(15 days)
The Equi-Flow™ Valve and Shunt Systems are used in the treatment of patients with hydrocephalus. The device is designed to shunt cerebrospinal fluid from the ventricles of the brain to an appropriate drainage site, such as the atrium of the heart or the peritoneal cavity.
The Equi-Flow™ Valve is indicated in patients where excessive reduction of intraventricular pressure or volume may be caused by the siphoning effect of hydrostatic pressure in the Distal Catheter of the shunt system.
The Integra NeuroSciences Equi-Flow™ Valve is a multi-function membrane valve incorporating a normally open Siphon Limiting Device, occluders, and integrant valving connectors. It is used in treatment of patients with hydrocephalus when shunting cerebrospinal fluid (CSF) from ventricles of the brain. It incorporates a central reservoir for pumping and injection, proximal and distal occluders, and a fully flexible profile.
The Siphon Limiting Device limits the siphon effect in the shunt system by closing when exposed to a negative Hydrostatic pressure (often caused by the patient sitting or standing).
The Equi-Flow Valve incorporates a central reservoir for pumping and injection, proximal and distal occluders, and a fully flexible profile. The Equi-Flow Valve design includes a flat silicone membrane, which provides resistance to CSF flow. The flat silicone membrane seats on a conical polypropylene base which is integral to the Siphon Limiting Device. This base is integral to a rigid outlet port. The design allows for accurate and precise regulation of CSF flow due to its structural integrity. The flat silicone membrane also prevents retrograde flow of CSF. The Equi-Flow valve is available in two sizes: Regular and Small. Both sizes are available in five pressure/flow characteristics ranges: Low/Low, Low, Low/Medium, Medium and High.
The provided text describes the Equi-Flow™ Valve and Shunt System, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data from a specific study against acceptance criteria.
Here's a breakdown of why the requested information cannot be extracted from the provided text:
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Table of acceptance criteria and reported device performance: This information is not present. The document mentions that the device "has been tested for pressure/flow, leakage, antireflux, catheter elongation and bending, and markings visual inspection," but it does not provide what the acceptance criteria were for these tests or the specific results achieved.
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Sample size used for the test set and data provenance: No specific test set or study with corresponding sample sizes or data provenance (country of origin, retrospective/prospective) is described.
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Number of experts used to establish ground truth and qualifications: Not applicable, as no study generating ground truth is detailed.
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Adjudication method: Not applicable, as no study requiring adjudication is detailed.
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Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned or referenced.
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Standalone (algorithm-only) performance: Not applicable, as this is a physical medical device, not an AI algorithm.
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Type of ground truth used: Not applicable, as no study generating ground truth is detailed.
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Sample size for the training set: Not applicable, as this is a physical medical device, not an AI algorithm requiring a training set.
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How ground truth for the training set was established: Not applicable, as this is a physical medical device.
Conclusion from the provided text:
The submission for the Equi-Flow™ Valve and Shunt System relies on demonstrating substantial equivalence to existing, legally marketed predicate devices (Equi-Flow™ Valve and Shunt System and Contour-Flex Valve and Shunt System), rather than a new standalone performance study against specific acceptance criteria. The document explicitly states: "The modified Equi-Flow™ Valve and Shunt System is substantially equivalent to the unmodified Equi-Flow Valve and Shunt System and Contour-Flex Valve and Shunt System. The modifications do not affect the intended use, the fundamental scientific technology of the device, and do not raise new issues of safety and effectiveness."
Therefore, based solely on the provided text, it is not possible to fill out the requested table or answer the other questions about acceptance criteria and a specific study proving device performance. The "Safety" section briefly lists tests performed (pressure/flow, leakage, antireflux, etc.) but does not provide quantitative acceptance criteria or results.
§ 882.5550 Central nervous system fluid shunt and components.
(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).