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percutaneous introducer kit
Accu-Line
Summary: The percutaneous introducer kit by Accu-Line is a medical device used primarily for venous access. It is FDA-cleared and supported by 13 studies, highlighting its utility in reducing infection rates in procedures like PEG.
FDA Clearance Information
Pathway
510K
Number
K831636 ↗
Decision Date
August 24, 1983
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The percutaneous introducer kit by Accu-Line received FDA clearance through the 510(k) pathway on August 24, 1983. It is classified as a Class 2 device under product code DQY.
What It Is
The percutaneous introducer kit is designed for facilitating venous access, commonly used in procedures requiring the insertion of catheters or stents. It provides a minimally invasive approach to access the vascular system.
Clinical Applications
This device is frequently used in clinical scenarios requiring percutaneous access, such as the placement of venous stents or feeding tubes. It is particularly useful in patients with conditions that necessitate long-term vascular access.
Evidence Summary
The available literature includes 13 studies, comprising randomized controlled trials, prospective and retrospective analyses, and case series. These studies span from 2012 to 2023, providing a comprehensive overview of the device's clinical utility.
Reported Outcomes
Published studies report that the percutaneous introducer kit is effective in reducing peristomal infection rates in PEG procedures. It has been shown to facilitate safe and efficient access in patients with upper digestive tract stenosis.
Safety Profile
Reported complications include peristomal infections, which have been reduced with the use of systemic prophylactic antibiotics. The device has been associated with lower complication rates compared to traditional methods.
Evidence Limitations
The evidence is limited by the variability in study designs and the relatively small sample sizes in some studies. Further research is needed to explore long-term outcomes and the device's efficacy in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for percutaneous introducer kit?
The device is indicated for procedures requiring venous access, such as the placement of venous stents and feeding tubes, particularly in patients with upper digestive tract stenosis.
What outcomes have been reported in clinical studies?
Studies have reported reduced peristomal infection rates and effective access in patients with upper digestive tract stenosis when using the percutaneous introducer kit.
What complications have been reported?
Safety data indicate that complications include peristomal infections, which are mitigated by systemic prophylactic antibiotics.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.