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510(k) Data Aggregation
(75 days)
RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM
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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