(110 days)
The Radionics Burr Hole Valve is indicated for the treatment of hydrocephalus. It is a device The Racebook and fluid from the ventricles of the brain to an appropriate drainage ate, such as the atrium of the heart or the peritoneal cavity. The Burr Hole Valve is designed to fit into a formal burr hole.
The Burr Hole Valve is designed for use as a cerebrospinal fluid shum. It is the commercially available Radionics Contour Flex membrane valve with an alternate shaped reservoir/ pumping chamber; the Burr Hole Valve is shaped to fit into a burr hole. The Radionics Burr Hole Valve has the same intended use and design characteristics as the PS Medical Burr Hole Valve and the Radionics Contour Flex Valve. The Radionics Burr Hole Valve has the same reservoir shape and similar dimensions to the PS Medical Burr Hole Valve. Both of these valves are designed in two sizes to fit a 12 mm and 16 mm burr hole. The fluid flow path is the same for the Radionics Burr Hole Valve and the Contour Flex Valve. In addition, the flow control element is the same for the Burr Hole and Contour Flex Valves. The same polypropylene base/ silicone membrane valve component is used in both systems resulting in the same pressure flow specifications for each type of valve.
The provided text is a 510(k) premarket notification for the Radionics Burr Hole Valve, which is a cerebrospinal fluid shunt. This submission focuses on establishing substantial equivalence to previously marketed devices rather than presenting data from a study designed to meet specific acceptance criteria for performance.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in this type of document. The 510(k) process primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often by showing it shares similar design, materials, and intended use as the predicate, rather than through extensive clinical trials for de novo performance evaluation.
Here's an analysis based on the information provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criterion | Reported Device Performance | Study that Proves the Device Meets the Criterion |
|---|---|---|
| Design/Functionality Equivalence to Predicate | The Burr Hole Valve has the same intended use and design characteristics as the PS Medical Burr Hole Valve and the Radionics Contour Flex Valve. It has the same reservoir shape and similar dimensions to the PS Medical Burr Hole Valve. The fluid flow path and flow control element are the same as the Contour Flex Valve. The same polypropylene base/silicone membrane valve component is used, resulting in the same pressure flow specifications. | Substantial Equivalence Determination (as described in the document) |
| Fit into Burr Hole | Designed to fit into a formal burr hole. Designed in two sizes to fit a 12mm and 16mm burr hole. | Not explicitly detailed as a separate test, but implied by design specifications and comparison to predicate device. |
| Pressure Flow Specifications | Same pressure flow specifications as the Contour Flex Valve. | Not explicitly detailed as a separate test, but implied by using the same valve component as the predicate. |
| Safe and Effective Use (when instructions followed) | Labeling includes description, directions for use, and safety information (contraindications, precautions, warnings). | Not explicitly detailed as a separate test for this specific device, but generally assumed for medical devices with proper labeling. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This submission is a 510(k) for substantial equivalence, not a clinical study with a test set of patient data to evaluate performance. The comparison is primarily based on device design, materials, and intended use to predicate devices.
3. 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)
- Not applicable. No test set requiring ground truth establishment by experts is described in this 510(k). The evaluation is based on a comparison to predicate devices and their established safety and effectiveness.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring adjudication is described.
5. 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
- No. This is a mechanical device (cerebrospinal fluid shunt) and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a mechanical device, not an algorithm, so this concept is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Indirect Ground Truth: The "ground truth" in a 510(k) context for this type of device is implicitly the established safety and effectiveness of the predicate devices (Radionics Contour Flex Valve and PS Medical Burr Hole Valve). The argument is that because the new device is substantially equivalent in design, materials, and intended use to these already-approved devices, it can be considered safe and effective.
8. The sample size for the training set
- Not applicable. As this is a mechanical device and not an AI/machine learning algorithm, there is no training set in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable. (See point 8).
Summary of the Study that Proves the Device Meets the Acceptance Criteria:
The "study" or evidence proving the device meets its "acceptance criteria" in this 510(k) submission is a comparison to predicate devices.
- Device Under Review: Radionics Burr Hole Valve
- Predicate Devices: Radionics Contour Flex Valve and PS Medical Burr Hole Valve.
- Methodology: The manufacturer demonstrated substantial equivalence by detailing that the Radionics Burr Hole Valve has:
- The same intended use (shunting cerebrospinal fluid from ventricles to a drainage site for hydrocephalus).
- Similar design characteristics and dimensions (reservoir shape, fit for 12mm/16mm burr holes).
- The same fluid flow path and flow control element as the Contour Flex Valve.
- The same polypropylene base/silicone membrane valve component as the Contour Flex Valve, leading to the same pressure flow specifications.
- Instructions for proper use and safety information.
- Conclusion: Based on these comparisons, the FDA determined the device to be substantially equivalent to the predicate devices, thereby establishing its safety and effectiveness without requiring new clinical trials or performance studies specific to the new device itself.
§ 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).