(184 days)
The Medtronic PS Medical® Strata® Valve and Strata® NSC Valve are shunt components designed to provide continued Cerebrospinal Fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or peritoneal cavity. The design allows the physician to non-invasively adjust valve pressure/performance level pre- and post-implantation by using an external magnetic adjustment tool without the need for radiographic confirmation.
Medtronic PS Medical® Strata® II Valve The Medtronic PS Medical® Strata® II Valve and shunt assemblies with and without BioGlide are shunt components designed to provide continued CSF flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design allows the physician to non-invasively adjust valve pressure/performance level pre- and post-implantation by using a special magnetic adjustment tool without the need for radiographic confirmation.
The Medtronic PS Medical® Strata® Type Valve is an adjustable valve designed for non-invasive pressure-flow adjustment.
The provided text is a 510(k) summary for a medical device (Medtronic PS Medical® Strata® Type Valve), which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a study.
Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets them.
Here's why and what information is present:
- Type of Submission: This is a 510(k) Pre-Market Notification. For this type of submission, the primary goal is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its absolute safety and effectiveness through extensive clinical trials with pre-defined acceptance criteria.
- Focus of the Document: The text explicitly states its purpose is to show "substantial equivalence, safety, and efficacy of the Medtronic PS Medical® Strata® Type Valves compared to the predicate and currently marketed devices." It does this by stating that the "materials of fabrication, intended use, and the fundamental scientific technology of the Medtronic PS Medical® Strata® Type Valves are the same as the previously reviewed and cleared Stratatype valves."
Consequently, I cannot fill out the requested table or answer the specific questions about acceptance criteria and performance studies because the document does not contain this information.
The document does provide:
- Device Name: Medtronic PS Medical® Strata® Type Valve
- Predicate Devices: K012052 - Medtronic PS Medical® Strata® Valve, K033850 - PS Medical® Strata® NSC Valve, K040943 - Strata® Valve Adjustment and Indicator Tools, K042465 - PS Medical® Strata® II Valve
- Intended Use: "The Medtronic PS Medical® Strata® Valve and Strata® NSC Valve are shunt components designed to provide continued Cerebrospinal Fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or peritoneal cavity. The design allows the physician to non-invasively adjust valve pressure/performance level pre- and post-implantation by using an external magnetic adjustment tool without the need for radiographic confirmation." (Similar for Strata® II Valve).
- Technological Comparison: States that the new device's materials, intended use, and fundamental scientific technology are the same as the predicate devices.
§ 882.5550 Central nervous system fluid shunt and components.
(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).