(10 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 atherectorny catheters, including CLiRpath Turbo 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 medical guidewire, allowing the attending physician to deliver laser energy targeted to a lesion (blockage) in the blood vessel. CLiRpath laser catheters are provided in models designed for both "over-the-wire" and rapid exchange interventional techniques. Laser energy impinged on a blockage ablates, 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 laser catheters will be supplied in addlional tip diameters between 0.9 and 2.3 mm, appropriate for interventional use in the peripheral vasculature of the leg.
This is a 510(k) summary for a medical device (CLiRpath Turbo Excimer Laser Catheter), not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and training/test set specifics for demonstrating AI performance is not applicable to this document.
The document discusses the substantial equivalence of the CLiRpath Turbo Excimer Laser Catheter to previously cleared predicate devices based on:
- Device Description: The CLiRpath Turbo models are variations of existing laser catheters, featuring a bundle of optical fibers to deliver UV laser light (308 nm) from a source to a catheter tip, intended for ablating vascular lesions. The new "Turbo" feature allows for continuous laser delivery without mandatory 5-second pauses, unlike prior models (except the 2.5mm Turbo predicate).
- Intended Use: For endovascular treatment of symptomatic infrainguinal lower extremity vascular disease where total obstructions cannot be crossed with standard guide wires.
- Comparison to Predicate Devices: The document explicitly states that the CLiRpath Turbo catheters are "substantially equivalent in form, fit, and function" to other Spectranetics CLiRpath laser catheters, including the 2.5 mm Turbo catheter (K043465) and other peripheral CLiRpath catheters (K040067). The main difference is the "Continuous-On" capability for a wider range of tip diameters (0.9 mm to 2.3 mm).
- Biocompatibility, Sterilization, Packaging, and Bench Testing: The new devices use the same components and materials as previously marketed Spectranetics products, and their biocompatibility has been confirmed according to ISO 10993. Sterilization processes are in accordance with ISO 11135, and packaging integrity is validated. Device integrity and functionality were qualified/validated to meet Spectranetics' in-house requirements and ISO 10555-1.
Key takeaway for your request: This document is about conventional medical device clearance, not an AI/ML device that would have acceptance criteria for algorithm performance. There are no models, test sets, ground truths, or expert adjudications as would be found in an AI/ML device submission.
§ 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).