(270 days)
This device is a disposable system designed for the drainage of cerebrospinal fluid from the brain ventricles to a calibrated collection bag, graduated to provide an approximate volume measurement of the fluid collected, and is indicated for use to relieve elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus).
CSF (TM) is a disposable system designed for the drainage of cebrospinal fluid from the brain ventricles to a calibrated collection bag, graduated to provide an approximate volume measurement of the fluid collected. The radiopaque silicone ventricular catheter has been specially designed to drain the cerebropinal fluid from the ventricles through a series of perforations, and it can be inserted into the ventricular cavity with a 30 cm stainless steel stylet included in the system. The CSF (TM) includes a 400 or 600 ml collection bag (respectively CSF400™ and CSF600™) with a bottom drainage port, a small reservoir of 50 ml for liquid just drained, a 270 mm height scale for system 600 and 200 mm for model 400 which is used for positioning the collection unit, a drip chamber which enables visualization of the CSF flow as the fluid enters the bag and permits an approximate measurement of the drainage flow rate, a one-way valve to prevent reflux of the fluid, a 3 way stopcock and a 20 cc syringe to prime the system before its connection to the catheter. The system is designed to facilitate ventricular drainage, fluid injection, CSF sampling and intracranial pressure monitoring. The CSF (TM) system is presented individually packed and sterile.
This submission describes the CSF400™ and CSF600™ Central Nervous System Fluid Drainage Sets, which are disposable systems designed for the drainage of cerebrospinal fluid from the brain ventricles to a calibrated collection bag. The purpose of this document is to determine whether the device meets acceptance criteria based on the provided information.
1. Acceptance Criteria and Reported Device Performance
The submission focuses on establishing substantial equivalence to a predicate device rather than defining and meeting specific analytical or clinical performance acceptance criteria with numerical targets. Therefore, the "acceptance criteria" are implied to be that the device exhibits "Similar" or "Identical" technological characteristics across various categories when compared to the predicate device.
| Technological Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (vs. K820247) |
|---|---|---|
| Indications for use | Identical (or substantially similar) | Identical |
| Target population | Identical (or substantially similar) | Identical |
| Design | Similar | Similar |
| Materials | Similar | Similar |
| Performance | Similar | Similar |
| Sterility | Similar | Similar |
| Biocompatibility | Similar | Similar |
| Mechanical safety | Similar | Similar |
| Chemical safety | Not Applicable | Not Applicable |
| Anatomical sites | Identical (or substantially similar) | Identical |
| Human factors | Similar | Similar |
| Energy used and/or delivered | Identical (or substantially similar) | Identical |
| Compatibility with environment and other devices | Identical (or substantially similar) | Identical |
| Where used | Identical (or substantially similar) | Identical |
| Standards met | Similar | Similar |
| Electrical safety | Not Applicable | Not Applicable |
| Thermal safety | Not Applicable | Not Applicable |
| Radiation safety | Not Applicable | Not Applicable |
Summary of Device Performance: The device's performance is reported as "Similar" or "Identical" across all relevant technological characteristics when compared to the predicate device, K820247. This fulfills the implicit acceptance criteria for substantial equivalence.
2. Sample Size and Data Provenance for the Test Set
The provided document does not describe a specific "test set" in the context of an algorithm's performance evaluation. This submission is a 510(k) premarket notification for a medical device (a CSF drainage set), not an AI/ML software device. Therefore, there is no discussion of a test set, sample size for a test set, or data provenance in the way one would analyze an AI/ML algorithm.
The demonstration of safety and effectiveness relies on comparison to a predicate device, assuming similar engineering, materials, and clinical indications imply similar safety and efficacy.
3. Number of Experts and Qualifications for Ground Truth of Test Set
As this is a 510(k) for a physical medical device and not an AI/ML algorithm, there is no mention or requirement for ground truth established by experts for a test set. The substantial equivalence is determined by reviewing the technological characteristics and intended use in comparison to a legally marketed predicate device.
4. Adjudication Method for the Test Set
Since there is no "test set" for an algorithm's performance, no adjudication method is described or relevant in this 510(k) submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study is typically relevant for evaluating the impact of AI systems on human reader performance (e.g., radiologists interpreting images). This submission does not discuss an MRMC study, as it is for a physical medical device (CSF drainage set) and not an AI/ML diagnostic or assistive tool. Therefore, there is no effect size reported for human readers improving with or without AI assistance.
6. Standalone Algorithm Performance Study
A standalone performance study (algorithm only, without human-in-the-loop) is a concept applicable to AI/ML software devices. This submission does not include or refer to a standalone algorithm performance study as the device is a physical medical device, not a software algorithm.
7. Type of Ground Truth Used
For a physical medical device like the CSF drainage set, the "ground truth" for demonstrating safety and effectiveness is generally derived from:
- Established engineering principles and testing: Verifying material properties, mechanical integrity, sterility, biocompatibility, etc., against recognized standards.
- Clinical experience with predicate devices: Relying on the known safety and efficacy profile of a substantially equivalent device already on the market.
- Performance testing: While not explicitly detailed as "ground truth," performance characteristics like flow rates, volume measurements, and prevention of reflux would be validated through engineering tests.
The document's statement: "This device is safe and effective as the other predicate device cited above" indicates that the ground truth for safety and effectiveness is tied to the established safety and effectiveness of the predicate device (K820247).
8. Sample Size for the Training Set
The concept of a "training set" applies to machine learning algorithms. This 510(k) submission for a physical medical device does not involve or mention a training set.
9. How the Ground Truth for the Training Set was Established
As there is no training set mentioned or applicable for this type of device submission, there is no discussion of how ground truth for a training set was established.
§ 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).