(422 days)
The ASAHI ULTIMATEbros 3 PTCA Guide Wire is intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI ULTIMATEbros 3 PTCA Guide Wire is not to be used in the cerebral blood vessel.
The ASAHI ULTIMATEbros 3 PTCA Guide Wire is a steerable guide wire with a maximum diameter of 0.014 inches (0.36mm) and available in 180 cm and 300 cm length. The guide wire is constructed from a stainless steel core wire with platinum-nickel coil. The coil part (distal end) of the guide wire has a radiopaque to achieve visibility. The distal end of the coil part is available straight and is made soft to easily bend with the vessel curve, or available as a pre shaped "J ". A hydrophilic coating is applied to the coil part (distal portion) of the guide wire. The proximal section of the guide wire is coated with PTFE, and the PTFE in the proximal coating is available in two types - PTFE type I and type II.
The provided text describes a 510(k) summary for a medical device, the ASAHI ULTIMATEbros 3 PTCA Guide Wire. However, it does not include the detailed information required to fill out the requested table and sections regarding acceptance criteria and a study proving the device meets those criteria.
The document primarily focuses on establishing substantial equivalence to predicate devices, outlining:
- Device Description: Physical characteristics and materials.
- Intended Use: Facilitating PTCA and PTA procedures, not for cerebral blood vessels.
- Technical Characteristics: Comparison to predicate devices, highlighting minor modifications in coating and dimensions.
- Performance Data: Lists various in vitro bench tests (tensile strength, torque strength, tip flexibility, coating adherence, etc.) and biocompatibility tests (systemic toxicity, hemolysis, cytotoxicity, etc.) that were conducted or leveraged from predicate devices.
- Conclusion: The device is substantially equivalent to specified predicate devices.
Missing Information:
Crucially, the document states that these tests were conducted and demonstrates that the device "performs as intended," but it does not report:
- Specific acceptance criteria for each performance test (e.g., minimum tensile strength, maximum turns to failure).
- The reported device performance values against those criteria.
- Details of any specific study (like a clinical trial or even a detailed bench test report with specific numeric results) that explicitly presents the acceptance criteria and the device's performance against them.
- Any information related to clinical studies, sample sizes, ground truth establishment, expert involvement, MRMC studies, or standalone performance in a clinical context. The performance data mentioned are bench and biocompatibility tests, not clinical efficacy or diagnostic performance.
Because the requested information for the acceptance criteria and the study proving it is not present in the provided text, I cannot complete the table or the other sections. The document serves as a regulatory submission for substantial equivalence based on technical and bench testing, not a detailed performance study with explicit acceptance criteria and results.
§ 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.