(284 days)
The Cordis STEER-IT Deflecting Tip Guidewires are intended for use in angiographic and interventional devices within the coronary and peripheral vasculature.
The Cordis STEER-IT Deflecting Tip Guidewire is similar in design and materials to the Cordis Wizdom Steerable Guidewire, Lake Region Manufacturing, Inc. Mandrel Guidewire, and the Lake Region Manufacturing, Inc. Steerable PTCA Guidewire. The difference is that the STEER-IT Deflecting Tip Guidewire employs a handle mechanism, which deflects the distal tip in two directions. The handle mechanism is butted into a stainless steel hypotube, which is soldered to a nitinol hypotube. The handle mechanism is similar to the USCI Commander™ Deflection Handle, an accessory of the USCI PilotWire™ Deflectable Guide Wire. The distal end of the STEER-IT Deflecting Tip Guidewire (3mm or 7mm) of the nitinol inner core wire is flattened, looped around and joined to the nitinol hypotube. The handle mechanism operates the movement of the distal tip by gripping the inner moveable core and allowing limited movement in two directions.
The provided text describes a 510(k) submission for the Cordis STEER-IT Deflecting Tip Guidewire. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical studies to prove safety and effectiveness. Therefore, the information requested in the prompt, which is typically derived from clinical trials or performance studies, is largely not present in this document.
However, based on the text, I can infer and state what is available regarding acceptance criteria and performance:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical/Physical Properties (e.g., joint strength, torqueability, coating integrity, linear stiffness, turns to failure, dimensional testing) | "The Cordis STEER-IT Deflecting Tip Guidewire passed all the established acceptance criteria." |
| Biocompatibility | "All materials were determined to be biocompatible." / "Biocompatibility... demonstrates no significant change to product characterization when compared to the predicate device." |
| Functional Equivalence | Similar in design, materials, and function to predicate steerable guidewires, specifically featuring a handle mechanism to deflect the distal tip in two directions, similar to the USCI Commander™ Deflection Handle. |
Study Information Pertaining to Acceptance Criteria:
-
Sample size used for the test set and the data provenance:
- The document does not specify a sample size for any "test set" in the context of clinical or large-scale performance studies. The testing mentioned (joint strength, torqueability, etc.) would have involved a sufficient number of samples to demonstrate compliance with internal specifications, but these numbers are not disclosed.
- Data provenance is not specified beyond "in vitro testing." No information on country of origin or whether testing was retrospective or prospective is provided.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The submission focuses on in vitro engineering tests and substantial equivalence claims, not clinical efficacy or diagnostic accuracy requiring expert ground truth for a test set.
-
Adjudication method for the test set:
- Not applicable. There is no mention of a test set requiring adjudication in this technical review.
-
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-powered diagnostic or assistive tool for human readers. Therefore, MRMC studies or AI performance metrics are irrelevant.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithmic or AI device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the mechanical and physical tests, the "ground truth" would be established engineering specifications and industry standards for guidewire performance. For biocompatibility, it would be established ISO standards for medical device biocompatibility. There is no biological or clinical "ground truth" in the sense of disease diagnosis or outcome for this type of device submission.
-
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
-
How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.
§ 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.