(90 days)
FasTRACKER® Infusion Catheter (Target Therapeutics)
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No
The summary describes a physical medical device (catheter) for delivering solutions and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No
The device delivers solutions but does not inherently treat a condition. It is a tool for delivery, not a therapy itself.
No.
The document states that the device is an "Infusion Catheter" indicated for "delivery of solutions into the peripheral and coronary vasculature," which describes a therapeutic function rather than a diagnostic one.
No
The device description and performance studies clearly indicate this is a physical catheter, not a software-only device.
Based on the provided information, the Segue Infusion Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "delivery of solutions into the peripheral and coronary vasculature." This describes a device used within the body for therapeutic or diagnostic purposes related to the circulatory system.
- Device Description: The description confirms it's a catheter designed for local delivery of solutions into the vasculature.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a person's health. The information provided about the Segue Infusion Catheter does not mention any such use or interaction with specimens outside the body.
Therefore, the Segue Infusion Catheter is an in vivo device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Segue Infusion Catheter is indicated for the delivery of solutions into the peripheral and coronary vasculature.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The Segue Infusion Catheter is a single lumen, over-the-wire designed to locally deliver solutions into the peripheral and coronary 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 and coronary vasculature
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 the effects of the device on the vessel wall as well as thrombogenicity effects of the device. There were no adverse results reported.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Segue™ Infusion Catheter, FasTRACKER® Infusion Catheter (Target Therapeutics)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
1-14-97
Section 2 - Summary & Certification
A. 510(k) Summary
| Trade Name: | Segue™ Infusion Catheter |
|---|---|
| Classification Name: | Continuous Flush Catheter |
| 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: | Segue™ Infusion Catheter |
| FasTRACKER® Infusion Catheter (Target Therapeutics) |
Device Description
The Segue Infusion Catheter is a single lumen, over-the-wire designed to locally deliver solutions into the peripheral and coronary vasculature.
Intended Use
The Segue Infusion Catheter is indicated for the delivery of solutions into the peripheral and coronary vasculature.
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.
Animal studies were conducted to assess the effects of the device on the vessel wall as well as thrombogenicity effects of the device. There were no adverse results reported.
1
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.