(90 days)
Draining and monitoring of CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to
- Reduce intracranial pressure (ICP), e.g. pre-intra- or postoperative;
- Monitor CSF chemistry, cytology and physiology;
- Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts.
The monitoring of the intracranial pressure (ICP) is indicated in selected patients with - Severe head injury;
- Subarachnoid hemorrhage graded III, IV or V preoperatively;
- Reves syndrome or similar encephalopathies;
- Hydrocephalus;
- Intracranial hemorrhage
- Miscellaneous problems when drainage is to be used as a therapeutic maneuver. Monitoring can also be used to evaluate the status pre-and postoperatively for space occupying lesions.
The reusable portion of the system is comprised of a pressure scale, mounting clamp and optional laser level. All components of the reusable device are integrated during manufacture. The scale has a blue anodized finish with contrasting pressure scale. Down the center of the scale is a track for the disposable device to be retained. The scale is integrated into a pole clamp that has been ergonomically designed to facilitate use. An optional laser device may be attached to the pole clamp. It is used to obtain a zero pressure reference with the patients Foramen of Monro.
The disposable device is comprised of three basic elements: a patient line that is attached to an externalized CSF drainage catheter, graduated drip chamber, and drainage bag. The drip chamber has an integrated mounting bracket that is inserted into the track on the reusable scale.
The Medtronic PS Medical Niveau Drainage System is deemed substantially equivalent to predicate devices, but the provided text does not contain detailed acceptance criteria, device performance data from specific studies, or any information regarding AI components.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state specific acceptance criteria or report detailed device performance metrics from a study (e.g., accuracy, precision, sensitivity, specificity, flow rates, ICP measurement accuracy, etc.). The document focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological comparison of features, and materials.
The table below outlines the comparison of features, which is presented as evidence of substantial equivalence rather than a direct performance against acceptance criteria.
| Feature Comparison | Medtronic PS Medical Niveau Drainage System | Clinical Neuro Systems MoniTorr | Codman External Drainage System II |
|---|---|---|---|
| Device Configuration/Contents | |||
| Locking bracket | Integral with mounting panel | Pole mount bracket assembly, braided cord and cord lock | Doubled 24 in. string w/Cord-loc® locking mechanism |
| Mounting panel | Main system section with pressure scale in mmHg and cmH2O | System Panel with instruction label | 27 cm measuring backboard |
| Drip Chamber | 50 cc Conical sliding graduated flow chamber with locking bracket and vent system | 100 ml graduated chamber with filter vent | 75 ml drip chamber with anti-reflux valve and atmospheric vent |
| Patient line | Nondistensible blue striped patient connection line | Nondistensible green striped patient connection line | 157 cm patient line with two slide clamps |
| Stopcocks | Two four-way stopcocks | Two four-way stopcocks | Two four-way stopcocks with female luer port |
| Injection/Sampling Sites | One non-latex injection/sampling site | Two injection sites | Two latex injection/sampling sites |
| Drainage Bag | 500 - 800 ml drainage bag (removable) with volumetric graduations, microbial filter, and drain port | 500ml drainage bag with valve and drain port | 700 ml capacity graduated vinyl collection bag |
| Drainage Bag connection line | Present | Not specified | Not specified |
| Leveling device | Laser leveling device | Line level | Not specified |
| Sterility Method | EtO | EtO | Not specified |
| Sterile | Sterile device with reusable mounting panel section and disposable fluid contact section | Sterile device with reusable mounting panel section and disposable fluid contact section | Sterile single use device |
2. Sample size used for the test set and the data provenance:
The provided document does not mention any specific test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective study) for evaluating the device's performance. The submission relies on a comparison to predicate devices rather than independent clinical testing data of the Niveau Drainage System against specific performance criteria.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the document does not describe a study involving a test set that required expert-established ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable as the document does not describe a study involving a test set that required adjudication.
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:
This information is not applicable. The provided document is for a medical device (drainage system) and makes no mention of Artificial Intelligence (AI) or any MRMC studies involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable as the device is a physical medical drainage system, not an algorithm, and the document makes no mention of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not applicable as the document does not describe a study that required the establishment of a ground truth for evaluating the device's performance. The basis for approval is substantial equivalence to existing predicate devices.
8. The sample size for the training set:
This information is not applicable, as there is no mention of an algorithm or a training set in the document.
9. How the ground truth for the training set was established:
This information is not applicable, as there is no mention of an algorithm or a training set in the document.
In summary, the provided document is a 510(k) premarket notification for a medical device (intracranial pressure monitoring and CSF drainage system) that primarily demonstrates substantial equivalence to existing predicate devices. It does not contain information about clinical studies with specific performance metrics, acceptance criteria for those metrics, or any methodologies related to AI or ground truth establishment.
§ 882.1620 Intracranial pressure monitoring device.
(a)
Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.(b)
Classification. Class II (performance standards).