Pressio 2 ICP Monitoring System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 17, 2017 SOPHYSA SA Etienne Duhot Quality and Regulatory Affairs Specialist 5, Rue Guy Moquet Orsay, Cedex, 91400 FR Re: K162108 Trade/Device Name: Pressio® 2 ICP Monitoring System Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial Pressure Monitoring Device Regulatory Class: Class II Product Code: GWM Dated: April 11, 2017 Received: April 14, 2017 Dear Etienne Duhot: 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. 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 devicerelated 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. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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, # Michael J. Hoffmann -S Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K162108 #### Device Name Pressio® 2 ICP Monitoring System #### Indications for Use (Describe) The Pressio® 2 Intracranial Pressure Monitoring system is indicated for continuous invasive monitoring of intracranial pressure by trained personnel of (neuro) intensive care units and neurosurgery departments. Depending the type of catheter used, the Pressio® 2 ICP Monitor can also display the intracrature. According to the clinical situation, users choose the appropriate Pressio® catheters: - Pressio® kit for monioring intracranial parenchymal pressure and temperature with bolt (PSO-PBT) indicated for use in parenchymal pressure and temperature monitoring. - Pressio® kit for monitoring intracranial pressure and temperature with tunneling (PSO-PTT) indicated for use in parenchymal pressure and temperature monitoring. - Pressio® kit for monitoring intracranial ventricular pressure with tunneling (PSO-VTT) indicated for use in intraventricular pressure and temperature monitoring and cerebrospinal fluid drainage application. The following Pressio® kits for Intracranial Pressure Monitoring are also compatible with the Pressio® 2 ICP Monitor: - Pressio® kit for monitoring intracranial paressure with bolt (PSO-PB) indicated for use in parenchymal pressure monitoring - Pressio® kit for monitoring intracranial parenchymal pressure with tunneling (PSO-PT) indicated for use in parenchymal pressure monitoring. - Pressio® kit for monitoring intracranial ventricular pressure with tunneling (PSO-VT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application. | Type of Use (Select one or both, as applicable) | |-----------------------------------------------------------------| | <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | | <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | #### 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." {3}------------------------------------------------ # K162108 510(K) SUMMARY | Submitter: | SOPHYSA SA<br>5 rue Guy Moquet<br>91400 Orsay<br>FRANCE<br>Tel: (+33) 1 69 35 35 00<br>Fax: (+33) 1 69 35 36 90 | |-------------------|-----------------------------------------------------------------------------------------------------------------| | Contact Person: | Etienne DUHOT<br>Quality and Regulatory Affairs Specialist, SOPHYSA, SA | | Date Prepared: | April 17, 2017 | | Proprietary Name: | Pressio® 2 ICP Monitoring System | | Classification: | 21 CFR 882.1620 Intracranial Pressure Monitoring Device<br>Class II, Product Code GWM | | Product Code: | GWM | Predicate Devices: | Applicant | Model | Document<br>number | Regulation &<br>Product Code | Review Panel | |-----------|----------------------------------------------------------------|--------------------|------------------------------|----------------------| | Integra® | Camino® ICP monitor | K121573 | 21 CFR 882.1620<br>GWM | Ear Nose &<br>Throat | | | Camino Parenchymal Bolt<br>ICP Monitoring catheter –<br>110-4B | K102875 | | Ear Nose &<br>Throat | | Raumedic® | Neurovent®-PTO 2L<br>Neurovent®-PTO | K130529 | 21 CFR 882.1620<br>GWM | Neurology | | | Neurovent®-TEMP IFD-S | K120252 | 21 CFR 882.1620<br>GWM | Ear Nose &<br>Throat | | Sophysa® | Sophysa® - PSO-PB<br>Sophysa® - PSO-PT<br>Sophysa® - PSO-VT | K062584 | 21 CFR 882.1620 | Neurology | #### Device: The Pressio® 2 ICP Monitoring System is composed of the following elements: - -Pressio® 2 ICP Monitor (PSO-4000) - Pressio® ICP implantable catheters indicated for pressure and temperature monitoring: - - Implantable catheter for parenchymal pressure and temperature monitoring with bolt ● (PSO-PBT). - . Implantable catheter for parenchymal pressure and temperature monitoring with tunneling (PSO-PTT). - Implantable catheter for ventricular pressure and temperature monitoring and cerebrospinal fluid drainage application with tunneling (PSO-VTT). - -Pressio® ICP implantable catheters indicated for pressure monitoring (already FDA approved K062584): {4}------------------------------------------------ - Implantable catheter for parenchymal pressure monitoring with bolt (PSO-PB). - . Implantable catheter for parenchymal pressure monitoring with tunneling (PSO-PT). - . Implantable catheter for ventricular pressure monitoring and cerebrospinal fluid drainage application with tunneling (PSO-VT) - Catheter extension cable (PSO-EC30). - - Patient Monitor connection cable for ICP (PSO -MCxx), depends on the type of patient monitor available in the hospital. It exists 9 different references (already FDA approved K062584): - . Patient monitor cable / Philips (Agilent), 12 pins (PSO-MC01) - Patient monitor cable / Siemens (Sirecust), 10 pins (PSO-MC02) ● - Patient monitor cable / Spacelab and Mindray, 6 pins (PSO-MC03) ● - Patient monitor cable / GE Datex Ohmeda, 10 ins (PSO-MC04) ● - Patient monitor cable / GE Solar (Marquette), 11 pins (PSO-MC05) - Patient monitor cable / Hellige, 10 pins (PSO-MC06) - Patient monitor cable / Siemens, 7 pins (PSO-MC07) - . Patient monitor cable / Nihon Kohden. 5 pins (PSO-MC08) - Patient monitor cable / Datascope, 6 pins (PSO-MC10) . - Patient monitor connection cable for ICT (PSO-MCT-Y), depends on the type of patient monitor available in the hospital. It exists 5 different references : - Patient monitor cable temperature / Philips (Agilent), 2 pins (PSO-MCT-A) ● - Patient monitor cable temperature / Siemens, 7 pins (PSO-MCT-B) ● - Patient monitor cable - temperature / Spacelabs, 10 pins (PSO-MCT-C) - Patient monitor cable temperature / GE solar (Marquette), GE DATEX-Ohmeda, 11 pins ● (PSO-MCT-E) - . Patient monitor cable temperature / HELLIGE, DATEX-Ohmeda, NIHON KOHDEN, MINDRAY & DATASCOPE – JACK 6.35mm (PSO-MCT-F) - -Power supply cable (5C010005). - Pressio® MRI support (PSO-MRI) - #### Device Description: The Pressio® 2 ICP Monitoring System is composed of a monitor (PSO-4000) with accessories and implantable catheters. The PSO-4000 monitor is an electromedical device designed for monitoring patient's intracranial pressure and temperature via catheters implanted in parenchyma (PSO-PBT and PSO-PTT) or in ventricles with drainage of cerebrospinal fluid (PSO-VTT). Previously marketed Pressio® kits (K062584) are also available on the Pressio® 2 ICP Monitor and allows monitoring of intracranial pressure via catheters implanted in parenchyma (PSO-PB and PSO-PT) or in ventricles (PSO-VT) with also drainage of cerebrospinal fluid. The Pressio® 2 ICP Monitor can also be connected to a patient monitor via a compatible monitor connection cable. This connection is not necessary for Pressio® 2 Intracranial Pressure Monitor functioning. The Pressio® 2 Monitor can also extract data to external computer via a USB cable. The Pressio® 2 ICP Monitoring System is sold as a kit containing a Pressio® 2 ICP Monitor (PSO-4000), a power supply cable (PSO-AC), a catheter extension cable (PSO-EC30). Intended Use: The Pressio® 2 Intracranial Pressure Monitoring system is indicated for continuous invasive monitoring of intracranial pressure by trained personnel of (neuro) intensive care units and neurosurgery departments. Depending the type of catheter used, the Pressio® 2 ICP Monitor can also display the intracranial temperature. According to the clinical situation, users choose the appropriate Pressio® catheters: - Pressio® kit for monitoring intracranial parenchymal pressure and temperature with bolt (PSO--PBT) indicated for use in parenchymal pressure and temperature monitoring. {5}------------------------------------------------ - -Pressio® kit for monitoring intracranial parenchymal pressure and temperature with tunneling (PSO-PTT) indicated for use in parenchymal pressure and temperature monitoring. - -Pressio® kit for monitoring intracranial ventricular pressure and temperature with tunneling (PSO-VTT) indicated for use in intraventricular pressure and temperature monitoring and cerebrospinal fluid drainage application. The following Pressio® kits for Intracranial Pressure Monitoring are also compatible with the Pressio® 2 ICP Monitor: - -Pressio® kit for monitoring intracranial parenchymal pressure with bolt (PSO-PB) indicated for use in parenchymal pressure monitoring - -Pressio® kit for monitoring intracranial parenchymal pressure with tunneling (PSO-PT) indicated for use in parenchymal pressure monitoring. - -Pressio® kit for monitoring intracranial ventricular pressure with tunneling (PSO-VT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage application. #### Non-Clinical Testing: The Pressio® 2 ICP Monitoring System is conform to the following non clinical testing standards: - ISO 10993-1:2009/(R)2010: Biological evaluation of medical devices part 1: Evaluation and testing within a risk management process- AAMI ANSI ISO 11135:2014: Sterilization of healthcare products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices. - ANSI IEC 60601-1 Ed.3, Medical electrical equipment - part 1: general requirements for basic safety and essential performance - IEC 60601-1-2 Edition 3:2007-03, Medical Electrical Equipment - part 1-2: General Requirements for Safety - collateral standard: Electromagnetic compatibility: Requirements and tests - IEC 60601-1-8:2006, Medical Electrical Equipment - part 1-8: General requirements for basic safety and essential performance - collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems - AAMI ANSI IEC EN 62304:2006 Medical device software - software life cycle processes - ISO 80601-2-56:2009, Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. - ISO 15223-1:2012, Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements. - IEC 62366-1:2007, Medical devices - Part 1: Application of usability engineering to medical devices - ANSI/AAMI NS28 (2010): Intracranial Pressure Monitoring Devices {6}------------------------------------------------ Substantial Equivalence: The following tables summarize the predicate devices comparison based on main technological characteristics. These summaries are organized by product code. #### ICP Monitors Substantial Equivalence Summary | Devices | Pressio® ICP<br>Monitoring<br>system | K062584Integra®<br>Camino® ICP<br>Monitoring<br>System K121573 | Pressio® 2 ICP<br>Monitoring System<br>K162108 | Rationale /<br>Comment | |-----------------------------|--------------------------------------|----------------------------------------------------------------|------------------------------------------------|------------------------| | Applicable<br>product codes | 21CFR 882.1620 | | | GWM; Same | #### Table 1: Predicate comparison: Intended uses and design (ICP Monitors) | Item | Integra® Camino® ICP<br>Monitoring System<br>K121573 | Pressio® 2 ICP Monitoring<br>System<br>K162108 | Comment | |------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------| | Manufacturer | Integra® | Sophysa® | N/A | | 510(k) no. | K121573 | K162108 | N/A | | Classification<br>regulation | 21 CFR 882.1620 | 21 CFR 882.1620 | Same | | Product no. | GWM | GWM | Same | | Indications<br>for Use | The Integra® Camino ® ICP<br>Monitoring system is indicated for<br>use by qualified neurosurgeons or<br>neurointensivists for measurement<br>of intracranial pressure and<br>temperature | The Pressio® 2 Intracranial<br>Pressure Monitoring system is<br>indicated for continuous<br>invasive monitoring of<br>intracranial pressure by trained<br>personnel of (neuro) intensive<br>care units and neurosurgery<br>departments.<br>Depending the type of catheter<br>used, the Pressio® 2 ICP<br>Monitor can also display the<br>intracranial temperature.<br>According to the clinical<br>situation, users choose the<br>appropriate Pressio® catheters:<br>-Pressio® kit for monitoring<br>intracranial parenchymal<br>pressure and temperature with<br>bolt (PSO-PBT) indicated for<br>use in parenchymal pressure and<br>temperature monitoring.<br>- Pressio® kit for monitoring<br>intracranial parenchymal<br>pressure and temperature with<br>tunneling (PSO-PTT) indicated<br>for use in parenchymal pressure<br>and temperature monitoring.<br>- Pressio® kit for monitoring<br>intracranial ventricular pressure<br>and temperature with tunneling<br>(PSO-VTT) indicated for use in<br>intraventricular pressure and<br>temperature monitoring and<br>cerebrospinal fluid drainage | Subject device<br>includes the<br>relevant bullet<br>points for each<br>particular<br>catheter. | {7}------------------------------------------------ | Item | Integra® Camino® ICP<br>Monitoring System<br>K121573 | Pressio® 2 ICP Monitoring<br>System<br>K162108 | Comment | |-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | | | application.<br>The following Pressio® kits for<br>Intracranial Pressure Monitoring<br>are also compatible with the<br>Pressio® 2 ICP Monitor:<br>- Pressio® kit for monitoring<br>intracranial parenchymal<br>pressure with bolt (PSO-PB)<br>indicated for use in parenchymal<br>pressure monitoring<br>- Pressio® kit for monitoring<br>intracranial parenchymal<br>pressure with tunneling (PSO-<br>PT) indicated for use in<br>parenchymal pressure<br>monitoring.<br>- Pressio® kit for monitoring<br>intracranial ventricular pressure<br>with tunneling (PSO-VT)<br>indicated for use in<br>intraventricular pressure<br>monitoring and cerebrospinal<br>fluid drainage application. | | | Prescription<br>use | Yes | Yes | Same | | Anesthesia<br>required | Yes | Yes | Same | | Physician<br>training<br>required | Yes | Yes | Same | | System<br>components | Monitor<br>Power cable<br>Battery<br>Patient bedside monitor cables<br>Integra® Catheter<br>Flex extension cable<br>USB adapter cable | Monitor<br>Power cable<br>Battery<br>Patient bedside monitor cables<br>Sophysa® Catheter<br>Catheter extension cable<br>USB adapter cable | Same | | | Table 2: Predicate comparison: Main functions and technological specifications (ICP Monitors) | |--|-----------------------------------------------------------------------------------------------| |--|-----------------------------------------------------------------------------------------------| | Item | Integra® Camino® ICP<br>Monitoring System<br>K121573 | Pressio® 2 ICP Monitoring<br>System<br>K162108 | Comment | |----------------------------------------|------------------------------------------------------|------------------------------------------------|---------| | Intracranial Pressure<br>Monitoring | Yes | Yes | Same | | Intracranial Temperature<br>Monitoring | Yes | Yes | Same | | Output to patient monitor<br>for ICP | Yes | Yes | Same | | Output to patient monitor<br>for ICT | Yes | Yes | Same | {8}------------------------------------------------ | Externalization to a PC | Yes (USB) | Yes (USB) | Same | |----------------------------------------------------------------------|--------------------------------------------------------|------------------------------------------------|---------| | Table 3: Predicate comparison, Safety (ICP Monitors) | | | | | Safety - ICP Monitor | Raumedic® ICP-<br>TEMP Monitoring<br>System<br>K120252 | Pressio® 2 ICP<br>Monitoring System<br>K162108 | Comment | | Electrical and EMC<br>standards conformity | IEC 60601-1<br>IEC 60601-1-2 | IEC 60601-1<br>IEC 60601-1-2 | Same | | Electrical safety -<br>Multifunction patient<br>monitoring equipment | IEC 60601-2-49 | IEC 60601-2-49 | Same | | Electrical safety -<br>Alarm systems | IEC 60601-1-8 | IEC 60601-1-8 | Same | | Software | ISO 62304 | ISO 62304 | Same | ## Parenchymal and Ventricular Implantable Catheters Equivalence Summary | Devices | Pressio® ICP<br>Monitoring<br>system<br>K062584 | Raumedic®<br>ICP-TEMP<br>Monitoring<br>System<br>K120252 | Raumedic® PTO<br>Monitoring<br>System<br>K130529 | Pressio® 2 ICP<br>Monitoring<br>System<br>K162108 | Comment | |--------------------------------|-------------------------------------------------|----------------------------------------------------------|--------------------------------------------------|---------------------------------------------------|--------------| | Applicable<br>product<br>codes | 21CFR 882.1620 | | | | GWM;<br>Same | #### Table 4: Predicate comparison: Parenchymal Implantable Catheters | Item | Raumedic® PTO<br>Monitoring System<br>K130529 | Pressio® ICP<br>Monitoring system<br>K062584 | Pressio® 2 ICP<br>Monitoring System<br>K162108 | Comment | |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------| | Trade Name | NEUROVENT®-<br>PTO (tunellisable)<br>NEUROVENT®-<br>PTO 2L (with Bolt) | SOPHYSA®-<br>PSO-PT<br>(with tunneling)<br>PSO-PB (with bolt) | SOPHYSA®-<br>PSO-PTT (with<br>tunneling)<br>PSO-PBT (with bolt) | N/A | | Indication<br>for use | The Raumedic®-PTO<br>Monitoring System is<br>indicated for use by a<br>qualified<br>neurosurgeon for<br>direct measurement<br>of intracranial<br>pressure and<br>temperature in the<br>parenchyma as well<br>as to determine the<br>partial oxygen<br>pressure PtiO2 of the<br>interstitial fluid. | The Pressio® PSO-<br>PB and PSO-PT<br>Monitoring Kit is<br>indicated for<br>continuous invasive<br>monitoring of<br>intracranial<br>parenchymal<br>pressure (ICP) by<br>trained personnel of<br>(neuro) intensive care<br>units and<br>neurosurgery<br>departments | The Pressio® PSO-<br>PBT and PSO-PTT<br>Monitoring Kit is<br>indicated for<br>continuous invasive<br>monitoring of<br>intracranial<br>parenchymal<br>pressure (ICP) and<br>temperature (ICT) by<br>trained personnel of<br>(neuro) intensive care<br>units and<br>neurosurgery<br>departments | Same - for<br>measurement<br>of intracranial<br>pressure and<br>temperature. | | Anatomical<br>Site Catheter | Brain Parenchyma | Brain Parenchyma | Brain Parenchyma | Same | | Sensors | Catheter tip | Catheter tip | Catheter tip | Same | {9}------------------------------------------------ ______________________________________________________________________________________________________________________________________________________________________________ | Item | Raumedic® PTO<br>Monitoring System<br>K130529 | Pressio® ICP<br>Monitoring system<br>K062584 | Pressio® 2 ICP<br>Monitoring System<br>K162108 | Comment | | |------------------------------------------------------------|-----------------------------------------------|----------------------------------------------|------------------------------------------------|----------------------------------------------------------------------------------------------------------------|------| | location | Single Use catheter | Yes | Yes | Yes | Same | | Sterilization<br>process | With ethylene Oxide | With ethylene oxide | With ethylene oxide | Same | | | Drainage | No | No | No | Same | | | ICP - sensor<br>design<br>catheter | Piezoresistive<br>pressure sensor | Piezoresistive<br>pressure sensor | Piezoresistive<br>pressure sensor | Same | | | ICT- sensor<br>design | Thermistor | - | Thermistor | Same - for<br>Raumedic.<br>The Pressio®<br>PSO-PT and<br>PSO-PB do<br>not read<br>intracranial<br>temperature. | | | MRI<br>conditional | Yes | Yes | Yes | Same | | | Product code | GWM | GWM | GWM | Same | | | Biocompatibility of<br>patient<br>contacting<br>components | ISO 10993-1 | ISO 10993-1 | ISO 10993-1 | Same | | | Sterilization | EN ISO 11135-1<br>ISO 11607 | EN ISO 11135-1<br>ISO 11607 | EN ISO 11135-1<br>ISO 11607 | Same | | # Table 5: Predicate Comparison: Ventricular Implantable catheters | Item | Raumedic® ICP-<br>TEMP Monitoring<br>System<br>K120252 | Pressio® ICP<br>Monitoring system<br>K062584 | Pressio® 2 ICP<br>Monitoring System<br>K162108 | Comment | |-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------| | Trade Name | NEUROVENT®-<br>TEMP-IFD-S | SOPHYSA®-<br>PSO-VT | SOPHYSA®-<br>PSO-VTT | N/A | | Indication for<br>use | The Raumedic®-<br>PTO Monitoring<br>System is indicated<br>for use by a<br>qualified<br>neurosurgeon for<br>direct measurement<br>of intracranial<br>pressure and<br>temperature in the<br>ventricle and<br>cerebrospinal | The Pressio® PSO-<br>VT Intracranial<br>Pressure Monitoring<br>Kit with tunneling is<br>indicated for<br>continuous invasive<br>monitoring of<br>intracranial<br>ventricular pressure<br>(ICP) by trained<br>personnel of (neuro)<br>intensive care units | The Pressio® PSO-<br>VTT Intracranial<br>Pressure Monitoring<br>Kit with tunneling is<br>indicated for<br>continuous invasive<br>monitoring of<br>intracranial ventricular<br>pressure (ICP) and<br>temperature (ICT) by<br>trained personnel of<br>(neuro) intensive care | Same for<br>Raumedic.<br>The PSO-<br>VT does not<br>read<br>intracranial<br>temperature. | {10}------------------------------------------------ | Item | Raumedic® ICP-<br>TEMP Monitoring<br>System<br>K120252 | Pressio® ICP<br>Monitoring system<br>K062584 | Pressio® 2 ICP<br>Monitoring System<br>K162108 | Comment | |---------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------| | applications | | and neurosurgery<br>departments with<br>cerebrospinal fluid<br>drainage application. | units and neurosurgery<br>departments with<br>cerebrospinal fluid<br>drainage application. | | | MRI<br>conditional | Yes | Yes | Yes | Same | | Anatomical<br>Site Catheter | Brain ventricle | Brain ventricle | Brain ventricle | Same | | Single Use<br>catheter | Yes | Yes | Yes | Same | | Sterilization<br>process | With ethylene<br>Oxide | With ethylene oxide | With ethylene oxide | Same | | Drainage | Yes | Yes | Yes | Same | | ICP - sensor<br>design<br>catheter | Piezoresistive<br>pressure sensor | Piezoresistive<br>pressure sensor | Piezoresistive pressure<br>sensor | Same | | ICT- sensor<br>design | Thermistor | - | Thermistor | Same<br>The<br>Pressio®<br>PSO-VT<br>does not<br>read<br>intracranial<br>temperature. | | Product code | GWM | GWM | GWM | Same | | Biocompatibility of patient<br>contacting<br>components | ISO 10993-1 | ISO 10993-1 | ISO 10993-1 | Same | | Sterilization | EN ISO 11135-1<br>ISO 11607 | EN ISO 11135-1<br>ISO 11607 | EN ISO 11135-1<br>ISO 11607 | Same | ### Table 6: Predicate comparison: Implantable catheters safety (summary) | Safety –<br>Implantable<br>catheters | Pressio®2 ICP<br>Monitoring System | Pressio® ICP<br>Monitoring system<br>K062584 | Raumedic®<br>Monitoring system<br>K130529, K120252 | Comment | |------------------------------------------------------------|------------------------------------|----------------------------------------------|----------------------------------------------------|---------| | Biocompatibility<br>of patient<br>contacting<br>components | ISO 10993-1 | ISO 10993-1 | ISO 10993-1 | Same | | Sterilization | EN ISO 11135-1<br>ISO 11607 | EN ISO 11135-1<br>ISO 11607 | EN ISO 11135-1<br>ISO 11607 | Same | {11}------------------------------------------------ | Devices | Raumedic®<br>PTO Monitoring<br>System<br>K130529 | Pressio® ICP<br>Monitoring<br>system<br>K062584 | Pressio® 2 ICP<br>Monitoring<br>System<br>K162108 | Comment | |------------------------------------------|--------------------------------------------------|-------------------------------------------------|---------------------------------------------------|---------| | Bolt for<br>introduction and<br>fixation | 21 CFR 882.1620 | | | Same | #### Parenchymal and Ventricular Intracranial and Temperature Monitoring kit accessories Equivalence Summary #### Table 7: Predicate comparison: Parenchymal and Ventricular Intracranial Pressure and Temperature Monitoring kit accessories (summary) | Item | Raumedic® PTO<br>Monitoring System<br>K130529 | Pressio® ICP<br>Monitoring system<br>K062584 | Pressio® 2 ICP<br>Monitoring System<br>K162108 | Comment | |---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | ACCESSORIES OF IMPLANTATION | | | | | | Type of<br>installation –<br>ICP<br>monitoring<br>with<br>tunneling | Spliceable Tunneling<br>Sleeve CH8:<br>- Trocar<br>- Tunneling sleeve | Monitoring kit with<br>tunneling (PSO-PT)<br>- Trocar<br>- Tunneling needle<br>with stylet<br>- Drill with<br>adjustable stop<br>- Allen key | Monitoring kit with<br>bolt (PSO-PBT):<br>- Trocar<br>- Tunneling needle<br>with stylet<br>- Drill with<br>adjustable stop<br>- Allen key | Similar - for<br>Raumedic<br>kit<br>Same – for<br>Sophysa®<br>monitoring | | Type of<br>installation –<br>Ventricular<br>pressure<br>monitoring | Spliceable Tunneling<br>sleeve CH12:<br>- Trocar<br>- Tunneling sleeve | Monitoring kit with<br>tunneling (PSO-VT):<br>- Trocar<br>- Tunneling sheath<br>- Drill with<br>adjustable stop<br>- Allen key | Monitoring kit with<br>tunneling (PSO-VT):<br>- Trocar<br>- Tunneling sheath<br>- Drill with<br>adjustable stop<br>- Allen key | Similar - for<br>Raumedic<br>kit<br>Same – for<br>Sophysa®<br>monitoring<br>kit | | PERFORMANCE TESTING | | | | | | Placement in<br>subdural<br>space -<br>Pressure<br>Measurement | No alteration of<br>pressure measured<br>with a Raumedic®<br>catheter when<br>inserted in a subdural<br>space | No alteration of<br>pressure measured<br>with a Pressio®<br>catheter when<br>inserted in a subdural<br>space | No alteration of<br>pressure measured<br>with a Pressio®<br>catheter when<br>inserted in a subdural<br>space | Same<br>performance<br>results<br>reached. | | Biocompatibi<br>lity of patient<br>contacting<br>components | ISO 10993-1 | ISO 10993-1 | ISO 10993-1 | Same | | Sterilization | EN ISO 11135-1<br>ISO 11607 | EN ISO 11135-1<br>ISO 11607 | EN ISO 11135-1<br>ISO 11607 | Same | {12}------------------------------------------------ | Devices | Camino Parenchymal<br>Bolt ICP Monitoring<br>catheter - 110-4B<br>K102875 | Pressio® 2 ICP<br>Monitoring System<br>K162108 | Comment | |-------------------------------|---------------------------------------------------------------------------|------------------------------------------------|---------| | Implantation | Parenchymal bone | Parenchymal bone | Same | | Number of lumens | 1 | 1 | Same | | Type of catheter<br>used with | Parenchymal catheter for<br>ICP monitoring | Parenchymal catheter for<br>ICP monitoring | Same | | Bolt components | Skull screw | Skull screw | Same | | | Turning wings | Turning wings | Same | | | Compression cap | Wing nut (tab) | Same | | | Spacer ring | Spacer ring | Same | | Piercing guide | Stylet | Stylet | Same | | Drilling way | Parenchymal bone | Parenchymal bone | Same | | Piercing kit<br>composition | Drill | Drill | Same | | | Adjustable safety stop | Adjustable Drill stopper | Same | | | Hex wrench for<br>adjustable safety stop | Allen key for adjustable<br>Drill stopper | Same | #### Table 8: Predicate comparison: Bolt for Introduction and Burr with adjustable stop comparison #### Conclusion The Pressio® 2 ICP Monitoring System (K162108) is substantially equivalent to the Integra® Camino® ICP Monitoring system (K121573), Integra® Camino® Parenchymal Bolt ICP Monitoring catheter (K102875), the Raumedic® Monitoring System (K130529 and K120252) and Pressio® ICP Monitoring System (K062584) in terms of intended uses, materials, design, functions and operating characteristics. Additionally, the same technology is used in order to perform intracranial pressure and temperature monitoring.