(624 days)
INTENDED USE. The VariSoft Guide Wire is intended to facilitate the placement of balloon dilatation catheters during PTCA and/or PTA. The VariSoft Guide Wire is not intended for use in the cerebral vasculature.
INTENDED USE. The ABD VariSoft Guide Wire Extension is intended to provide the necessary length to allow the exchange of one dilatation catheter for another while maintaining the position of the ABD VariSoft Steerable Guide Wire in the coronary artery. After the dilatation catheter exchange has been completed, the ABD VariSoft Guide Wire Extension can be detached and the ABD VariSoft Steerable Guide Wire can be used as a conventional steerable guide wire.
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The provided text is a 510(k) clearance letter from the FDA for a medical device: the ABD-VariSoft Guide Wire and Extension. This document does not contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."
This indicates that the device was cleared based on substantial equivalence to a predicate device, rather than a clinical study proving its performance against acceptance criteria in the manner requested. Clinical study data, if any, would have been part of the 510(k) submission, but is not included in this letter.
§ 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.