(75 days)
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.
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
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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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 |
|---|---|
| ----------- | ------------- |
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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
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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
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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
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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- SYSTEMventricular(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 DesignCatheter | Miniatur transducer | Miniatur transducer | Miniatur transducer | YES |
| Temperature-SensorDesign Catheter | Thermistor | --- | --- | NO-- see SE-List withpredicate devices:Camino NeuroCareIntracranial Pressure-Temperature Monitoring Kit |
| Temperature Range | 25°C - 45°C | --- | --- | NO-- see SE-List withpredicate devices:Camino NeuroCareIntracranial 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- SYSTEMventricular(K112017) | SE? |
|---|---|---|---|---|
| Zero Point StabilityCatheter | Less than 1mmHg duringfirst 24 hours | Less than 1mmHg duringfirst 24 hours | Less than 1mmHg duringfirst 24 hours | YES |
| Less than 2mmHg duringthe first 7 days | Less than 2mmHg duringthe first 7 days | Less than 2mmHg duringthe first 7 days | ||
| Sensitivity System | 5 µV/V/mmHg on themonitor side | 5 µV/V/mmHg on themonitor side | 5 µV/V/mmHg on themonitor side | YES |
| Maximum pressureCatheter | 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 tunnellingsleeve | Spliceable TunnellingSleeve with Trocar | --- | Spliceable TunnellingSleeve with Trocar | YES |
| TEMP-Adapter | ICP-TEMP-AdapterICP-TEMP-Adapter HP /Philips | --- | --- | NO- see SE-List withpredicate devices:Camino NeuroCareIntracranial Pressure-Temperature Monitoring Kit |
| Product Code | GWM | GWM | GWM | YES |
| Registration # | Pending | K103206 | K112017 | N/A |
| Applicant | RAUMEDIC AGHermann-Staudinger-Str.2 | RAUMEDIC AGHermann-Staudinger-Str.2 | RAUMEDIC AGHermann-Staudinger-Str.2 | N/A |
| 95233 HelmbrechtsGermany | 95233 HelmbrechtsGermany | 95233 HelmbrechtsGermany |
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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 Pressureand TemperatureMonitoring Kit | Camino® NeuroCare™Intracranial Pressureand TemperatureMonitoring Kit | SE? |
|---|---|---|---|---|
| Pressure Range | -50 to +250 mmHg | -10 to +250 mmHg | -10 to +250 mmHg | NO- see SE-List withpredicate devices:RAUMEDICO® ICP-MONITORING- SYSTEMandRAUMEDICO® ICP-MONITORING- SYSTEMventricular |
| Zero Point StabilityCatheter | Less than 1 mmHg duringfirst 24 hoursLess than 2 mmHg duringthe first 7 days | Less than 2 mmHg duringfirst 24 hoursLess than 1 mmHg perday during the first 5 days | Less than 2 mmHg duringfirst 24 hoursLess than 1 mmHg perday during the first 5 days | NO- see SE-List withpredicate devices:RAUMEDICO® ICP-MONITORING- SYSTEMandRAUMEDICO® ICP-MONITORING-SYSTEMventricular |
| Sensitivity System | 5 µV/V/mmHg on themonitor side | 5 µV/V/mmHg on themonitor side | 5 µV/V/mmHg on themonitor side | YES |
| Maximum pressureCatheter | 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
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| 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
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Page 3 of 3
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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
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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
§ 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).