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The Selethru™ NC PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

The SelethruTM NC PTCA Balloon Dilatation Catheter is a rapid exchange (RX) PTCA Balloon Catheter used for the purpose of dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
And it is a sterile, single-use, intravascular medical device with a working length of 142cm. The non-compliant balloons are available in diameters 2.0 and 5.0mm and lengths from 6-30mm, and have a rated burst pressure of 22 atm for φ2.0 mm and 20 atm for φ5.0mm.
The proximal shaft is PTFE coated stainless steel tube, which allows for exceptional push ability and a smooth transition to the distal shaft, which is composed of an outer tube, an inner tube, and a balloon. A hydrophilic coating is applied to the distal section. Moreover, the proximal shaft of the catheter has two marker sections of 5mm length that aid in gauging dilatation catheter position relative to the guiding catheter tip (marker located closest to the dilatation catheter adaptor is for femoral guiding catheters and the other marker is for brachial guiding catheters).
The distal shaft of the catheter has an integrated shaft system. The shaft has a combination of single lumen and dual lumen tubing. One lumen is used for inflation of the balloon with contrast medium. The other lumen, in the distal shaft, permits the use of a guide wire to facilitate advancement of the dilatation catheter to and through the stenosis to be dilated. The guidewire enters the catheter tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of the catheter with a single standard length guidewire
Two radiopaque Platinum/Iridium marker bands are located within the balloon segment to aid in positioning the balloon in the stenosis, and are designed to provide an expandable segment of known diameter and length at a specific pressure. The design of this dilatation catheter does not incorporate a lumen for distal dye injections and distal pressure measurements.

This document is an FDA 510(K) Premarket Notification summary for a medical device (Selethru™ NC PTCA Balloon Dilatation Catheter). The information provided focuses on the device's technical specifications, safety, and substantial equivalence to predicate devices, rather than an AI-powered diagnostic tool.

Therefore, the requested information about acceptance criteria, study details (sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance), and ground truth establishment is not applicable to this document. These categories are typically relevant for AI/ML device submissions, which involve clinical performance metrics and validation against a reference standard.

The document states that:

• Acceptance Criteria and Device Performance: "The test results met all acceptance criteria and ensure that the Selethru™ NC Catheter design and construction are suitable for its intended use as recommended by the Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (FDA; September 8, 2010)."
• Study Types: Both "in vitro performance tests" and "biocompatibility tests" were conducted.

Specific results for each test against acceptance criteria are not detailed in this summary. The summary lists the types of tests performed:

• In vitro performance tests: dimensional verification, balloon rated burst pressure, balloon fatigue, balloon compliance, balloon inflation and deflation time, catheter bond strength, tip pull strength, flexibility and kinking, torque strength, radiopacity, coating integrity, and particulate evaluation.
• Biocompatibility tests: cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility (hemolysis, complement activation, and in vivo thromboresistance), and pyrogenicity.

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