(63 days)
This device is intended for use as a torque device for guidewires with a diameter of 0.014 --0.038" to facilitate twisting and advancing the guidewire during a procedure.
The JS Vascular Guide Wire Vise™ is a sterile single-use wire vise/torque device consisting of a dual pin vise clamp construction. Guidance and tracking of a guidewire through the coronary or peripheral vasculature is accomplished by manual manipulation of the vise.
The provided document is a 510(k) summary for the JS Vascular Guide Wire Vise™. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain information on acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance studies with acceptance criteria in the same way a PMA (Pre-Market Approval) or clinical trial might.
Therefore, I cannot extract the requested information from the provided text. The document does not describe:
- A table of acceptance criteria and the reported device performance: This is not present.
- Sample size used for the test set and the data provenance: No test set or study data is described.
- Number of experts used to establish the ground truth for the test set and qualifications: Not applicable as no test set is detailed.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned.
- Standalone performance study (algorithm only without human-in-the-loop performance): Not applicable as this is a physical medical device, not an AI algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document states that "performance testing results provided in this pre-market notification" were used to demonstrate substantial equivalence, but these results are not detailed in the provided text. For 510(k) submissions of devices like this torque device, performance testing usually involves bench testing to ensure the device performs its intended mechanical function safely and effectively (e.g., proper gripping of guidewires, durability, biocompatibility if applicable). However, the specific details of such tests, their acceptance criteria, and results are not included in this 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.