(184 days)
The Miethke proGAV® Programmable Shunt System is intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the peritoneum. Adjustments of the proGAV shunt can be verified by using the verification instrument but must be confirmed by radiograph (X-ray).
The proGAV® is a "programmable" shunt that can be set for a range of pressures. The valve in the new proGAV® is a leaf spring and ball mechanism that is mechanically controlled by internal magnets. The outer case for the device is made of titanium. The shunt comes with a manual device to verify the pressure setting and another to set or re-set the pressure. These manual accessories are both for external use bu the physician. Once verified using the instrument the setting must be confirmed with an X-ray. Various Miethke shunt system accessories such as shunt assistants, connectors, deflectors and reservoirs are also offered with the proGAV®
This submission pertains to the Miethke proGAV® Programmable Shunt System, a Class II medical device (Product Code JXG). This is a 510(k) submission for marketing clearance, asserting substantial equivalence to previously cleared devices.
Based on the provided text, the submission does not contain specific performance data, acceptance criteria, or a detailed study description for the device's efficacy or accuracy.
Here's a breakdown of what can be extracted or inferred, and what information is missing:
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A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not specified in the provided text.
- Reported Device Performance: Not specified in the provided text.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This information is not provided in the document. The submission does not detail any specific test set or clinical study to evaluate the device's performance against acceptance criteria.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- This information is not provided as no specific test set or study is described. The device's setting "must be confirmed by radiograph (X-ray)," implying expert interpretation of X-rays for ground truth in clinical use, but not for a performance study within this submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided as no specific test set or study is described.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This is not applicable. The device is a physical shunt system, not an AI-powered diagnostic or assistive tool. No MRMC study is mentioned.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is not applicable. The device is a physical shunt, not an algorithm. The text explicitly states that adjustments "must be confirmed by radiograph (X-ray)," indicating a human-in-the-loop process for clinical verification of the setting, not 'standalone' algorithm performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the clinical use of the device, the "ground truth" for verifying the shunt setting is an "X-ray." This implies expert radiological interpretation. However, for a device performance study, this information is not provided.
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The sample size for the training set:
- Not applicable/Not provided. This is a physical medical device, not a machine learning model, so there is no concept of a "training set" in the context of this submission.
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How the ground truth for the training set was established:
- Not applicable/Not provided. As above, no training set for an algorithm is involved.
Summary of Device and Evidence presented:
The document describes the Miethke proGAV® Programmable Shunt System, intended to shunt cerebrospinal fluid (CSF). Its key feature is programmability and its setting must be manually verified and "confirmed by radiograph (X-ray)."
The basis for this 510(k) submission is Substantial Equivalence to existing, legally marketed predicate devices, specifically:
- Aesculap - Miethke Shunt System (K011030)
- Sophy Polaris SPV Valve (K042481)
- Medtronic's Strata II Adjustable Valve (K042465)
- Hakim Programmable Valve System from Johnson & Johnson (K980778)
The submission states, "No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for this device." This statement, coupled with the focus on substantial equivalence, indicates that the submission relies on the established safety and effectiveness of the predicate devices and the physical/operational similarities of the proGAV® shunt, rather than presenting new, specific performance data from a dedicated clinical or non-clinical study for this specific version of the device. Therefore, the detailed study information requested is not present in the provided text.
§ 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).