Solution Administration Sets with 0.2 Micron Filter

K153158 · Baxter Healthcare Corporation · FPA · Dec 28, 2015 · General Hospital

Device Facts

• Record ID: K153158
• Device Name: Solution Administration Sets with 0.2 Micron Filter
• Applicant: Baxter Healthcare Corporation
• Product Code: FPA · General Hospital
• Decision Date: Dec 28, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

For the retention of microorganisms and removal of air and particulate matter from infusion fluids.

Device Story

Solution Administration Sets are sterile, single-use disposable devices used to deliver fluids from a container to a patient's vascular system via a needle or catheter. The device incorporates a 0.2 micron polyethersulfone (PES) solution membrane and a 0.1 micron polyvinylidene fluoride (PVDF) air vent membrane within a copolyester housing. These filters function to retain microorganisms and remove air and particulate matter from infusion fluids. The device is used in clinical settings by healthcare professionals. The modification involves replacing the existing hydrophilic PES membrane with an equivalent hydrophilic PES material. The device output is the filtered infusion fluid delivered to the patient, which benefits the patient by reducing the risk of infection and air embolism during intravenous therapy.

Clinical Evidence

Bench testing only. Performance data included air diffusion, bubble point, gravity flow rate, flow rate post-sterile water conditioning, flow rate post-parenteral nutrition conditioning, and bacterial retention tests. All tests met acceptance criteria. Biocompatibility testing was conducted per ISO-10993 and FDA Blue Book Memorandum #G95-1, including cytotoxicity, systemic toxicity, intracutaneous, hemolysis, pyrogen, sensitization, and USP physicochemical tests.

Technological Characteristics

Materials: Copolyester housing, PES solution membrane, PVDF air vent membrane, PVC tubing, stainless steel cannula, ABS spike, synthetic polyisoprene plug. Energy source: None (gravity/pump-driven). Connectivity: None. Sterilization: Sterile. Software: None.

Indications for Use

Indicated for the retention of microorganisms and removal of air and particulate matter from infusion fluids in patients requiring intravenous fluid administration.

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 Administration Sets with 0.22 Micron Filter (K964850)

Reference Devices

• K123868
• K150860

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

December 28, 2015

Baxter Healthcare Corporation Mr. Gary Chumbimune Manager, Regulatory Affairs 32650 N Wilson Road Round Lake. Illinois 60073

Re: K153158

Trade/Device Name: Solution Administration Sets with 0.2 Micron Filter Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: December 2, 2015 Received: December 3, 2015

Dear Mr. Chumbimune:

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.

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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 (reporting of medical device-related 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.

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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 vours.

Tina
Kiang -S

for Erin I. Keith, M.S. 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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# Indications for Use

510(k) Number (if known)

K153158

#### Device Name

Solution Administration Sets with 0.2 Micron Filter

Indications for Use (Describe)

For the retention of microorganisms and removal of air and particulate matter from infusion fluids.

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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# Section 5. 510(k) Summary K153158

October 30, 2015

#### OWNER:

Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015

### CONTACT PERSON:

Gary Chumbimune Manager, 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 or Proprietary Name: Solution Administration Sets with 0.2 Micron Filter Classification Panel: 80 General Hospital Classification: Set, Administration, Intravascular (21 CFR 880.5440) Class: Class II

Product Code: FPA

#### Table 1. Product Codes for Solution Administration Sets with 0.2 Micron Filter

| Code Number | Name |
|-------------|------------------------------------------------------------|
| 2C6572 | INTERLINK System CONTINU-FLO Solution Set |
| 2H6480 | INTERLINK System Non-DEHP Solution Set with DUO-VENT Spike |
| 2H8671 | CLEARLINK System Non-DEHP Extension Set |
| 1C8363 | Extension Set |

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### PREDICATE DEVICE:

| Device | Company | Predicate 510(k) | Clearance Date |
|---------------------------------------------------------|----------------------------------|------------------|----------------------|
| Solution Administration Sets with 0.22<br>Micron Filter | Baxter Healthcare<br>Corporation | K964850 | February 25,<br>1997 |

#### Table 2. Predicate Device

# DESCRIPTION OF THE DEVICE:

The Solution Administration Sets with a 0.2 micron filter product line consists of sterile, non-pyrogenic, single use disposable devices used for the administration of fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. They are indicated for the retention of microorganisms and removal of air and particulate matter from infusion fluids. The filter consists of a 0.2 micron polyethersulfone (PES) solution membrane and 0.1 micron polyvinylidene fluoride air vent membrane enclosed in a copolyester housing. These devices were previously cleared under 510(k) premarket notification K964850 (cleared February 25, 1997)

The basis for this premarket notification is a modification to the 0.2 micron filter currently used in this product line. The modification consists of a change to the solution membrane material. The solution membrane material is changing from a hydrophilic polyethersulfone (PES) to another hydrophilic polyethersulfone (PES). The solution membrane currently used is no longer available and will be replaced with an equivalent material.

These modifications do not impact the intended use or the fundamental scientific technology of the devices. No other materials of construction are being introduced into these devices as part of this update. The product labels are also being updated to revise statements regarding latex and pump device references, add the indications for use statement of the device, and implement other modifications to comply with Baxter's labeling standards.

#### INDICATIONS FOR USE:

For the retention of microorganisms and removal of air and particulate matter from infusion fluids.

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# TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:

The proposed devices have equivalent technological characteristics as Baxter's currently legally marketed devices cleared under 510(k) premarket notification K964850 (cleared on February 25, 1997). The intended use, design and function of the proposed devices are equivalent to the predicate devices.

# DEVICE COMPARISON TABLE:

Table 3 is a device comparison table outlining the differences between the current (predicate) devices and the proposed devices.

| Features | | Current Devices<br>(Cleared under K964850) | Proposed Devices |
|--------------------------|----------------------|--------------------------------------------------------------------------------------------------------|------------------|
| Intended Use | | For the retention of microorganisms and removal<br>of air and particulate matter from infusion fluids. | Same |
| Indications for Use | | For the retention of microorganisms and removal<br>of air and particulate matter from infusion fluids. | Same |
| Sterile | | Yes | Same |
| Non-Pyrogenic | | Yes | Same |
| Single Use | | Yes | Same |
| Materials | | | |
| Spike | | Acrylonitrile Butadiene Styrene | Same |
| Blue Plug | | Synthetic Polyisoprene | Same |
| Cannula | | 304 Stainless Steel | Same |
| Drip Chamber | | Polyvinyl Chloride | Same |
| Check Valve | | Polymethyl Methacrylate and Silicone Rubber | Same |
| 0.2 Micron<br>Filter | Housing | Copolyester | Same |
| | Solution<br>Membrane | Polyethersulfone (PES) | Same |
| | Air Vent<br>Membrane | Polyvinylidene (PVDF) | Same |
| Trilayer<br>Tubing | Inner Layer | Linear Low Density Polyethylene | Same |
| | Middle<br>Layer | Polyolefin Adhesive | Same |
| | Outer Layer | Polyvinyl Chloride | Same |
| Tubing | | Polyvinyl Chloride | Same |
| Bushing | | Polyvinyl Chloride | Same |
| Interlink Y-Site | | Copolyester and Synthetic Polyisoprene | Same |
| Clearlink Y-Site | | Polycarbonate and Silicone | Same |
| Male Luer Lock Connector | | Acrylonitrile Butadiene Styrene | Same |

### Table 3. Device Comparison

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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 were conducted to evaluate the effect of the modification to the 0.2 micron filter:

- Air diffusion test ●
- Bubble point test
- Gravity flow rate test ●
- Flow rate test post sterile water conditioning ●
- Flow rate test post parenteral nutrition conditioning
- Bacterial retention test

All tests met the acceptance criteria.

### Biocompatibility:

The basis for this premarket notification is a modification to the 0.2 micron filter solution membrane material. The solution membrane material is changing from a hydrophilic polyethersulfone (PES) to another hydrophilic polyethersulfone (PES). No other materials of construction are being introduced into these devices as part of this update.

Biocompatibility assessments were conducted in accordance with ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," for prolonged duration, external communicating device, indirect blood path, and FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993" as recommended in the IV Administration Sets guidance, "Guidance for Industry and FDA Staff: Intravascular Administration Sets Premarket Notification Submissions [510(k)]''. The battery of testing included the following tests:

- . Cytotoxicity
- Systemic Toxicity ●
- Intracutaneous ●

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- Hemolysis ●
- Pyrogen ●
- Sensitization ●
- USP Physicochemical ●

All other materials found in these devices, that are the subject of this submission, have been previously cleared under Baxter's 510(k) premarket notifications K123868 (cleared January 8, 2013) and K150860 (cleared April 16, 2015).

# CONCLUSION:

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