(58 days)
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Not Found
No
The device description and performance studies focus on the mechanical and fluid dynamics of stopcock gangs, with no mention of AI or ML.
No.
The device facilitates the administration of drugs and solutions but does not directly provide therapy. It is an accessory to an IV set, providing multiple access points.
No
The device is a stopcock manifold gang used for fluid administration, not for diagnosis. Its description and intended use focus on providing multiple access sites for drugs and solutions, and performance studies relate to functional aspects like pressure seal and flow rate, not diagnostic capabilities.
No
The device description clearly outlines a physical medical device consisting of assembled stopcocks and luer connectors, with performance studies focused on physical properties and functionality. There is no mention of software as a component or the primary function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "administration of drugs and solutions" through an IV set and indwelling intravascular catheter. This is a therapeutic or delivery function, not a diagnostic one.
- Device Description: The description focuses on the physical components and how they facilitate fluid administration. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Using reagents or assays
The device is a medical device used for fluid delivery, not for performing in vitro diagnostic tests.
N/A
Intended Use / Indications for Use
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Product codes
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Medex, Inc. Ultra® Stopcock, Medex, Inc. Stopcock Manifold Gangs, Baxter Stopcock Manifold Gangs
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 880.5440 Intravascular administration set.
(a)
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.(b)
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.
0
ANG 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.
1
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.