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To drain cerebrospinal fluid (CSF) for the management of hydrocephalus.

The Sophy® Pressure Adjustable Valve System SM8 is an implantable device designed for the treatment of hydrocephalus in adult and pediatric patients by shunting, thereby providing continuous, controlled intraventricular pressure and CSF drainage from the cerebral ventricles. Intraventricular pressure is maintained at a constant level by the device's ball-in-cone valve seat deign, and the value is pressure-adjustable transcutaneously. Drainage is directed to the abdominal cavity or to the right atrium of the heart. The Sophy® Pressure Adjustable Valve System SM8 technology allows for the non-invasive manual adjustment of the operating pressure via 8 pressure settings, ranging from 30 mm H20 to 200 mm H20, as follows: 30 = Low, 110 = Medium (intermediate 50, 70, 90) and 200 = High (intermediate 140, 170).

The principle of the Sophy® Pressure Adjustable Valve System SM8, nearly identical to that of its predicate Sophy@SU8 FDA cleared hydrocephalus valve (K992465), is based on the pressure change exerted on a synthetic ruby ball by a semi-circular spring at different points of its curvature. This spring is connected to a magnetic rotor whose position can be adjusted noninvasively by using a adjustment magnet oriented at different angles with selected orientations corresponding to different pressures. Radio-opaque identification dots indicate three main positions of the rotor corresponding to Low, Medium, and High operating pressures. For manual pressure setting, a specific adjustment kit is necessary, including a compass, magnet, and pressure selector.

The Sophy® Pressure Adjustable Valve System SM8 is a miniaturized version of the predicate Sophy®SU8 (K992465), with a nearly 50% volume reduction and an approximately 45% weight reduction.

This document is a 510(k) summary for the Sophy® SM8 Pressure Adjustable Valve System. It seeks to demonstrate substantial equivalence to a previously cleared device, the SOPHYSA Sophy® SU8 (K992465), rather than providing a study proving a device meets specific acceptance criteria based on novel performance metrics.

Therefore, the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets them.

The document outlines:

• Device Identification: Sophy® Pressure Adjustable Valve System, Model SM8, a hydrocephalus shunt.
• Predicate Device: SOPHYSA Sophy® SU8 (K992465).
• Device Description: An implantable device for treating hydrocephalus by shunting CSF. It features 8 adjustable pressure settings (30 to 200 mm H2O) adjusted non-invasively by a magnetic rotor, similar in principle to the predicate device but miniaturized (50% volume reduction, 45% weight reduction).
• Substantial Equivalence: Claimed based on "intended use, materials, design, performance, function, and operating characteristics" to the predicate Sophy®SU8 (K992465).
• Indications for Use: To drain cerebrospinal fluid (CSF) for the management of hydrocephalus.

To directly answer your prompt based on the provided text, the requested information elements are not present. The 510(k) process for this device relies on demonstrating substantial equivalence to a predicate device, not on presenting novel performance data against new acceptance criteria.

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