(169 days)
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:
| Performance Specification | Predicate Device: MicroVention Chaperon Guide (6Fr) | Predicate Device: MicroVention Chaperon Leader (5Fr) | Hansen Medical Magellan Robotic Catheter 9Fr Guide (Long) | Hansen Medical Magellan Robotic Catheter 9Fr Leader |
|---|---|---|---|---|
| Outer Diameter (OD) | 6Fr (0.084 in) | 9Fr (0.128 in) | 6Fr (0.084 in) | |
| Inner Diameter (ID) | 5Fr (0.071 in) | 6Fr (0.084 in) | 3Fr (0.039 in) | |
| Guidewire Compatibility | 0.035 in, 0.018 in, 0.014 in | 0.035 in | 0.035 in, 0.018 in, 0.014 in | 0.035 in, 0.018 in, 0.014 in |
| Total Insertion Length | 95 cm | 117 cm | 80 cm | 101 cm |
| Distal Flex Length | 7 cm | 7 cm | 2.7 cm | 3.0 cm |
| Hydrophilic Coating Length | N/A | 15 cm | 45 cm | 85 cm |
| Tip Configuration | STR, MP2, BUR | VTR, SIM2, JB2 | Configurable bend to any angle up to 90° in all directions | Configurable bend to any angle up to 180° in all directions |
| Intended Use (Neurovasculature) | Yes (inclusive of neurovasculature) | Yes (inclusive of neurovasculature) | Yes (expanded to neurovasculature for 80cm length) | Yes (expanded to neurovasculature for 80cm length) |
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.
§ 870.1280 Steerable catheter.
(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).