(92 days)
To drain cerebrospinal fluid (CSF) for the management of hydrocephalus.
The Polaris® Pressure Adjustable Valve models SPV-140, SPV-300, SPV-400 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 ballin-cone valve seat design, and the value is pressure-adjustable transcutaneously. Drroinage is directed to the abdominal cavity or to the right atrium of the heart.
The basic settings of the Polaris® SPV-140 Valve are 10, 40, 80, 110 and 140 mm H₂O; adjustments to intermediate pressures are made manually in 30 mm H20 increments (decrements).
The basic settings of the Polaris® SPV-300 Valve are 50, 100, 150, 220 and 300 mm H2O; adjustments to intermediate pressures are made manually in 50-70 mm H20 increments (decrements).
The basic settings of the Polaris® SPV-400 Valve are 80, 150, 230, 330 and 400 mm H2O; adjustments to intermediate pressures are made manually in 70-100 mm H20 increments (decrements).
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 and the pressure setting remains fixed and constant.
This application (K042481) for the Polaris® SPV-140, SPV-300, SPV-400 Pressure Adjustable Valve is a 510(k) Special Summary and does not contain the detailed study information needed to answer all aspects of your request. This type of submission relies on substantial equivalence to a previously cleared device (predicate device K031097), often meaning that extensive new studies are not required if the new device has only minor changes from the predicate.
However, based on the provided text, I can infer some information and identify what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not include a table of acceptance criteria or specific reported device performance metrics for the Polaris® SPV-140, SPV-300, SPV-400 system. The submission states that the device is "substantially equivalent to the SOPHYSA Sophy® Polaris® SPV Valve (K031097) previously cleared and currently marketed" in terms of "intended use, materials, biocompatibility, design, performance, function, and operating characteristics." This implies that the performance is expected to be the same as the predicate device, but no specific performance data for this particular submission is presented.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not describe a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). This is typical for a 510(k) Special Summary where the focus is on demonstrating substantial equivalence to a predicate, rather than presenting new clinical study data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The provided text does not mention any experts being used to establish ground truth for a test set. As no new clinical study data is presented, this information would not be part of this submission.
4. Adjudication Method
The provided text does not describe any adjudication method. This is because no new clinical study data requiring adjudication is presented.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not mention any MRMC comparative effectiveness study. This type of study would typically be performed for new, more complex diagnostic or AI-driven devices, which is not the case for this hydrocephalus shunt.
6. Standalone (Algorithm Only) Performance Study
The device described is a physical medical device (a pressure adjustable valve), not an algorithm or AI system. Therefore, a "standalone algorithm performance study" is not applicable and not mentioned in the document.
7. Type of Ground Truth Used
The concept of "ground truth" (expert consensus, pathology, outcomes data) is not directly applicable in the context of this 510(k) submission for a physical device. The "truth" here revolves around the device's physical and functional characteristics being equivalent to a known, safe, and effective predicate device.
8. Sample Size for the Training Set
The provided text does not describe a training set or its sample size. This device is a physical product, not a machine learning model that would require a training set.
9. How the Ground Truth for the Training Set Was Established
As no training set is applicable, the establishment of ground truth for a training set is not relevant to this submission.
Summary of Device and Evidence Presented:
The Polaris® SPV-140, SPV-300, SPV-400 Pressure Adjustable Valve is an implantable device used to treat hydrocephalus by draining cerebrospinal fluid. It is designed to maintain constant intraventricular pressure and is transcutaneously adjustable. The key feature highlighted is a self-locking rotor-shuttle micro-magnet system that prevents accidental pressure setting changes by unidirectional magnetic fields (like domestic magnets or MRI).
The study that "proves the device meets the acceptance criteria" in this context is the demonstration of substantial equivalence to the predicate device, the SOPHYSA Sophy® Polaris® SPV Valve (K031097). This means that the FDA has determined that the new device is as safe and effective as the predicate based on comparisons of:
- Intended Use: Both devices are for draining CSF for hydrocephalus management.
- Materials: Implied to be the same or similar, leading to similar biocompatibility.
- Biocompatibility: Assumed to be equivalent due to similar materials.
- Design: The new models are variations of the predicate.
- Performance: Expected to be equivalent to the predicate.
- Function: Operates in the same manner as the predicate.
- Operating Characteristics: Similar pressure ranges, adjustment increments, and mechanism for pressure setting.
The provided document does not contain new experimental data or clinical trials for the K042481 submission itself, but rather references the predicate device (K031097) as the basis for its safety and effectiveness.
§ 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).