(153 days)
The Micrus Ascent Occlusion Balloon Catheter is intended for use in the blood vessels of the peripheral and neuro vasculature where temporary occlusion is desired and offers a vessel selective technique of temporary vascular occlusion which is useful in selectively stopping or controlling blood flow. The Micrus Ascent Occlusion Balloon Catheter is also intended to assist in the delivery of diagnostic agents such as contrast media, and therapeutic agents such as occlusion coils, into the peripheral and neuro vasculature.
The Micrus® Ascent™ Occlusion Balloon Catheter is a coaxial dual lumen balloon catheter comprised of an inner guidewire lumen and a separate outer lumen to inflate and deflate the balloon. The balloon catheter is designed for use over any .014" or smaller guidewire. The balloon can be inflated and deflated independently of guidewire position. The balloon is equipped with a vent hole for easy preparation and removal of air from the balloon, and with two radiopaque markers for balloon positioning.
The provided text is a 510(k) Premarket Notification for the Micrus Ascent Occlusion Balloon Catheter. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing new clinical study data with specific acceptance criteria as would be found in a PMA (Premarket Approval) application for novel devices often involving AI/ML.
Therefore, the document does not contain the information requested regarding acceptance criteria for device performance, details of a study proving such criteria, sample sizes for test/training sets, expert qualifications, or details about comparative effectiveness studies with AI assistance.
The document states that the Micrus Ascent Occlusion Balloon Catheter is considered substantially equivalent to predicate devices based on:
- Intended use
- Design
- Specifications
- Materials
- Methods and materials in construction, packaging, and sterilization
The "study" in this context refers to the comparison made to predicate devices to establish substantial equivalence, not a performance study against specific acceptance criteria.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).