(48 days)
The VSI Guidewire is indicated for percutaneous entry of peripheral vessels using the Seldinger Technique. The device is not indicated for use in the coronary or cerebral vasculature.
The VSI Guidewire is available in a diameter of 0.018" and lengths ranging from 40-130 cm. The device is available with a stainless steel or nitinol shaft with a stainless steel or tungsten tip. Some models are PTFE coated to increase lubricity.
The provided text is a 510(k) summary for the VSI Guidewire. It states that no performance testing was conducted because the subject device is identical in design, materials, construction, and indications for use to the predicate device (VascuPuncture™ PICC Guidewire, K012861 and K043398). Therefore, the device did not undergo a study to prove it met specific acceptance criteria in the context of device performance.
Here's a breakdown of why many of your requested items cannot be answered from this document:
- A table of acceptance criteria and the reported device performance: Not applicable. No performance testing was conducted.
- Sample size used for the test set and the data provenance: Not applicable. No test set was used for performance evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set was used for performance evaluation.
- Adjudication method for the test set: Not applicable. No test set was used for performance evaluation.
- If a multi-reader multicase (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 is a medical device, not an AI/imaging device. No such study was performed.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not an AI/imaging device. No such study was performed.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No performance testing was conducted.
- The sample size for the training set: Not applicable. No training set was used for an algorithm.
- How the ground truth for the training set was established: Not applicable. No training set was used for an algorithm.
Summary based on the provided text:
The submission for the VSI Guidewire relied on demonstrating substantial equivalence to a previously cleared predicate device rather than conducting new performance testing against specific acceptance criteria. The manufacturer explicitly states: "Because the subject and predicate devices are identical in design, materials, construction, and Indications for Use, no performance testing was conducted or is warranted in support of the determination of substantial equivalence."
§ 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.