(89 days)
The RAUMEDIC® -ICP-Monitoring-System ventricular is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. Use of the ventricular intracranial pressure monitoring kit with bolt is contra-indicated in children under one year old. The RAUMEDIC® catheters are MR Unsafe.
The RAUMEDIC® -ICP-Monitoring-System ventricular is composed of NEUROVENT® components, spliceable tunneling sleeves, and bolt and drill kits. The device is used for intracranial pressure monitoring and cerebrospinal fluid drainage applications, and is implanted in the ventricle using various methods.
Despite the user's request, the provided document does not contain the detailed information necessary to describe acceptance criteria, device performance, or study details such as sample sizes, ground truth establishment, or multi-reader multi-case studies for a diagnostic AI device.
The document is a 510(k) summary for a medical device called the "RAUMEDIC® -ICP-Monitoring-System ventricular." This device is an intracranial pressure monitoring system, not an AI-powered diagnostic tool. The information provided is typical for a traditional medical device submission, focusing on:
- Device Identification: Name, applicant, contact, date.
- Device Description: Components (NEUROVENT® components, tunneling sleeves, bolt and drill kits).
- Intended Use/Indications for Use: Ventricular pressure monitoring and cerebrospinal fluid drainage, contraindications (children under one year old for the bolt kit), and MR safety status (MR unsafe).
- Substantial Equivalence: Comparison to predicate devices (K103206 and K062584).
- Testing: Mentions biocompatibility studies and performance testing to demonstrate safety and compliance with standards, but does not provide details on specific performance metrics, acceptance criteria, or study methodologies that would be relevant for an AI diagnostic device.
- Regulatory Classification: Class II, product code GWM.
Therefore, I cannot fulfill the request for information on acceptance criteria and study details as they pertain to an AI diagnostic device, because the provided text describes a physical medical device for monitoring and fluid drainage, not an AI software.
§ 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).