(118 days)
ASAHI PTCA Guide Wires:
ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The ASAHI PTCA Guide Wires are not to be used in the neurovasculature.
ASAHI Peripheral Guide Wires:
ASAHI Peripheral Guide Wires are intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. This device is intended for peripheral vascular use only.
ASAHI Guide Wire Extension:
The ASAHI Guide Wire Extension accessory is intended for extension of the working length of an already introduced guide wire when exchanging over-the-wire interventional devices during an angioplasty procedure.
This modification details a change relating to the removal of perfluorooctanoic acid (PFOA) used by suppliers in the manufacture of PTFE (polytetrafluoroethylene) coating used on the ASAHI family of guidewires including ASAHI PTCA guide wires and ASAHI peripheral guidewires. All of these wires are steerable guide wires, constructed with a core wire with coil assembly. The distal ends of the guide wires have a radiopaque tip to achieve visibility. Various coatings are applied to the distal and proximal portions of the guidewires.
This submission covers the addition of an alternate type of PTFE coating material. The designs and performance of the guidewires are unchanged.
The provided document is a 510(k) premarket notification for ASAHI PTCA Guide Wires, ASAHI Peripheral Guide Wires, and ASAHI Guide Wire Extension. This type of submission is for medical devices that are substantially equivalent to legally marketed predicate devices, meaning they do not require extensive novel clinical trials to demonstrate safety and effectiveness as a brand new device would.
The document does not describe a study involving an AI/Machine Learning device, nor does it pertain to a device that would typically have "accuracy," "sensitivity," or "specificity" as acceptance criteria in the traditional sense of diagnostic or prognostic AI. Instead, it describes acceptance criteria for a physical medical device (guidewires) based on material changes (specifically, a change in the PTFE coating to remove PFOA) and proves it meets those criteria through non-clinical (bench) testing and biocompatibility assessments.
Therefore, I cannot provide the information requested in points 2-9, nor can I create a table with "accuracy," "sensitivity," and "specificity" as these metrics are not relevant to this type of device and study.
However, I can extract the acceptance criteria and the "reported device performance" as presented in the non-clinical testing section for this specific medical device.
Acceptance Criteria and Reported Device Performance (Non-Clinical Testing)
| Test | Acceptance Criteria (Implied by Test Method Summary and Intent) | Reported Device Performance (Results/Conclusions) |
|---|---|---|
| Coating Adherence | Integrity of the coated core wire maintained after pretreatment and manipulation in excess of expected clinical use. | Test results confirmed that the coating adhesion was maintained during simulated clinical use in all test articles. |
| Coating Integrity & Particulate Characterization | Coating integrity maintained and particulate generation characterized during simulated use (advancing/retracting through a clinically relevant model). | This testing characterized the coating integrity and particulate generation during simulated use. The test results confirmed that the coating integrity was maintained during simulated clinical use of the test articles. |
Biocompatibility Testing (All acceptance criteria are "Passed" based on the results)
| Test | Acceptance Criteria (Implied by Test Method Summary and Intent - typically "Pass" based on recognized standards) | Reported Device Performance (Results/Conclusions) |
|---|---|---|
| Cytotoxicity | No evidence of causing cell lysis or toxicity. | Passed. No evidence of causing cell lysis or toxicity. |
| Intracutaneous Irritation | Difference between test article and control less than 1.0. | Passed. Difference between test article and control less than 1.0. |
| Sensitization | No evidence of causing delayed dermal contact sensitization. | Passed. No evidence of causing delayed dermal contact sensitization. |
| Systemic Toxicity | No mortality or evidence of systemic toxicity. | Passed. No mortality or evidence of systemic toxicity. |
| Material Mediated Pyrogenicity | Test article judged as non-pyrogenic. | Passed. Test article judged as non-pyrogenic. |
| Hemocompatibility - Hemolysis | Hemolytic index within acceptable limits (e.g., |
§ 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.