CSF-Flow Control Valve-BUR

• • Ongoing Z-1117-2021 FDA Class II ·initiated 11 Jan 2021

  Potential for variation in radiopaque marking visibility under radiographic imaging for adjustable and fixed-pressure valves that are used in the management of hydrocephalus

Full name

P-S Medical Csf-Flow Control Valve-Bur

510(k) Number

K831678 ↗

FDA Product Code

JXG

Device Class

Class II

Regulation

21 CFR Part 882.5550

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

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See all devices from Pudenz-Schulte Medical Research Corp. →

• Is this valve designed for single-use or can it be reused after sterilization?

  The valve is classified as a reusable component, as indicated by the regulatory submission. It is not sterile at the time of shipment and must be sterilized prior to use, allowing for multiple uses after proper sterilization procedures are followed.

• What medical specialty is this device intended for, and how does it function within neurosurgical procedures?

  This device is categorized under the medical specialty of Neurology and is specifically designed for use in neurosurgical shunt systems. It functions as a pressure-sensitive valve that regulates cerebrospinal fluid (CSF) flow between the intracranial space and distal drainage sites, helping manage hydrocephalus by ensuring controlled drainage while preventing over-drainage or blockage.

• Are there different sizes or models available for this valve, and if so, how are they distinguished?

  The provided data does not specify any size variations or distinct model numbers for this valve. All listed registration numbers correspond to the same device name (P-S MEDICAL CSF-FLOW CONTROL VALVE-BUR), suggesting a single standardized design without additional size or model differentiation.

• How was this device’s regulatory clearance determined, and what pathway was used?

  The device was cleared via the Traditional 510(k) pathway with a Substantially Equivalent (SESE) determination by the Neurology Advisory Committee. This means the FDA found it to be comparable to a legally marketed predicate device, ensuring it meets safety and effectiveness standards for use in managing CSF flow in hydrocephalus treatment.

• What storage or handling instructions should be followed for this valve before sterilization?

  Since the valve is not sterile at shipment, it must be stored in a clean, dry environment to prevent contamination before sterilization. The manufacturer’s instructions (not detailed here) should be followed for proper sterilization procedures prior to clinical use, as reuse is intended. Avoid exposure to moisture, extreme temperatures, or physical damage to maintain functionality.