Search Results

The Hansen Medical Magellan™ Robotic Catheter 9Fr 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 9Fr Long Length (80 cm) is also indicated for use as a conduit for manual placement of therapeutic devices in the neuro vasculature.

The Magellan™ Robotic Catheter 9Fr is intended to be used with the Hansen Medical Magellan™ M Robotic System and accessories.

The proposed change to the Hansen Medical Magellan™ Robotic Catheter (MRC) 9Fr is to the Indications for Use only; there is no change to the fit, form, or function of the device or to any of its components and accessories cleared under K132369.

The MRC 9Fr is a telescoping design comprised of a steerable Leader within a steerable Guide and is designed to be used with the Hansen Medical Magellan™ Robotic System (Magellan System). The distal sections of each Hansen Catheter component articulate individually and the distal end of the Leader can extend up to 21cm beyond the distal end of the Guide.

The Leader is a tubular catheter with four pull wires articulating the distal 3cm. The Leader has a 6Fr outer diameter and 3Fr inner diameter, and is available in 125cm, 141cm, and 158cm lengths. The Leader fits inside the Guide and is only used in conjunction with the Guide. The distal end of the Leader has a 3cm flexible articulating section. The Leader has a radiopaque marker band between the articulating section and the atraumatic tip. The tip extends 4mm distal to the marker band.

The Guide is a tubular catheter with four pull wires articulating the distal 2.8cm. The Guide has a 6Fr inner diameter and 9Fr outer diameter. The Guide is available in 50cm, 65cm, or 80cm lengths. The Guide fits around the Leader and may be used with or without the Leader. When the Leader is removed from the Guide, a 6Fr compatible percutaneous catheter may be delivered through the Guide.

The Hansen Catheter family consists of three different lengths of Leader and Guide pairs, and all sizes are sterilized via EtO for single use only. However, the MRC 9Fr Short (50cm) and MRC 9Fr Medium (65cm) catheters are not included for the expanded indication as they are not long enough to access the target anatomy.

This document is a 510(k) premarket notification for the Hansen Medical Magellan Robotic Catheter 9Fr, which is intended to facilitate navigation to anatomical targets and provide a conduit for therapeutic devices. The submission focuses on expanding the indications for use of the 80cm long version of the catheter to include neurovasculature.

Here's an analysis of the provided text with respect to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a numerically defined threshold for performance for a new AI/medical device. Instead, it relies on demonstrating substantial equivalence to a predicate device. This is a common approach for Class II medical devices seeking 510(k) clearance in the US. The "performance" assessment is a comparison of technological characteristics and intended use.

Here's a table based on the "Performance Attribute and Characteristic Comparison" table (on page 8) for the expanded indication compared to the predicate device:

Reported Device Performance (against the predicate): The document states: "The minor differences in the characteristics between the two products do not alter the performance and do not present any new issues of safety or effectiveness." It concludes that the device "is substantially equivalent with respect to intended use and technological characteristics as the predicate device, and is expected to perform equivalently in accessing the neuro vasculature." The "performance" is demonstrated through design validation and verification activities described in Section 18.0 Performance Testing (which is not included in the provided text but is referenced).

2. Sample size used for the test set and the data provenance

The document explicitly states: "Clinical evaluation is not required for this device." Therefore, there is no "test set" in the sense of patient data for clinical evaluation, nor is there information on sample size or data provenance for such a test. The evaluation relies on comparing technological characteristics and performance data from internal design validation and verification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no clinical test set was required or used.

4. Adjudication method for the test set

Not applicable, as no clinical test set was required or used.

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 is a robotic steerable catheter, not an AI-assisted diagnostic or interpretative device that augments human readers.

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

Not applicable. This is a physical robotic catheter, not a standalone algorithm.

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

The document does not detail specific "ground truth" as would be used in an AI or diagnostic imaging study. Instead, the "truth" for this device's performance relies on engineering and performance testing data (referenced as "design validation and verification activities described in Section 18.0 Performance Testing" on page 7) to ensure physical characteristics (dimensions, flexibility, guidewire compatibility, etc.) meet specifications and are comparable to the predicate device for the intended use in neurovasculature.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/machine learning device that requires a training set.

Ask a specific question about this device

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.

Ask a specific question about this device

The Hansen Medical Magellan Robotic Catheter 6Fr 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 6Fr is intended to be used with the Hansen Medical Magellan Robotic System and accessories.

The Magellan Robotic Catheter 6Fr v1.2 and accessories are a modification of the predicate Magellan Robotic Catheter 6Fr (MRC 6Fr) and accessories cleared under K133552. Both the predicate device and the modified Magellan Robotic Catheter 6Fr are comprised of a Guide (Outer Catheter) with dual bend articulating sections (distal and proximal) paired with a nonarticulating Leader (Inner Catheter). The devices are provided in two lengths (60cm and 95cm). Like the predicate device, the MRC 6Fr v1.2 is designed to be used with Hansen Medical Magellan Robotic System and is intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. Both the MRC 6Fr v1.2 and the predicate may also be used for delivery of diagnostic contrast agents. The modified MRC 6Fr is compatible with power contrast injection systems up to a maximum of 600 psi. Whereas, the predicate device is rated for a maximum pressure of 100 psi. The device is provided sterile and is intended for single use only. The catheter is one of several compatible devices available for use with Hansen Medical's Magellan Robotic System cleared under K111004, K132369 and K141614.

This document, an FDA 510(k) summary for the Hansen Medical Magellan Robotic Catheter 6Fr v1.2, is a premarket notification for a medical device. It focuses on demonstrating "substantial equivalence" to a previously cleared predicate device, rather than proving performance against specific acceptance criteria for a novel AI device or diagnostic. Therefore, the information required to answer your specific questions about acceptance criteria, a study proving the device meets those criteria, and details about a test set, expert involvement, and ground truth is largely not present in this document.

The document mainly describes modifications to an existing device (increased pressure rating for contrast injection) and uses design verification testing to show that the performance remains substantially equivalent to the predicate device.

However, I can extract the following information that is tangentially related or directly stated:

1. A table of acceptance criteria and the reported device performance

The document states:

• "All of the pre-determined acceptance criteria were met."
• "Testing performed on the Magellan Robotic Catheter 6Fr v1.2 included the following:
  • Tensile Strength Testing
  • Simulated Use Testing
  • Pressure Burst Testing
  • ISO MEM Elution Cytotoxicity Testing
  • ASTM Hemolysis
  • Chemical Characterization Testing"

However, the specific numerical or qualitative acceptance criteria themselves and the reported device performance values are NOT detailed in this public summary. This level of detail would typically be found in the full test reports submitted to the FDA, not in the summary document.

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: Not specified. The document only mentions "testing" and "design verification testing."
• Data provenance: Not specified, but given it's a 510(k) for a US market device, the testing would typically be conducted under US regulatory standards. It's pre-market testing, so it's inherently prospective for the device modifications being assessed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable / Not specified. This type of information relates to clinical studies, particularly for diagnostic devices or AI, which is not the focus of this 510(k) given its scope is modification of a previously cleared Class II catheter. The document explicitly states: "Clinical evaluation is not required for this device."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Not specified. See point 3.

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. This is not an AI device or a diagnostic device. It's a robotic catheter used for navigation and delivery of therapeutic devices. MRMC studies are not relevant here.

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

• Not applicable. This is a physical medical device (catheter) used with a robotic system, not a standalone algorithm.

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

• For the engineering tests conducted (Tensile Strength, Pressure Burst, etc.), the "ground truth" would be the engineering specifications and validated test methods. For example, a pressure burst test would have a defined pass/fail pressure, which is the ground truth. There is no expert consensus, pathology, or outcomes data used as "ground truth" for these types of mechanical and material tests.

8. The sample size for the training set

• Not applicable. This isn't an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

• Not applicable. This isn't an AI/machine learning device.

In summary: This document is a regulatory submission for a minor modification to an existing robotic catheter. It confirms that the modified device remains substantially equivalent to its predicate. The proof of meeting acceptance criteria lies in standard engineering and material compatibility testing, not in clinical studies involving human interpretation or AI performance that would require the detailed information you are seeking.

Ask a specific question about this device