IVAC NEEDLE FREE VALVE ADMINISTRATION SETS

K960280 · Y · FPA · Apr 4, 1996 · General Hospital

Device Facts

• Record ID: K960280
• Device Name: IVAC NEEDLE FREE VALVE ADMINISTRATION SETS
• Applicant: Y
• Product Code: FPA · General Hospital
• Decision Date: Apr 4, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use for the IVAC Needle Free Valve administration sets is to allow IV fluid delivery of a wide range of fluids. The needle free valve allows the user to add medication into the primary line without the use of a needle.

Device Story

IVAC Needle Free Valve administration sets; intravascular administration set; enables needle-free medication addition to primary IV lines. Operation: male connector of syringe/secondary line compresses internal rubber piston; piston expands into valve housing to open fluid path; removal of connector triggers bellows-driven spring force to return piston to sealed position. Flat, smooth surface allows cleaning; no cap required for sterility. Used in clinical settings by healthcare providers for fluid/medication delivery.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Intravascular administration set; needle-free valve mechanism; rubber piston with bellows spring force; standard materials; flat, smooth surface for cleaning; no cap required for sterility.

Indications for Use

Indicated for patients requiring IV fluid delivery and medication administration via needle-free access.

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

• ICU Medical, Inc. Clave Connector

Submission Summary (Full Text)

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960280

APR - 4 1996

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

1. SUBMITTER'S NAME: IVAC CORPORATION
10300 Campus Point Drive
San Diego, CA 92121-1579
[phone]

CONTACT PERSON: Jennifer S. Hankard
Sr. Manager of QA/RA

DATE PREPARED: January 17, 1996

2. DEVICE NAME: Proprietary Name: IVAC Needle Free Valve Administration Sets
Common Name: Intravascular Administration Set
Classification Name: Intravascular Administration Set

3. PREDICATE DEVICE: ICU Medical, Inc. Clave Connector

4. DEVICE DESCRIPTION: The IVAC Needle Free Valve administration sets incorporate standard IVAC set components using standard materials. The sets include a needle free valve that allows the user to add medication into the primary line without the use of a needle. When the valve is in the closed position it has a flat smooth surface for cleaning. When the male connector of a syringe or secondary line is pushed into the valve the rubber piston inside the valve is compressed. The top of the rubber piston is then allowed to expand into the increased diameter inside the valve. Fluid path is achieved through the male connector into the center of the rubber piston and the valve housing. When the male connector is removed from the valve, the bellows section of the piston provides a spring force to return the piston to the top of the valve and to maintain a sealed fluid path. A cap is not required to maintain sterility.

5. INTENDED USE: The intended use for the IVAC Needle Free Valve administration sets is to allow IV fluid delivery of a wide range of fluids. The needle free valve allows the user to add medication into the primary line without the use of a needle.

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6. TECHNOLOGICAL CHARACTERISTICS:

The IVAC Needle Free Valve administration sets and the ICU Medical, Inc. Clave Connector use the same method of manufacture, incorporate standard set components, and use standard materials. The primary function of the IVAC Needle Free Valve administration sets is the same as the ICU Medical, Inc. Clave Connector: to allow the user to add medication into the primary line without the use of a needle. The technological characteristics of the devices are the same and raise no new questions of safety and effectiveness. IVAC Corporation concludes that the IVAC Needle Free Valve administration sets are substantially equivalent to the ICU Medical, Inc. Clave Connector.