(248 days)
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No
The summary describes a physical medical device (catheter) for fluid delivery and details physical and biocompatibility testing. There is no mention of software, algorithms, image processing, or terms related to AI/ML.
Yes
The device is indicated for the delivery of "therapeutic agents" into the peripheral vasculature, which directly supports its role in therapy. While the device itself is a catheter, its intended use is to facilitate therapeutic processes.
No
The device is described as an infusion catheter for delivering therapeutic agents, not for diagnosing conditions. Its intended use and description focus on treatment delivery.
No
The device description and performance studies clearly indicate that this is a physical catheter device, not a software-only device. The testing includes physical properties like dimensional inspection, bond strength, and animal testing.
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 body), not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device is a catheter designed to deliver fluids into the body. This aligns with a therapeutic device, not a diagnostic one that analyzes samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory testing.
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 for treatment.
N/A
Intended Use / Indications for Use
The Flower™ 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 Flower™ Infusion Catheter is a multi-lumen, over-the-wire device designed to locally deliver fluids into the peripheral 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 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, trackability, and guide catheter compatibility. All testing results were within product engineering and marketing specifications.
Biocompatibility testing was performed on the sterile materials used in the construction of these infusion catheters. All materials passed the biocompatibility testing and are suitable for this application.
Animal testing was conducted to assess placement of the device in a vessel as well as thrombus accumulation on the device. All results were satisfactory.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
FasTRACKER® Infusion Catheter
Reference Device(s)
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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
AUG - 8 1996
510(k) Summary Flower™ Infusion Catheter
General Information
| Trade Name: | Flower™ Infusion Catheter |
|---|---|
| Classification Name: | Catheter, Percutaneous |
| Classification: | Class II |
| Submitted By: | Interventional Innovations Corp. |
| 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 Flower™ Infusion Catheter is a multi-lumen, over-the-wire device designed to locally deliver fluids into the peripheral vasculature.
Intended Use
The Flower™ 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, trackability, and guide catheter compatibility. All testing results were within product engineering and marketing specifications.
Biocompatibility testing was performed on the sterile materials used in the construction of these infusion catheters. All materials passed the biocompatibility testing and are suitable for this application.
1
Animal testing was conducted to assess placement of the device in a vessel as well as thrombus accumulation on the device. All results were satisfactory.
Summary of Substantial Equivalence
The Flower™ Infusion Catheter is constructed of the same or substantially equivalent materials to the predicate device. The sizes and configurations available along with the packaging and sterilization methods are also equivalent. 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.