<br>not have an Interlink Y-<br>Site. Design control<br>activities confirmed there<br>was no impact to the<br>safety or effectiveness of<br>the device due to this<br>change. | |
| Clearlink Y-Site | N/A | Silicone Rubber (Gland)<br>Polycarbonate (Housing,<br>Housing Inlet, and Center<br>Post) | The predicate device does<br>not have a Clearlink Y-<br>Site. Design control<br>activities confirmed there<br>was no impact to the<br>safety or effectiveness of<br>the device due to this<br>change. | |
| Features | Predicate Device<br>(K952074) | Proposed Devices | Assessment of<br>Differences | |
| Two-Piece Male<br>Luer Lock<br>Connector | N/A | Acrylonitrile Butadiene<br>Styrene | The predicate device does<br>not have a Two-Piece<br>Male Luer Lock<br>Connector. Design control<br>activities confirm the<br>device meets the<br>functional test<br>requirements when used<br>in accordance with the<br>instructions for use. | |
| One-Piece Male<br>Luer Lock<br>Connector | Acrylonitrile Butadiene<br>Styrene | 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<br>(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.