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Model 5311b A-V Pacing System Analyzer
Medtronic Vascular
Summary: The Model 5311b A-V Pacing System Analyzer by Medtronic Vascular is used to evaluate the performance of pacemakers. It is primarily utilized by cardiologists and electrophysiologists in clinical settings.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K910595 ↗
Decision Date ?
May 7, 1991
Product Code ?
DTC
Device Class ?
Class 2
Evidence ?
0 studies
The Model 5311b A-V Pacing System Analyzer was cleared through the FDA 510k pathway on May 7, 1991. Manufactured by Medtronic Vascular, it is classified as a Class 2 device under product code DTC.
What It Is
The Model 5311b A-V Pacing System Analyzer is a diagnostic tool designed to assess the functionality of atrioventricular pacemakers. It measures parameters such as pacing thresholds, lead impedance, and sensing capabilities. This device is essential for ensuring the optimal performance of pacemakers and is used during implantation and follow-up evaluations.
FDA-Cleared Indications
- For analysis and assessment of atrioventricular pacemaker systems.
- For measuring pacing-system parameters, including pacing thresholds, lead impedance, and sensing performance.
- For use during pacemaker implantation and evaluation of existing pacemaker systems.
Clinical Applications
- Testing atrial and ventricular pacing thresholds during pacemaker implantation.
- Measuring pacemaker lead impedance to assess lead and connection integrity.
- Evaluating sensing of intrinsic cardiac activity by pacemaker leads.
- Checking pacemaker-system function during follow-up evaluation.
- Supporting programming or adjustment decisions based on measured pacing-system parameters.
Practical Considerations
- The analyzer is intended for use by trained cardiac electrophysiology or pacemaker-implantation personnel.
- Compatibility depends on the pacemaker generator, lead configuration, connectors, and testing requirements; clinicians should verify compatibility before use.
- The device is an external testing analyzer, not an implanted pacemaker or lead.
- Use requires appropriate sterile technique and electrical safety precautions when connected to implanted or newly implanted leads.
- The available FDA record does not establish MRI compatibility for the analyzer; MRI use should be addressed according to current manufacturer labeling and institutional policy.
Frequently Asked Questions
What is the Model 5311b A-V Pacing System Analyzer used for?
It is used to evaluate and optimize the performance of atrioventricular pacemakers.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in clinical settings.
What are the FDA-cleared indications?
The device is indicated for assessing and optimizing pacemaker function in patients requiring cardiac pacing.
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.