(30 days)
The Turbo-Elite devices are indicated for use in treatment, including atherectomy, of infrainguinal stenoses and occlusions.
The 0.014" and 0.018" Over-the-wire (OTW) Turbo-Elite laser catheters are also indicated for use as an accessory to the use of the Turbo-Tandem System in the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, when used in conjunction with Percutaneous Transluminal Angioplasty (PTA).
Turbo-Elite laser atherectomy catheters are percutaneous intravascular devices constructed of multiple optical fibers in a concentric array around a guidewire lumen. The optical fibers are enclosed in an outer jacket and the working length of the device is coated with a hydrophilic coating. The distal tip of the catheter includes a Platinum Iridium outer Marker Band which is visible under fluoroscopy. The proximal end consists of a tail tube and a coupler which connects the device to the CVX-300 or PLS laser systems.
Turbo-Elite is designed and intended to be used exclusively with Spectranetics' CVX-300 Excimer Laser System and Philips Laser System (PLS).
The catheters transmit ultraviolet energy from the laser system to the obstruction in the artery. The ultraviolet energy is delivered to the tip of the laser catheter to photoablate lesions which may be comprised of atheroma, fibrosis, calcium, and thrombus, thus recanalizing diseased vessels. Photoablation is the process by which energy photons cause molecular bond disruption at the cellular level without thermal damage to surrounding tissue.
During a laser atherectomy, and under fluoroscopic guidance, a physician advances the introducer sheath to the target lesions. The Turbo-Elite catheters are then advanced to the proximal end of the lesion to be treated.
The provided text is a 510(k) summary for the Spectranetics Turbo-Elite Laser Atherectomy Catheter. It outlines the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria or a study proving that the device meets those criteria, especially not regarding performance in terms of AI/algorithm effectiveness.
The document states:
- "The subject device has the same technological characteristics as the predicate device with no significant updates to device design, specification, or performance."
- "Other minor changes related to component suppliers and certain adhesives used were supported via applicable design verification and validation testing and related rationales."
These statements imply that testing was performed to demonstrate that the minor changes did not negatively impact performance, and that the device performs equivalently to the predicate. However, it does not provide any specific quantitative acceptance criteria or the results of any clinical or analytical studies proving such performance, nor does it mention any AI or algorithmic components. The device described is a physical medical device (laser atherectomy catheter), not a software or AI-driven diagnostic tool.
Therefore, I cannot provide the requested information about acceptance criteria or a study proving an AI device meets them based on the provided text. The questions are largely centered around AI/algorithm performance and ground truth, which are not relevant to the content of this 510(k) summary.
In summary, the provided document does NOT contain the information requested in your prompt regarding acceptance criteria and algorithmic performance studies.
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).