SOLUTION ADMINISTRATION SET WITH 0.22 MICRON HIGH PRESSURE EXTENDED LIFE FILTER

K964850 · Baxter Healthcare Corp · FPA · Feb 25, 1997 · General Hospital

Device Facts

• Record ID: K964850
• Device Name: SOLUTION ADMINISTRATION SET WITH 0.22 MICRON HIGH PRESSURE EXTENDED LIFE FILTER
• Applicant: Baxter Healthcare Corp
• Product Code: FPA · General Hospital
• Decision Date: Feb 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The Millipore 0.22 micron filter which Baxter intends to incorporate into various configurations of solution sets for the administration of intravenous solutions.

Device Story

Device consists of Millipore 0.22 micron filter integrated into Baxter intravenous solution administration sets. Filter removes particulates and microorganisms from IV fluids during administration. Used in clinical settings by healthcare professionals. Device functions as passive in-line filtration component. Benefits include reduction of particulate and microbial contamination in infused solutions.

Clinical Evidence

Bench testing only. Testing included reverse pressure filter integrity, unit venting, gravity flow, inlet axial stress, housing integrity/female luer fitment, forward pressure filter integrity, downstream particle count, accelerated endurance, outlet deflection stress, in-line filter wettability, bacterial endotoxins, bioburden evaluation, burst strength, and MVI resistance. Results indicate filter meets or exceeds all functional requirements.

Technological Characteristics

0.22 micron membrane filter; in-line configuration for IV administration sets. Materials and design identical to Millipore filter cleared under K960466. Mechanical filtration principle.

Indications for Use

Indicated for use in intravenous solution administration sets to filter solutions during 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

• Abbott Solution Sets with 0.22 Micron Filter (K960466)
• Baxter Solution Sets with 0.22 Micron Filter

Submission Summary (Full Text)

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K964850

FEB 25 1997

# 510(k) SUMMARY

Solution Administration Sets with 0.22 Micron Filter

## Submitted by:

Mary Ellen Snyder
Baxter Healthcare Corporation
I.V. Systems Division
Rte. 120 and Wilson Road
Round Lake, IL 60073

## Date Prepared:

November 26, 1996

## Proposed Device:

0.22 Micron Filter Sets

## Predicate Devices:

Abbott Solution Sets with 0.22 Micron Filter
Baxter Solution Sets with 0.22 Micron Filter

## Proposed Device Description:

The subject of this submission is the Millipore 0.22 micron filter which Baxter intends to incorporate into various configurations of solution sets for the administration of intravenous solutions. The filter is manufactured by Millipore and has been recently cleared for marketing in Abbott solution administration sets covered by K960466.

Baxter will purchase the 0.22 micron filter from Millipore and incorporate it into currently marketed solution administration sets. Baxter is making no changes to the design, components or materials of the Millipore filter.

## Summary of Technological Characteristics of New Device to Predicate Devices

The Millipore 0.22 micron filter to be incorporated in Baxter solution administration sets is identical to that which has been recently cleared for marketing in Abbott solution administration sets under K960466 for the same intended use. Baxter is making no changes to the design, components, or materials of the Millipore filter. The proposed Baxter sets are identical to currently marketed Baxter sets except for the change in the 0.22 micron filter to the Millipore I.V. Express™ filter. All other components of the solution administration sets remain unchanged.

NOV 26 1996

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# Discussion of NonClinical Tests

Data regarding the functional performance of the 0.22 micron filter were generated by Millipore. Testing included Reverse Pressure Filter Integrity, Unit Venting, Gravity Flow, Inlet Axial Stress, Housing Integrity/Female Luer Fitment, Forward Pressure Filter Integrity, Downstream Particle Count, Accelerated Endurance, Outlet Deflection Stress, In-Line Filter Wettability, Bacterial Endotoxins, Bioburden Evaluation, Burst Strength, and MVI Resistance. The data indicate that the filter meets or exceeds all functional requirements.

# Conclusions Drawn from Nonclinical Tests

Functional, microbiological, and drug compatibility data indicate that the proposed filter meets or exceeds all functional requirements and support its suitability for use in Baxter sets.

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NOV 26 1996