Search Results

The Strata Burr Hole valve is a shunt component designed to provide continued cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The Strata Burr Hole valve allows the physician to noninvasively adjust the pressure/ flow performance level ore- and post-implantation without the need for radiographic confirmation in order to address changing patient needs.

The PS Medical® Strata® Burr Hole Valve is an adjustable valve designed for non-invasive pressure flow adjustment.

The provided text is a 510(k) summary for the PS Medical® Strata® Burr Hole Valves and Shunt Assemblies. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices through technological comparison rather than presenting a performance study with acceptance criteria.

Therefore, the information regarding acceptance criteria and a study proving the device meets these criteria is not present in the provided text.

Specifically, the document states:

• "Medtronic Neurosurgery submits that the Strata Burr Hole Valves and Shunt Assemblies included in this submission are manufactured of identical materials, and have the same intended use and fundamental scientific technology as the previously reviewed and cleared:
  • Medtronic PS Medical Strata II Valves and Shunt Assemblies with and without BioGlide (K042465)
  • PS Medical Strata NSC Burr Hole Valves and Shunt Assemblies (K082127)."
• "Based upon the summary above, Medtronic Neurosurgery has determined that the proposed Strata Burr Hole Valves and Shunt Assemblies are safe and effective and substantially equivalent to the predicate and currently marketed devices."

This indicates that the submission is based on substantial equivalence, implying that a new performance study with acceptance criteria was not required or described in this particular 510(k) summary.

Ask a specific question about this device