(80 days)
K 9954595, K 945616
K 9954595, K 945616
No
The summary describes a standard catheter sheath introducer and makes no mention of AI or ML capabilities.
No
The device is a catheter sheath introducer used for vascular access, which is a diagnostic or interventional support function, not a therapeutic treatment itself.
No
The device is described as an introducer sheath for percutaneous introduction of catheters and other intravascular devices for arterial and venous procedures, indicating an interventional or access role rather than a diagnostic one. It facilitates access for procedures, but doesn't itself perform a diagnostic function.
No
The device description clearly describes a physical catheter sheath introducer, which is a hardware 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 the device is for "percutaneous introduction of catheters and other intravascular devices" in arterial and venous procedures. This describes a device used within the body for accessing blood vessels, not a device used to test samples outside the body.
- 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 manipulating the vascular system in vivo.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
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 purely procedural and related to accessing the vascular system.
N/A
Intended Use / Indications for Use
The Avanti + Catheter Sheath Introducer is indicated for use in arterial and venous 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
Not Found
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
K 9954595, K 945616
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).
0
00-00035
PREMARKET NOTIFICATION 510(k) Cordis Corporation Avanti + Catheter Sheath Introducer
SUMMARY OF SAFETY AND EFFECTIVENESS
APR 24 1997
l. General Provisions
Common or Usual Name: Catheter Sheath Introducer or Sheath Introducer System
Proprietary Name: Cordis Avanti + Catheter Sheath Introducer System
.. Name of Predicate Devices
Brite Tip Catheter Sheath Introducer, K 9954595, October 02, 1995 Avanti™ Catheter Sheath Introducer, K 945616, November 14, 1994
III. Classification
ﺔ ﺍﻟﻤ
Class II
Performance Standards IV.
Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act.
V. Intended Use and Device Description
The Avanti + Catheter Sheath Introducer is indicated for use in arterial and venous 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 previously performed on the materials used for the Cordis Avanti + Catheter Sheath Introducer. No new tests were performed, since all materials had been successfully tested on previously concurred devices.
1
00-00036
PREMARKET NOTIFICATION 510(k) Cordis Corporation Avanti + Catheter Sheath Introducer
VII. Summary of Substantial Equivalence
ﮯ ﮐﮧ ﺍﯾﮏ ﺭﮨﺎﺋﺸﯽ ﮐﮯ ﺷﮩﺮ
ﺷﮩﺮ
The Cordis Avanti + Catheter Sheath Introducer is similar in design, construction, indication for use, and performance characteristics to other commercially available sheath introducers.