(22 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 Asahi PTCA Guide Wires are steerable guide wires with a maximum diameter of 0.014" and available in a 300 cm length. The extension wire is connected to the end of the guide wire outside the body. The wire is constructed from stainless steel core wire with varying core lengths and diameters for each design. The core wire and core are soldered. The distal end of the 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 describes a 510(k) premarket notification for the JoWire Asahi PTCA Guide Wires, which aims to demonstrate substantial equivalence to a predicate device. The document states that performance data was collected through bench and biocompatibility testing.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document | "Met the acceptance criteria and performed similarly to the predicate devices." |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Not specified, but based on the nature of bench and biocompatibility testing, it would be in vitro (bench testing) and potentially in vivo (biocompatibility, if animal studies were performed, though not explicitly stated for this 510(k)). There is no indication of human clinical data or geographical origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as the testing described is bench and biocompatibility, not expert-adjudicated clinical data.
4. Adjudication method for the test set:
- Not applicable for bench and biocompatibility testing. Performance is assessed against pre-defined engineering and biological criteria.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a medical guidewire, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used:
- For bench testing: Engineering specifications, performance standards, and comparisons to predicate device characteristics.
- For biocompatibility testing: Established biological safety standards and guidelines.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
Summary from the provided text:
The submission highlights that bench and biocompatibility testing were conducted. The crucial statement is: "Bench and biocompatibility testing were conducted according to the recommendations from relevant guidances to demonstrate that the JoWire Asahi PTCA Guide Wires met the acceptance criteria and performed similarly to the predicate devices." This indicates that the study performed was the bench and biocompatibility testing, and its outcome was that the device successfully met the predefined acceptance criteria and showed performance comparable to the predicate device. However, the specific details of these criteria (e.g., tensile strength, lubricity targets, specific biological response limits) and the quantitative results are not provided in the summary.
§ 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.