(29 days)
The Sterling Monorail PTA Balloon Dilatation Catheter is indicated for Percutaneous Transluminal Angioplasty in the peripheral vasculature, including iliac, femoral, popliteal, renal, and carotid arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon expandable and selfexpanding stents in the peripheral vasculature.
The Sterling Balloon Dilatation Catheter is a Monorail brand rapid exchange catheter with a semicompliant balloon fixed at the distal tip. The balloon catheter has a coaxial shaft design. The outer lumen is used for inflation of the balloon, and the wire lumen permits the use of guidewires 0.014 in / 0.018 in to facilitate advancement of the catheter to and through the stenosis to be dilated. The product's catheter includes a tapered tip to facilitate advancement of the catheter to and through the stenosis. Two radiopaque marker bands (one proximal and one distal), in conjunction with fluoroscopy, enable accurate positioning of the balloon. The effective length of the balloon catheter is 200 cm; catheter markers indicate the exit of the dilatation catheter tip out of the guiding catheter (one at 90 cm and two at 100 cm).
This document is a 510(k) summary for a medical device called the Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter. It seeks to demonstrate substantial equivalence to a predicate device.
The provided text does not contain information related to an AI/ML device or its performance criteria. Therefore, I cannot furnish the requested details regarding acceptance criteria, study methodologies for AI performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance.
The document focuses on the bench testing performed to demonstrate substantial equivalence for this physical medical device (a balloon catheter), not a software or AI/ML product. The performance data section explicitly lists:
- Sterilization Testing
- Bench Testing (Dimensional Verification, Simulated Use, Balloon Inflation & Deflation Time, Catheter Bond Strength, Flexibility & Kink test, Torque Strength, Shaft & Bond Burst, Catheter Extension & Deflation, Packaging Testing, Design Validation Testing)
These are typical tests for a physical medical device to ensure its mechanical properties, function, and safety, not for evaluating an AI algorithm's diagnostic or predictive capabilities.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).