📋 FDA Reference
Unipolar Lead Configuration Conductor
Daig
Summary: The unipolar lead configuration conductor by Daig is a medical device used primarily in cardiac pacing. It is utilized by cardiologists and electrophysiologists for patients requiring cardiac rhythm management.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K800348 ↗
Decision Date ?
May 28, 1980
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The unipolar lead configuration conductor was cleared via the FDA 510(k) pathway on May 28, 1980. Manufactured by Daig, it is classified as a Class 3 device under product code DTB.
What It Is
This device is a unipolar lead used in cardiac pacing systems. It consists of a single conductor that connects the pacemaker to the heart tissue, delivering electrical impulses to regulate heartbeats. Unipolar leads are known for their simplicity and flexibility, making them suitable for certain pacing scenarios. They are typically less bulky compared to bipolar leads, which can be advantageous in specific clinical situations.
FDA-Cleared Indications
- Use as a unipolar lead component in cardiac pacing systems.
- Provide electrical stimulation to the heart in patients requiring cardiac pacing for bradycardia, heart block, or other clinically indicated rhythm disorders.
- Connect a compatible cardiac pacemaker generator with the intended cardiac pacing site.
Clinical Applications
- Temporary or permanent cardiac pacing when a compatible unipolar pacing configuration is clinically selected.
- Pacing patients with bradycardia or heart block requiring rhythm support.
- Use during implantation or revision of a compatible cardiac pacemaker system.
- Placement by cardiology or electrophysiology teams in a hospital or specialized cardiac facility.
Practical Considerations
- Compatibility with the pacemaker generator, connector, lead dimensions, and intended pacing system must be confirmed before use.
- Unipolar systems may be more susceptible to electromagnetic interference and skeletal-muscle or myopotential sensing than bipolar systems.
- Lead placement and fixation require appropriate imaging, electrical testing, and assessment of pacing thresholds and sensing.
- MRI safety is not established from the provided FDA record; MRI should be performed only if the complete implanted system is specifically labeled as MR Conditional and all conditions are met.
- The record does not provide a specific size range, durability period, or universal contraindication list; clinicians should follow the device labeling and current pacemaker-system instructions.
Related Literature
The linked study evaluated a thin bipolar pacing lead, highlighting its reduced thickness and increased flexibility compared to traditional bipolar leads. The study found that the new design achieved a body diameter and flexibility similar to unipolar leads, potentially offering the benefits of both configurations. However, the study's focus on a bipolar lead limits direct applicability to unipolar leads, and further research would be needed to confirm these findings in unipolar configurations.
Frequently Asked Questions
What is a unipolar lead configuration conductor used for?
It is used for cardiac pacing to regulate heart rhythms in patients with arrhythmias or heart block.
What specialties typically use this device?
Cardiologists and electrophysiologists typically use this device in cardiac pacing procedures.
What are the FDA-cleared indications?
The device is indicated for use in patients requiring cardiac pacing due to arrhythmias or heart block.
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.