BIOMEDIX I.V. EXTENSION LINE W/ STOPCOCK MODEL B50-102/B51-102

K961928 · Biomedix, Inc. · FPA · Sep 16, 1996 · General Hospital

Device Facts

• Record ID: K961928
• Device Name: BIOMEDIX I.V. EXTENSION LINE W/ STOPCOCK MODEL B50-102/B51-102
• Applicant: Biomedix, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Sep 16, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

This product would be used by Nurses and Paramedics in prehospital, emergency room and field situations.

Device Story

I.V. Extension with Stopcock facilitates intravenous fluid/drug administration; provides extra length between I.V. supply and patient; includes four-way stopcock for fluid source selection; features slip-type clamp to prevent backflow/dilution. Used by nurses and paramedics in prehospital, emergency room, and field settings. Available in two models: standard needle-type injection site or blunt cannula (needleless) injection site. Device connects to primary I.V. set to allow direct injection at patient catheter site.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

I.V. extension line assembly with four-way stopcock. Features include threaded and/or slip luer connections, 3.75 mL capacity, and 0.114" I.D. tubing. Available with needle-type or blunt cannula (needleless) injection sites. Includes slip-type tubing clamp. Construction utilizes commercially available components similar to existing I.V. sets.

Indications for Use

Indicated for use by nurses and paramedics in prehospital, emergency room, and field settings to extend intravenous lines and provide additional ports for the administration of fluids and drugs.

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

• Baxter PHARMASEAL K52 NOVEX Three-Way Stopcock with Extension Tube (K52)
• Medex Extension Set
• McGaw G0719 I.V. Extension Set
• McGaw G0726 I.V. Extension Set
• McGaw G0716 I.V. Extension Set

Submission Summary (Full Text)

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BIOMEDIX
quality medical products
K961928
SEP 16 1996

TO: Food and Drug Administration
Center for Devices and Radiological Health (HFZ-401)
9200 Corporate Blvd.
Rockville, MD 20850

FROM: Daniel J. Dyar, President

DATE: May 17, 1996 (Revised June 11, 1996)

SUBJECT: 510 K Summary

TRADE NAME: I.V. Extension with Stopcock.

COMMON NAME: I.V. Extension

CLASSIFICATION NAME: [ 880.5440 ] Intravascular Administration Set

SUBSTANTIALLY
EQUIVALENT TO:

Biomedix, Inc. claims substantial equivalence regarding this design of the I.V. Extension Line Assembly with Stopcock as follows:

Products currently on the market include:

Baxter PHARMASEAL K52 NOVEX Three-Way Stopcock with Extension Tube.
( Sterile, For Single Use Only, Capacity 2.3 mL, Length 50.8 cm. Blue Protector covers Male Adapter. )

Medex Extension Set - 12" Extension with "Y" Injection Site.

McGaw - G0719 I.V. Extension Set, Female and Needle Adapter, Vol. 3 mL., Length 21"
G0726 I.V. Extension Set with (2) Injection Sites, Vol. 6 mL., Length 33"
G0716 I.V. Extension Set with (2) Injection Sites with check valve and
flashtube., Vol. 6 mL., Length 34"
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45 South Main Street P.O. Box 231 Spencer, Indiana 47460 800-627-2765 812-829-9667 FAX: [phone]

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510 K SUMMARY ( CONTINUED )

DESIGN COMPARISONS:

| COMPONENT | BIOMEDIX | BAXTER K52 | MEDEX EXTENSION SET |
| --- | --- | --- | --- |
| Stopcock | All 3 ports include both threaded and / or slip luer connections. | ( 1 ) Port has removeable needle injection site. ( 2 ) remaining ports have slip luer conn. only. | ( 1 ) Y - Port for Sharps Devices. |
| Capacity | 3.75 ml. | 2.3 ml. | N/A |
| Tubing | .114 +/- .002" I.D. | .088-.090" I.D. | N/A |
| Connections | Choice of Needle or Blunt Cannula Y-Site with Male Slip Luer Connector. | Male Slip Luer Connector Only. | Male Slip Luer Connector Only. |

The Biomedix design allows injection of solutions directly at the Patient I.V. Catheter. A slip-type clamp on the tubing portion of the I.V. Extension Line allows the line to be shut-off preventing backflow and/or dilution of administered fluids away from the patient.

DESCRIPTION:

The I.V. Extension Line Assembly with Stopcock is attached to the Primary I.V. to facilitate two advantages. One, is to add extra length between the I.V. Supply and the Patient. A second, is to provide additional supply ports for the administration of alternate solutions and special drugs that are administered intravenously. A four-way stopcock offers selection of the fluid types and sources. Biomedix is offering two models, one with a standard Needle-Type Injection Site at the Outlet and a second with a Blunt Cannula (Needleless) Type Injection Site at the outlet.

INTENDED USE:

This product would be used by Nurses and Paramedics in prehospital, emergency room and field situations.

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510 K SUMMARY ( CONTINUED )

## SUMMARY OF DEVICE COMPARISONS:

Basic construction of both Biomedix and Competitive Products of this type are of commercially available components. Biomedix already employs a process and construction similar to this in their existing Selec-3 Primary I.V. Set.

Sincerely,


Daniel J. Dyar
President Biomedix, Inc.

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