(59 days)
Magellan Robotic System: 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.
Magellan Robotic Catheter 9Fr. The Hansen Medical Magellan Robotic Catheter 9Fr is 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 Catheter 9Fr is intended to be used with the Hansen Medical Magellan Robotic System and accessories.
The Hansen Medical Magellan Robotic System and Magellan Robotic Catheter 9Fr 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 modifications to the Magellan System were made to expand system-quide wire compatibility, provide alternate quide wire navigation using the Master Input Device in addition to the existing Workstation and Bedside Controllers and to provide support for future compatible Hansen vascular catheters.
This document describes a Special 510(k) submission for modifications to the Hansen Medical Magellan Robotic System and Magellan Robotic Catheter 9Fr. This type of submission focuses on demonstrating that the modified device remains substantially equivalent to the previously cleared predicate device, rather than proving new clinical effectiveness. Therefore, the information typically associated with studies proving device performance against acceptance criteria (like sample sizes, ground truth establishment, or clinical effectiveness studies) is largely absent or stated as not required.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list quantitative acceptance criteria in a table format with specific performance metrics (e.g., sensitivity, specificity, accuracy) for an AI/algorithm-based device. This is because the submission is for a robotic catheter system, not an AI diagnostic tool.
Instead, the "acceptance criteria" are implied by the comprehensive design verification and validation testing performed to ensure the modified system continues to meet design specifications and customer requirements. The reported device performance is that it successfully passed these tests and was found to be substantially equivalent to the predicate device.
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| System Set Up | Test Passed |
| Catheter Installation | Test Passed |
| System-Guide Wire Compatibility | Test Passed |
| Procedure Simulation (Catheter & Guide Wire Navigation) | Test Passed |
| Magellan Catheters Drive Modes | Test Passed |
| User Interface | Test Passed |
| 3D Controller | Test Passed |
| System Status and Error Message Handling | Test Passed |
| System Power Cycle | Test Passed |
| Emergency and Configuration | Test Passed |
| Electrical Safety | Test Passed |
| Risk analysis (ISO 14971 compliance) | Activities Completed |
| Substantial Equivalence to Predicate Device | Demonstrated through non-clinical testing and comparison of characteristics, indicating successful performance in all modified aspects. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of an AI algorithm with data samples. The testing described is verification and validation of a physical/software system. Therefore, details like country of origin or retrospective/prospective data are not applicable. The testing would involve a combination of simulated scenarios, bench testing, and potentially animal/cadaveric studies (though not detailed here for this specific submission).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The "ground truth" for a robotic catheter system's performance is typically established through engineering specifications, regulatory standards, and objective measurements during verification and validation testing, not through expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, which is not the primary focus of this submission for a robotic system.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC study was done, nor would it typically be expected for this type of device modification submission. The device is a robotic system to facilitate navigation, not a diagnostic tool that humans would use to interpret cases. The focus is on the functional equivalence of the system, not on comparing human reading performance with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This is not applicable. The Magellan system is a master/slave control system, inherently designed for human-in-the-loop operation. It is not an autonomous algorithm operating without human intervention for diagnostic or treatment decisions.
7. The Type of Ground Truth Used
The "ground truth" for the verification and validation tests performed for this robotic system would be based on:
- Engineering Specifications: Whether the system performs according to its design parameters (e.g., catheter tip movement, guide wire compatibility).
- Customer Requirements: Whether the system meets the functional needs for which it was designed.
- Regulatory Standards: Compliance with relevant standards like electrical safety (implied by "Electrical Safety Test") and risk management (ISO 14971).
- Performance against Predicate Device: Demonstration of substantial equivalence in intended use, technological characteristics, and safety/effectiveness.
8. The Sample Size for the Training Set
This is not applicable. The Magellan system is not an AI/machine learning model in the sense of requiring a "training set" of data samples. Its software modifications relate to system functionality, user interface, and compatibility, not learning from a dataset.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no "training set." The software modifications were likely developed and tested against established engineering requirements and functional specifications based on the device's intended use and the predicate device's performance.
§ 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).