(277 days)
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No
The description details a mechanical device for fluid control and does not mention any computational or learning capabilities.
No
A therapeutic device is one that treats or alleviates a disease or condition. This device is a fluid control mechanism, not a treatment itself.
No
The device is described as a stopcock designed for controlled fluid flow, specifically for administering three different fluids into one line. It regulates the flow of substances rather than collecting or analyzing information to diagnose a condition.
No
The device description clearly outlines physical components (body, stem/handle, swivel nut) and their mechanical function for controlling fluid flow, indicating it is a hardware device.
Based on the provided information, the Tri-Flow™ 3-Way Stopcock is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is described as being used in "any medical procedure where controlled flow of fluid is required" and specifically for "procedures where three different fluids are administered into one line." This describes a device used in vivo (within the body) for managing fluid delivery to a patient.
- Device Description: The description details a mechanical device for controlling fluid flow through luer ports. There is no mention of it being used to examine specimens in vitro (outside the body) to provide information about a physiological state, health, or disease.
- 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 analytes
- Providing diagnostic information
- Reagents or assays
The Tri-Flow™ 3-Way Stopcock is a medical device used for fluid management during medical procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Tri-Flow™ 3-Way Stopoock is designed to be used in any medical procodure 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.
Product codes
880.5440
Device Description
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 reducc 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 lucr 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 significs 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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
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Key Metrics
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Predicate Device(s)
Medex, Inc. 3-Way stopcock, North American Instrument Corporation stopcock, and Tronomed/Mallinckrodt stopcock.
Reference Device(s)
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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.
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Image /page/0/Picture/0 description: The image shows the word "North" in a bold, sans-serif font. Above the "N" is a black arrow pointing upwards, symbolizing the direction north. Below the word "North" is the word "Incorporated" in a smaller, regular font.
K96 198 2
510(k) Summary 3-Way Stopcock
FEB 2 1 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 cquivalcnt 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 reducc 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 lucr 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 significs 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.
Similar in intended use to the sclected legally marketed devices, the Tri-Flow™ 3-Way Stopoock is designed to be used in any medical procodure 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 cquivalent. Device dimensions are substantially equivalent. The Tri-Flow™ 3-Way Stopcock is a relatively simple device with no exceptional material requirements. The matcrials sclected are identical to those used in the above referenced legally marketed devices.
V. P. / President / Vice-President
Jim Pokorhey, President, North, Inc.
11/2.7/74
Date