(154 days)
The Pantheris LV System is indicated to remove plaque (atherectomy) from partially occluded native or restenotic vessels, including in-stent restenosis (ISR), in the peripheral vasculature with a reference diameter of 3.0 mm, using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures, and vessel morphologies. The Pantheris LV System is NOT intended for use in the iliac, coronary, cerebral, renal or carotid vasculature.
The Pantheris LV catheter combines the use of Avinger's optical coherence tomography (OCT) technology with peripheral vascular atherectomy capabilities. The Pantheris LV System consists of the Pantheris LV catheter, a Lightbox Sled with integrated umbilical (referred to as "Sled"), and the Lightbox Imaging Console (referred to as "Lightbox"). The Pantheris LV catheter is a 7 French device with a working length of 110 cm. It is comprised of two components-an outer support catheter and an inner assembly or drive shaft. It is provided sterile and is a single-use device compatible with 5 Fr vascular sheaths. The Pantheris LV catheter incorporates an optical fiber that allows real-time diagnosis of vessel condition and morphology as well as OCT-guided atherectomy during the procedure with its connection to the Lightbox.
This document is a 510(k) summary for the Pantheris LV Atherectomy Catheter. It outlines the device's indications for use, compares it to predicate and reference devices, and describes the performance data used to demonstrate substantial equivalence.
Based on the provided text, the Pantheris LV Atherectomy Catheter is not an AI/ML enabled device. This conclusion is drawn from the following observations:
- Absence of AI/ML terminology: The document does not mention any terms typically associated with AI or machine learning, such as "algorithm," "model," "deep learning," "neural network," "AI assistance," "inference," "training data," "validation data," "ground truth establishment" for algorithms, or "performance metrics" relevant to AI (e.g., sensitivity, specificity, AUC for an AI-driven diagnostic).
- Focus on mechanical and optical characteristics: The device description and performance data sections primarily detail mechanical properties, optical coherence tomography (OCT) imaging capabilities (which are optical imaging not AI-driven image interpretation), electrical safety, electromagnetic compatibility, and biocompatibility.
- Comparison to existing devices based on physical design: The substantial equivalence argument relies heavily on comparing the Pantheris LV's physical design attributes (e.g., catheter size, tip length, working length, mechanism of atherectomy) and shared operational characteristics with existing cleared devices, rather than any advanced computational functionalities.
- Nature of the device: The device is described as an "atherectomy catheter" used to "remove plaque." Its functionality involves physical plaque removal assisted by OCT imaging for guidance, not AI-driven diagnosis, interpretation, or decision-making. The OCT is explicitly stated as "OCT-assisted orientation and imaging" and "an adjunct to fluoroscopy by providing images of vessel lumen, wall structures, and vessel morphologies," referring to human interpretation of these images, not AI analysis of them.
- Lack of AI-specific study types: The "Performance Data" section details mechanical, electrical, and biocompatibility testing. There is no mention of studies that would be typical for an AI/ML device, such as those evaluating diagnostic accuracy (e.g., standalone performance, MRMC studies, reader studies). The sections on "Animal Testing" and "Clinical Studies" explicitly state they "were not necessary" for this particular submission, further indicating the absence of complex data-driven (AI) performance validation.
Therefore, the request to describe acceptance criteria and study data for an AI/ML device is not applicable to the Pantheris LV Atherectomy Catheter based on this document. The provided text does not contain information related to AI/ML acceptance criteria or 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).