(123 days)
The RAUMEDIC® -ICP-Monitoring-System is indicated for use in parenchymal pressure monitoring. Use of the parenchymal intracranial pressure monitoring kit with bolt is contra-indicated in children under one year old. The RAUMEDIC® precision pressure catheters are MR Unsafe.
The RAUMEDIC® -ICP-Monitoring-System determines safely, quickly and accurately the level and change in intracranial pressure (ICP) by using semi-conductor pressure sensors. The Neurovent® - P and Neurovent® - P - C are indicated for use in parenchymal pressure monitoring. Both types of catheters are implanted in parenchyma via a RAUMEDIC® - Bolt Kit CH5. In addition to the catheter a zero point module NPS2 x is needed. "x" depends on the type of patient monitor available in the hospital - there are 20 different references. To the equipment also belongs an ICP-Temp-Cable and a NPS3 pressure display unit. The difference between the Neurovent® - P and the Neurovent® - P - C is that the housing material in the C-version is ceramic instead of titanium. The RAUMEDIC® -ICP-Monitoring-System is composed of the following elements: Neurovent® - P, Neurovent® P C, RAUMEDIC® - Bolt Kit (CH 5), RAUMEDIC® Drill Kit 4,5 mm (CH 5), ICP-TEMP-Cable, NPS2, NPS3.
The provided document is a 510(k) summary for the RAUMEDIC® -ICP-Monitoring-System, which describes the device, its intended use, and its substantial equivalence to a predicate device. While it mentions device testing, it does not contain a detailed study proving the device meets specific acceptance criteria with performance metrics, sample sizes, ground truth establishment, or multi-reader studies.
Therefore, I cannot provide the requested information in the format of a table of acceptance criteria and reported performance, nor can I detail the specifics of a study that is not present in the document.
However, I can extract what is mentioned about device testing and regulatory acceptance:
Key Takeaways from the Document Regarding Testing and Acceptance:
- Substantial Equivalence: The primary basis for acceptance is substantial equivalence to a legally marketed predicate device (Pressio® ICP MONITORING SYSTEM, K062584). This means the FDA determined the RAUMEDIC® system is as safe and effective as the predicate device.
- Biocompatibility: Studies were conducted per ISO 10993 standard, demonstrating the materials are safe for intended use.
- Performance Testing (Catheters): The two implantable catheters (Neurovent® P and Neurovent® P C) "were subjected to extensive performance testing." The results "showed that the catheter designs are safe for their intended uses." No specific performance metrics, acceptance criteria, or study details are provided.
- Safety Tests (NPS3): The NPS3 unit "underwent numerous safety tests, including testing to IEC 60601-1." No specific safety metrics or acceptance criteria are provided.
- Manufacturing Compliance: The manufacturing process complies with FDA and European Standards for medical devices.
Missing Information:
The document explicitly states that performance characteristics are "suitable for designated indications for use," but does not define these characteristics quantitatively (e.g., accuracy +/- X mmHg, drift rate, etc.) or provide a study demonstrating achievement of these criteria. Therefore, most of the requested points cannot be answered based on the provided text.
Specifically, the document does not include:
- A table of specific acceptance criteria and detailed reported device performance for clinical accuracy or efficacy.
- Sample sizes used for a "test set" (clinical data) or data provenance.
- Information on experts used to establish ground truth or their qualifications.
- Adjudication methods.
- Any multi-reader multi-case (MRMC) comparative effectiveness study.
- Detailed standalone (algorithm-only) performance results.
- The type of ground truth used (beyond implying the predicate device's established performance).
- Sample size for a training set (as this is a hardware device, not an AI/ML algorithm in the context of the questions).
- How ground truth for a training set was established.
This is a typical scope for a 510(k) summary, which often relies on demonstrating equivalence through design, materials, and general performance testing rather than a de novo clinical trial with defined acceptance criteria and statistical power to show performance against those criteria.
§ 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).