(139 days)
The Pantheris System is intended 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 to 7.0 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 system is not intended for use in the iliac, coronary, cerebral, renal or carotid vasculature.
The Pantheris System consists of a Pantheris atherectomy catheter, a Lightbox Sled with integrated umbilical (referred to as "Sled"), and a Lightbox HS Imaging Console (referred to as "Lightbox"). The Pantheris atherectomy catheter is a 7 French device with a working length of 110 cm. It 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 via the Sled accessory.
The following provides an analysis of the acceptance criteria and study findings for the Pantheris System, based on the provided FDA 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Endpoint | Acceptance Criteria (Performance Goal) | Reported Device Performance (Pantheris System) |
|---|---|---|
| Primary Safety: Freedom from Major Adverse Events (MAE) at 30 days | MAEs occurring in 79% | 89% (86 out of 97 subjects) had 61% |
| Secondary Effectiveness: Procedural Success (residual stenosis ≤ 30% post-Pantheris + adjunctive therapy) | Not explicitly defined as a performance goal with a specific threshold. | 80% (78 out of 97 subjects) had residual stenosis |
§ 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).