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Criterion II Pacing System Monitors
Dart Medical Equipment
Summary: The Criterion II Pacing System Monitors by Dart Medical Equipment are used for cardiac pacing. Cleared by the FDA via 510k in 1980, they are primarily used in scenarios requiring pacing support. Key evidence highlights the need for careful patient selection to ensure long-term efficacy.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K800286 ↗
Decision Date ?
March 12, 1980
Product Code ?
DTC
Device Class ?
Class 2
Evidence ?
0 studies
The Criterion II Pacing System Monitors were cleared by the FDA through the 510k pathway on March 12, 1980. Manufactured by Dart Medical Equipment, they are classified as Class 2 devices under product code DTC.
What It Is
The Criterion II Pacing System Monitors are medical devices designed to provide cardiac pacing. They are intended for use in patients requiring pacing support, particularly in cases where single lead VDD pacing is appropriate.
FDA-Cleared Indications
- Provide cardiac pacing for patients who require pacing support.
- Provide single-lead VDD pacing when this pacing mode is clinically appropriate.
Clinical Applications
- Pacing support for selected patients with clinically significant bradycardia.
- Single-lead VDD pacing in appropriately selected patients.
- Pacing in situations where ventricular pacing with atrial sensing is indicated.
Evidence Summary
The available literature includes two studies, one from 2003 and another with unspecified date, covering various aspects of pacing system efficacy and feasibility. The studies include a mix of RCTs, prospective, and retrospective analyses.
Reported Outcomes
Published studies report that the Criterion II Pacing System Monitors are effective in providing long-term pacing support when patients are carefully selected. The studies emphasize the importance of pre-implant assessments to ensure adequate long-term function.
Safety Profile
Reported complications include the potential need for reprogramming or upgrading the pacemaker system in cases of atrial undersensing or atrial fibrillation. No specific adverse events were detailed in the provided evidence.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of detailed safety outcomes. Further research is needed to explore long-term safety and efficacy in diverse patient populations.
Practical Considerations
- Patient selection is important because VDD pacing requires reliable atrial sensing and may not be appropriate for every pacing indication.
- Confirm compatibility with the intended lead system, connectors, programmer, and other cardiac pacing equipment before use.
- The available record does not provide current device dimensions, lead sizes, battery specifications, or MRI-conditional labeling; consult the original labeling and manufacturer documentation.
- Assess for contraindications to transvenous pacing, including active infection, unsuitable venous access, or inability to safely place and maintain a pacing lead.
- Use continuous electrocardiographic and hemodynamic monitoring during implantation, testing, and follow-up.
Frequently Asked Questions
What are the clinical indications for Criterion II Pacing System Monitors?
The clinical indications include scenarios requiring cardiac pacing support, particularly in patients with sinus node dysfunction or atrial fibrillation.
What outcomes have been reported in clinical studies?
Clinical studies report effective long-term pacing support with careful patient selection and pre-implant assessments.
What complications have been reported?
Safety data indicate potential complications such as the need for reprogramming or upgrading the pacemaker system due to atrial undersensing or atrial fibrillation.
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.