(271 days)
No
The device description and performance studies focus on the physical properties and function of a vascular introducer sheath and dilator, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device facilitates catheter insertion, which is a procedural step, not a therapeutic action in itself.
No
The device is an introducer sheath and dilator used to facilitate the insertion of catheters into the vascular system. It does not perform any diagnostic function.
No
The device description clearly details physical components (sheath, dilator) made of materials like High Density Polyethylene and PTFE, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "obtain central ventral venous chipel catheter insertion into the central venous system." This describes a procedure for accessing the vascular system to insert a catheter, which is a therapeutic or interventional procedure, not a diagnostic test performed on a sample outside the body.
- Device Description: The device is described as a "peel-able introducer sheath and vessel dilator" used to "obtain vascular access and facilitate intravascular catheter insertion." This aligns with a device used for a medical procedure, not for analyzing a biological sample.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (like blood, urine, tissue, etc.) to provide diagnostic information. The device's function is purely mechanical – to create an opening for catheter insertion.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Vascu-Sheath® II introducers are intended to obtain central venous access to facilitate catheter insertion into the central venous system.
VASCU-SHEATH II® II INTRODUCERS ARE INTENDED TO OBTAIN CENTRAL VENTRAL VENOUS CHIPEL CATHETER INSERTION INTO THE CENTRAL VENOUS SYSTEM.
Product codes
DYB
Device Description
The Medcomp Vascu-Sheath® II is a two-part single use device used to obtain vascular access and facilitate intravascular catheter insertion. The Medcomp Vascu-Sheath® II consists of a peel-able introducer sheath and vessel dilator. The dilator is comprised of a cylindrical tube with a hub; the sheath is also a cvlindrical tube with a hub. The dilator extends beyond the sheath to provide a zero tolerance clearance between sheath and dilator. The device is available in three dilator lengths, 5cm, 10cm and 13.5cm and a range of French sizes from 5F thru 7F for the 5 and 10cm lengths and 5F thru 18F for the 10cm length. The sheath and dilator when used in conjunction with an introducer needle and guidewire provide a means to obtain a percutaneous opening to the vascular system to facilitate the insertion of a catheter. After removing the dilator a catheter can then be placed through the sheath. Breaking the sheaths hub and peeling the sheath away from the catheter then allows the sheath to be removed. The dilator is composed of a High Density Polyethylene with Barium Sulfate in the dilator for visibility under fluoroscopy by the attending physician during insertion. The sheath is composed of PTFE to provide a smooth, consistent peel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central venous system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
attending physician
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
In Vitro performance data for the Medcomp Vascu-Sheath® II, including peel force, demonstrates that this device is substantially equivalent to the legally marketed device.
Clinical studies were not deemed necessary since in-vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to the legally marketed predicate device.
Key Metrics
Not Found
Predicate Device(s)
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).
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