(78 days)
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.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not specified in document) | (Not specified in document) |
| Tensile Strength acceptable limits | Met |
| Simulated Use successful operation | Met |
| Pressure Burst resistance to 600 psi | Met |
| ISO MEM Elution Cytotoxicity within limits | Met |
| ASTM Hemolysis within limits | Met |
| Chemical Characterization within limits | Met |
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.
§ 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).