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The Hansen Medical Magellan™ Robotic Catheter eKit is intended 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 eKit is intended to be used with the Hansen Medical Magellan™ Robotic System and accessories.

The Hansen Medical Magellan™ Robotic Catheter eKit (MRC eKit) incorporates Microcatheter Driver components to be used in conjunction with the Magellan Robotic Catheter 6Fr (MRC 6Fr ) cleared under K515463. Both the predicate device (MRC 6Fr) and the MRC eKit are comprised of a Guide (Outer Catheter) with dual bend articulating sections (distal and proximal) paired with a non-articulating Leader. The devices are both provided in two lengths (60cm and 95cm) and have been designed to be used with Hansen Medical Magellan Robotic System. Both the MRC 6Fr and the MRC eKit are intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices.

The MRC eKit is comprised of the Hansen Medical 6Fr Guide catheter that is found in the commercialized product MRC 6Fr, and Microcatheter Driver components. The Microcatheter Driver components include a Microcatheter Support, a Microcatheter Driver base, a Connector Tube, a Support Tube packaged with and for use with the Leader, and a Microcatheter Valve. These components function the same as the Wire Support in the MRC 6Fr device to robotically insert and retract the Leader. Modifications have been made to now allow for robotic insertion and retraction of third-party inner catheters / microcatheters compatible with 5F Guiding catheters (

Here's an analysis of the provided text regarding the acceptance criteria and study for the Hansen Medical Magellan Robotic Catheter eKit:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document states that "All of the pre-determined acceptance criteria were met," but it does not explicitly list the specific numerical or qualitative acceptance criteria for each test. This is a significant gap in the provided information.

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

The document does not specify the sample sizes used for any of the tests (Dimensional Analysis, Burst Pressure Testing, Joint Separation Force Testing, Simulated Use Testing).

The data provenance is from in-house design verification testing conducted by Hansen Medical, Inc. based in Mountain View, CA, USA. The studies appear to be prospective as they were conducted as part of the device's design verification.

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

This information is not applicable to the type of testing performed. The studies described are engineering/mechanical and functional performance tests of a medical device, not clinical studies requiring expert ground truth for interpretation of medical data (e.g., image analysis, diagnosis). The "ground truth" here is the adherence to design specifications and mechanical performance standards, which would be assessed by engineers and quality control personnel.

4. Adjudication Method for the Test Set

This information is not applicable as the described tests are objective measurements of physical properties and functional operation, rather than subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The provided text indicates that "Clinical evaluation is not required for this device." The studies focused on confirming the device's physical and functional performance against pre-determined criteria.

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

This question is not applicable as the device is a physical robotic surgical catheter, not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed was based on engineering design specifications and performance standards. For example, burst pressure would be measured against a specified maximum pressure tolerance dictated by the design. Similarly, joint separation force would need to meet a minimum threshold. The "reliability of inserting and retracting a third party microcatheter" in simulated use testing would be assessed against a defined successful operation criterion.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical medical instrument, not an AI model that requires a training set.

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

This question is not applicable as there is no training set for this device.

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