đź“‹ FDA Reference
Pacer Sensing Analyzer Psa 100
Oscor Medical
Summary: The Pacer Sensing Analyzer PSA 100 is a medical device used to assess pacemaker functionality. It is primarily used by cardiologists and electrophysiologists to ensure proper pacemaker operation.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K882327 ↗
Decision Date ?
October 6, 1988
Product Code ?
DTC
Device Class ?
Class 2
Evidence ?
0 studies
The Pacer Sensing Analyzer PSA 100 was cleared by the FDA through the 510(k) pathway on October 6, 1988. It is manufactured by Oscor Medical and classified as a Class 2 device.
What It Is
The Pacer Sensing Analyzer PSA 100 is a diagnostic tool used to evaluate the performance of pacemakers. It measures the electrical signals from the heart and the pacemaker, ensuring the device is functioning correctly. This analyzer is crucial for detecting any malfunctions or adjustments needed in pacemaker settings.
FDA-Cleared Indications
- For evaluation of pacemaker sensing and pacing function in patients with implanted pacemakers.
- For assessing electrical signals from the heart and pacemaker system to support verification of proper operation.
Clinical Applications
- Testing pacemaker sensing and pacing during pacemaker implantation.
- Evaluating pacemaker function during routine follow-up visits.
- Identifying possible pacemaker sensing, pacing, or connection problems.
- Supporting clinician adjustments to pacemaker settings when indicated.
Practical Considerations
- Use requires appropriate connections, leads, and knowledge of the specific pacemaker system being evaluated.
- Compatibility should be confirmed for the pacemaker model, connector type, and testing configuration before use.
- The analyzer is operated by trained cardiac or electrophysiology personnel; readings should be interpreted with the patient's clinical findings and other device-testing information.
- The available record does not establish that the analyzer itself is MRI safe or MR conditional. Do not bring it into an MRI environment unless current manufacturer labeling specifically permits it.
- The device evaluates pacemaker performance but does not replace clinical assessment, electrocardiography, imaging, medication, or surgical treatment when those are needed.
Frequently Asked Questions
What is the Pacer Sensing Analyzer PSA 100 used for?
It is used to assess and ensure the proper functioning of pacemakers by measuring electrical signals from the heart and the pacemaker.
What specialties typically use this device?
Cardiologists and electrophysiologists primarily use this device in both hospital and outpatient settings.
What are the FDA-cleared indications?
The device is indicated for use in patients with pacemakers to verify their functionality and make necessary adjustments.
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.