(277 days)
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 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 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 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 straddles the two ports which are connected. In the center position, the handle aligns with and indicates a straight flow pathway.
This 510(k) summary describes a 3-way stopcock, a medical device for controlling fluid flow. It asserts substantial equivalence to legally marketed predicate devices. However, it does not include any information about acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot provide the requested information in the table or the subsequent numbered points because none of that data is present in the provided text.
The document focuses on:
- Device Classification: 21 CFR §880.5440 (Stopcock)
- Predicate Devices: Medex, Inc. 3-Way stopcock, North American Instrument Corporation stopcock, and Tronomed/Mallinckrodt stopcock.
- Device Description: Disposable, one-time use, three injection-molded components (body, stem/handle, swivel nut), medical-grade fluid lubricant, four fluid channels (three female luer ports, one male luer port), rotating stem/handle to control flow.
- Intended Use: Similar to predicate devices, for controlled fluid flow in medical procedures, specifically when three different fluids are administered into one line.
- Technological Characteristics: Substantially equivalent to predicate devices in mode of operation, user interface, dimensions, and materials.
Conclusion: The provided text is a 510(k) summary focused on establishing substantial equivalence based on design and intended use, not on presenting performance data against specific acceptance criteria.
§ 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.