(75 days)
No
The device description focuses on hardware components (sensors, thermistors, catheters, adapters) for direct measurement of pressure and temperature. There is no mention of AI, ML, or any software processing that would suggest the use of these technologies for analysis, prediction, or interpretation of the data. The performance studies are related to biocompatibility and basic performance testing, not validation of AI/ML algorithms.
No.
This device is described for direct measurement of intracranial pressure and temperature, as well as for cerebrospinal fluid drainage applications, but not for treating or rehabilitating a disease or condition.
Yes
The device measures intracranial pressure and temperature, which are physiological parameters used to assess a patient's condition and help diagnose neurological issues. While it doesn't directly provide a diagnosis, the data it collects is diagnostic in nature and used by a qualified neurosurgeon for diagnostic purposes.
No
The device description explicitly lists hardware components such as "semi-conductor pressure sensors," "thermistors," and specific catheter models (NEUROVENT®-TEMP IFD-S, NEUROVENT®-TEMP IFD-R, NEUROVENT®-P-TEMP, ICP-TEMP-Adapter, ICP-TEMP-Adapter HP / Philips). This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the direct measurement of intracranial pressure and temperature within the body (parenchyma and ventricle) and for cerebrospinal fluid drainage. This is an in vivo measurement, not an in vitro test performed on samples taken from the body.
- Device Description: The device uses sensors and thermistors to measure pressure and temperature directly. It does not analyze biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device is a monitoring system for physiological parameters within the body.
Therefore, the RAUMEDIC®-ICP-TEMP-Monitoring-System falls under the category of a medical device for physiological monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
GWM
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 NEUROVENT®-TEMP IFD-S is implanted in the ventricle by using a soft mandrel and the spliceable tunneling sleeve CH12 (already cleared to market under 510 (k) K112017) or via a RAUMEDIC® - BOLT KIT CH9 (already cleared to market under 510 (k) K112017). The NEUROVENT®-TEMP IFD-R is implanted in the ventricle only by using a rigid mandrel and a RAUMEDIC® - BOLT KIT CH9 (already cleared to market under 510 (k) K112017). The NEUROVENT® P-TEMP is implanted in parenchyma via a RAUMEDIC® - spliceable tunnelling sleeve CH8 (already cleared to market under 510 (k) K112017) or via a RAUMEDIC® - BOLT KIT CH5 (already cleared to market under 510 (k) K103206).
In addition to the catheters used for pressure and temperature monitoring an ICP-TEMPcable (already cleared to market under 510 (k) K103206) as well as an ICP-TEMP-Adapter or an ICP-TEMP-Adapter HP / Philips (depending on the type of monitor used) and a zero point module NPS2 x (already cleared to market under 510 (k) K103206) is needed to set up the measuring chain.
"x" depends on the type of patient monitor available in the hospital - there are 20 different references. To measure the pressure and temperature the NPS2 and the temperature plug have to be connected to the monitor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Brain parenchyma/ventricle
Indicated Patient Age Range
Contra-indicated in children under one year old.
Intended User / Care Setting
Qualified neurosurgeon
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Biocompatibility studies were conducted per ISO 10993 standard.
Extensive performance testing on the catheters.
Results showed catheter designs are safe for intended uses.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows a black and white symbol that appears to be a stylized representation of a letter "C" within a circle. The letter "C" is not fully closed, and there are two horizontal lines below the circle. The symbol is simple and graphic, with a bold, solid fill.
APR 1 1 2012
e to Health
| RAUMEDIC AG - Postfach 5 01 - D - 95205 Münchberg | Forschung & Entwicklung |
|---|---|
| Food and Drug Administration | Telefon: (0 92 52) 359-0 |
| Center for Devices and Radiological Health | Telefax: (0 92 52) 359-10 00 |
| Document Mail Center - W066-0609 | info@RAUMEDIC.com |
| 10903 New Hampshire Avenue | www.RAUMEDIC.de |
| Silver Spring, MD 20993-0002 | Direktkontakt: |
| Telefon: (0 92 52) 359-2782 | |
| Ihre Nachricht vom | |
| Ihre Zeichen | |
| Reiner.Thiem@RAUMEDIC.com | |
| Tag | |
| 19 th of December 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.
- Name, address, phone and fax number of the applicant
| RAUMEDIC AG | |
|---|---|
| Hermann-Staudinger-Straße 2 | |
| 95233 Helmbrechts | |
| D - Germany | |
| Tel.: 0049/9252/359-0 | |
| Fax: 0049/9252/359-1000 |
- Contact person
| Mr. Reiner Thiem | |
|---|---|
| Head of Regulatory Affairs | |
| Hermann-Staudinger-Straße 2 | |
| 95233 Helmbrechts | |
| D - Germany | |
| Tel.: 0049/9252/359-2782 |
- Date of preparation of the summary
December, the 19th 2011
| Device #: | Page 1 of 4 |
|---|---|
| ----------- | ------------- |
1
Image /page/1/Picture/0 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" in a smaller, italicized font. The circular graphic appears to be a stylized representation of a globe or planet.
Image /page/1/Figure/1 description: The image shows the logo for RAUMEDIC, a company that provides lifeline to health. The logo consists of a stylized globe-like icon on the left, followed by the company name in bold, sans-serif font. Below the name is the tagline "Lifeline to Health" in a smaller, italicized font, flanked by horizontal lines.
4. Name of the device
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
Device Classification Name:
Classification Panel: CFR Section: Device Class: Product Code:
Device, Monitoring, Intracranial Pressure and Temperature Neurology 21 CFR §882.1620 Class II GWM
5. 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 NEUROVENT®-TEMP IFD-S is implanted in the ventricle by using a soft mandrel and the spliceable tunneling sleeve CH12 (already cleared to market under 510 (k) K112017) or via a RAUMEDIC® - BOLT KIT CH9 (already cleared to market under 510 (k) K112017). The NEUROVENT®-TEMP IFD-R is implanted in the ventricle only by using a rigid mandrel and a RAUMEDIC® - BOLT KIT CH9 (already cleared to market under 510 (k) K112017). The NEUROVENT® P-TEMP is implanted in parenchyma via a RAUMEDIC® - spliceable tunnelling sleeve CH8 (already cleared to market under 510 (k) K112017) or via a RAUMEDIC® - BOLT KIT CH5 (already cleared to market under 510 (k) K103206).
In addition to the catheters used for pressure and temperature monitoring an ICP-TEMPcable (already cleared to market under 510 (k) K103206) as well as an ICP-TEMP-Adapter or an ICP-TEMP-Adapter HP / Philips (depending on the type of monitor used) and a zero point module NPS2 x (already cleared to market under 510 (k) K103206) is needed to set up the measuring chain.
"x" depends on the type of patient monitor available in the hospital - there are 20 different references. To measure the pressure and temperature the NPS2 and the temperature plug have to be connected to the monitor.
Device #:
Page 2 of 4
2
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Image /page/2/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 extending from each side of the text.
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
6. Device Intended Use
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 (such as cranio-cerebral traumas, GCS ≤ 8; malignant medial cardiac infarctions; hepatic encephalopathy; SAB Hunt / tradinas, IV + V; cerebral edema; hydrocephalus) or of patients whose clinical picture may be linked to an increase of the ICP and cerebrospinal fluid drainage applications.
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.
7. Substantial Equivalence Summary
The RAUMEDIC® -ICP-TEMP-Monitoring-System is substantially equivalent to those of the legally marketed predicate devices, the Camino NeuroCare Intracranial Pressure-Temperature Monitoring Kit, Model 110-4BT and Camino NeuroCare Intracranial Pressure-Temperature Monitoring Kit, Model 110-4HMT, which were cleared to market under 510 (k) K962928 on December 20th 1996 and the RAUMEDIC® -ICP-Monitoring-System which was cleared to market under 510 (k) K103206 on 04th of March 2011 and the RAUMEDIC® -ICP-Monitoring-System ventricular which was cleared to market under 510 (k) K112017 on 11° of October 2011.
In details this means that
- ils this means that
the NEUROVENT® TEMP IFD-S and the NEUROVENT® -TEMP IFD-R are substantially equivalent to those of the Camino NeuroCare Intracranial Pressure-Temperature Monitoring Kit, Model 110-4HMT and RAUMEDIC® -ICP-Monitoring-System ventricular. - the NEUROVENT®-P-TEMP is substantially equivalent to those of the Camino the NEGT Intracranial Pressure-Temperature Monitoring Kit, Model 110-4BT and the RAUMEDIC® -ICP-Monitoring-System.
Fur further information see device comparison tables attached.
Device #:
Page 3 of 4
3
Image /page/3/Picture/0 description: The image shows the Raumedic logo. 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. The logo appears to be for a medical or healthcare-related company.
Image /page/3/Picture/1 description: The image shows the Raumedic logo. The logo consists of a stylized circle on the left, followed by the word "RAUMEDIC" in bold, sans-serif font. Below the word is the tagline "Lifeline to Health" in a smaller, italicized font, with a line on either side.
Based on performance testing and the available information concerning the referenced comparison device, the RAUMEDIC® -ICP-TEMP-Monitoring-System is equivalent in that:
The devices have the same intended use and indication for use.
- 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
Based on this, the anticipated clinical performance of the RAUMEDIC® ICP-TEMP-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-TEMP-Monitoring-System are safe for its intended use.
In addition, the mentioned catheters were subjected to extensive performance testing. Results of the testing showed that the catheter designs are safe for their intended uses.
Finally, the manufacturing process of the RAUMEDIC® - ICP-TEMP- Monitoring - System complies with the United States Food and Drug Administration and European Standards for the manufacturing of medical devices.
Device #:
Page 4 of 4
4
Image /page/4/Picture/0 description: The image shows the Raumedic logo with the tagline "Lifeline to Health" underneath. The logo consists of a stylized circle with horizontal lines inside, followed by the word "RAUMEDIC" in bold, sans-serif font. Above the logo, there is a handwritten code "K120252".
See attachment 2: Device comparison tables (complete 5 pages).
Table 1
| Feature | RAUMEDIC® ICP-
TEMP-MONITORING-
SYSTEM | RAUMEDIC® ICP-
MONITORING-SYSTEM
(K103206) | RAUMEDIC® ICP-
MONITORING- SYSTEM
ventricular
(K112017) | SE? |
|---------------------------------------|-------------------------------------------------------------------------------|--------------------------------------------------|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Trade Name | NEUROVENT®-P-TEMP,
NEUROVENT®-TEMP-
IFD-S,
NEUROVENT®-TEMP-
IFD-R | NEUROVENT®-P,
NEUROVENT®-P-C | NEUROVENT®,
NEUROVENT®-IFD-S,
NEUROVENT®-IFD-R | N/A |
| Indication for Use | SAME | SAME | SAME | YES |
| Anatomical Site-Catheter | Brain parenchyma/
ventricle | Brain parenchyma | Brain ventricle | YES |
| ICP-Sensor Design
Catheter | Miniatur transducer | Miniatur transducer | Miniatur transducer | YES |
| Temperature-Sensor
Design Catheter | Thermistor | --- | --- | NO
-- see SE-List with
predicate devices:
Camino NeuroCare
Intracranial Pressure-
Temperature Monitoring Kit |
| Temperature Range | 25°C - 45°C | --- | --- | NO
-- see SE-List with
predicate devices:
Camino NeuroCare
Intracranial Pressure-
Temperature Monitoring Kit |
| Transducer Location | Catheter Tip | Catheter Tip | Catheter Tip | YES |
| Non-fluid coupling Catheter | YES | YES | YES | YES |
| Single-use-Catheter | YES | YES | YES | YES |
| Pressure Range | -50 to +250 mmHg | -50 to +250 mmHg | -50 to +250 mmHg | YES |
| Feature | RAUMEDIC® ICP-
TEMP- MONITORING-
SYSTEM | RAUMEDIC® ICP-
MONITORING- SYSTEM
(K103206) | RAUMEDIC® ICP-
MONITORING- SYSTEM
ventricular
(K112017) | SE? |
|----------------------------------|------------------------------------------------------|---------------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Zero Point Stability
Catheter | Less than 1mmHg during
first 24 hours | Less than 1mmHg during
first 24 hours | Less than 1mmHg during
first 24 hours | YES |
| | Less than 2mmHg during
the first 7 days | Less than 2mmHg during
the first 7 days | Less than 2mmHg during
the first 7 days | |
| Sensitivity System | 5 µV/V/mmHg on the
monitor side | 5 µV/V/mmHg on the
monitor side | 5 µV/V/mmHg on the
monitor side | YES |
| Maximum pressure
Catheter | 1,250 mmHg | 1,250 mmHg | 1,250 mmHg | YES |
| Sterilization process | With Ethylene Oxide | With Ethylene Oxide | With Ethylene Oxide | YES |
| Bolt | Bolt with compression cap | Bolt with compression cap | Bolt with compression cap | YES |
| Spliceable tunnelling
sleeve | Spliceable Tunnelling
Sleeve with Trocar | --- | Spliceable Tunnelling
Sleeve with Trocar | YES |
| TEMP-Adapter | ICP-TEMP-Adapter
ICP-TEMP-Adapter HP /
Philips | --- | --- | NO
- see SE-List with
predicate devices:
Camino NeuroCare
Intracranial Pressure-
Temperature Monitoring Kit |
| Product Code | GWM | GWM | GWM | YES |
| Registration # | Pending | K103206 | K112017 | N/A |
| Applicant | RAUMEDIC AG
Hermann-Staudinger-Str.
2 | RAUMEDIC AG
Hermann-Staudinger-Str.
2 | RAUMEDIC AG
Hermann-Staudinger-Str.
2 | N/A |
| | 95233 Helmbrechts
Germany | 95233 Helmbrechts
Germany | 95233 Helmbrechts
Germany | |
5
11 6 - Lifeline to Health
Table 2
.
ﺬ. ﻳﻌﺘ ﺮ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ
| Feature | RAUMEDIC® ICP-TEMP-MONITORING-System | Camino® NeuroCare™ Intracranial Pressure and Temperature Monitoring Kit | Camino® NeuroCare™ Intracranial Pressure and Temperature Monitoring Kit | SE? |
|---|---|---|---|---|
| Trade Name | NEUROVENT®-P-TEMP, NEUROVENT®-TEMP-IFD-S, NEUROVENT®-TEMP-IFD-R | Micro-Ventricular Pressure-Temperature Monitoring Kit (110-4HMT) | Parenchymal Pressure-Temperature Monitoring Kit (110-4BT) | N/A |
| Indication for Use | SAME | SAME | SAME | YES |
| Anatomical Site-Catheter | Brain parenchyma/ventricle | Brain ventricle | Brain parenchyma | YES |
| ICP-Sensor Design Catheter | Miniatur transducer | Optical reflector | Optical reflector | NO - see SE-List with predicate devices: RAUMEDIC® ICP-MONITORING-SYSTEM and RAUMEDIC® ICP-MONITORING-SYSTEM ventricular |
| Temperature-Sensor Design Catheter | Thermistor | Thermistor | Thermistor | YES |
| Temperature Range | 25°C - 45°C | 30°C - 40°C | 30°C - 40°C | NO - see SE-discussion 1 below table |
| Transducer Location | Catheter Tip | Catheter Tip | Catheter Tip | YES |
| Non-fluid coupling Catheter | YES | YES | YES | YES |
| Single-use-Catheter | YES | YES | YES | YES |
- Page 1 of 3
| Feature | RAUMEDICO ICP-
TEMP- MONITORING-
System | Camino® NeuroCare™
Intracranial Pressure
and Temperature
Monitoring Kit | Camino® NeuroCare™
Intracranial Pressure
and Temperature
Monitoring Kit | SE? |
|----------------------------------|------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pressure Range | -50 to +250 mmHg | -10 to +250 mmHg | -10 to +250 mmHg | NO
- see SE-List with
predicate devices:
RAUMEDICO® ICP-
MONITORING- SYSTEM
and
RAUMEDICO® ICP-
MONITORING- SYSTEM
ventricular |
| Zero Point Stability
Catheter | Less than 1 mmHg during
first 24 hours
Less than 2 mmHg during
the first 7 days | Less than 2 mmHg during
first 24 hours
Less than 1 mmHg per
day during the first 5 days | Less than 2 mmHg during
first 24 hours
Less than 1 mmHg per
day during the first 5 days | NO - see SE-List with
predicate devices:
RAUMEDICO® ICP-
MONITORING- SYSTEM
and
RAUMEDICO® ICP-
MONITORING-SYSTEM
ventricular |
| Sensitivity System | 5 µV/V/mmHg on the
monitor side | 5 µV/V/mmHg on the
monitor side | 5 µV/V/mmHg on the
monitor side | YES |
| Maximum pressure
Catheter | 1,250 mmHg | 1,250 mmHg | 1,250 mmHg | YES |
| Sterilization process | With Ethylene Oxide | With Ethylene Oxide | With Ethylene Oxide | YES |
| Bolt | Bolt with compression cap | Bolt with compression cap | Bolt with compression cap | YES |
6
EDIC e to Health -Lifelin
.
| Feature | RAUMEDIC® ICP- TEMP-MONITORING- System | Camino® NeuroCare™ Intracranial Pressure and Temperature Monitoring Kit | Camino® NeuroCare™ Intracranial Pressure and Temperature Monitoring Kit | SE? |
|---|---|---|---|---|
| Spliceable tunnelling sleeve | Spliceable Tunnelling Sleeve with Trocar | - | - | NO - see SE-List with predicate devices: RAUMEDIC® ICP- MONITORING-SYSTEM and RAUMEDIC® ICP- MONITORING-SYSTEM ventricular |
| TEMP-Adapter | ICP-TEMP-Adapter ICP-TEMP-Adapter HP / Philips | ICT-XX (XX stands for specific Monitor-Type) | ICT-XX (XX stands for specific Monitor-Type) | YES |
| Product Code | GWM | GWM | GWM | YES |
| Registration # | Pending | K962928 | K962928 | N/A |
| Applicant | RAUMEDIC AG Hermann-Staudinger-Str. 2 95233 Helmbrechts Germany | RAUMEDIC AG Hermann-Staudinger-Str. 2 95233 Helmbrechts Germany | RAUMEDIC AG Hermann-Staudinger-Str. 2 95233 Helmbrechts Germany | N/A |
- The beneature range the AAUKED(OP) (CATEM Street Met merature rager the Camines
News and Pressure and Temperation of the register vegilender register regisser regisser
:
Page 3 of 3
:
. '
.
.
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 1 1 2012
RAUMEDIC AG c/o Mr. Olaf Teichert TUV SUD America, Inc. 1775 Old Highway 8 NW New Brighton, MN 55112-1891
Re: K120252
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: January 24, 2012 Received: January 27, 2012
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.
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.
8
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 (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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Earle R. Hunt Jr.
Malvina B. Eydelman, M Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
Lifeline to Health
Indications for Use
510(k) Number (if known): K
Device Name: Device, Monitoring, Intracranial Pressure and Temperature
Indications for 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.
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 X
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear,
Nose and Throat Devices
510(k) Number K120252