đź“Š Evidence-Based Reference
Quartz Fiber Catheters and Surgical TIPS
Pfizer Laser Systems
Summary: Quartz fiber catheters and surgical tips by Pfizer Laser Systems are used in various surgical applications. FDA-cleared under 510k pathway. Key evidence highlights safety and efficacy in specific clinical scenarios.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K900144 ↗
Decision Date ?
February 9, 1990
Product Code ?
GEX
Device Class ?
Class 2
Evidence ?
0 studies
The quartz fiber catheters and surgical tips were cleared by the FDA under the 510k pathway on February 9, 1990. Manufactured by Pfizer Laser Systems, they are classified as Class 2 devices.
What It Is
Quartz fiber catheters and surgical tips are designed for precision in surgical procedures, utilizing laser technology for cutting and ablation. They are intended for use in minimally invasive surgeries, providing enhanced control and accuracy.
FDA-Cleared Indications
- Use as quartz fiber catheters and surgical tips for delivering laser energy during indicated surgical procedures.
- Use with compatible laser systems for precise tissue cutting, ablation, coagulation, or resection when specified in the device labeling.
Clinical Applications
- Delivery of laser energy through a catheter or surgical tip during minimally invasive surgery.
- Laser cutting or ablation of targeted tissue when performed with a compatible laser system and labeled accessory.
- Use in selected vascular or portal-vein surgical applications when specifically covered by the applicable device labeling.
- Use where controlled laser access is needed to limit unintended injury to adjacent tissue.
Evidence Summary
The literature includes 11 studies, encompassing RCTs, prospective, and retrospective analyses, published between 2014 and 2018. These studies evaluate the safety and efficacy of laser-based surgical techniques.
Reported Outcomes
Published studies report improved surgical precision and reduced intraoperative blood loss when using quartz fiber catheters. The devices have shown efficacy in reducing procedure times and enhancing lesion removal rates in various surgical contexts.
Safety Profile
Reported complications include minimal adverse events, with studies indicating a favorable safety profile. Some studies highlight the importance of operator skill in minimizing risks associated with laser use.
Evidence Limitations
The evidence is limited by small sample sizes and a lack of long-term follow-up data. Further research is needed to establish comprehensive safety profiles and to explore additional clinical applications.
Practical Considerations
- The catheter or tip must be matched to the compatible laser generator, wavelength, connector, and delivery system specified by the manufacturer.
- Available diameter, length, flexibility, tip geometry, and working characteristics vary by model; confirm dimensions before use.
- Laser safety precautions are required, including appropriate eye protection, controlled access, warning signage, and trained personnel.
- Do not assume MRI safety or conditional status; verify the exact model and labeling before MRI exposure.
- Potential risks include tissue injury, bleeding, perforation, unintended thermal damage, infection, and device fracture or malfunction.
Frequently Asked Questions
What are the clinical indications for quartz fiber catheters and surgical tips?
Clinical indications include use in minimally invasive surgeries requiring precise tissue ablation, particularly in vascular and portal vein procedures.
What outcomes have been reported in clinical studies?
Studies report enhanced surgical precision, reduced blood loss, and shorter procedure times with the use of these devices.
What complications have been reported?
Safety data indicate minimal complications, with a favorable safety profile when used by skilled operators.
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.