(127 days)
The Shockwave Medical Intravascular Lithotripsy (IVL) System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, popliteal, infrapopliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.
The Shockwave Medical IVL System has three components: a proprietary balloon Catheter, a Generator, and a Connector Cable. The IVL Catheter has integrated lithotripsy emitters and is designed to enhance percutaneous transluminal angioplasty by enabling delivery of the calcium disrupting capability of lithotripsy prior to full balloon dilatation at low pressures. The application of lithotripsy mechanical pulse waves alters the structure of an occlusive vascular deposit (stenosis) prior to low-pressure balloon dilation of the stenosis and facilitates the passage of blood.
The IVL Catheter is delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat lesion. The balloon is partially inflated and the lithotripsy emitters are energized thereby generating pulsatile mechanical energy within the balloon at the target treatment site and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The IVL Generator delivers energy through the IVL Connector Cable to the pulse emitters located inside the balloon in the IVL Catheter. The IVL Catheter is a single-use device supplied sterile to the customer. The IVL Generator and Connector Cable are non-sterile reusable devices.
The provided text is a 510(k) Summary for the Shockwave Medical Intravascular Lithotripsy (IVL) System, specifically for a line extension (Shockwave S4 IVL Catheter). This document is primarily focused on demonstrating substantial equivalence to a predicate device, rather than defining specific acceptance criteria for a standalone AI/algorithm device and proving its performance against those criteria.
Therefore, the information required to answer the prompt's questions about acceptance criteria, study design for AI/algorithm performance, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, and ground truth types is not present in the provided text.
The document discusses:
- Device Description and Indications for Use: The Shockwave Medical IVL System, its components, and its intended use for lithotripsy-enhanced balloon dilatation in peripheral vasculature.
- Technological Comparison: Details how the new S4 Catheter sizes compare to the predicate device, highlighting similarities in intended use, principles of operation, and technological characteristics, while noting updates in materials, emitter design, and packaging.
- Summary of Performance Data (Bench and Biocompatibility): This section describes the engineering and material performance tests (e.g., tensile strength, kink resistance, balloon inflation/deflation, biocompatibility tests) conducted to ensure the device meets design specifications and is substantially equivalent. These are not 'acceptance criteria' in the context of an AI algorithm's diagnostic or predictive performance.
- Clinical Study (DISRUPT BTK Study): This was a clinical study of the predicate device's configuration to assess its safety and effectiveness in treating stenotic, infrapopliteal arteries. It evaluated clinical endpoints like Major Adverse Events (MAE) and reduction in percent diameter stenosis, and procedural success. This is a clinical trial for a medical device, not a study to prove AI algorithm performance.
In summary, the provided document does not contain the information requested in the prompt regarding acceptance criteria for an AI/algorithm-based device and the study proving its performance.
§ 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).