TRI-FLOW THREE WAY STOPCOCK

K961982 · North, Inc. · FMG · Feb 21, 1997 · General Hospital

Device Facts

• Record ID: K961982
• Device Name: TRI-FLOW THREE WAY STOPCOCK
• Applicant: North, Inc.
• Product Code: FMG · General Hospital
• Decision Date: Feb 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The Tri-Flow™ 3-Way Stopcock is designed to be used in any medical procedure where controlled flow of fluid is required. It is specifically designed to be used in procedures where three different fluids are administered into one line.

Device Story

Disposable 3-way stopcock; used in clinical settings for controlled fluid administration. Device consists of injection-molded body, stem/handle, and swivel nut. Operates by rotating stem/handle to align internal passageways, creating fluid path between male luer port and one of three female luer ports. 'ON' indicator on handle identifies active ports. Used by clinicians to manage multi-fluid delivery into single line. Simple mechanical design; no electronic components or software.

Clinical Evidence

Bench testing only; no clinical data.

Technological Characteristics

Disposable 3-way stopcock; injection-molded body, stem/handle, and swivel nut. Medical grade fluid lubricant used at stem/body interface. Four-channel body design with three female luer ports and one male luer port. Mechanical rotation of stem/handle controls fluid path. No energy source, software, or connectivity.

Indications for Use

Indicated for use in medical procedures requiring controlled fluid flow, specifically for the administration of three different fluids into a single line.

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

• Medex, Inc. 3-Way stopcock
• North American Instrument Corporation stopcock
• Tronomed/Mallinckrodt stopcock

Submission Summary (Full Text)

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North Incorporated

K90/1982

510(k) Summary

3-Way Stopcock

FEB 21 1997

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

The Tri-Flow™ 3-Way Stopcock is a stopcock as classified in 21 CFR §880.5440.

The Tri-Flow™ 3-Way Stopcock is substantially equivalent to the following legally marketed devices: Medex, Inc. 3-Way stopcock, North American Instrument Corporation stopcock, and Tronomed/Mallinckrodt stopcock.

The Tri-Flow™ 3-Way Stopcock is a disposable stopcock designed for one time use. The device consists of three injection molded components: a body, a stem/handle, and a swivel nut. A small amount of medical grade fluid is used as a lubricant to reduce friction at the stem/body interface. The body contains four channels for fluid flow. Three channels end in female luer ports and the other channel terminates as a male luer port. The swivel nut is press fit onto the male luer port. The stopcock body has a cylindrical bore intersecting all four channels into which the stem/handle is press fit mounted. The stem/handle contains two independent passageways.

A fluid pathway can be created between the male luer port and one, and only one, of the three female ports. This is achieved by rotating the stem/handle to one of three distinct positions. The word "ON" located on the stem/handle signifies which ports are connected. In either extreme handle position, the handle straddles the two ports which are connected. In the center position, the handle aligns with and indicates a straight flow pathway.

Similar in intended use to the selected legally marketed devices, the Tri-Flow™ 3-Way Stopcock is designed to be used in any medical procedure where controlled flow of fluid is required. It is specifically designed to be used in procedures where three different fluids are administered into one line.

The technological characteristics of the device are substantially equivalent to those of the above mentioned legally marketed stopcocks. The mode of operation and user interface are substantially equivalent. Device dimensions are substantially equivalent. The Tri-Flow™ 3-Way Stopcock is a relatively simple device with no exceptional material requirements. The materials selected are identical to those used in the above referenced legally marketed devices.


North, Inc. 303 Washington Street Suite B Northfield, Minnesota 55057 507/663-6170 Fax [phone]