E-Z SET INFUSION SET/SAF-T E-Z SET INFUSION SET

K970259 · Becton Dickinson Vascular Access, Inc. · FPA · Apr 8, 1997 · General Hospital

Device Facts

• Record ID: K970259
• Device Name: E-Z SET INFUSION SET/SAF-T E-Z SET INFUSION SET
• Applicant: Becton Dickinson Vascular Access, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Apr 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use is to provide access to the vascular system to administer fluids intravenously. The device is also suitable for sampling blood and monitoring blood pressure.

Device Story

Single-use intravascular administration set; stainless steel needle with butterfly wings and short extension set; provides vascular access for fluid administration, blood sampling, and blood pressure monitoring; used in clinical settings by healthcare professionals.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Stainless steel needle; butterfly wings; short extension set; single-use; sterile.

Indications for Use

Indicated for patients requiring vascular access for intravenous fluid administration, blood sampling, or blood pressure monitoring.

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

• Becton Dickinson Vascular Access E-Z SET® and SAF-T E-Z SET® infusion sets

Submission Summary (Full Text)

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K970259
April 8, 1997

# SUMMARY OF SAFETY AND EFFICACY

A. The submitter’s name, address, telephone number, contact person, and date of preparation.

Submitted by Becton Dickinson Vascular Access, 9450 South State Street, Sandy, UT 84070.
Contact: C. J. Welle. Telephone: [phone]. Prepared: January 22, 1997

B. The name of the device including trade or proprietary name if applicable, the common or usual name, and the classification name.

Name: Intravascular Administration Set
Brand: E-Z SET® and Saf-T E-Z SET® Infusion Sets
Common Name: Infusion Set
Classification Name: Intravascular Administration Set (80 FPA)

C. An identification of the predicate or legally marketed device to which substantial equivalence is claimed:

Predicate Device: The Becton Dickinson Vascular Access E-Z SET® and SAF-T E-Z SET® brand infusion sets.

D. A description of the device that is the subject of the Premarket Notification submission.

The subject catheter is a single use intravascular administration set of various gauges and lengths which is designed to provide access to the vascular system. It is stainless steel needle set with butterfly wings and a short extension set.

E. Statement of intended use of the device.

The intended use is to provide access to the vascular system to administer fluids intravenously. The device is also suitable for sampling blood and monitoring blood pressure.

F. A statement of how the technological characteristics compare to those of the predicate or legally marketed device identified in section C above.

The proposed infusion sets differ from the E-Z SET® and SAF-T E-Z SET® brand infusion sets currently marketed in that the intended use clarifies the suitability for additional uses. The device is unchanged.

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