(241 days)
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No
The summary describes a physical catheter for fluid delivery and mentions only physical and biocompatibility testing, with no indication of software, image processing, or AI/ML components.
No
The device is an infusion catheter, which is used to deliver therapeutic agents, but it is not itself a therapeutic agent or device that directly treats a condition. It is a delivery system.
No
Explanation: The device is an infusion catheter, which is used for delivering therapeutic agents, not for diagnosing conditions.
No
The device description and performance studies clearly indicate a physical catheter, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of therapeutic agents into the peripheral vasculature. This is a therapeutic intervention performed in vivo (within the living body).
- Device Description: The device is a catheter designed to locally deliver fluids into the vasculature. This is a delivery mechanism, not a diagnostic test performed in vitro (outside the living body).
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to deliver substances into the body, which is a therapeutic action.
N/A
Intended Use / Indications for Use
The Segue ™ Infusion Catheter is indicated for the delivery of therapeutic agents into the peripheral vasculature. It is not indicated for use in coronary or cerebral vasculature. It is not intended for use with thrombolytics. It is not intended for use with power injection pumps.
Product codes
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Device Description
The Segue ™ Infusion Catheter is a single lumen, over-the-wire device designed to locally deliver fluids into the peripheral (non-coronary, non-cerebral) vasculature
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
peripheral (non-coronary, non-cerebral) vasculature
Indicated Patient Age Range
Not Found
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
Physical testing of the product under simulated conditions included: dimensional inspection, deployment and recoil verification, marker band attachment, infusion flow rate, internal pressurization, bond strength, flexural fatigue strength, radial force and trackability. All testing results were within product engineering and marketing specifications.
Biocompatibility testing was performed on the sterile materials used in the construction of this infusion catheter. All materials passed the biocompatibility testing and are suitable for this application
Animal studies were conducted to assess placement of the device in a vessel as well as thrombus accumulation on the device. There were no adverse results reported.
Key Metrics
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Predicate Device(s)
FasTRACKER® Infusion Catheter
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).
0
1 1996
510(k) Summary Segue™ Infusion Catheter
| Trade Name: | Segue ™ Infusion Catheter |
|---|---|
| Classification Name: | Catheter, Percutaneous |
| Classification: | Class II |
| Submitted By: | Interventional Innovations Corporation |
| 2670 Patton Road | |
| St. Paul, MN 55113 | |
| (612) 636-6634 | |
| Contact: | Karen Peterson |
| Director of Clinical and Regulatory Affairs | |
| Predicate Device: | FasTRACKER® Infusion Catheter |
| Target Therapeutics |
Device Description
The Segue ™ Infusion Catheter is a single lumen, over-the-wire device designed to locally deliver fluids into the peripheral (non-coronary, non-cerebral) vasculature
Intended Use
The Segue ™ Infusion Catheter is indicated for the delivery of therapeutic agents into the peripheral vasculature. It is not indicated for use in coronary or cerebral vasculature. It is not intended for use with thrombolytics. It is not intended for use with power injection pumps.
Testing
Physical testing of the product under simulated conditions included: dimensional inspection, deployment and recoil verification, marker band attachment, infusion flow rate, internal pressurization, bond strength, flexural fatigue strength, radial force and trackability. All testing results were within product engineering and marketing specifications.
Biocompatibility testing was performed on the sterile materials used in the construction of this infusion catheter. All materials passed the biocompatibility testing and are suitable for this application
1
Animal studies were conducted to assess placement of the device in a vessel as well as thrombus accumulation on the device. There were no adverse results reported.
Summary of Substantial Equivalence
The Segue ™ Infusion Catheter is constructed of the same or substantially equivalent materials as found in the predicate device. The sizes and configurations available are comparable as is the packaging methods and materials. The clinical indications for use are substantially equivalent to those of the predicate device. Because of the similarities in materials, construction, indications for use, packaging and testing results, this product does not raise any new safety or effectiveness issues.