Polaris Pressure Adjustable Valve System Modes SPV, SPVA, SPVB
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Sophysa SA
Identifiers
- 510(k) Number
- K031097 FDA 510(k)
- FDA Product Code
- JXG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5550 FDA 510(k)
- Regulation Number
- 882.5550 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Polaris Pressure Adjustable Valve System is a central nervous system shunt designed to regulate cerebrospinal fluid (CSF) pressure in the brain. It belongs to the category of shunt devices used primarily in the management of hydrocephalus, allowing controlled drainage of excess CSF while maintaining intracranial pressure within physiological limits. The system includes adjustable valve modes to accommodate varying clinical needs, ensuring precise fluid dynamics for patient stability.
This device is supplied as a reusable medical component, intended for use in sterile surgical environments. It is classified under FDA Class II and adheres to the Medical Device Directive (MDD) for regulatory compliance. The system is engineered for compatibility with MRI settings, though specific MRI safety parameters must be confirmed with the manufacturer. Storage and handling follow standard sterile medical device protocols, and its use is governed by FDA 510(k) clearance and MDD authorization.
Frequently asked questions
What clinical conditions is the Polaris Pressure Adjustable Valve System primarily designed to manage?
The Polaris Pressure Adjustable Valve System is designed to regulate cerebrospinal fluid (CSF) pressure in the brain, primarily for the management of hydrocephalus. This condition involves an abnormal accumulation of CSF, leading to increased intracranial pressure, and the valve helps control drainage to maintain physiological pressure levels.
Is the Polaris Pressure Adjustable Valve System intended for single-use or can it be reused?
The Polaris Pressure Adjustable Valve System is supplied as a reusable medical component, meaning it is intended for use in sterile surgical environments and can be reused after proper cleaning, sterilization, and handling procedures. It is not a single-use device.
Can this valve system be used safely in MRI environments, and what precautions should be taken?
The Polaris Pressure Adjustable Valve System is engineered for MRI compatibility, but specific MRI safety parameters must be confirmed with the manufacturer before use. Always verify compatibility to ensure patient safety during imaging.
What regulatory pathways does this device follow, and how was its equivalence determined?
The Polaris Pressure Adjustable Valve System follows the FDA 510(k) clearance pathway and adheres to the Medical Device Directive (MDD) for regulatory compliance. Its equivalence was determined through a Traditional 510(k) review by the FDA’s Neurology (NE) Advisory Committee, where it was classified as Substantially Equivalent (SESE) to a predicate device.
How should the Polaris Pressure Adjustable Valve System be stored and handled to maintain sterility?
The device must be stored and handled following standard sterile medical device protocols, as it is intended for use in sterile surgical environments. Proper storage ensures sterility and functionality, preventing contamination or damage before and during surgical procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Polaris Inc. - Wikipedia
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K031097 | Class II | Active |
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Manufacturer
- Manufacturer
- Sophysa SA
Sources (2)
- FDA 510(k) K031097 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026