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Models for ventricular application:
The Integra Flow Regulating Valve Systems are implantable systems used in the treatment of patients with hydrocephalus, to shunt CSF from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium.

Models for lumbar application:
The Lumbar Integra Flow Regulating Valve Systems are implantable systems used in the treatment of patients with communicating hydrocephalus to shunt CSF from the lumbar subarachnoid region to the peritoneal cavity.

The Integra Flow Regulating Hydrocephalus Valve Systems are implantable devices for controlled cerebrospinal fluid (CSF) drainage from the ventricles to the peritoneal cavity or other appropriate drainage site such as the heart's right atrium (ventricular application) or from the lumbar subarachnoid region to the peritoneal cavity (lumbar application). Unlike conventional valves, these are variable resistance valves which maintain a drainage rate constant within the physiological range (for the specified populations and disorders) of intracranial pressure. The mechanism incorporates a safety pressure relief mode to prevent accidental intracranial hypertension.

The various models include two flow regulating ranges, two antechamber sizes, and various accessories allowing either a ventricular or a lumbar application. The two flow regulating ranges are:

Standard flow regulating: maintains a drainage rate close to the normal CSF secretion rate, around 20ml/hr (18-30ml/h).

Low flow regulating: maintains a lower drainage rate than OSV II Valve Systems, around 10ml/hr (8-17ml/h).

The systems are available in different configurations. A system generally consists of a ventricular or lumbar (proximal) catheter, a valve unit, and a drainage (distal) catheter. Some configurations contain an antechamber (standard or low profile) or a burr hole cap.

Various accessories are available for the implantation procedure or to be implanted in addition to the valves.

All products are sold sterilized, for single use only

The provided text is a 510(k) summary for the Integra OSV II Valve Systems. This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. It describes non-clinical performance and does not include an acceptance criteria table or a study proving device meeting clinical acceptance criteria based on human or expert evaluation.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies proving the device meets those criteria, as that information is not present in the provided text. The document focuses on demonstrating substantial equivalence through non-clinical testing after a material change (epoxy glue), rather than presenting clinical performance data or acceptance criteria for such.

The document does include the following non-clinical testing information:

• Non-Clinical Tests Performed:

  • Load Testing (up to 15N (1.5kg))
  • Water Test (at 37℃ for 28 days)
  • Biocompatibility testing (Sensitization, Genotoxicity (Bacterial Reverse Mutation, In Vitro Chromosomal Aberration, Mouse Peripheral Blood Micronucleus), Pyrogen (Rabbit Pyrogen Study))
  • MR Conditional status testing (Radio Frequency Induced Heating Test, MR Image Artifacts, Magnetically Induced Displacement Force Test, Magnetically Induced Torque Test).

• Conclusion from Non-Clinical Data: The biocompatibility testing and design verification testing have verified that the change of glue has no impact on the product specifications, performance, and reliability. This testing supports the safety of the modified devices and demonstrates that they should perform as intended.

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