RAUMEDIC ICP MONITORING SYSTEM

K112017 · Raumedic AG · GWM · Oct 11, 2011 · Neurology

Device Facts

• Record ID: K112017
• Device Name: RAUMEDIC ICP MONITORING SYSTEM
• Applicant: Raumedic AG
• Product Code: GWM · Neurology
• Decision Date: Oct 11, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1620
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

Intended Use

The RAUMEDIC® -ICP-Monitoring-System ventricular is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. Use of the ventricular intracranial pressure monitoring kit with bolt is contra-indicated in children under one year old. The RAUMEDIC® catheters are MR Unsafe.

Device Story

RAUMEDIC ICP-Monitoring-System ventricular device monitors intracranial pressure and facilitates cerebrospinal fluid drainage. System comprises NEUROVENT components, spliceable tunneling sleeves, and bolt/drill kits. Implanted in ventricle via surgical methods. Used in clinical settings by healthcare professionals. Provides pressure data to assist clinical decision-making regarding neurological status and fluid management. Benefits include accurate pressure monitoring and therapeutic drainage capabilities.

Clinical Evidence

Bench testing only. Biocompatibility studies and performance testing conducted to demonstrate safety and compliance with relevant standards.

Technological Characteristics

Ventricular catheter-based system for intracranial pressure monitoring and CSF drainage. Includes NEUROVENT components, tunneling sleeves, and bolt/drill kits. MR Unsafe. Class II device (21 CFR 882.1620).

Indications for Use

Indicated for ventricular pressure monitoring and cerebrospinal fluid drainage. Contraindicated in children under one year old for the ventricular intracranial pressure monitoring kit with bolt.

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

• K103206
• K062584

Submission Summary (Full Text)

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)<112017

Image /page/0/Picture/1 description: The image shows the logo for RAUMEDIC. The logo consists of a circular graphic on the left, followed by the word "RAUMEDIC" in bold, sans-serif font. Below the word is the tagline "Lifeline to Health" between two horizontal lines. The graphic on the left appears to be a stylized representation of an eye.

OCT 1 1 2011

i

◉ **RAUMEDIC**

*Lifeline to Health*

| RAUMEDIC AG Postfach 5 01 D-95205 Münchberg | Forschung & Entwicklung |
|---------------------------------------------|------------------------------|
| Food and Drug Administration | Telefon: [phone] |
| Center for Devices and Radiological Health | Telefax: (0 92 52) 359-10 00 |
| Document Mail Center - W066-0609 | [e-mail] |
| 10903 New Hampshire Avenue | www.RAUMEDIC.de |
| Silver Spring, MD 20993-0002 | Direktkontakt: |
| | Telefon: [phone] |
| Ihre Nachricht vom | Sachbearbeiter H Thiem |
| Ihre Zeichen | Unsere Zeichen thi |
| | [e-mail] |
| | Tag |
| | 03.06.2011 |

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

June, the 03^rd 2011

| Device #: ____________________ | Page 1 of 3 |
|--------------------------------|-------------|
|--------------------------------|-------------|

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K112017

Image /page/1/Picture/1 description: The image shows the Raumedic logo. The logo consists of a circular symbol on the left, followed by the word "RAUMEDIC" in bold, uppercase letters. Below the word is the tagline "Lifeline to Health" with a line on either side. The logo appears to be for a healthcare or medical company.

Image /page/1/Picture/2 description: This document describes the RAUMEDIC® -ICP-Monitoring-System ventricular device. The device is composed of NEUROVENT® components, spliceable tunneling sleeves, and bolt and drill kits. The device is used for intracranial pressure monitoring and cerebrospinal fluid drainage applications, and is implanted in the ventricle using various methods. The document also includes the device classification name, panel, CFR section, class, and product code.

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K11 2017

Image /page/2/Picture/1 description: The image shows the Raumedic logo. The logo consists of a circular graphic 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 on either side of the text. The circular graphic appears to have a stylized "C" shape within it.

Image /page/2/Picture/2 description: This document describes the intended use, equivalence, and testing of the RAUMEDIC® -ICP-Monitoring-System ventricular device. The device is indicated for ventricular pressure monitoring and cerebrospinal fluid drainage applications. It is substantially equivalent to predicate devices cleared under 510(k) K103206 and K062584. Biocompatibility studies and performance testing have demonstrated the device's safety and compliance with relevant standards.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

## Public Health Service

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

TUV SUD America, Inc. c/o Mr. Olaf Teichert Foreign Affairs 1775 Old Highway 8 NW Suite 104 New Brighton, MN 55112-1891

OCT 1 1 2011

Re: K112017

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: July 11, 2011 Received: July 14, 2011

Dear Mr. Teichert:

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.

4 J-

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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Page 2 - Mr. Olaf Teichert

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 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,

Melvin R. Fields, DMD

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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K11201+

Image /page/5/Picture/1 description: The image shows the logo for RAUMEDIC. The logo consists of a circular graphic 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 on either side of the text. The logo is simple and professional, and the tagline suggests that the company is involved in the healthcare industry.

Indications for Use

| 510(k) Number (if known): K | |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Device, Monitoring, Intracranial Pressure |
| Indications for Use: | |
| | The RAUMEDIC® -ICP-Monitoring-System ventricular is indicated for use in ventricular pressure monitoring and cerebrospinal fluid drainage applications. |
| | Use of the ventricular intracranial pressure monitoring kit with bolt is contra-indicated in children under one year old. |
| | The RAUMEDIC® catheters are MR Unsafe. |

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

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

| Prescription Use (Per 21 CFR 801.109) | X |
|---------------------------------------|---|
|---------------------------------------|---|

(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

| 510(k) Number | k112017 |
|---------------|---------|
|---------------|---------|