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.

Summary

FDA 510(k) Clearance Letter - NEUROVENT Devices

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

August 29, 2025

Raumedic Ag
Hannes Engelhardt
Head of Regulatory Affairs
Hermann-Staudinger-Straße 2
Helmbrechts, Bavaria 95233
Germany

Re: K250285

Trade/Device Name: NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOLT KIT CH9 (091688-003); BOLT KIT PTO (096026-003); DRILL KIT CH5 (091878-002); DRILL KIT CH9 (091668-002); Tunneling KIT CH8 (090516-001); Tunneling KIT CH12 (090727-001)

Regulation Number: 21 CFR 882.1620
Regulation Name: Intracranial pressure monitoring device
Regulatory Class: Class II
Product Code: GWM
Dated: July 31, 2025
Received: July 31, 2025

Dear Hannes Engelhardt:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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K250285 - Hannes Engelhardt Page 2

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

Page 3

K250285 - Hannes Engelhardt Page 3

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Adam D. Pierce, Ph.D.
Assistant Director
DHT5A: Division of Neurosurgical,
Neurointerventional, and
Neurodiagnostic Devices
OHT5: Office of Neurological and
Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known): K250285

Device Name:

NEUROVENT-P
NEUROVENT
NEUROVENT-IFD-R
NEUROVENT-IFD-S
NEUROVENT-P-TEMP
NEUROVENT-TEMP
NEUROVENT-TEMP-IFD-R
NEUROVENT-TEMP-IFD-S
NEUROVENT-PTO
NEUROVENT-PTO 2L
NEUROVENT-PX
BOLT-DRILL KIT CH5
BOLT-DRILL KIT CH9
BOLT-DRILL KIT PTO
BOLT KIT CH5
BOLT KIT CH9
BOLT KIT PTO
DRILL KIT CH5
DRILL KIT CH9
Tunneling KIT CH8
Tunneling KIT CH12

Indications for Use (Describe)

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).

Page 5

tissue temperature.

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.

Type of Use (Select one or both, as applicable)

☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Page 6

510(k) Summary

510(k) #: K250285
Prepared on: 2025-08-28

Contact Details

21 CFR 807.92(a)(1)

Field	Information
Applicant Name	RAUMEDIC AG
Applicant Address	Hermann-Staudinger-Straße 2 Helmbrechts Bavaria 95233 Germany
Applicant Contact Telephone	004992523591530
Applicant Contact	Dr. Hannes Engelhardt
Applicant Contact Email	hannes.engelhardt@raumedic.com

Device Name

21 CFR 807.92(a)(2)

Device Trade Name:

NEUROVENT-P
NEUROVENT
NEUROVENT-IFD-R
NEUROVENT-IFD-S
NEUROVENT-P-TEMP
NEUROVENT-TEMP
NEUROVENT-TEMP-IFD-R
NEUROVENT-TEMP-IFD-S
NEUROVENT-PTO
NEUROVENT-PTO 2L
NEUROVENT-PX
BOLT-DRILL KIT CH5
BOLT-DRILL KIT CH9
BOLT-DRILL KIT PTO
BOLT KIT CH5
BOLT KIT CH9
BOLT KIT PTO
DRILL KIT CH5
DRILL KIT CH9
Tunneling KIT CH8
Tunneling KIT CH12

Field	Information
Common Name	Intracranial pressure monitoring device
Classification Name	Device, Monitoring, Intracranial Pressure
Regulation Number	882.1620
Product Code(s)	GWM

Legally Marketed Predicate Devices

21 CFR 807.92(a)(3)

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K103206	RAUMEDIC® ICP-MONITORING-SYSTEM	GWM
K112017	RAUMEDIC® ICP-MONITORING-SYSTEM ventricular	GWM

Page 7

| K120252 | RAUMEDIC® ICP-TEMP-MONITORING-SYSTEM | GWM |
| K130529 | RAUMEDIC® PTO-MONITORING-SYSTEM | GWM |
| K153347 | Codman® Codman Microsensor Basic Kit | GWM |

Device Description Summary

21 CFR 807.92(a)(4)

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 includes components needed to facilitate the surgical implantation of NEUROVENT® catheters.

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

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).

Page 8

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.

Indications for Use Comparison

21 CFR 807.92(a)(5)

The RAUMEDIC® NEUROMONITORING-SYSTEM is substantially equivalent to the legally marketed predicate devices:

RAUMEDIC®-ICP-MONITORING-SYSTEM (K103206),
RAUMEDIC-ICP-Monitoring-System ventricular (K112017),
RAUMEDIC®-ICP-TEMP-MONITORING-SYSTEM (K120252),
RAUMEDIC-PTO-Monitoring-System (K130529), and
Codman Microsensor Basic Kits (K153347).

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.

Based on this, the anticipated clinical performance of the RAUMEDIC® NEUROMONITORING-SYSTEM is substantially equivalent to the referenced systems and does not raise new issues of safety or effectiveness.

Technological Comparison

21 CFR 807.92(a)(6)

The RAUMEDIC® NEUROMONITORING-SYSTEM is substantially equivalent to the legally marketed predicate devices:

RAUMEDIC®-ICP-MONITORING-SYSTEM (K103206),
RAUMEDIC-ICP-Monitoring-System ventricular (K112017),
RAUMEDIC®-ICP-TEMP-MONITORING-SYSTEM (K120252),
RAUMEDIC-PTO-Monitoring-System (K130529), and
Codman Microsensor Basic Kits (K153347).

Based on performance testing and the available information concerning the referenced comparison devices, the RAUMEDIC® NEUROMONITORING-SYSTEM is equivalent in that:

The devices are made of the same materials or substantially equivalent materials.
The devices have equivalent form, function, procedures and features.
Performance characteristics are suitable for designated indications for use.

Non-Clinical and/or Clinical Tests Summary & Conclusions

21 CFR 807.92(b)

MR safety requirements of the RAUMEDIC® NEUROMONITORING-SYSTEM have been tested and confirmed as MR conditional by the

Page 9

following tests:

Magnetically induced displacement force (ASTM F 2052-15)
Magnetically induced torque (ASTM F2213-06)
Image artifacts (ASTM F2119-07)
Gradient-induced heating (ISO/TS 10974:2018, Clause 9)
Gradient-induced malfunction (ISO/TS 10974:2018, Clause 16)
RF-induced heating (ISO/TS 10974:2018, Clause 8, Tier 3)
RF-induced malfunction (ISO/TS 10974:2018, Clause 15)
Combined Fields (ISO/TS 10974:2018, Clause 17)

Regulation Number and Section

§ 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).