Search Results

The InnerDyne, Inc., REVAS product is intended to provide percutaneous access to the vasculature. The REVAS product is indicated for the following use: Percutaneous vascular access.

The REVAS product consists of an expandable sleeve assembly. The tubular member of the expandable is configured so as to be radially compressed to reduce the outside diameter of the device prior to insertion. Upon use, the expandable sleeve assembly is inserted through the skin and surrounding tissue into the selected vessel over a previously placed guidewire according to the techniques of Seldinger. (An alternative placement method would have the needle placed within the lumen of the expandable sleeve, and the combined needle and sleeve inserted into the target vessel. The guidewire would be placed and the needle removed.) The dilator/sheath assembly, which consists of a tapered dilator and sheath with integral hemostasis valve, is inserted over the guidewire through the lumen of the expandable sleeve which expands radially to accommodate the dilator/sheath. This process in turn, radially expands the surrounding tissue. Following dilation the dilator is removed, leaving the expandable sleeve and sheath with integral hemostasis valve in place to provide a sealed port for passage of instruments.

This system configuration allows the user to initially place a small diameter sheath for passage of small instruments. The sheath can then be removed from the lumion the sleeve while leaving the sleeve inserted in the vessel. A larger dirmeter dilator/sheath can then be inserted through the sleeve to create a larger port for passage of the larger instruments.

The device is assembled from medical grade materials under GMP and ISO conditions. Components are molded and machined by qualified suppliers. The components are assembled and secured by adhesives, welds, and mechanical interlocks.

The provided text describes a medical device, the InnerDyne, Inc., Radially Expanding Vascular Access System (REVAS™), and its 510(k) submission for market clearance. However, it does not contain information regarding acceptance criteria or a study that proves the device meets those criteria in the format requested.

Here's why and what information is missing:

• No Acceptance Criteria Table or Reported Performance: The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating "substantial equivalence" to a predicate device. It doesn't present specific acceptance criteria (e.g., success rates, complication rates, force required, etc.) or a quantitative performance report against such criteria.
• No Study Details: The text states, "The subject InnerDyne, Inc., REVAS product is as safe and effective as currently marketed devices for the stated indications," and "The FDA finding of substantial equivalence... permits your device to proceed to the market." This indicates that the primary method for demonstrating safety and effectiveness was through comparison to existing, legally marketed devices (predicates), not through a new, independent clinical trial or bench study with specific performance endpoints.
• Lack of detailed ground truth, sample sizes, expert qualifications, adjudication, or MRMC studies: These elements are typically part of a comprehensive clinical or performance study report, which is not present in this 510(k) summary. The 510(k) pathway often relies on demonstrating similarity to established devices rather than new performance benchmarks.

Therefore, I cannot populate the requested table or answer the specific questions based on the provided text. The document's purpose is to establish substantial equivalence, not to report on a detailed performance study with acceptance criteria.

Ask a specific question about this device