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The Hansen Medical Sensei® Robotic Catheter System and Accessories are Intended to facilitate manipulation, positioning and control of Hansen Medical's robotically Steerable electrophysiological catheters for collecting electro-anatomic mapping and recording data within the heart atria with collecting mapping catheters: the Polarissystems, using the following percutaneous catheters made by Boston Scientific Corporation DX™ Steerable Diagnostic catheters made by St. Jude Medical.

The Hansen Medical Sensei Robotic Catheter System and Accessories, when used with compatible Control Catheters, are designed to facilitate manipulation, positioning and control of mapping percutaneous catheters within the atria of the heart. The fundamental concept of the system is based on a master-slave control system that enables and visualizes catheter tip at a desired point inside the heart, while enabling a physician to remain seated and away from the x-ray radiation source. The modifications to the Sensei Robotic Catheter System include the ability to import electroanotomic maps from a 3D party mapping system.

This 510(k) submission (K091808) for the Hansen Medical Sensei Robotic Catheter System does not contain a study that provides acceptance criteria and reported device performance in the way typically expected for a performance study evaluating diagnostic or therapeutic efficacy.

Instead, this is a Special 510(k) Submission for a modification to an already cleared device (K090365). The documentation focuses on demonstrating substantial equivalence to the predicate device, not on presenting new performance data against specific acceptance criteria. This type of submission would typically involve engineering analysis, bench testing, and sometimes limited animal or human use data to show that the modifications do not negatively impact safety or effectiveness or alter the fundamental scientific technology.

Therefore, the specific information requested cannot be fully extracted from the provided text, as the document does not describe a clinical performance study with acceptance criteria and results.

However, I can extract information related to the device's predicate, intended use, and the FDA's decision, which are relevant to its acceptance.

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, a formal table of acceptance criteria and reported device performance in the context of a validation study is not provided in this Special 510(k) summary. This type of submission relies on demonstrating that the modified device is substantially equivalent to a previously cleared device (K090365) and that the modifications do not raise new questions of safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided as there is no described clinical performance study with a 'test set' in the context of efficacy or diagnostic accuracy. The submission focuses on substantial equivalence based on prior clearance and potentially engineering testing for the modifications.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided as there is no described clinical performance study requiring expert ground truth establishment for a test set.

4. Adjudication Method for the Test Set

This information is not provided as there is no described clinical performance study requiring adjudication for a test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size

An MRMC comparative effectiveness study is not mentioned or described in the provided documents.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

A standalone algorithm performance study is not mentioned or described in the provided documents. The device is a "Robotic Catheter System" designed for physician control and manipulation of catheters.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not provided as there is no described clinical performance study requiring ground truth.

8. The Sample Size for the Training Set

This information is not provided as there is no described algorithm training set.

9. How the Ground Truth for the Training Set Was Established

This information is not provided as there is no described algorithm training set or ground truth establishment for it.

Summary of FDA's "Acceptance" (Substantial Equivalence Determination):

• Predicate Device: The modified Hansen Medical Sensei Robotic Catheter System (K091808) is deemed substantially equivalent to the earlier Sensei System (K090365).
• Basis for Equivalence: The modifications described "do not significantly affect the safety or effectiveness of the device or alter the fundamental scientific technology associated with the device."
• Intended Use: The modified device has the same intended use as the predicate: "to facilitate manipulation, positioning and control of Hansen Medical's robotically Steerable Electrophysiological Control Catheters of Hansen Medical or to facilitate manipulation, positioning and control of mapping percutaneous catheters within the atria of the heart to acquire electro-anatomic mapping and recording data within the heart atria with our existing mapping catheters: the Polaris X™ Steerable Diagnostic catheters made by Boston Scientific Corporation, and the DX-S™ Steerable Diagnostic catheters made by St. Jude Medical."
• FDA Limitation/Warning: The FDA imposed a critical labeling limitation: "The safety and effectiveness of this device for use with cardiac ablation catheters, in the treatment of cardiac arrhythmias including atrial fibrillation, have not been established." This warning must be prominently displayed on the device, packaging, and all promotional materials. This indicates a specific aspect where the device's performance (for ablation) was not accepted without further evidence.

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