(187 days)
The Medtronic® MUSTANG™ Steerable Guide Wire is for use in introducing and placing interventional catheters during percutaneous transluminal coronary angioplasty (PTCA) and/or percutaneous transluminal angioplasty (PTA).
The Medtronic® MUSTANG™ Steerable Guide Wire is a guide wire having a maximum diameter of 0.014" (0.36 mm). The proximal shaft is coated with a polymer and the distal 33 cm contains a lubricious coating. The distal segment of the wire contains a spring which is radiopaque. The MUSTANG™ is provided sterile, and is intended for one procedure use only (disposable).
The provided text describes a medical device, the Medtronio® MUSTANG™ Steerable Guide Wire, and its verification through in vitro testing. However, it does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria, as typically seen for AI/ML-based medical devices or diagnostic tools.
This 510(k) summary is for a physical medical device (a guide wire), and the verification methods are standard for such devices, focusing on physical properties and biocompatibility. The prompt's questions are tailored towards the evaluation of algorithms, AI models, or diagnostic software, which require different types of performance metrics and study designs.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: The text mentions "applicable specifications" but does not detail them or provide quantitative performance metrics against these specifications. It focuses on the type of tests performed rather than the specific results or targets.
- Sample size used for the test set and the data provenance: Not applicable to this type of in vitro testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The closest information available is:
1. Acceptance Criteria and Reported Device Performance (Partial, Qualitative Only):
| Acceptance Criteria Category | Reported Device Performance (Qualitative) |
|---|---|
| Tensile Strength | Met applicable specifications |
| Torque Strength | Met applicable specifications |
| Torqueability | Met applicable specifications |
| Tip Flexibility | Met applicable specifications |
| Coating Adherence/Integrity | Met applicable specifications |
| Catheter Compatibility | Met applicable specifications |
| Biocompatibility | Met applicable specifications |
Study Details:
- Study Type: In vitro testing and biocompatibility assessment.
- Conclusion: "Test results verified that the MUSTANG™ meets all of the applicable specifications and is deemed adequate for the intended use."
The document focuses on demonstrating substantial equivalence to existing devices based on these physical and biological tests, not on diagnostic performance or algorithmic output.
§ 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.