(281 days)
The Safe-Steer™ Guide Wire System is indicated for use in facilitating the placement of catheters used in percutaneous interventions in native coronary arteries with total occlusions.
The IntraLuminal Therapeutics, Inc. SAFE-STEER™ Guide Wire System is comprised of a sterile single-use guide wire with an integrated optical fiber. The guide wire is used with a support catheter of choice that will accommodate a .014" guidewire. The optical fiber in the guide wire is connected to a reusable Optical Coherence Reflectometry (OCR). The guide wire core has an embedded optical fiber that transmits near infrared light and the reflection is relayed back to the OCR unit and then a unique intensity versus distance measurement is exhibited on the OCR display. The trace of the slope on the OCR display distinguishes the distance from the tip of the wire and the vessel wall. The display output exhibits the relative distance between the wire tip and vessel wall. The guide wire is provided in lengths of 175 cm and 275 cm long and has a diameter of 0.014" with a lubricious hydrophilic coating in the distal region. The guide wire is sterilized by ethylene oxide and packaged to maintain the sterile barrier.
The provided document is a 510(k) premarket notification for the SAFE-STEER™ Guide Wire System. It details the device, its intended use, and claims substantial equivalence to predicate devices, but it does not contain acceptance criteria or a study designed to prove the device meets specific performance criteria.
Instead, the document states that "Safety and performance testing was performed to demonstrate that the IntraLuminal Therapeutics SAFE-STEER™ Guide Wire System is substantially equivalent to the predicate devices." It then broadly lists the types of testing conducted: "software, performance, biocompatibility, packaging, clinical and comparative tests."
Therefore, I cannot extract the requested information as it is not present in the provided text. The document concludes with a claim of substantial equivalence and meeting internal product specifications, rather than reporting against specific, publicly available acceptance criteria.
§ 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.