(238 days)
The RAUMEDIC® - PTO-Monitoring-System measures intracranial pressure, temperature and oxygen and is intended as an adjunct monitor of trends in these parameters, indicating the perfusion status of cerebral tissue local to sensor placement. RAUMEDIC® - PTO-Monitoring-System values are relative within an individual, and should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide data additional to that obtained by current clinical practice, in cases where hypoxia or ischemia is a concem.
Use of the parenchymal intracranial pressure monitoring kit with bolt is indicated for children who are at least one year old.
The RAUMEDIC® -PTO-Monitoring-System determines the level and change in intracranial pressure (ICP) by using semi-conductor pressure sensors, in temperature using thermistors, and in partial oxygen pressure ptiO2 using a luminescence optical sensor fibre.
The PTO-Monitoring-System consists of intracranial catheters, a cranial bolt kit, the user interface unit (EASY logO), cables to connect the catheters to the EASY logO and cables for the EASY logO to send the measurements to specific patient monitoring units.
Three intracranial catheters are provided: NEUROVENT®-PTO, NEUROVENT® TO and NEUROVENT® PTO 2L. The NEUROVENT®-PTO measures three physiological parameters - ICP, temperature and partial oxygen pressure. The application has to be made with a single lumen Bolt (BOLT-KIT PTO). The NEUROVENT -PTO 2L also measures these three parameters, but has to be placed with a multi lumen Bolt (BOLT KIT PTO 2L) or via tunneling process. The NEUROVENT® TO measures two physiological parameters – temperature and partial oxygen pressure. The application has to be made with a single lumen Bolt (BOLT-KIT PTO).
The NEUROVENT®-PTO or the NEUROVENT®-TO is implanted in the parenchyma using a BOLT KIT PTO. The NEUROVENT®-PTO 2L is implanted in the parenchyma using a BOLT KIT PTO 2L or using a RAUMEDIC® spliceable tunnelling sleeve CH8 (already cleared for market under 510(k) K112017).
For connecting the catheters to the EASY logO two cables – cable PTO and cable LWL - are needed. The cable PTO transfers the electrical signal for ICP and temperature. The cable LWL transfers the optical signal for oxygen pressure.
The EASY logO is the user interface that displays the measurements and alerts the user to the status of the intracranial catheters. The EASY logO displays: oxygen partial pressure pO2, intracranial pressure ICP, pulse amplitude ICPA and temperature T. ICP is a pulsatile signal that consists of the ICP average value and a pulsatile ICPA component, which is superimposed over the ICP average value.
DATALOGGER cables allows the EASY logO to send the measurements to specific patient monitoring units.
The provided text describes the RAUMEDIC® -PTO-Monitoring-System and its performance testing to demonstrate substantial equivalence to previously cleared devices. It does not contain information about a study proving the device meets explicit acceptance criteria in the format requested. However, it does provide performance specifications and comparison to predicate devices, which serve as a de facto set of acceptance criteria for regulatory clearance.
Here’s a summary of the available information, fitted to the request structure where possible.
Device Name: RAUMEDIC® -PTO-Monitoring-System
Intended Use: Measures intracranial pressure (ICP), temperature, and oxygen (ptiO2) as an adjunct monitor of trends, indicating perfusion status of cerebral tissue local to sensor placement. Not for use as the sole basis for diagnosis or therapy. For use in children at least one year old.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the performance specifications of the predicate devices and relevant standards (ANSI/AAMI NS 28:1988/(R) 2006 for ICP, ASTM E1112-00 (2006) for Temperature, and comparison to K980380 for ptiO2). The tables provided (Table 5, Table 6, and Table 7) list the performance testing and results, demonstrating that the device meets these established comparables.
| Feature / Parameter | Acceptance Criteria (from Predicate/Standards) | Reported Device Performance (RAUMEDIC® -PTO-Monitoring-System) |
|---|---|---|
| ICP Performance (Based on ANSI/AAMI NS 28:1988/(R) 2006) | ||
| Frequency response | > 100 Hz | 167 Hz (Meets Standard) |
| Slew rates | > 7,500 torr/s | 10,000 torr/s (Meets Standard) |
| Time constants | 40 °C (104 °F) | max. 39.5 °C (Meets Standard) |
| Temperature Performance (Based on ASTM E1112-00 (2006)) | ||
| Cleaning | No visible of technical changes | No visible of technical changes (Meets Standard) |
| Toxicity | Toxicity Test | Toxicity Test (Meets Standard) |
| Accuracy | No difference between the in vivo and in vitro accuracy | No difference between the in vivo and in vitro accuracy (Meets Standard) |
| Operating Environment (Temp/RH) | 120 mmHg) | 150.00+/-15 mmHg (for predicate: 135.0-165.0 mmHg for values from 120-200 mmHg) |
| Response time T90 | 13 mm² (predicate: ≥ 5 mm²) | ≥ 15.1 mm² (> 5mm² is o.k. in brain) (Yes) |
| Length ptiO2 sensitive area | > 4mm | > 4.9 mm (within predicate's > 4 mm) (Yes) |
| Outer catheter diameter |
§ 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).