CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET

K961225 · Baxter Healthcare Corp · FPA · Jun 21, 1996 · General Hospital

Device Facts

• Record ID: K961225
• Device Name: CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET
• Applicant: Baxter Healthcare Corp
• Product Code: FPA · General Hospital
• Decision Date: Jun 21, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Baxter Healthcare Corporation intends to manufacture and market solution administration sets with an alternate design of the spike and drip chamber components.

Device Story

Modified solution administration sets; alternate design of spike and drip chamber components. Device facilitates fluid delivery from solution containers to patients. Spike interfaces with containers; drip chamber regulates flow. Used in clinical settings by healthcare professionals. Design maintains compatibility with Baxter and competitive containers. Functional performance verified via air passage, air leakage, and tensile strength testing.

Clinical Evidence

Bench testing only. Functional performance data generated for spike and drip chamber assemblies, including air passage, air leakage, and tensile strength tests. Results indicate proposed components meet or exceed functional requirements.

Technological Characteristics

Solution administration set with modified spike and drip chamber. Materials identical to predicate. Mechanical interface for fluid administration. No electronic or software components.

Indications for Use

Indicated for the administration of intravenous solutions to patients requiring fluid therapy.

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

• Current Baxter Solution Administration Sets

Submission Summary (Full Text)

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K96/225

JUN 21 1996

510(k) Premarket Notification

Modified Solution Administration Sets

# 510(k) SUMMARY

## Submitted by:

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

## Date Prepared:

March 18, 1996

## Proposed Device:

Modified Baxter Solution Administration Sets

## Predicate Devices:

Current Baxter Solution Administration Sets

## Proposed Device Description:

Baxter Healthcare Corporation intends to manufacture and market solution administration sets with an alternate design of the spike and drip chamber components.

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

The proposed Baxter sets are the same as existing Baxter sets except for the design change in the spike and drip chamber components. All other components of the solution administration sets remain unchanged. The proposed spike and drip chamber components are identical in material composition and function to existing components. The spike remains the same in all container interfacing dimensions. Thus the proposed sets will continue to be compatible with both Baxter and competitive solution containers as was established in K860272 for the current spike design. Also the geometry of the drop former and portion of the spike which engages the drip chamber is the same as the current design.

## Discussion of Nonclinical Tests; Conclusions Drawn from Nonclinical Tests

Data regarding the functional performance of the proposed spike and drip chamber assemblies have been generated including air passage, air leakage and tensile strength tests. Performance testing indicates that sets with the proposed components will meet or exceed all functional requirements.

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