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The Hansen Medical Artisan S Control Catheter is intended to facilitate manipulation, positioning and control, for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems, using the following percutaneous mapping catheters: the Polaris-Dx™ Steerable Diagnostic catheters made by Boston Scientific Corporation and the Livewire™ Electrophysiology catheters made by St. Jude Medical.

The Control Catheter is intended to be used with the Hansen Medical Sensei® Robotic Catheter System.

The Hansen Medical Artisan S Control Catheter is designed to facilitate manipulation, positioning and control of mapping percutaneous catheters within the atria of the heart. The Control Catheter consists of an Inner Guide and an Outer Guide Catheter. The Control Catheter is designed to be used with the Hansen Medical Sensei® Robotic Catheter System.

The provided text is a 510(k) summary for the Hansen Medical Artisan S Control Catheter. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, device performance testing, study design, sample sizes, ground truth establishment, or expert involvement, as these are typically detailed in the full 510(k) submission, not the public summary.

Therefore, I cannot fulfill your request for specific details about the acceptance criteria and the study that proves the device meets them based solely on the provided text.

The document states:

• Device Information: Hansen Medical Artisan S Control Catheter
• Intended Use: To facilitate manipulation, positioning, and control for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems, using specific percutaneous mapping catheters (Polaris-Dx™ and Livewire™). Intended for use with the Hansen Medical Sensei® Robotic Catheter System.
• Predicate Device: Hansen Medical Steerable Guide Catheter (SGC) and Sheath ("Artisan Control Catheter") (K073225).
• Comparison to Predicate: The Artisan S Control Catheter is a "minor modification" to the predicate, with modifications not affecting intended use or fundamental scientific technology.
• Substantial Equivalence: Based on indications for use and "design and engineering data provided in this pre-market notification," it has been shown to be substantially equivalent.

Key Missing Information (which would be in the full 510(k) submission, but not in this summary):

• Acceptance Criteria Table: No specific performance metrics or acceptance criteria are listed.
• Reported Device Performance: No test results or performance data are provided.
• Sample Sizes/Data Provenance for Test Set: Not mentioned.
• Number of Experts/Qualifications for Ground Truth: Not applicable as no specific test data or ground truth seems to be discussed in the summary.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: No mention of such a study.
• Standalone Performance: Not explicitly stated, but the summary focuses on comparing it to a predicate rather than detailed performance numbers.
• Type of Ground Truth: Not mentioned.
• Training Set Sample Size/Ground Truth Establishment for Training Set: Not applicable as this is not an AI/machine learning device; it's a medical device (catheter). The concept of "training set" is not relevant here.

The document indicates that the substantial equivalence was based on "design and engineering data," which would include bench testing, biocompatibility, sterilization validation, etc., but these details are not provided in this 510(k) summary. The FDA's letter (K090365 page 2/2) confirms the substantial equivalence determination and establishes a labeling limitation regarding its use with cardiac ablation catheters for treating arrhythmias. This limitation suggests that efficacy for these specific applications was not established.

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