(87 days)
The Contour Flex and Contour Flex Plus Valves are indicated for the treatment of hydrocephalus. They are devices 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 Contour Flex Plus Valve is indicated for 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 Contour Flex Valve and Contour Flex Plus Valve are designed for use as a cerebrospinal fluid shunts. The Contour Flex Plus Valve is the Contour Flex membrane valve with an integral Siphon Limiting Device. The Siphon Limits the reduction of the intraventricular pressure and volume caused by the siphoning effect caused by elevation of the ventricular catheter in relation to the distal catheter (often caused by the patient sitting or standing). This 510(k) covers the use of an alternate material for the upper housing of these valves.
The provided text does not contain the detailed information required to fully answer the questions regarding acceptance criteria and the comprehensive study that proves the device meets those criteria.
This document is a 510(k) summary for a premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with acceptance criteria and performance metrics.
Here's a breakdown of what can be inferred or what is explicitly missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance (Inferred/Stated) |
|---|---|
| Biocompatibility: Meet requirements of ISO Standard 10993 for alternate material. | "This material was subjected to and passes biocompatability testing like the unmodified commercially available valves, designed to meet the requirements of the ISO Standard 10993." |
| Performance Testing: Confirm valve performance with alternate material. (Specific metrics not provided) | "In addition, performance testing was performed on the valves with the alternate material to confirm valve performance." (No specific quantitative performance metrics are provided, but the statement implies it met internal performance criteria for successful confirmation.) |
| Design, dimensions, or specifications: No change from predicate device with alternate material. | "There is no change to the design, dimensions, or specifications of the valves with the use of the alternate material." |
| Substantial Equivalence: Device is as safe and effective as predicate. | The FDA reviewed the 510(k) and "determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976." This implies that the device met the criteria for substantial equivalence, which is the primary "acceptance criterion" for a 510(k) submission. No specific numerical performance endpoints (e.g., sensitivity, specificity, accuracy) are mentioned as this is not a diagnostic device and the focus is on material change. |
Missing Information for Questions 2-9:
The document is a 510(k) summary, primarily focused on demonstrating substantial equivalence (SE) for a material change in an existing cerebrospinal fluid shunt valve. It is not a detailed clinical study report for a novel device, nor does it present the kind of performance data (e.g., sensitivity, specificity, or reader studies) that would typically be associated with AI/software devices. Therefore, most of the requested information is not present in this type of regulatory document.
- 2. Sample size used for the test set and the data provenance: Not mentioned. The testing mentioned (biocompatibility, performance) would likely involve laboratory or bench testing of device components, not a "test set" of patient data in the sense of a diagnostic algorithm.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of diagnostic performance, is not discussed here. The "truth" for biocompatibility and performance testing refers to adherence to engineering standards and prior established device performance.
- 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This is a shunt valve, not an AI diagnostic device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For biocompatibility, the ground truth is the ISO 10993 standard. For performance testing, it would be the established performance specifications of the predicate device.
- 8. The sample size for the training set: Not applicable. No algorithms or machine learning models are discussed.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, this 510(k) submission successfully demonstrated that a material change to an existing device (the Radionics Contour Flex Valve and Contour Flex Plus Valve) did not alter its fundamental safety or effectiveness. The "study" proving this involved biocompatibility testing against ISO standards and performance testing to confirm the valve's function, implying that the new material performed equivalently to the original. The specifics of these tests (e.g., number of units tested, precise measurement thresholds) are not included in this summary.
§ 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).