(35 days)
For use in the endovascular treatment of symptomatic infrainguinal lower extremity vascular disease where total obstructions can not be crossed with standard guide wires.
Spectranetics' CLiRpath excimer laser atherectomy catheters, including CLiRpath Turbo Plus™ models, consist of a bundle of optical fibers, encased within medical grade tubing. The optical fibers conduct ultraviolet laser light (excimer laser light at 308 nm) from a source to the tip of the catheter. The catheter is inserted into a patient's vasculature along the length of a previously inserted guidewire, allowing the operator to deliver laser energy targeted to a lesion (blockage) in the vasculature. CLiRpath laser catheters are provided in models designed for both "over-the-wire" and "rapid exchange" interventional techniques. Laser energy impinged on a blockage photoablales, or debulks, the lesion material re-establishing blood flow within the vessel, and permitting placement of devices used in vascular interventions.
Spectranetics brand CLiRpath Turbo Plus™ excimer laser catheters will add 80 Hz as a maximum repetition rate for pulsed laser energy to the peripheral atherectorny catheter models not already cleared for 80 Hz operation.
The provided text describes a 510(k) premarket notification for the CLiRpath Turbo Plus™ Excimer Laser Catheter. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study to prove performance against specific acceptance criteria in the context of AI/ML-based medical devices.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details cannot be extracted from the provided text.
The document highlights:
- Device Identification: CLiRpath Turbo Plus™ Excimer Laser Catheter, a peripheral atherectomy catheter.
- Intended Use: For endovascular treatment of symptomatic infrainguinal lower extremity vascular disease where total obstructions cannot be crossed with standard guidewires.
- Comparison to Predicate Devices: The core of the submission is to establish substantial equivalence to existing CLiRpath Turbo excimer laser catheters. The primary enhancement of the "Plus" version is an increased pulse repetition rate from 40 Hz to 80 Hz, leading to faster ablation speeds.
- Testing Mentioned: Biocompatibility, sterilization, packaging, and bench testing were performed. These tests confirmed that the device meets Spectranetics' in-house requirements and ISO 10555-1 standards. However, specific acceptance criteria or performance metrics for these tests are not detailed.
In summary, this submission is not a clinical study report or a performance validation for an AI/ML device, but rather a regulatory filing asserting substantial equivalence based on material and functional similarities, with an enhanced operational parameter (80 Hz pulse rate).
§ 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).