(141 days)
The Stryker Neurovascular TransForm™ Occlusion Balloon Catheters (Compliant and Super Compliant) are indicated for use in the neuro and peripheral vasculature to temporarily stop or control blood flow and for balloon assisted embolization of intracranial aneurysms.
Stryker Neurovascular's TransForm Occlusion Balloon Catheters (Compliant and Super Compliant) are compliant, variable stiffness reinforced balloon catheters. The outer surface of the catheter's distal segment is coated with a lubricious hydrophilic coating designed to reduce friction. Each balloon catheter has two radiopaque markers to facilitate fluoroscopic visualization. The proximal end of the balloon catheter incorporates a strain relief and a standard luer fitting to facilitate the attachment of accessories.
Here's an analysis of the provided 510(k) summary for the TransForm™ Occlusion Balloon Catheter, detailing acceptance criteria and proof of their fulfillment.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (bench testing, shelf life, packaging, and biocompatibility). The "acceptance criteria" for this type of submission are typically that the new device meets the performance requirements for its intended use and is proven safe and effective for that use, typically demonstrated by showing it performs comparably or better than the predicate for relevant attributes.
Since specific numerical acceptance criteria (e.g., "Deflation time must be
§ 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).