(280 days)
The ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon rilation catheters during percutaneous transluminal coronary angioplasty (PTCA) and thatator outhers wantely (PTA). The Asahi PTCA Guide Wires are not to be used in the cerebral blood vessel.
Asahi PTCA Guide Wiles are steerable gulde with a maximaling to wire 114 inches (0.56mm) and available in Too children wire is constructed from the more is constructed from connected to the end of the guide wille batside the body. The wild besign. The with the stight stainless steel core with varying core ichgitis and diamotors for backless of the dights innd or wire and coil are soldered or welded depending upon specific encluded at onl of ewire and coll are soldered of welded deportung upon open open on and is and is and is a radiopaque tip to achieve visibility, and is available straight and is made soft to easily bend with the vessel curve or, available as are shaped " "The ade soit to easily bend with the vooool ed to the distal portion of the guide wire. The mating (nydropmine and Silicone) is applica to the title guilter of the galler series noximal section of the galde wire is outlou with hydrophilic coating applied to the distal there is poryal and the proximal section of this guide wire is coated with PTFE.
The provided text describes a medical device, the ASAHI PTCA Guide Wire, and its 510(k) submission to the FDA. It details the device's design, indications for use, and a summary of performance testing.
Here's an analysis of the provided information against your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Equivalence | The ASAHI PTCA Guide Wires are of the same materials as the predicate devices with the exception of the modified coating material. |
| Dimensional Specifications and Design | The dimensional specifications and design of the device ensures compatibility for the intended use. |
| Mechanical and Functional Performance | Bench testing demonstrates that the ASAHI PTCA Guide Wires performs as intended. |
| Substantial Equivalence | The ASAHI PTCA Guide Wire characteristics with the modified PTFE coating are substantially equivalent to the currently marketed Asahi guidewires for the same indication for use. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the sample size used for the bench testing. It only mentions "mechanical and functional bench testing."
- Data Provenance: The study was conducted by Asahi Intecc Co., Ltd. in Japan (applicant address provided). The data is retrospective in the sense that it's bench testing conducted by the manufacturer for regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- This information is not provided in the document. The testing described is mechanical and functional bench testing, not clinical studies involving expert interpretation of data or images. Therefore, the concept of "ground truth established by experts" as typically applied to AI/imaging studies does not directly apply here. The "ground truth" for this device would be its physical specifications and performance metrics against engineering standards.
4. Adjudication Method for the Test Set:
- This information is not applicable/provided. Since the testing is mechanical and functional bench testing, there's no mention of an adjudication method among experts. Performance is likely measured against predefined engineering specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. The document describes mechanical and functional bench testing only. This is a physical medical device (a guide wire), not a diagnostic or AI-driven system that would typically undergo MRMC studies to assess human reader improvement with AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Not applicable/No. This device is a physical guidewire, not an algorithm or AI system. The concept of "standalone performance" for an algorithm doesn't apply. The "standalone" performance here refers to the guidewire's inherent mechanical and functional characteristics during bench testing.
7. Type of Ground Truth Used:
- The ground truth for this device's performance would be engineering specifications and established performance standards for guide wires. The document states that the "dimensional specifications and design... ensures compatibility for the intended use" and that "bench testing demonstrates that the device functions as intended." This implies that the device's performance was compared against predetermined technical criteria.
8. Sample Size for the Training Set:
- This information is not applicable/provided. The device is a physical guidewire, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
- This information is not applicable/provided. As explained above, this device does not involve an AI model or a training set in the conventional sense.
§ 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.