(16 days)
The MRWire Guide Wire is intended to direct a catheter to the desired anatomical location in the vasculatory system during diagnostic or interventional procedures.
The MRWire Guide Wire is a sterile, disposable guide wire for the introduction and/or placement of diagnostic or interventional devices. The MRWire is constructed from a high strength core composite of glass fibers and polymers, protected by a high-strength aramid fiber mantle and covered with a PTFE extrusion. The distal tip of the MRWire is marked with discrete ring markers for MRI and X-Ray visibility and comes in different configurations such as straight and angled. Guide wires are supplied sterile and nonpyrogenic. The MRWire's diameter is 0.035" (0.89 mm).
The provided text describes a 510(k) submission for a medical device called the "MRWire Guide Wire." This section outlines the device, its modifications from a predicate device, and the non-clinical tests performed to demonstrate its substantial equivalence and safety.
Here's an analysis of the provided text in relation to the requested information:
Key Takeaway: The provided document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical performance testing. It explicitly states that no clinical tests were performed or included in this submission. Therefore, much of the requested information regarding human-in-the-loop performance, expert ground truth, and patient-data-driven studies is not applicable to this specific submission.
However, I can extract information related to the physical performance testing of the device for manufacturing and safety purposes.
Acceptance Criteria and Device Performance (Non-Clinical)
The document primarily focuses on a comparison to a predicate device and adherence to established standards and in-house criteria for physical and material properties. The "acceptance criteria" here refer to the device meeting or surpassing the performance of the predicate device and complying with relevant ISO standards and FDA guidance documents.
Here's a table summarizing the modifications and the performance outcomes, which serve as the "acceptance criteria" for demonstrating substantial equivalence for these specific changes:
| Modification Feature | Technological Difference | Benchmark Test | Acceptance Criteria (Performance vs. Predicate) | Reported Device Performance / Outcome |
|---|---|---|---|---|
| Modification 1: | PTFE heat shrink tube instead of Pebax® outer extrusion | Simulated Use Test | No differences expected compared to predicate. | No differences in the Simulated Use Test. |
| Flexing and Bending Resistance | No differences expected compared to predicate. | No differences in Flexing and Bending Resistance Test. | ||
| Biocompatibility Testing | Device should be free from biological risks under applied conditions (per ISO 10993-1). | Under the applied conditions, the device is free from biological risks. (Evaluated through extended biocompatibility testing for new blood-contacting materials). | ||
| Torquability Test | Comparable or improved torquability compared to predicate. | The torqueability of the subject device is slightly increased compared to the predicate. | ||
| Particulate Testing | No generation of particles. | Both (subject and predicate) generate no particles. | ||
| U-Turn Test | No differences expected compared to predicate. | No differences in the U-turn test. | ||
| Usability Scoring Test | No difference in usability expected compared to predicate. | No difference in usability. | ||
| Modification 2: | Glass fiber core diameter decreased (0.52mm to 0.50mm) for PTFE extrusion | Simulated Use Test | No differences expected compared to predicate. | No differences in the Simulated Use Test. |
| Fracture Test | No differences expected compared to predicate. | No differences in the Fracture Test. | ||
| Tensile Strength Test | Comparable or improved tensile strength compared to predicate to withstand normal tensile loading. | The tensile strength is slightly higher than the predicate device, making it better to withstand normal tensile loading for the intended use. | ||
| Bending Module Test (shaft) | Shaft stiffness in the same order of magnitude as predicate. | Shaft stiffness is in the same order of magnitude. | ||
| Torquability Test | Comparable or improved torquability compared to predicate. | The torqueability of the subject device is slightly increased compared to the predicate. | ||
| Torque Strength Test | Comparable or improved torque strength compared to predicate to withstand normal rotational loading. | The torque Strength of the subject device is increased compared to the predicate making it better to withstand normal rotational loading for the Intended use. | ||
| U-Turn Test | No differences expected compared to predicate. | No differences in the U-turn test. | ||
| Usability Scoring Test | No difference in usability expected compared to predicate. | No difference in usability. | ||
| Modification 3: | Tip is preformed instead of grinding, no need for Pebax® tip extrusions | Simulated Use Test | No differences expected compared to predicate. | No differences in the Simulated Use Test. |
| Tensile Strength Test | Comparable or improved tensile strength compared to predicate. | The tensile strength is slightly higher than the predicate device, making it better to withstand normal tensile loading for the intended use. | ||
| Radiopacity Testing | Both should have radiopaque elements in the tip. | Both have radiopaque elements in the tip. | ||
| Torquability Test | Comparable or improved torquability compared to predicate. | The torqueability of the subject device is slightly increased compared to the predicate. | ||
| Tip Flexibility Test | Tip flexibility comparable to predicate. | The tip flexibility of the subject devices is comparable to the predicate. | ||
| Torque Strength Test | Comparable or improved torque strength compared to predicate. | The torque Strength of the subject device is increased compared to the predicate making it better to withstand normal rotational loading for the Intended use. | ||
| Usability Scoring Test | No difference in usability expected compared to predicate. | No difference in usability. | ||
| MRI Compatibility | No difference in MRI labeling. | No difference in MRI labelling. (MR Conditional status; Max temp rise |
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.