(284 days)
The SiphonGuard™ CSF Control Device is a component of hydrocephalus shunt systems designed to shunt CSF from the lateral ventricles of the brain into the peritoneal cavity or right atrium of the heart.
The SiphonGuard™ CSF Control Device is designed to reduce the potential hazards of excessive lowering of intraventricular pressure (with respect to atmospheric pressure) when a patient is in an upright position.
The SiphonGuard™ CSF Control Device is a siphon control device that is designed with two internal passages. The primary passage is a ruby ball-in-seat valve design that opens and closes depending on the CSF flow rate. The secondary passage is a longer spiral passage that remains permanently open but effectively slows the progress of the CSF through the device. The device has two basic modes of operation:
- Normal CSF Flow Conditions: Maiority of the CSF flows through the ruby ball-in-seat valve and exits directly out of the distal port of the SiphonGuard™ CSF Control Device. The remaining CSF travels through a spiral passage that surrounds the primary passage, and reioins the fluid that passes through the primary passage, distal to the ball-in-seat valve.
- Excessive CSF Flow Conditions: Ball-in-seat valve closes and the entire volume of CSF is forced through the longer spiral passage, effectively slowing the rate at which CSF is shunted from the brain. Once the CSF flow rate is reduced. the ruby ball separates from the valve seat, reopening the primary passage, and returning the SiphonGuard™ CSF Control Device to normal CSF flow conditions.
As long as CSF continues to be shunted from the ventricles, flow through the secondary passage never stops, regardless of patient position. The rigid device shell prevents inadvertent closure of the device by externally applied pressure.
The provided document describes the SiphonGuard™ CSF Control Device, a component of hydrocephalus shunt systems. The information primarily focuses on establishing substantial equivalence to existing devices rather than presenting a standalone study with detailed acceptance criteria and performance metrics in the way a diagnostic AI device would.
Here's an analysis based on the provided text, addressing your questions where possible:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Reduction of CSF flow rate (implicit, as main function) | "Pressure-flow test results showed that the SiphonGuard™ CSF Control Device is substantially equivalent to the Delta® Valve antisiphon component and the Transguard™ antisiphon device in reducing CSF flow rate." |
| Material compatibility (implicit for safety and function) | "use of the identical materials used in the CODMAN HAKIM™ Micro Precision Valve (K973774)." |
| Intended Use (similarity to predicate) | "similarity in intended use... to the Delta® Valve (K902783), and Transquard™ device (preamendment)" |
| Design (similarity to predicate) | "similarity in... design... to the Delta® Valve (K902783), and Transquard™ device (preamendment)" |
Note: The document explicitly states "Performance: Pressure-flow test results showed that the SiphonGuard™ CSF Control Device is substantially equivalent to the Delta® Valve antisiphon component and the Transguard™ antisiphon device in reducing CSF flow rate." This implies that the acceptance criteria for performance were met by demonstrating equivalence to established predicate devices in pressure-flow characteristics that are relevant to reducing CSF flow rate. Specific quantitative thresholds for pressure or flow rate are not provided in this summary.
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a test set or data provenance in the context of a clinical study for performance evaluation. The "pressure-flow test results" mentioned are likely bench testing (laboratory-based) to compare the device's physical properties to predicate devices. Information regarding human patient data, its origin, or whether it was retrospective or prospective is not available in this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable and not provided. The device is a medical device (antisiphon component) and its performance evaluation for FDA clearance (510(k)) focuses on engineering design, materials, and substantial equivalence to existing devices, not on diagnostic accuracy requiring expert ground truth in the context of imaging or clinical decision-making. The "ground truth" here would be established by the physical laws of fluid dynamics and established engineering standards for such devices.
4. Adjudication Method for the Test Set
This information is not applicable and not provided for the same reasons as point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not conducted and is not applicable to this type of device and its 510(k) submission. This is a physical device, not an AI or diagnostic algorithm that human readers would interact with.
6. Standalone Performance Study (Algorithm Only)
A standalone performance study in the context of an "algorithm only (without human-in-the-loop performance)" was not conducted and is not applicable. This is a physical medical device, not a software algorithm. The "performance" described relates to its physical function in controlling CSF flow.
7. Type of Ground Truth Used
The "ground truth" for this device's evaluation is primarily based on engineering and physical performance metrics (e.g., pressure-flow characteristics) as measured in a lab setting, comparing it to well-established predicate devices. It is not based on expert consensus, pathology, or outcomes data in the way a diagnostic device would be. The overarching ground truth is that the device "reduces the potential hazards of excessive lowering of intraventricular pressure" as demonstrated by its substantial equivalence to other devices proven to do so.
8. Sample Size for the Training Set
This information is not applicable and not provided. There is no "training set" in the context of machine learning or AI as this is a physical medical device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the same reasons as point 8.
§ 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).