đź“Š Evidence-Based Reference
pacepath model 810
Pacesetter Systems
Summary: The Pacepath Model 810 is a medical device used in clinical settings, primarily for managing cardiac conditions. Key evidence includes studies on predictive models for atrial fibrillation and delirium in ICU patients.
FDA Clearance Information
Pathway
510K
Number
K801416 ↗
Decision Date
October 31, 1980
Product Code
DTB
Device Class
Class 3
Evidence
0 studies
The Pacepath Model 810 was cleared by the FDA through the 510(k) pathway on October 31, 1980. It is manufactured by Pacesetter Systems and classified as a Class III device.
What It Is
The Pacepath Model 810 is a clinician-facing device designed for use in cardiac care. It is intended to assist in the management of heart rhythm disorders, providing critical data to inform treatment decisions.
Clinical Applications
Commonly used in scenarios involving cardiac arrhythmias, the Pacepath Model 810 is integral in monitoring and managing conditions such as atrial fibrillation. It provides real-time data that aids in clinical decision-making.
Evidence Summary
The literature includes 10 studies, predominantly from 2025, covering various predictive models and risk assessments. These studies encompass a range of methodologies, including retrospective analyses and systematic reviews.
Reported Outcomes
Published studies report advancements in predictive modeling for conditions such as atrial fibrillation and delirium in ICU patients. These models enhance the ability to anticipate and manage postoperative complications, improving patient outcomes.
Safety Profile
Reported complications include the potential for inaccurate predictions in certain patient populations, highlighting the need for careful interpretation of data. No direct adverse events related to the device itself were noted in the studies.
Evidence Limitations
The evidence base is limited by a focus on predictive modeling rather than direct device efficacy. Further research is needed to validate these models across diverse patient populations and to explore direct clinical outcomes associated with device use.
Frequently Asked Questions
What are the clinical indications for Pacepath Model 810?
The device is indicated for use in managing cardiac arrhythmias, particularly in scenarios requiring detailed monitoring and data analysis.
What outcomes have been reported in clinical studies?
Studies have reported improved predictive capabilities for atrial fibrillation and delirium, aiding in better management of these conditions.
What complications have been reported?
Safety data indicate potential inaccuracies in predictive models, necessitating cautious data interpretation. No direct device-related adverse events were reported.
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.