(55 days)
The ENROUTE Transcarotid Neuroprotection System is intended to provide transcarotid vascular access, introduction of diagnostic agents and therapeutic devices, and embolic protection during carotid artery angioplasty and stenting procedures for patients diagnosed with carotid artery stenosis and who have appropriate anatomy described below:
- · Adequate femoral venous access
- Common carotid artery reference diameter of at least 6mm
- · Carotid bifurcation is a minimum of 5 cm above the clavicle as measured by duplex Doppler ultrasound (DUS) or computerized axial tomopgraphy (CT) angiography or magnetic resonance (MR) angiography.
The ENROUTE® Transcarotid Neuroprotection System (Modified) is designed to provide direct transcarotid arterial access to the common carotid artery (CCA), provide introduction of diagnostic agents and therapeutic devices, and provide embolic protection during carotid artery angioplasty and stenting procedures for patients diagnosed with carotid artery stenosis. The ENROUTE Transcarotid NPS (Modified) is designed to transport emboli away from the carotid artery circulation by reversing blood flow at the treatment site prior to crossing a lesion in the carotid artery and during lesion manipulation. It has an integrated filter used to capture and contain embolic material liberated during the procedure.
The ENROUTE Transcarotid NPS (Modified) consists of four primary components: the Transcarotid Arterial Sheath with Dilator, the Venous Return Sheath with Dilator, the Flow Controller and a 0.035" Extra Support J-Tip Guidewire. When assembled and inserted into the patient, the components of the ENROUTE Transcarotid NPS (Modified) create an arteriovenous shunt. When used in conjunction with occlusion of the proximal common carotid artery, the ENROUTE Transcarotid NPS (Modified) reverses the direction of blood flow in the internal carotid artery (ICA), shunting embolic particles away from the cerebral circulation, and into the venous circulation. Flow through the arteriovenous shunt is regulated by the Flow Controller.
The provided text is a 510(k) summary for the ENROUTE® Transcarotid Neuroprotection System (Modified). It describes the device, its intended use, and the testing conducted to demonstrate its substantial equivalence to a predicate device. However, the document does not contain any information about a study involving an AI/Machine Learning device or human readers.
Therefore, I cannot extract the information required to answer your questions regarding acceptance criteria for an AI device, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance.
The document entirely focuses on the substantial equivalence of a mechanical medical device (a catheter system) based on:
- Biocompatibility testing: Ensuring materials are safe for patient contact.
- Design Verification (Bench-Top Testing): Evaluating physical and mechanical properties.
- Sterilization, Packaging Validation, and Shelf Life: Ensuring the device remains sterile and functional over time.
It explicitly states: "The subject, ENROUTE® Transcarotid Neuroprotection System (Modified) met all established requirements." but these requirements are related to the physical and biological performance of the mechanical device, not AI performance.
§ 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).