(29 days)
The Shockwave Medical IVL System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, iliofemoral, popliteal, and renal arteries. Not for use in the coronary, carotid or cerebral vasculature.
The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat calcified stenosis. Energizing the lithotripsy device will generate acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The IVL Catheter is comprised of an integrated balloon with an array of integrated lithotripsy emitters for the localized delivery of acoustic pressure pulses. The system consists of an IVL Catheter, an IVL Connector Cable and an IVL Generator.
The Shockwave L Peripheral IVL Catheter shaft contains an inflation lumen, a guidewire lumen, and the lithotripsy emitters are positioned along the length of the balloon working length for delivery of acoustic pressure pulses. The balloon is located near the distal tip of the catheter. Two radiopaque marker bands within the balloon denote the balloon to aid in positioning of the balloon during treatment. The balloon is designed to provide an expandable segment of known length and diameter at a specific pressure.
The IVL Generator and Connector Cable are used with a Shockwave Medical IVL Catheter to deliver localized, lithotripsy-enhanced, balloon dilatation of calcified, stenotic arteries. The IVL Generator, IVL Connector Cable and IVL Catheters are designed to exchange data during patient treatment.
This document is a 510(k) Summary for the Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter. It describes the device, its intended use, and the testing conducted to demonstrate substantial equivalence to a predicate device.
Based on the provided information, the device discussed is primarily a mechanical device (a catheter system that uses lithotripsy) and not an AI/ML powered device. The document does not contain the specific information requested in questions 1 through 9, which are typically associated with the acceptance criteria and study designs for AI/ML-powered medical devices. The performance data section refers to "design verification and validation testing" for mechanical and electrical properties (e.g., guidewire compatibility, balloon diameter, sonic output, pulse rate), not AI/ML model performance metrics.
Therefore, I cannot provide a response filling in the requested table and answering questions 1-9 accurately, as the provided text does not contain information about acceptance criteria, study details, expert involvement, or ground truth for an AI/ML-powered device.
To answer your request, the provided document does not contain the necessary information regarding: AI/ML acceptance criteria, performance metrics, sample sizes for AI/ML test/training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone AI performance, or ground truth establishment relevant to an AI/ML device.
§ 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).