(118 days)
To facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The JoWire Neo's Guide Wires are not to be used in the cerebral blood vessel.
The JoWire Neo's PTCA Guide Wires are steerable guide wires with a maximum diameter of 0.014" and available in a 180 cm length. The extension wire is connected to the end of the guide wire outside the body. The wire is constructed from a stainless steel core wire with varying core lengths and diameters for each design. The core wire and coil are soldered. The distal end of the wire guide wire has a radiopaque tip that is available straight and is made soft to easily bend with the vessel curve. The coating (hydrophilic or silicone) is applied to the distal portion of the wire guide wire. The proximal section of the guide wire is coated with PTFE.
The provided text is a 510(k) summary for the JoWire Neo's PTCA Guide Wires, submitted by JOMED Inc. in August 2002. This document describes a medical device and its intended use, but it does not contain the detailed information required to fill out the table and answer the specific questions about acceptance criteria, study design, and ground truth for an AI/algorithm-based device.
Instead, the document states:
- "Bench and biocompatibility testing were conducted according to the recommendations from relevant FDA guidance to demonstrate that the JoWire Neo's Guide Wires met the acceptance criteria and performed similarly to the predicate devices."
- "No new safety or effectiveness issues were raised during the testing."
This indicates that standard device performance and safety testing (bench testing, biocompatibility) was performed, which is typical for physical medical devices like guide wires. It does not refer to the kind of "acceptance criteria" or "study" (like an MRMC study or standalone algorithm performance) that would be relevant for an AI or algorithm-based device.
Therefore, I cannot provide answers to your specific questions based on the input text. The questions you've asked are designed for the evaluation of AI/ML-driven medical devices, for which this 510(k) document is not applicable.
§ 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.