(52 days)
The Hansen Medical Magellan Robotic System and accessory components are intended to be used to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices.
The Magellan Robotic System is intended to be used with compatible Hansen Medical robotically steerable catheters.
The Hansen Medical Magellan Robotic System and accessory components are designed to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. 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 vasculature, while enabling a physician to remain seated and away from the x-ray radiation source. The modification adds a mechanical joint between the Magellan Robotic System Rail and Adapter Plate to facilitate removal.
The Magellan Robotic System and accessory components are compatible with Hansen Medical robotically steerable catheters approved under previous 510(k)s.
This document describes a 510(k) premarket notification for the Hansen Medical Magellan Robotic System, which is a steerable catheter control system. The submission is for a modification to an already cleared device (K132369).
Here's the breakdown of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Visual and Dimensional Verification Testing | All pre-determined acceptance criteria were met. |
| IEC 606061-1 Testing | All pre-determined acceptance criteria were met. |
| Table Compatibility | All pre-determined acceptance criteria were met. |
| Life cycle Testing | All pre-determined acceptance criteria were met. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail specific sample sizes for the visual, dimensional, IEC, table compatibility, or life cycle testing. It simply states that testing was performed and all pre-determined acceptance criteria were met. The data provenance is not explicitly mentioned (e.g., country of origin or retrospective/prospective). Given that the testing categories are related to engineering and regulatory standards, it's highly likely this was internal, prospective testing performed by the manufacturer or a contracted lab.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. The testing described (visual, dimensional, IEC, table compatibility, life cycle) are engineering and technical verification tests, not clinical performance tests requiring expert ground truth establishment for a test set in the traditional sense of AI/clinical studies.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human readers or clinical adjudication. The acceptance criteria were met based on the results of the specified engineering and technical tests.
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
No MRMC comparative effectiveness study was performed or described. This submission is for a robotic system for facilitating navigation in the peripheral vasculature, not an AI-assisted diagnostic or interpretative device that would typically involve human readers. The document explicitly states: "No additional clinical evaluation of the Magellan Robotic System is required as a result of these changes."
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not directly applicable in the context of an algorithm's standalone performance for diagnostic or interpretive tasks. The "device" itself (the Magellan Robotic System) operates in a master/slave control system with a physician-in-the-loop for navigation. The testing performed was "Design verification testing," which focuses on the device's technical specifications and adherence to standards rather than an algorithm's standalone clinical accuracy.
7. The Type of Ground Truth Used
The "ground truth" for the engineering and technical tests would be the established specifications, standards (e.g., IEC 606061-1), and design requirements for the device. For example, for dimensional verification, the ground truth would be the engineering drawings and specified tolerances. For IEC testing, the ground truth would be the pass/fail criteria defined by the standard.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML product developed using a training set in the typical sense. It is a robotic system with physical and operational characteristics verified through engineering tests.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device and submission.
§ 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).