(314 days)
The Cleaner™ Rotational Thrombectorny System is indicated for mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts.
The Cleaner™ Rotational Thrombectorny System is a 5.8Fr perculaneous mechanical thrombectorny catheter. It is a sterile, single use disposable device. Its handle contains a battery operated motor that spins a flexible "S" shaped guidewire at approximately 4000 rpm. The wall contacting rotational wire, with integrated soft distal tip, permits atraumatic mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts. The wire creates a fluid vortex as it spins that macerates clot and allows it to be aspiration through an introducer sheath.
The provided text describes a medical device, the Cleaner™ Rotational Thrombectomy System, and its regulatory submission. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/algorithm-driven device.
The document is a 510(k) summary for a thrombectomy catheter. The "Non-Clinical Performance Testing" section mentions: "The expanded indications for use to include native vessel dialysis fistulae are based on the bench testing and animal data presented in the performance section of the submission. A GLP animal study was conducted utilizing the Cleaner Rotational Thrombectomy System in a Lagomorph IVC model."
This indicates that an animal study and bench testing were performed to support the expanded indications, but these are not for an AI/algorithm-driven device, nor do they detail specific acceptance criteria for performance metrics that would be relevant to such a device (e.g., sensitivity, specificity, accuracy).
Therefore, the requested information regarding acceptance criteria and a study proving an AI/algorithm-driven device meets those criteria cannot be extracted from this document, as the device is a mechanical thrombectomy system.
§ 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).