RAUMEDIC- ICP-MONITORING SYSTEM

K103206 · Raumedic AG · GWM · Mar 4, 2011 · Neurology

Device Facts

• Record ID: K103206
• Device Name: RAUMEDIC- ICP-MONITORING SYSTEM
• Applicant: Raumedic AG
• Product Code: GWM · Neurology
• Decision Date: Mar 4, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1620
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The RAUMEDIC® -ICP-Monitoring-System is indicated for use in parenchymal pressure 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 intracranial pressure increases (such as cranio-cerebral traumas, GCS ≤ 8; malignant medial cardiac infarctions; hepatic encephalopathy; SAB Hunt / Hess IV + V; cerebral edema; hydrocephalus) or of patients whose clinical picture may be linked to an increase of the ICP.

Device Story

System uses semi-conductor pressure sensors in parenchymal catheters (Neurovent P/PC) to measure intracranial pressure (ICP); calculates cerebral perfusion pressure (CPP) via subtraction of ICP from central arterial blood pressure. Catheters implanted via bolt kit; connected to zero-point module (NPS2) and pressure display unit (NPS3) via ICP-Temp-Cable. Used in clinical settings (e.g., ICU) by physicians to manage patients with suspected intracranial hypertension. Output displayed on NPS3 unit; assists clinicians in monitoring neurological status and guiding treatment decisions. Benefits include accurate, rapid pressure measurement to facilitate timely clinical intervention.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993. Performance testing conducted on implantable catheters to verify safety and accuracy. NPS3 display unit tested for electrical safety per IEC 60601-1. No clinical trial data presented.

Technological Characteristics

System components: semi-conductor pressure catheters (Neurovent P/PC), bolt kit, zero-point module (NPS2), pressure display (NPS3), and cables. Materials: titanium or ceramic (C-version) catheter housing. Sensing principle: semi-conductor pressure transducer. Connectivity: wired connection between catheter, module, and display. Sterilization: not specified. Electrical safety: IEC 60601-1 compliant.

Indications for Use

Indicated for parenchymal intracranial pressure (ICP) monitoring in patients suspected of increased ICP (e.g., traumatic brain injury, GCS ≤ 8; malignant medial cardiac infarctions; hepatic encephalopathy; SAB Hunt/Hess IV+V; cerebral edema; hydrocephalus). Contraindicated in children under one year old.

Regulatory Classification

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.

Predicate Devices

• Pressio® ICP MONITORING SYSTEM (K062584)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for RAUMEDIC, a company that provides "Lifeline to Health". The logo consists of a stylized circle with horizontal lines inside, followed by the company name in bold, sans-serif font. Below the company name is the tagline "Lifeline to Health". The number K103206 is written in a handwritten style.

#### - 4 2011 MAH

RAUMEDIC AG . Postfach 5 01 . D - 95205 Münchberg

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center - W066-0609 10903 New Hampshire Avenue Silver Spring, MD 20993-0002

#### Forschung & Entwicklung

Telefon: [phone] Telefax: (0 92 52) 359-10 00 [e-mail] www.RAUMEDIC.de

Direktkontakt: Telefon: [phone]

[e-mail]

Ihre Nachricht vom Ihre Zeichen

Sachbearbeiter H Thiem thi Unsere Zeichen

Tag 22.02.2011

510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

1. Name, address, phone and fax number of the applicant

RAUMEDIC AG Hermann-Staudinger-Straße 2 95233 Helmbrechts D - Germany Tel.: [phone] Fax: [phone]

# 2. Contact person

Mr. Reiner Thiem Head of Regulatory Affairs Hermann-Staudinger-Straße 2 95233 Helmbrechts D - Germany Tel.: [phone]

# 3. Date of preparation of the summary

August, the 26" 2010

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Image /page/1/Picture/0 description: The image shows the logo for RAUMEDIC. The logo consists of a circular symbol on the left, followed by the word "RAUMEDIC" in bold, sans-serif font. Below the word is the tagline "Lifeline to Health" with a line on either side of the text.

# 4. Name of the device

The RAUMEDIC® -ICP-Monitoring-System is composed of the following elements:

- Neurovent® P .
- Neurovent® P C .
- RAUMEDIC® Bolt Kit (CH 5) .
- . RAUMEDIC® - Drill Kit 4,5 mm (CH 5)
- ICP-TEMP-Cable .
- NPS2 .
- NPS3 .

Device Classification Name: Device, Monitoring, Intracranial Pressure Neurology Classification Panel: 21 CFR §882.1620 CFR Section: Device Class: Class II GWM Product Code:

## 5. Device Description

The RAUMEDIC® -ICP-Monitoring-System determines safely, quickly and accurately the level and change in intracranial pressure (ICP) by using semi-conductor pressure sensors.

The Neurovent® - P and Neurovent® - P - C are indicated for use in parenchymal pressure monitoring. Both types of catheters are implanted in parenchyma via a RAUMEDIC® - Bolt Kit CH5. In addition to the catheter a zero point module NPS2 x is needed. "x" depends on the type of patient monitor available in the hospital - there are 20 different references. To the equipment also belongs an ICP-Temp-Cable and a NPS3 pressure display unit. The difference between the Neurovent® - P and the Neurovent® - P - C is that the housing material in the C-version is ceramic instead of titanium.

The RAUMEDIC® -ICP-Monitoring-System is composed of the following elements:

- . Neurovent® - P
- Neurovent® P C ●
- . RAUMEDIC® - Bolt Kit (CH 5)
- RAUMEDIC® Drill Kit 4,5 mm (CH 5) ●
- ICP-TEMP-Cable .
- NPS2 ●
- NPS3 .

### 6. Device Intended Use

The RAUMEDIC® -ICP-Monitoring-System is indicated for use in parenchymal pressure 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 intracranial pressure increases (such as cranio-cerebral traumas, GCS ≤ 8; malignant medial cardiac infarctions; hepatic encephalopathy; SAB Hunt / Hess IV + V; cerebral edema; hydrocephalus) or of patients whose clinical picture may be linked to an increase of the ICP.

Device #: ____________________________________________________________________________________________________________________________________________________________________

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Image /page/2/Picture/0 description: The image shows the logo for RAUMEDIC. The logo consists of a circular symbol on the left, followed by the word "RAUMEDIC" in bold, sans-serif font. Below the word "RAUMEDIC" is the tagline "Lifeline to Health," with a line above and below the text.

Use of the parenchymal intracranial pressure monitoring kit with bolt is contrachildren under one vear old.

The RAUMEDIC® precision pressure catheters are MR Unsafe.

### 7. Substantial Equivalence Summary

The RAUMEDIC® -ICP-Monitoring-System is substantially equivalent to those of a legally marketed predicate device, the Pressio® ICP MONITORING SYSTEM, which was cleared to market under 510 (k) K062584 on July 5. See device comparison table attached.

Based on performance testing and the available information concerning the referenced comparison device, the RAUMEDIC® -ICP-Monitoring-System is similar in that:

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

Based on this, the anticipated clinical performance of the RAUMEDIC® -ICP-Monitoring-System is equivalent to the referenced systems.

#### 8. Device Testing

Biocompatibility studies were conducted per ISO 10993 standard and have demonstrated that the materials used to manufacture the RAUMEDIC® -ICP-Monitoring-System are safe for its intended use.

In addition, the two implantable catheters were subjected to extensive performance testing. Results of the testing showed that the catheter designs are safe for their intended uses.

The NPS3 underwent numerous safety tests, including testing to IEC 60601-1.

Finally, the manufacturing process of the RAUMEDIC® - ICP- Monitoring -System complies with the United States Food and Drug Administration and European Standards for the manufacturing of medical devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Raumedic AG c/o Mr. Norbert Stuiber TUV SUD Product Service GmbH 1775 Old Highway 8, NW Suite 104 New Brighton, MN 55112-1891

MAR - 4 2011

Re: K103206

Trade/Device Name: RAUMEDIC® - ICP Monitoring System Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial Pressure Monitoring Device Regulatory Class: Class II Product Code: GWM Dated: February 25, 2011 Received: February 28, 2011

Dear Mr. Stuiber:

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 (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. 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.

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.

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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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Kesia Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K103206

# Indications for Use

510(k) Number (if known): K

Device, Monitoring, Intracranial Pressure Device Name:

Indications for Use:

The RAUMEDIC® -ICP-Monitoring-System is indicated for use in parenchymal pressure monitoring.

Use of the parenchymal intracranial pressure monitoring kit with bolt is contra-indicated in children under one year old.

The RAUMEDIC® precision pressure catheters are MR Unsafe.

Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Signature

r

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K103206

Prescription Use. (Per 21 CFR 801.109) ×