(81 days)
The Hansen Medical Sensel® X Robotic Catheter System and Accessories are intended to facilitate manipulation, positioning and control of Hansen Medical's robotically steerable catheters 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 Hansen Medical Sensei X Robotic Catheter System and Accessories, when used in conjunction with compatible Hansen 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 positioning of a steerable 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 X Robotic Catheter System include an enhancement to the motion scaling feature.
The provided document is a 510(k) summary for the Hansen Medical Sensei® X Robotic Catheter System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a performance study in the way one would expect for a new, non-substantially equivalent device.
Therefore, the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not present in this 510(k) summary.
Key takeaways from the document:
- Device: Hansen Medical Sensei® X Robotic Catheter System.
- Purpose: To facilitate manipulation, positioning and control of robotically steerable catheters for collecting electrophysiological data within the heart atria.
- Modification: An enhancement to the motion scaling feature.
- Predicate Device: Earlier Sensei System (K091808).
- Basis for Approval: Substantial equivalence, meaning the modified device performs as safely and effectively as the previously cleared (predicate) device, and the modifications do not affect its intended use or fundamental scientific technology.
Since the submission is a "Special 510(k)" for a modification, the focus is on demonstrating that the change does not raise new safety or effectiveness concerns, rather than conducting a full performance study as if it were a novel device. The FDA typically relies on the established safety and effectiveness of the predicate device.
To directly answer your questions based only on the provided text, many fields will be "Not Reported" or "Not Applicable" for this type of submission:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Reported | Not Reported |
| The device is considered "substantially equivalent" to its predicate, meaning it performs as safely and effectively. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not reported.
- Data Provenance: Not reported. (For a Special 510(k) focusing on a modification, often internal verification and validation data are used rather than clinical studies in the traditional sense, but the specifics are not disclosed here.)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not reported. This type of performance study for ground truth establishment is typically not part of a Special 510(k) submission for a device modification.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not reported.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a robotic catheter system, not an AI-assisted diagnostic tool. No human reader study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a robotic system, not a standalone algorithm. The performance evaluation focuses on the safety and functionality of the robotic system itself and its interaction with compatible catheters, implicitly with a human operator.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable/Not reported. The submission focuses on demonstrating substantial equivalence, often through engineering and functional testing rather than direct clinical ground truth comparison in the context of diagnostic accuracy.
8. The sample size for the training set
- Not applicable/Not reported. (This is not an AI/machine learning device that would have a "training set" in that context.)
9. How the ground truth for the training set was established
- Not applicable/Not reported.
§ 870.1290 Steerable catheter control system.
(a)
Identification. A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the motion of the steerable catheter.(b)
Classification. Class II (performance standards).