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The NEUROVENT is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP).

The NEUROVENT IFD-S is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP).

The NEUROVENT IFD-R is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP).

The NEUROVENT-P is indicated for use in parenchymal pressure monitoring and can be used for the measurement of the intracranial pressure (ICP).

The NEUROVENT-PX is indicated for use in parenchymal pressure monitoring and can be used for the measurement of the intracranial pressure (ICP).

The NEUROVENT-P-TEMP is indicated for use in parenchymal pressure monitoring and can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature.

The NEUROVENT-TEMP is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature.

The NEUROVENT-TEMP IFD-S is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature.

The NEUROVENT-TEMP-IFD-R is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. It can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature.

The NEUROVENT-PTO is indicated for use in parenchymal pressure monitoring and can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature. Additional measurement of the oxygen partial pressure is an adjunct monitor of trends indicating the perfusion status of cerebral tissue local to sensor placement. The measured values are relative within an individual and should not be used as the sole basis for decisions as to diagnosis or therapy.

The NEUROVENT-PTO-2L is indicated for use in parenchymal pressure monitoring and can be used for the measurement of the intracranial pressure (ICP). Additional measurement of the brain temperature allows the direct measurement of the cerebral tissue temperature. Additional measurement of the oxygen partial pressure is an adjunct monitor of trends indicating the perfusion status of cerebral tissue local to sensor placement. The measured values are relative within an individual and should not be used as the sole basis for decisions as to diagnosis or therapy.

The BOLT(-DRILL) KITs are indicated to provide a cranial access for RAUMEDIC neurosurgical precision pressure catheters of the RAUMEDIC NEUROMONITORING-SYSTEM.

The DRILL KITs are indicated to provide a cranial access for RAUMEDIC neurosurgical precision pressure catheters of the RAUMEDIC NEUROMONITORING-SYSTEM.

The Tunneling KITs are indicated to provide a cranial access for catheters of the RAUMEDIC NEUROMONITORING-SYSTEM.

Device Description

The RAUMEDIC® NEUROMONITORING-SYSTEM consists of several different models of probes and probe catheters capable of performing one or several different functions:

Models with a dedicated lumen can be used for drainage of cerebrospinal fluid (CSF).
Models equipped with ICP sensors can determine the level and change in intracranial pressure (ICP).
Models equipped with temperature thermistors can monitor intracranial temperature.
Models equipped with fiber optic sensors can monitor partial tissue oxygen pressure (ptiO2).

The RAUMEDIC® NEUROMONITORING-SYSTEM is intended to be used in conjunction with previously cleared RAUMEDIC® EASY logO Monitor (K130529), RAUMEDIC® MPR2 logO DATALOGGER (K171666), RAUMEDIC® NPS3 (K103206) or RAUMEDIC® NPS2 X (Brand name for NPS2 cleared in K103206).

The RAUMEDIC® NEUROMONITORING-SYSTEM includes components needed to facilitate the surgical implantation of NEUROVENT® catheters.

The RAUMEDIC® NEUROMONITORING-SYSTEM can be used in MR environment under specific constraints (MR conditional). Those constraints vary by device type, implantation method (bolting or tunneling), and magnetic field strength (1.5 or 3.0 Tesla).

AI/ML Overview

The provided FDA 510(k) clearance letter for NEUROVENT Devices does not contain the specific details required to describe the acceptance criteria and the study that proves the device meets those criteria, particularly for performance metrics.

The document primarily focuses on:

Device Identification: Listing all device names, regulation numbers, classification, and product codes.
Regulatory Equivalence: Stating that the device is substantially equivalent to previously cleared predicate devices based on intended use, indications for use, and technological characteristics.
Intended Use/Indications for Use: Detailed descriptions of what each NEUROVENT component is used for (e.g., ICP monitoring, CSF drainage, brain temperature, tissue oxygen partial pressure).
MR Safety Testing: A list of ASTM and ISO/TS standards used to confirm the device's MR conditional status, along with the specific tests performed (magnetically induced displacement force, torque, image artifacts, heating, malfunction for various fields).

Crucially, the document explicitly states: "Based on performance testing and the available information concerning the referenced comparison devices, the RAUMEDIC® NEUROMONITORING-SYSTEM is equivalent in that: - The devices have the same intended use and indication for use. - Performance characteristics are suitable for designated indications for use."

However, it does NOT provide:

A table of specific numerical acceptance criteria (e.g., ICP accuracy within X mmHg, temperature accuracy within Y °C, ptiO2 accuracy within Z mmHg).
The reported device performance metrics against those criteria.
Details about the "performance testing" beyond the MR safety tests. This implies that the performance characteristics (accuracy, precision, etc., for measuring ICP, temperature, ptiO2) were either derived from the predicate devices, established using bench testing, or considered suitable without presenting detailed clinical performance data in this 510(k) summary. Given the device type, it's highly likely a combination of bench and possibly animal/cadaveric testing, as well as reliance on the long-established performance of similar predicate devices, was used.
Information about clinical study design. There is no mention of human subject data, test sets, training sets, ground truth establishment, expert adjudication, or MRMC studies. The phrases "anticipated clinical performance" and "does not raise new issues of safety or effectiveness" suggest reliance on the substantial equivalence principle rather than novel clinical trial data.

Therefore, based solely on the provided text, I cannot complete the requested information for acceptance criteria and the study proving the device meets them, beyond the MR safety aspects.

I will indicate "Not provided in the document" for sections where the information is missing.

1. A table of acceptance criteria and the reported device performance

Performance Parameter	Acceptance Criteria (from document)	Reported Device Performance (from document)
Intracranial Pressure (ICP) Monitoring Accuracy	Not explicitly provided beyond "suitable for designated indications for use" and "equivalent to predicates".	Not explicitly provided (implied to be equivalent to predicate devices).
Brain Temperature (Temp) Monitoring Accuracy	Not explicitly provided beyond "suitable for designated indications for use" and "equivalent to predicates".	Not explicitly provided (implied to be equivalent to predicate devices).
Oxygen Partial Pressure (ptiO2) Monitoring Accuracy	Not explicitly provided beyond "suitable for designated indications for use" and "equivalent to predicates".	Not explicitly provided (implied to be equivalent to predicate devices).
Magnetically Induced Displacement Force	"tested and confirmed as MR conditional" (implied compliance with ASTM F 2052-15)	"tested and confirmed as MR conditional"
Magnetically Induced Torque	"tested and confirmed as MR conditional" (implied compliance with ASTM F2213-06)	"tested and confirmed as MR conditional"
Image Artifacts	"tested and confirmed as MR conditional" (implied compliance with ASTM F2119-07)	"tested and confirmed as MR conditional"
Gradient-induced Heating	"tested and confirmed as MR conditional" (implied compliance with ISO/TS 10974:2018, Clause 9)	"tested and confirmed as MR conditional"
Gradient-induced Malfunction	"tested and confirmed as MR conditional" (implied compliance with ISO/TS 10974:2018, Clause 16)	"tested and confirmed as MR conditional"
RF-induced Heating	"tested and confirmed as MR conditional" (implied compliance with ISO/TS 10974:2018, Clause 8, Tier 3)	"tested and confirmed as MR conditional"
RF-induced Malfunction	"tested and confirmed as MR conditional" (implied compliance with ISO/TS 10974:2018, Clause 15)	"tested and confirmed as MR conditional"
Combined Fields	"tested and confirmed as MR conditional" (implied compliance with ISO/TS 10974:2018, Clause 17)	"tested and confirmed as MR conditional"

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for test set: Not provided in the document. The document primarily refers to "performance testing" and "MR safety requirements" being "tested and confirmed" to meet standards, rather than a clinical test set from human subjects.
Data provenance: Not provided. The MR safety tests are likely laboratory-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided. The document does not describe a study involving expert-established ground truth for performance evaluation of vital sign monitoring. The evaluation methodology focuses on substantial equivalence and laboratory testing for MR compatibility.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a monitoring system and a kit for surgical access, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The performance evaluation discussed pertains to the physical and functional aspects of the hardware (catheters, sensors, and their compatibility with MR environments), not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the MR safety testing, the "ground truth" would be established by the specifications and measurement techniques defined in the referenced ASTM and ISO/TS standards.
For the core physiological measurements (ICP, temp, ptiO2), the "ground truth" would typically refer to the accuracy of the sensors against calibrated reference standards in laboratory or animal models. This specific detail is not provided, but it's implied compliance with recognized industry standards or internal validation that is deemed "suitable for designated indications for use" and "equivalent."

8. The sample size for the training set

Not applicable. The document does not describe the use of machine learning or AI, and therefore, no "training set."

9. How the ground truth for the training set was established

Not applicable.

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K Number

K120252

Device Name

RAUMEDIC-ICP-TEMP-MONITORING-SYSTEM

Manufacturer

RAUMEDIC AG

Date Cleared

2012-04-11

(75 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K112017,K103206,K962928

Intended Use

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.

Device Description

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

AI/ML Overview

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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