(88 days)
Not Found
No
The 510(k) summary describes a standard catheter sheath introducer and makes no mention of AI, ML, image processing, or any related performance metrics or training/test data.
No
The device is described as an introducer kit for percutaneous introduction of catheters and other intravascular devices, and for vascular access, hemostasis, fluid infusion, and blood withdrawal. These are procedural tools, not devices that directly treat a disease or condition.
No
Explanation: The device is described as an introducer and sheath for percutaneous introduction of catheters and other intravascular devices, and for maintaining hemostasis and infusing/withdrawing fluids. Its function is to facilitate medical procedures, not to diagnose a condition.
No
The device description clearly describes a physical medical device (catheter sheath introducer kit) with components like a valve and sideport, 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 clearly states it's for "percutaneous introduction of catheters and other intravascular devices" in arterial procedures. This describes a device used in vivo (within the body) for accessing blood vessels.
- Device Description: The description focuses on providing vascular access, maintaining hemostasis, and allowing fluid infusion/blood withdrawal. These are all functions related to accessing and managing blood flow within the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples outside the body (in vitro) to diagnose a condition, monitor a treatment, or screen for diseases. IVDs typically involve reagents, assays, or instruments used to test biological samples like blood, urine, or tissue.
Therefore, the Avanti™ Trans-Radial Catheter Sheath Introducer kit is a medical device used for accessing the vascular system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AvantiTM Trans-Radial Catheter Sheath Introducer kit is intended for use in (radial) arterial procedures requiring percutaneous introduction of catheters and other intravascular devices. As with other currently marketed Cordis CSIs mentioned in this submission, these devices provide vascular access for various intravascular devices through the valve while simultaneously maintaining hemostasis. Infusion of fluids into the vasculature and withdrawal of blood from the vasculature are possible using the sheath sideport.
Product codes
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Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
radial arterial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
K945616, K932733, K911794, K810675
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
OCT 11 1996
Summary of Safety and Effectiveness Pursuant to Section 513(I) of the Federal Food, Drug, and Cosmetic Act
General Provisions I.
| Classification Name: | Catheter Sheath Introducer (CSI) Kit |
|---|---|
| Common or Usual Name: | Sheath Introducer Kit or Trans-Radial |
| Introducer Kit | |
| Proprietary Name: | Cordis AvantiTM Trans-Radial Sheath |
| Introducer Kit | |
| Applicant Name and Address: | Cordis |
| P.O. Box 025700 | |
| Miami, FL 33015-5700 |
II. Name of Predicate Devices
| Cordis Avanti™ Catheter Sheath Introducer | K945616 and K932733 |
|---|---|
| Cordis Plus Catheter Sheath Introducer | K911794 |
| Arrow Radial Artery Catheterization Set | K810675 |
III. Classification
Catheter Sheath Introducer Kits are Cardiovascular Diagnostic Devices and are classified as Class II devices according to 21 CFR 870.1340.
IV. Performance Standards
Performance standards have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act.
1
V. Intended Use and Device Description
The Avanti™ Trans-Radial Catheter Sheath Introducer kit is intended for use in (radial) arterial procedures requiring percutaneous introduction of catheters and other intravascular devices. As with other currently marketed Cordis CSIs mentioned in this submission, these devices provide vascular access for various intravascular devices through the valve while simultaneously maintaining hemostasis. Infusion of fluids into the vasculature and withdrawal of blood from the vasculature are possible using the sheath sideport.
VI. Biocompatibility
All appropriate biocompatibility tests were performed on the new material used for the Trans-Radial CSI Kit. All other materials were tested on previously concurred devices and passed.
VII. Summary of Substantial Equivalence
Except for the site of entry (radial instead of femoral) and the addition of the radial vessel dilator and needle (thus making it a complete kit), the Cordis Avanti™ Trans-Radial Catheter Sheath Introducer Kit has the same intended use as other sheath introducers already on the market (i.e., Cordis Avanti™ CSI and Cordis Plus CSI). In addition, the Avanti™ Trans-Radial CSI Kit is similar in its basic design, construction, and indication for use to currently marketed catheter sheath introducer systems.