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Polaris Pressure Adjustable Valve System, Models SPV-140, SPV-300, SPV-400

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K042481

by Sophysa SA

Identifiers

510(k) Number
K042481 FDA 510(k)
FDA Product Code
JXG FDA 510(k)
Models / Variants
Spv-140 FDA 510(k)EUDAMED
Spv-300 FDA 510(k)EUDAMED
Spv-400 FDA 510(k)EUDAMED

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 within the ventricular system. It is classified as a shunt, central nervous system and components, and functions to control CSF flow by adjusting resistance to drainage, thereby managing conditions such as hydrocephalus.

The system is supplied as a reusable, non-sterile device intended for surgical implantation and is regulated under FDA 510(k) clearance and the EU Medical Device Directive (MDD). Models SPV-140, SPV-300, and SPV-400 vary in pressure adjustment ranges, with specific resistance values tailored for different clinical needs. Storage and handling follow standard surgical implant protocols, and its regulatory classification aligns with Class II medical devices under the FDA’s device classification system.

Frequently asked questions

Is the Polaris Pressure Adjustable Valve System intended for single-use or can it be reused in clinical settings?

The Polaris Pressure Adjustable Valve System is explicitly described as a reusable device, meaning it is designed for surgical implantation and can be reused after proper cleaning, sterilization, and handling procedures. Since it is non-sterile as supplied, it must undergo sterilization before reuse, adhering to standard surgical implant protocols.

What are the key differences between the SPV-140, SPV-300, and SPV-400 models, and how do they relate to patient needs?

The SPV-140, SPV-300, and SPV-400 models differ in their pressure adjustment ranges and resistance values, which are tailored to manage cerebrospinal fluid (CSF) pressure in hydrocephalus patients. While the exact resistance values aren’t specified, the variation suggests each model is designed for different clinical scenarios—such as lower, moderate, or higher CSF pressure control—to optimize drainage and patient outcomes.

How is the Polaris Pressure Adjustable Valve System regulated in the U.S. and Europe, and what does that mean for purchasing?

The device holds FDA 510(k) clearance, meaning it has been deemed substantially equivalent to a legally marketed predicate device under U.S. regulations. In Europe, it complies with the EU Medical Device Directive (MDD), classifying it as a Class II device. This regulatory pathway ensures compliance with safety and performance standards, but purchasers should confirm local compliance requirements before procurement.

What storage and handling precautions should be taken for the Polaris Pressure Adjustable Valve System before surgical use?

Since the system is non-sterile as supplied, it must be sterilized before use following standard surgical implant protocols. Storage should adhere to manufacturer guidelines for reusable medical devices, ensuring protection from contamination, moisture, and physical damage. Proper packaging and environmental controls are critical to maintain device integrity until sterilization.

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.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sophysa SA

Sources (2)

  • FDA 510(k) K042481 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026