(84 days)
The Mustang™ Steerable Guide Wire is indicated 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 quide 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 Medtronic® MUSTANG™ Steerable Guide Wire, and its 510(k) submission for market clearance. However, it does not include information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML algorithm.
The document discusses the following:
- Device Description: The Medtronic® MUSTANG™ Steerable Guide Wire, its models, intended use (introducing and placing interventional catheters during PTCA and PTA), and physical characteristics.
- Performance Testing: It mentions "In vitro testing included tensile strength, torque strength, torqueability, tip flexibility, coating adherence/integrity and catheter compatibility. Testing was also performed to assess the biocompatibility of the device."
- Acceptance: "Test results verified that the MUSTANG™ meets all of the applicable specifications and is deemed adequate for the intended use."
- Substantial Equivalence: The primary basis for clearance is substantial equivalence to legally marketed predicate devices, not AI performance.
Therefore, I cannot provide the requested information for an AI/ML device, as this document pertains to a traditional medical device (a guidewire) and its premarket notification (510(k)) based on substantial equivalence and in-vitro performance testing, not an AI/ML algorithm.
If you have a document describing an AI/ML device and its validation study, please provide that.
§ 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.