(88 days)
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.
This document is a 510(k) summary for a medical device (Cordis Avanti™ Trans-Radial Sheath Introducer Kit). It describes the device, its intended use, and its equivalence to predicate devices. However, it does not contain any information about acceptance criteria, device performance metrics, or any study design that would prove the device meets specific performance criteria.
Therefore, I cannot provide the requested information. The provided text is a regulatory submission focused on demonstrating substantial equivalence to existing devices, not a performance study report with specific acceptance criteria and results.
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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-RadialIntroducer Kit |
| Proprietary Name: | Cordis AvantiTM Trans-Radial SheathIntroducer Kit |
| Applicant Name and Address: | CordisP.O. Box 025700Miami, 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.
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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.
§ 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).