(65 days)
The SCIMED ChoICE Guide Wires are intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The ChoICE Guide Wires are not intended for use in the cerebral vasculature. The devices are provided sterile and intended for one procedure only.
The ChoICE Guide Wires are steerable guide wires available in a nominal diameter of 0.014 inches and two tip configurations, straight shapeable and pre-formed J-Tip. The available tip flexibilities are
- · Floppy,
- · Intermediate,
- · Extra Support,
- · Standard,
- · Super Support, and
- · Super Support II
A polymer sleeve extending from the spring coil to the proximal fluorinated polymer coated core wire, surrounds the tapered core wire and is coated with ICE Hydrophilic Coating.
The available lengths for the guide wires are
• ChoICE-190 cm,
• ChoICE Plus-182 cm, and
• ChoICE Exchange-300 centimeters.
The provided document is a 510(k) Notification for medical devices (PTCA Guide Wires). It focuses on regulatory approval based on equivalence to predicate devices and describes the device's characteristics and intended use. However, it does not contain information about clinical studies with acceptance criteria or device performance data in the way typically found for algorithms or AI-driven devices.
Therefore, I cannot fulfill your request for information regarding acceptance criteria, study details, sample sizes, ground truth, or MRMC studies as these are not present in the provided text.
The document primarily states:
- The device (SCIMED ChoICE, ChoICE Plus, and ChoICE Exchange PTCA Guide Wires) is intended to facilitate the placement and exchange of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures.
- It refers to Non-Clinical Test Summary stating that Additional testing of the modified ChoICE Extra Support Guide Wires was not performed since the identical core wire dimension is present on the ChoICE PT Extra Support Guide Wires. And Testing presented in K960657, ChoICE PT Extra Support on the first support diameter is directly applicable to the ChoICE Extra Support because of the identical design in this section of the wire. This indicates reliance on previous testing of a similar predicate device, rather than new, detailed performance studies for this specific submission.
In summary, the provided text does not contain the information needed to answer your questions about acceptance criteria, device performance, study methodology, or ground truth establishment for a clinical study.
§ 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.