(31 days)
The ASAHI PTCA Guide Wire, Fielder FC is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The Asahi PTCA Guide Wires are not to be used in the cerebral blood vessel.
The Asahi PTCA Guide Wire, Fielder FC is steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 180 cm and 300 cm length. The extension wire is connected to the end of the guide wire outside the body for 180cm wire. The wire is constructed from a stainless steel core wire. The core wire and coil are soldered. The distal tip of the guide wire has a radiopaque tip to achieve visibility, and is available straight and is made soft to easily bend with the vessel curve. And there is polyurethane coating covered with hydrophilic coating applied to the distal section of the guide wire. The proximal section of this guide wire is coated with PTFE.
This 510(k) summary does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device. The provided text describes a medical device, the ASAHI PTCA Guide Wire, Fielder FC, which is a steerable guide wire used in percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA).
The information focuses on establishing substantial equivalence to predicate devices based on:
- Materials: Stating it uses the same materials as predicate devices.
- Dimensional specifications and design: Ensuring compatibility for the intended use.
- Performance Data: "This 510(k) notice includes mechanical and functional bench testing that demonstrates that the ASAHI ASAHI PTCA Guide Wire, Fielder FC performs as intended."
Crucially, there is no mention of:
- AI/ML components: The device is a physical medical instrument, not a software algorithm.
- Acceptance criteria (quantitative metrics): The document generally states "performs as intended" without providing specific pre-defined thresholds for performance.
- Specific study details: While "mechanical and functional bench testing" is mentioned, no details are provided regarding:
- Test protocols
- Specific parameters measured (e.g., tensile strength, friction, torque, tip flexibility, navigation capabilities)
- Numerical results
- Sample sizes for these tests
- How ground truth was established (as it's a physical device, functional tests would be against engineering specifications or established physical properties).
- Any multi-reader multi-case (MRMC) studies or standalone performance evaluations as these are irrelevant for a physical guide wire.
- Number or qualifications of experts.
- Adjudication methods.
- Training set information.
In summary, the provided document does not align with the request for information on acceptance criteria and study details for an AI/ML device because the device in question is a physical medical guide wire and not an AI/ML product.
§ 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.