(204 days)
The Aesculap® - Spiegelberg Brain Pressure Monitoring System is indicated for use in those conditions where continuous monitoring of intracranial pressure is required. As dictated by clinical judgment, direct measurement of intracranial pressure (ICP) may be obtained from subdural, parenchymal or intraventricular probe locations.
An intracranial pressure monitoring device is a device used for short-term monitoring and rolling of intracranial pressures and pressure trends. The transducer, monitor, and interconnecting hardware.
This 510(k) submission, K003759, for the Aesculap® - Spiegelberg Brain Pressure Monitoring System, is a premarket notification for a Class II medical device. As such, it relies on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with acceptance criteria for device performance. The document focuses on comparing features and intended use with existing legally marketed devices.
Therefore, many of the requested elements typically found in studies proving device performance against specific acceptance criteria (such as sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of submission.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The submission does not present explicit acceptance criteria for device performance in terms of numerical thresholds for accuracy, precision, sensitivity, or specificity. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to an existing predicate device based on features, intended use, and existing standards.
The table below summarizes the comparison with predicate devices, highlighting features to demonstrate this equivalence, which serves as the basis for "acceptance" in a 510(k) submission.
| Feature | Aesculap® - Spiegelberg Brain Pressure Monitoring System | Integra NeuroCare Predicate | Codman Predicate | Substantially Equivalent (SE)? |
|---|---|---|---|---|
| Indications for Use | The device is indicated for use in conditions where continuous monitoring of intracranial pressure is required. Direct measurement of ICP may be obtained from subdural, parenchymal, or intraventricular probe locations. | SAME | SAME | YES |
| Brain Probes | 3 locations, 6 styles | 3 locations, 3 styles | 3 locations, 3 styles | YES |
| Sterility | Ethylene Oxide | SAME | SAME | YES |
| Non-fluid coupling | Yes | Yes | Yes | YES |
| Materials | Polyurethane | Unknown | Nylon & titanium | YES |
| Auto Zero | Yes | No | No | YES |
| Manufacturer | Spiegelberg | Camino Neurocare | Codman | YES |
| Monitoring Sites | Dura, Parenchymal, Ventricular | SAME | Dura, Parenchymal, Ventricular | YES |
| Transducer Location | ICP Monitor | Catheter Tip | Catheter Tip | NO |
| CPP Monitor | Yes | Yes | No | YES |
| Product Code / K-Number | 84GWM / Pending (K003759) | 84GWM / K962928 (Integra NeuroCare) | 84GWM / K991222 (Codman Neuoscan Monitor) | YES |
Note: The "NO" for Transducer Location indicates a difference but does not prevent substantial equivalence if the overall performance and safety are comparable, which is implicitly argued for in the submission.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. As this is a 510(k) submission primarily relying on substantial equivalence, detailed performance studies with test sets in the context of clinical data are generally not required or presented in the same way as a PMA submission. The "test" for this device is the comparison of its features and intended use to predicate devices, and adherence to specific controls (material, biocompatibility, labeling) and QSR.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. Ground truth establishment by experts for a clinical test set is not applicable to this type of 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is not applicable to this type of 510(k) submission.
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
An MRMC study is not applicable to this device. This is a brain pressure monitoring system, not an AI or imaging diagnostic device that involves human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is an intracranial pressure monitoring system, not an algorithm, and its function involves direct measurement, not an AI prediction or diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the safety and effectiveness established for the predicate devices through their prior marketing clearance. The new device is deemed equivalent because its fundamental characteristics match those of already approved devices, implying similar safety and effectiveness. No new ground truth was established for this submission.
8. The sample size for the training set
This information is not applicable as there is no mention of a "training set" for an algorithm in this submission.
9. How the ground truth for the training set was established
This information is not applicable as there is no mention of a "training set" for an algorithm in this submission.
In summary, the K003759 submission for the Aesculap® - Spiegelberg Brain Pressure Monitoring System demonstrates "acceptance" by establishing substantial equivalence to legally marketed predicate devices, focusing on comparable intended use, materials, features, and adherence to regulatory controls, rather than through new clinical performance studies with explicit acceptance criteria and statistical outcomes.
§ 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).