K962581 · Baxter Healthcare Corp · FMG · Aug 28, 1996 · General Hospital
Device Facts
Record ID
K962581
Device Name
STOPCOCK MANIFOLD GANGS
Applicant
Baxter Healthcare Corp
Product Code
FMG · General Hospital
Decision Date
Aug 28, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 880.5440
Device Class
Class 2
Indications for Use
Stopcock manifold gangs consist of individual stopcocks assembled in series through common luer fittings to form a manifold or stopcock gang. These pre-assembled stopcock gangs provide multiple access sites into a common fluid path for the administration of drugs and solutions. The luer connectors on either end of the stopcock gang allow connection to an IV set for fluid administration through an indwelling intravascular catheter.
Device Story
Device consists of 2, 3, or 5 individual stopcocks assembled in series via luer fittings; provides multiple access sites for drug/solution administration into a common fluid path. Used in clinical settings for IV therapy; operated by clinicians. Connects to IV sets and indwelling intravascular catheters. May include backing plate for IV pole attachment. Facilitates multi-drug delivery through single catheter access; improves workflow efficiency for clinicians.
Clinical Evidence
Bench testing only. Testing included pressure seal tests, ANSI MD70.1-1983 luer conformance, lipid compatibility, luer-to-luer stability, flow rate, and mechanical security of backing plate. Results indicate performance meets or exceeds functional requirements.
Technological Characteristics
Assembly of 3 or 4-way stopcocks (large or standard bore) with male/female luer locks. Materials previously cleared in Medex/Baxter devices. Luer connections conform to ANSI MD70.1-1983. Includes port protectors and backing plate for pole mounting.
Indications for Use
Indicated for use as a fluid path access point for the administration of drugs and solutions via an indwelling intravascular catheter in patients requiring IV therapy.
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. Ultra® Stopcock
Medex, Inc. Stopcock Manifold Gangs
Baxter Stopcock Manifold Gangs
Submission Summary (Full Text)
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K962581
AUG 28 1996
510(k) SUMMARY
Stopcock Manifold Gangs
Submitted by:
Mary Ellen Snyder
Baxter Healthcare Corporation
I.V. Systems Division
Rte. 120 and Wilson Road
Round Lake, IL 60073
Date Prepared:
June 18, 1996
Proposed Device:
Baxter Stopcock Manifold Gangs
Predicate Devices:
Medex, Inc. Ultra® Stopcock
Medex, Inc. Stopcock Manifold Gangs
Baxter Stopcock Manifold Gangs
Proposed Device Description:
Stopcock manifold gangs consist of individual stopcocks assembled in series through common luer fittings to form a manifold or stopcock gang. These pre-assembled stopcock gangs provide multiple access sites into a common fluid path for the administration of drugs and solutions. The luer connectors on either end of the stopcock gang allow connection to an IV set for fluid administration through an indwelling intravascular catheter.
Baxter will purchase stopcocks from Medex, Inc. and will assemble individual stopcocks into ganged configurations containing 2, 3 or 5 stopcock units. Baxter will use Medex stopcocks which vary in the number of flow paths (3 or 4 way), internal lumen diameter (large bore or standard bore) and type of luer connection (male luer slip, rotating male luer lock, and female luer lock) may be used to produce the gangs. The stopcock manifold gangs may also be marketed with a pre-attached backing plate which can be used to attach the stopcock gang to an IV pole.
JUN 18 1996
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510(k) Summary
Stopcock Manifold Gangs
Page 2
# Summary of Technological Characteristics of New Device to Predicate Devices
The proposed Baxter stopcock manifold gangs will consist of multiple Medex stopcocks preassembled with Baxter port protectors and backing plate. These stopcocks are currently manufactured and marketed as single unit products only. The differences from currently marketed Medex stopcocks include assembly into multiple unit gangs, and the addition of Baxter port protectors and backing plate. There are no other changes in the design, components, materials, function or intended use of the Medex stopcocks.
In addition, Medex markets stopcock manifold gangs consisting of multiple stopcocks of a different type but with the same configurations as the proposed Baxter products e.g. 2, 3 and 5 unit gangs consisting of 3 or 4 way and large or standard bore stopcocks with varying luer type connections.
There are no new materials involved in the proposed products. Solution-contacting materials to be used in Baxter’s proposed stopcock manifold gangs have been previously used in marketed Medex stopcocks or in other Baxter devices for similar IV solution administration applications.
# Discussion of Nonclinical Tests; Conclusions Drawn from Nonclinical Tests
Data regarding the functional performance of the proposed stopcock manifold gangs has been generated. Testing includes pressure seal tests, stopcock luer conformance to ANSI standard MD70.1-1983, lipid compatibility, luer to luer stability, flow rate and mechanical security of stopcock gang to backing plate. Performance testing indicates that the proposed products meet or exceed all functional requirements and support their suitability for use.
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