FLUID ADMINISTRATION SET - CONTRAST MANAGER

K961794 · Merit Medical Systems, Inc. · FPA · Aug 1, 1996 · General Hospital

Device Facts

• Record ID: K961794
• Device Name: FLUID ADMINISTRATION SET - CONTRAST MANAGER
• Applicant: Merit Medical Systems, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Aug 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The Contrast Management System is intended for use as an intravascular administration set for the delivery of contrast media.

Device Story

Contrast Management System consists of spike assembly and Miser fluid administration set; spike assembly inserts into contrast media container; Miser attaches to spike assembly and manifold port/stopcock. Burette chamber fills to ~10 ml; shut-off disc prevents air entry upon container depletion. Physician/technician aspirates contrast into control syringe via manifold; injects into indwelling catheter. System includes redundant one-way check valves to prevent retrograde flow/cross-contamination and air filters to prevent airborne contamination. Used in clinical settings for contrast delivery; benefits include efficient contrast management and air embolism prevention.

Clinical Evidence

No clinical data. Bench testing performed: redundant one-way check valves challenged to verify prevention of retrograde flow; air filters challenged for aerosol filtration efficiency; 100% leak testing implemented for all tubing sets. Literature review cited regarding anti-bacterial properties of radiological contrast agents.

Technological Characteristics

Intravascular administration set comprising spike assembly and burette-based fluid administration set. Features redundant one-way check valves and air filters at intake ports. Includes shut-off disc for air prevention. 100% leak testing performed on all sets. Materials compatible with ionic and non-ionic contrast media.

Indications for Use

Indicated for the intravascular administration of contrast media in patients undergoing radiological procedures requiring contrast injection.

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

• contrast savings delivery system (K903493)

Submission Summary (Full Text)

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K961794

510(k) SUMMARY OF SAFETY and EFFECTIVENESS

AUG - 1 1996

| Date of Summary: | May 8, 1996 |
| --- | --- |
| Submitter's name: | Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095-2415
[phone] |
| Contact Person: | Dennis (Dan) Reigle |
| Name of device: | Contrast Management System |
| Class: | Class II |
| Classification name: | Intravascular Administration Set |
| Predicate device: | The predicate device is the "contrast savings delivery system" manufactured by North American Instrument Company (NAMIC®) and reviewed by FDA under premarket notification number K903493. |

MERIT MEDICAL SYSTEMS, INC.
1600 WEST
MERIT PARKWAY
SOUTH JORDAN.
UTAH 84095
801-253-1600

## DEVICE DESCRIPTION

The device consists of two parts; the spike assembly and the Miser™ fluid administration set. The spike assembly is inserted into a container of contrast media. The Miser is then attached to the spike assembly. The distal end (fixed male luer) of the Miser is attached to a manifold port (or stopcock with syringe). The stopcock on the spike assembly is opened to allow the contrast to flow into the Miser's burette chamber. The burette is filled to approximately the 10 ml level and then the contrast flow stopped by closing the stopcock on top of the burette. As contrast is withdrawn from the Miser, the level within the burette will remain at approximately the same level until the contrast in the container is depleted. The shut-off disc within the burette prevents air from entering the system when the contrast container becomes empty. The stopcock below the burette may be opened to allow the contrast contained within the proximal tubing to be aspirated.

The contrast manager is attached to a manifold port or a three way stopcock. A control syringe is connected to the manifold or stopcock on the opposite side from the indwelling catheter. Opening the port between the contrast manager and the syringe allows the syringe to aspirate contrast media. The port between the syringe and catheter is opened and the contrast can be injected into the catheter. This process can be repeated until the contrast is expended.

FAX [phone]

142

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MERIT MEDICAL

# Safety Considerations

The components in the fluid administration set have been used for four years with various types of contrast media (ionic and non-ionic) without overt problems.

The redundant one way check valves were challenged to verify a high degree of reliability that retrograde flow is not possible through the one way valves thus preventing patient cross contamination.

An arbitrary six hour time limit was imposed by the predicate device manufacturer for the spike assembly to remain connected to the container of contrast. Merit agrees with this time limit and has indicated this limitation in the Instructions for Use. Merit used the six hour time limit as the exposure time for challenging the one way check valves.

The protective dust cap (that is placed on the spike assembly between cases) is packaged in a separate pouch thereby preserving its sterility until needed.

Air filters are connected to all ports where air may be drawn into the system thereby preventing contamination from airborne contaminants. The air filter was challenged to verify its ability to effectively filter a test aerosol.

The Medical Device Reporting database was searched for MDRs from the two predicate device manufacturers for events relating to contrast infusion sets.

Although there were no reports directly naming the predicate devices, there were several related reports. The events reported either air leaking into the infusion set or contrast leaking out. To prevent tubing set leaks, Merit has incorporated a final leak test for all (100%) tubing sets to verify set integrity. In addition, a cautionary statement is included in the labeling to verify connection integrity before use.

A study has shown radiological contrast agents to have anti-bacterial (bactericidal or bacteristatic) activity.