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510(k) Data Aggregation
(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 |
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(75 days)
The RAUMEDIC®-ICP-TEMP-Monitoring-System is indicated for use by a qualified neurosurgeon for direct measurement of intracranial pressure and temperature in the parenchyma and in the ventricle and cerebrospinal fluid drainage applications.
Use of the parenchymal and 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-TEMP-Monitoring-System determines the level and change in intracranial pressure (ICP) by using semi-conductor pressure sensors and temperature monitoring using thermistors.
The NEUROVENT®-TEMP IFD-S and NEUROVENT®-TEMP IFD-R are indicated for use in ventricular pressure and temperature monitoring and cerebrospinal fluid drainage applications. The NEUROVENT®-P-TEMP is indicated for use in parenchymal pressure and temperature monitoring.
The RAUMEDIC® -ICP-TEMP-Monitoring-System is composed of the following elements:
- NEUROVENT®-TEMP IFD-S
- NEUROVENT®-TEMP IFD-R
- NEUROVENT®-P-TEMP
- ICP-TEMP-Adapter
- ICP-TEMP-Adapter HP / Philips
The company Raumedic AG submitted a 510(k) premarket notification for their RAUMEDIC® -ICP-TEMP-Monitoring-System (K120252), an intracranial pressure and temperature monitoring device.
Here's an analysis of the provided information regarding acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the device's technical specifications and compares them to predicate devices, rather than explicit "acceptance criteria" and "reported performance" of a clinical trial. However, we can infer some performance characteristics from the comparison tables. It's important to note that these are design specifications and bench test results, not clinical performance data in terms of diagnostic accuracy or patient outcomes.
| Feature | Acceptance Criteria (Implied from Predicate/Design) | Reported Device Performance (as per submission) |
|---|---|---|
| Intended Use | Same as predicate devices (parenchymal and ventricular pressure/temperature monitoring, CSF drainage, measurement of ICP and CPP, and brain temperature monitoring for patients with suspected ICP increases or cerebral edema) | The RAUMEDIC® -ICP-TEMP-Monitoring-System is indicated for use in parenchymal and ventricular pressure and temperature monitoring and can be used for the measurement of the intra-cranial pressure (ICP) as well as of the cerebral perfusion pressure (central arterial blood pressure minus ICP) which is the essential pre-requisite for an effective treatment of patients suspected of suffering from intra-cranial pressure increases... Additional the measurement of the brain temperature allows the direct measurement of the cerebral the measurature. This temperature can deviate from the patient's overall body temperature. Measuring the brain's temperature permits episodes of cerebral hypothermia to temperated and also provides additional temperature information during hypothermia treatment. |
| Materials | Made of the same or substantially equivalent materials as predicate devices. | "The devices are made of the same materials or substantially equivalent materials." Biocompatibility studies conducted per ISO 10993 demonstrated materials are safe. |
| Form, Function, Procedures, Features | Equivalent to predicate devices. | "The devices have equivalent form, function, procedures and features." |
| ICP-Sensor Design | Miniatur transducer (matching predicate RAUMEDIC® devices) OR Optical reflector (matching predicate Camino® devices) | Miniatur transducer |
| Temperature-Sensor Design | Thermistor | Thermistor |
| Temperature Range | Minimum of 30°C - 40°C (predicate Camino® devices). The RAUMEDIC® device extended this range. | 25°C - 45°C (The submission states "NO - see SE-discussion 1 below table" for the comparison to Camino, indicating deviation but likely within acceptable limits for a wider temperature measurement capability) |
| Pressure Range | At least -10 to +250 mmHg (predicate Camino® devices). The RAUMEDIC® device slightly extended the lower range. | -50 to +250 mmHg (The submission states "NO - see SE-List with predicate devices: RAUMEDICO® ICP-MONITORING-SYSTEM and RAUMEDICO® ICP-MONITORING-SYSTEM ventricular" indicating a difference but again, likely accepted for broader capability) |
| Zero Point Stability (ICP) | Less than 1mmHg during first 24 hours AND Less than 2mmHg during the first 7 days (matching RAUMEDIC® predicate devices) OR Less than 2 mmHg during first 24 hours AND Less than 1 mmHg per day during the first 5 days (predicate Camino® devices). The RAUMEDIC® device claims better stability. | Less than 1mmHg during first 24 hours. Less than 2mmHg during the first 7 days. (The submission states "NO - see SE-List with predicate devices: RAUMEDICO® ICP-MONITORING-SYSTEM and RAUMEDICO® ICP-MONITORING-SYSTEM ventricular" in comparison to Camino, but aligns perfectly with its own cleared ICP monitoring systems, implying this is the performance against its own higher standard.) |
| Sensitivity System | 5 µV/V/mmHg on the monitor side | 5 µV/V/mmHg on the monitor side |
| Maximum Pressure | 1,250 mmHg | 1,250 mmHg |
| Sterilization Process | With Ethylene Oxide | With Ethylene Oxide |
2. Sample Size and Data Provenance for the Test Set
The submission does not describe a clinical study or a "test set" in the context of evaluation of diagnostic or predictive performance. Instead, it details "extensive performance testing" of the catheters and biocompatibility studies.
- Sample Size: Not specified in terms of number of devices or number of patient cases typically associated with a test set for clinical performance. The testing mentioned appears to be bench testing on the device itself.
- Data Provenance: The biocompatibility studies were conducted "per ISO 10993 standard." The performance testing of catheters also appears to be laboratory/bench-based. No mention of human patient data or country of origin for such data.
- Retrospective/Prospective: Not applicable as no clinical study or patient data test set is described.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. As no clinical study or test set involving human data is described, there's no mention of experts establishing ground truth for diagnostic or prognostic performance. The 'ground truth' for the device's technical specifications would be established against engineering standards and validated measurement techniques during the performance testing.
4. Adjudication Method for the Test Set
Not applicable. No test set involving human interpretation requiring adjudication is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The submission is for a medical device (intracranial pressure and temperature monitoring system), not a diagnostic algorithm that enhances human reader performance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical medical monitoring system, not a software algorithm that performs diagnostic analysis. It measures physiological parameters (ICP and temperature) directly, and its performance is assessed by comparing its measurements to established standards or other validated monitoring systems through bench testing or direct physical validation, not through an "algorithm only" study.
7. Type of Ground Truth Used
For the performance testing mentioned:
- Biocompatibility: Established by adherence to ISO 10993 standard, which involves a series of tests to evaluate the biological response to medical devices.
- Catheter Performance Testing: Ground truth would be established through engineering and metrological standards, using calibrated reference instruments to verify accuracy, stability, and range of pressure and temperature measurements. This is intrinsic to device design and validation.
8. Sample Size for the Training Set
Not applicable. The device is hardware-based, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. No training set is involved.
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