(325 days)
To drain cerebrospinal fluid (CSF) for the management of hydrocephalus.
The Polaris® Pressure Adjustable Valve is an implantable device designed for the treatment of hydrocephalus in adult and pediatric patients by shunting, thereby providing continuous, controlled intraventricular pressure and CSF drainage from the cerebral ventricles. Intraventricular pressure is maintained at a constant level by the device's ball-in-cone valve seat design, and the value is pressure-adjustable transcutaneously. Drainage is directed to the abdominal cavity or to the right atrium of the heart. The basic settings of the Polaris® Valve are 30, 70, 110, 150 and 200. Adjustments to intermediate pressures are made manually in 40 mm Hy0 increments (decrements) in three operating ranges, low pressure (LP = 30 mm H20), medium pressure (MP = 110 mm H20), and high pressure (HP = 200 mm H20).
The specific feature of the self-locking rotor-shuttle micro-magnet system of the passive Polaris® SPV Valve is that the adjustment position of each pressure setting cannot be changed by a unidirectional magnetic field. A domestic magnetic field or an exposure to MRI attracts the shuttles in the same direction and thus cannot unlock them simultaneously, therefore the rotor cannot be mobilized
The provided text describes the Polaris® Pressure Adjustable Valve, a device for treating hydrocephalus, and its substantial equivalence to a predicate device. However, the document does not contain information about specific acceptance criteria, a study demonstrating the device meets those criteria, or quantitative performance metrics.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance studies with acceptance criteria.
Here's a breakdown of the requested information based on the provided text, highlighting what is missing:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. The 510(k) focuses on demonstrating substantial equivalence to a predicate device rather than specific acceptance criteria for a new performance study. | Not specified in the document. No quantitative performance metrics such as accuracy, sensitivity, or specificity are provided. The document states that the Polaris® valve is "substantially equivalent to the Sophy® Pressure Adjustable Valve System" in terms of "biocompatibility, Industry, and operating characteristics." This is a qualitative statement of equivalence, not a quantitative performance report against pre-defined criteria. |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not specified.
- Data provenance: Not specified. The document refers to the predicate device (Sophy® SM8 Valve, K013488) but doesn't detail any specific clinical or performance testing data for the Polaris® valve itself in the context of a new study to establish performance metrics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No new performance study with a test set requiring expert ground truth establishment is described.
4. Adjudication method for the test set:
- Not applicable. No new performance study with a test set requiring adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:
- No MRMC comparative effectiveness study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mechanical shunt, not an algorithm.
7. The type of ground truth used:
- Not applicable. No new performance study with ground truth is described. The basis for clearance is substantial equivalence to a predicate device, which implies the predicate's established performance serves as the benchmark.
8. The sample size for the training set:
- Not applicable. This device is a mechanical shunt, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This device is a mechanical shunt, not an AI/ML algorithm that requires a training set.
In summary: The provided document is a 510(k) summary for a medical device (a hydrocephalus shunt). Its purpose is to demonstrate that the new device (Polaris® Pressure Adjustable Valve) is "substantially equivalent" to an already legally marketed device (Sophy® SM8 Valve). This regulatory pathway typically relies on comparison of design, materials, and intended use, rather than extensive new clinical performance studies with specific acceptance criteria and ground truth, as would be expected for novel devices or AI algorithms. The document explicitly states the basis for substantial equivalence is "biocompatibility, Industry, and operating characteristics" to the predicate device.
§ 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).