CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K221112 FDA 510(k)
- FDA Product Code
- DQK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1425 FDA 510(k)
- Regulation Number
- 870.1425 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) is a catheter-based electroanatomical mapping system designed for cardiac electrophysiology procedures. It integrates magnetic navigation and advanced catheter location technologies to create detailed 3D maps of cardiac chambers, enabling precise localization of arrhythmogenic substrates. This system is intended for use in both atrial and ventricular electrophysiological studies and ablation procedures, facilitating targeted interventions. The AFM feature enhances spatial resolution and focus mapping to improve procedural accuracy and outcomes.
The system is supplied as a reusable medical device and is intended for use in clinical electrophysiology laboratories. It requires integration with compatible catheters equipped with magnetic sensors and advanced catheter location technologies. The device is not classified as MRI-safe or MRI-conditional, and its use must adhere to standard electrophysiological laboratory protocols. Storage and handling follow manufacturer guidelines to maintain system integrity, and its regulatory status includes FDA 510(k) clearance under the Traditional pathway. No additional sterility or single-use specifications are indicated.
Frequently asked questions
What is the CARTO 3 EP Navigation System with AFM used for?
The CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) is designed for cardiac electrophysiology procedures, specifically electroanatomical mapping during atrial and ventricular electrophysiological studies and ablation. It uses magnetic navigation and advanced catheter location technologies to create highly detailed 3D maps of cardiac chambers, enabling precise localization of arrhythmogenic substrates. This helps clinicians perform targeted interventions with improved accuracy, reducing procedural risks and enhancing outcomes.
How is the CARTO 3 AFM system supplied and intended for use?
The CARTO 3 AFM system is supplied as a reusable medical device, intended for use in clinical electrophysiology laboratories. It requires integration with compatible catheters equipped with magnetic sensors and advanced location technologies. The system is not meant for standalone use but must be paired with these specific catheters to function effectively. Its design aligns with standard electrophysiological laboratory protocols, ensuring safe and accurate procedural navigation.
Is the CARTO 3 AFM system MRI-safe or MRI-conditional?
No, the CARTO 3 AFM system is not classified as MRI-safe or MRI-conditional. This means it should not be used in or near MRI environments, as its components may interact unpredictably with magnetic fields. Procedures involving this system must adhere strictly to standard electrophysiological laboratory protocols to avoid exposure to MRI equipment.
What storage and handling guidelines apply to the CARTO 3 AFM system?
The CARTO 3 AFM system requires adherence to manufacturer-provided storage and handling guidelines to maintain its integrity and functionality. These guidelines typically include proper environmental conditions (e.g., temperature, humidity), protection from physical damage, and regular maintenance as specified in the user manual. Following these protocols ensures the system remains reliable for accurate electroanatomical mapping during procedures.
How does the Advanced Focus Mapping (AFM) feature improve procedural outcomes?
The Advanced Focus Mapping (AFM) feature enhances the CARTO 3 system by improving spatial resolution and focus mapping capabilities. This allows clinicians to achieve finer detail in 3D cardiac chamber visualization, enabling more precise identification of arrhythmogenic substrates. By refining the localization of abnormal electrical activity, AFM helps guide targeted ablation therapies, potentially reducing procedure time and improving long-term success rates for patients.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: CARTO - The Agentic GIS Platform, 3D Navigation System | Biosense Webster | J&J MedTech, Carto (company) - Wikipedia, CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM), CARTO™ System | J&J MedTech US - Johnson & Johnson Medical Devices
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221112 | Class II | Active |
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Manufacturer
- Manufacturer
- Biosense Webster Inc
- FDA Applicant
- Biosense Webster, Inc.
Sources (1)
- FDA 510(k) K221112 24 fields · synced Oct 1, 2026