I.V. ADMINISTRATION SETS

K955821 · Medical Associates Network, Inc. · FPA · Jul 10, 1996 · General Hospital

Device Facts

• Record ID: K955821
• Device Name: I.V. ADMINISTRATION SETS
• Applicant: Medical Associates Network, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Jul 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The I.V. Administration Sets of this Notification provide a means for administering Parenteral solutions from a standard solution container intravenously to a patient.

Device Story

Device consists of rigid plastic spike for solution container attachment; PVC tubing; flow control clamp; male luer lock connector. Optional configurations include needleless injection sites, check valves, and air-venting filters. Used in clinical settings for parenteral fluid delivery. Operated by healthcare professionals. Provides controlled fluid path from container to patient venous access site.

Clinical Evidence

Bench testing only; no clinical data provided. Equivalence based on material consistency and industry-standard sterilization procedures.

Technological Characteristics

Components: rigid plastic spike, PVC tubing, flow control clamp, male luer lock connector. Optional: needleless injection sites, check valves, air-venting filters. Materials consistent with industry standards for parenteral administration sets. Sterilization: standard medical device industry procedures.

Indications for Use

Indicated for patients requiring intravenous administration of parenteral solutions.

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

• K944320
• K860605

Submission Summary (Full Text)

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K955821 JUL 10 1996

# SUMMARY OF SAFETY AND EFFECTIVENESS

RE: 510(k) NOTIFICATION
Intravascular Administration Set

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA of 1990 and 21 CFR part 807.92.

The I.V. Administration Sets of this Notification provide a means for administering Parenteral solutions from a standard solution container intravenously to a patient. The sets include a rigid plastic spike or other means for attachment to a solution source, a length of PVC tubing, a clamp for controlling solution flows through the tubing and a male luer lock connector. Some configurations of the sets include needleless injection sites, check valves and air-venting filters. Various configurations are substantially equivalent to pre-amendment devices or to devices found substantially equivalent to prior devices in 510(k) Nos. K944320 and/or K860605. Components of the sets are made of the same materials usually used by previously-marketed sets and both packaging and sterilization procedures are consistent with those generally used in the medical device industry.

Robert T. Merrick
Regulatory Consultant

Dated: 12/15/95