(262 days)
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.
-
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.
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).
The provided text is a 510(k) Premarket Notification from the FDA for the SOPHYSA SA Pressio® 2 ICP Monitoring System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for de novo approval. Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, test set details, ground truth establishment, expert adjudication, MRMC studies, and training set information is not present in this document.
However, based on the non-clinical testing section and comparative tables, we can extract some information related to the device's conformance to standards, which implicitly defines some "acceptance criteria" through compliance.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of acceptance criteria with numerical performance targets and actual device performance results in the way one would see for a de novo submission focusing on clinical accuracy. Instead, it refers to conformance to established medical device standards as the primary means of demonstrating performance and safety, thereby implicitly defining acceptance criteria.
| Acceptance Criteria (Implied by Standard Conformance) | Reported Device Performance (Claimed Conformance) |
|---|---|
| Biological Evaluation: Adherence to ISO 10993-1:2009/(R)2010 for evaluation and testing within a risk management process. | "The Pressio® 2 ICP Monitoring System is conform to the following non clinical testing standards: ISO 10993-1:2009/(R)2010" |
| Sterilization: Requirements for development, validation, and routine control of ethylene oxide sterilization processes per AAMI ANSI ISO 11135:2014 AND EN ISO 11135-1 / ISO 11607. | "The Pressio® 2 ICP Monitoring System is conform to the following non clinical testing standards: AAMI ANSI ISO 11135:2014" and "Sterilization: EN ISO 11135-1 ISO 11607" for both device and catheters. |
| Electrical Safety & Essential Performance: General requirements for basic safety and essential performance per ANSI IEC 60601-1 Ed.3. | "The Pressio® 2 ICP Monitoring System is conform to the following non clinical testing standards: ANSI IEC 60601-1 Ed.3" |
| Electromagnetic Compatibility (EMC): Requirements and tests per IEC 60601-1-2 Edition 3:2007-03. | "The Pressio® 2 ICP Monitoring System is conform to the following non clinical testing standards: IEC 60601-1-2 Edition 3:2007-03" |
| Alarm Systems: General requirements, tests, and guidance for alarm systems in medical electrical equipment per IEC 60601-1-8:2006. | "The Pressio® 2 ICP Monitoring System is conform to the following non clinical testing standards: IEC 60601-1-8:2006" |
| Software Life Cycle Processes: Requirements for medical device software per AAMI ANSI IEC EN 62304:2006. | "The Pressio® 2 ICP Monitoring System is conform to the following non clinical testing standards: AAMI ANSI IEC EN 62304:2006" |
| Clinical Thermometers for Body Temperature Measurement: Particular requirements for basic safety and essential performance per ISO 80601-2-56:2009 (for temperature monitoring aspect). | "The Pressio® 2 ICP Monitoring System is conform to the following non clinical testing standards: ISO 80601-2-56:2009" |
| Symbols on Labels: General requirements for symbols used with medical device labels per ISO 15223-1:2012. | "The Pressio® 2 ICP Monitoring System is conform to the following non clinical testing standards: ISO 15223-1:2012" |
| Usability Engineering: Application of usability engineering to medical devices per IEC 62366-1:2007. | "The Pressio® 2 ICP Monitoring System is conform to the following non clinical testing standards: IEC 62366-1:2007" |
| Intracranial Pressure Monitoring Devices: General requirements specific to ICP monitoring devices per ANSI/AAMI NS28 (2010). | "The Pressio® 2 ICP Monitoring System is conform to the following non clinical testing standards: ANSI/AAMI NS28 (2010)" |
| Pressure Measurement Performance (Subdural Space): No alteration of pressure measured when inserted in a subdural space. | "No alteration of pressure measured with a Pressio® catheter when inserted in a subdural space" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document is a 510(k) submission, primarily relying on non-clinical testing (bench testing, component analysis, and conformance to standards) to demonstrate substantial equivalence, rather than new clinical trials with patient test sets. Therefore, details about a "test set" in the context of clinical data (like patient numbers, retrospective/prospective nature, or country of origin) are not included. The performance testing mentioned (e.g., "Placement in subdural space - Pressure Measurement") would refer to bench or simulated testing, not a clinical patient sample size.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as this is a non-clinical submission relying on engineering/bench testing and conformance to standards, not human expertise for ground truth in image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There's no mention of a human-read test set or adjudication process.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an ICP monitoring system, not an AI-assisted diagnostic tool for human readers/interpreters.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the device's intrinsic ability to measure ICP and temperature as designed. The entire non-clinical testing described (conformance to standards for electrical safety, EMC, software, biological evaluation, etc.) is essentially evaluation of the device's standalone performance against defined engineering and safety benchmarks. The performance claim "No alteration of pressure measured with a Pressio® catheter when inserted in a subdural space" is a direct standalone performance assessment.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is established by engineering specifications, physical measurements/calibrations, and compliance with recognized industry standards (e.g., ISO, IEC, AAMI) for medical device safety, performance, and functionality. For example, the ground truth for pressure measurement accuracy would be established by calibrated pressure sensors and established metrology.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a "training set."
9. How the ground truth for the training set was established
Not applicable.
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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) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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{3}------------------------------------------------
K162108 510(K) SUMMARY
| Submitter: | SOPHYSA SA5 rue Guy Moquet91400 OrsayFRANCETel: (+33) 1 69 35 35 00Fax: (+33) 1 69 35 36 90 |
|---|---|
| Contact Person: | Etienne DUHOTQuality 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 DeviceClass II, Product Code GWM |
| Product Code: | GWM |
Predicate Devices:
| Applicant | Model | Documentnumber | Regulation &Product Code | Review Panel |
|---|---|---|---|---|
| Integra® | Camino® ICP monitor | K121573 | 21 CFR 882.1620GWM | Ear Nose &Throat |
| Camino Parenchymal BoltICP Monitoring catheter –110-4B | K102875 | Ear Nose &Throat | ||
| Raumedic® | Neurovent®-PTO 2LNeurovent®-PTO | K130529 | 21 CFR 882.1620GWM | Neurology |
| Neurovent®-TEMP IFD-S | K120252 | 21 CFR 882.1620GWM | Ear Nose &Throat | |
| Sophysa® | Sophysa® - PSO-PBSophysa® - PSO-PTSophysa® - 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® ICPMonitoringsystem | K062584Integra®Camino® ICPMonitoringSystem K121573 | Pressio® 2 ICPMonitoring SystemK162108 | Rationale /Comment |
|---|---|---|---|---|
| Applicableproduct codes | 21CFR 882.1620 | GWM; Same |
Table 1: Predicate comparison: Intended uses and design (ICP Monitors)
| Item | Integra® Camino® ICPMonitoring SystemK121573 | Pressio® 2 ICP MonitoringSystemK162108 | Comment |
|---|---|---|---|
| Manufacturer | Integra® | Sophysa® | N/A |
| 510(k) no. | K121573 | K162108 | N/A |
| Classificationregulation | 21 CFR 882.1620 | 21 CFR 882.1620 | Same |
| Product no. | GWM | GWM | Same |
| Indicationsfor Use | The Integra® Camino ® ICPMonitoring system is indicated foruse by qualified neurosurgeons orneurointensivists for measurementof intracranial pressure andtemperature | The Pressio® 2 IntracranialPressure Monitoring system isindicated for continuousinvasive monitoring ofintracranial pressure by trainedpersonnel of (neuro) intensivecare units and neurosurgerydepartments.Depending the type of catheterused, the Pressio® 2 ICPMonitor can also display theintracranial temperature.According to the clinicalsituation, users choose theappropriate Pressio® catheters:-Pressio® kit for monitoringintracranial parenchymalpressure and temperature withbolt (PSO-PBT) indicated foruse in parenchymal pressure andtemperature monitoring.- Pressio® kit for monitoringintracranial parenchymalpressure and temperature withtunneling (PSO-PTT) indicatedfor use in parenchymal pressureand temperature monitoring.- Pressio® kit for monitoringintracranial ventricular pressureand temperature with tunneling(PSO-VTT) indicated for use inintraventricular pressure andtemperature monitoring andcerebrospinal fluid drainage | Subject deviceincludes therelevant bulletpoints for eachparticularcatheter. |
{7}------------------------------------------------
| Item | Integra® Camino® ICPMonitoring SystemK121573 | Pressio® 2 ICP MonitoringSystemK162108 | Comment |
|---|---|---|---|
| application.The following Pressio® kits forIntracranial Pressure Monitoringare also compatible with thePressio® 2 ICP Monitor:- Pressio® kit for monitoringintracranial parenchymalpressure with bolt (PSO-PB)indicated for use in parenchymalpressure monitoring- Pressio® kit for monitoringintracranial parenchymalpressure with tunneling (PSO-PT) indicated for use inparenchymal pressuremonitoring.- Pressio® kit for monitoringintracranial ventricular pressurewith tunneling (PSO-VT)indicated for use inintraventricular pressuremonitoring and cerebrospinalfluid drainage application. | |||
| Prescriptionuse | Yes | Yes | Same |
| Anesthesiarequired | Yes | Yes | Same |
| Physiciantrainingrequired | Yes | Yes | Same |
| Systemcomponents | MonitorPower cableBatteryPatient bedside monitor cablesIntegra® CatheterFlex extension cableUSB adapter cable | MonitorPower cableBatteryPatient bedside monitor cablesSophysa® CatheterCatheter extension cableUSB adapter cable | Same |
| Table 2: Predicate comparison: Main functions and technological specifications (ICP Monitors) | |
|---|---|
| -- | ----------------------------------------------------------------------------------------------- |
| Item | Integra® Camino® ICPMonitoring SystemK121573 | Pressio® 2 ICP MonitoringSystemK162108 | Comment |
|---|---|---|---|
| Intracranial PressureMonitoring | Yes | Yes | Same |
| Intracranial TemperatureMonitoring | Yes | Yes | Same |
| Output to patient monitorfor ICP | Yes | Yes | Same |
| Output to patient monitorfor ICT | Yes | Yes | Same |
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| Externalization to a PC | Yes (USB) | Yes (USB) | Same |
|---|---|---|---|
| Table 3: Predicate comparison, Safety (ICP Monitors) | |||
| Safety - ICP Monitor | Raumedic® ICP-TEMP MonitoringSystemK120252 | Pressio® 2 ICPMonitoring SystemK162108 | Comment |
| Electrical and EMCstandards conformity | IEC 60601-1IEC 60601-1-2 | IEC 60601-1IEC 60601-1-2 | Same |
| Electrical safety -Multifunction patientmonitoring equipment | IEC 60601-2-49 | IEC 60601-2-49 | Same |
| Electrical safety -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® ICPMonitoringsystemK062584 | Raumedic®ICP-TEMPMonitoringSystemK120252 | Raumedic® PTOMonitoringSystemK130529 | Pressio® 2 ICPMonitoringSystemK162108 | Comment |
|---|---|---|---|---|---|
| Applicableproductcodes | 21CFR 882.1620 | GWM;Same |
Table 4: Predicate comparison: Parenchymal Implantable Catheters
| Item | Raumedic® PTOMonitoring SystemK130529 | Pressio® ICPMonitoring systemK062584 | Pressio® 2 ICPMonitoring SystemK162108 | Comment |
|---|---|---|---|---|
| Trade Name | NEUROVENT®-PTO (tunellisable)NEUROVENT®-PTO 2L (with Bolt) | SOPHYSA®-PSO-PT(with tunneling)PSO-PB (with bolt) | SOPHYSA®-PSO-PTT (withtunneling)PSO-PBT (with bolt) | N/A |
| Indicationfor use | The Raumedic®-PTOMonitoring System isindicated for use by aqualifiedneurosurgeon fordirect measurementof intracranialpressure andtemperature in theparenchyma as wellas to determine thepartial oxygenpressure PtiO2 of theinterstitial fluid. | The Pressio® PSO-PB and PSO-PTMonitoring Kit isindicated forcontinuous invasivemonitoring ofintracranialparenchymalpressure (ICP) bytrained personnel of(neuro) intensive careunits andneurosurgerydepartments | The Pressio® PSO-PBT and PSO-PTTMonitoring Kit isindicated forcontinuous invasivemonitoring ofintracranialparenchymalpressure (ICP) andtemperature (ICT) bytrained personnel of(neuro) intensive careunits andneurosurgerydepartments | Same - formeasurementof intracranialpressure andtemperature. |
| AnatomicalSite Catheter | Brain Parenchyma | Brain Parenchyma | Brain Parenchyma | Same |
| Sensors | Catheter tip | Catheter tip | Catheter tip | Same |
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| Item | Raumedic® PTOMonitoring SystemK130529 | Pressio® ICPMonitoring systemK062584 | Pressio® 2 ICPMonitoring SystemK162108 | Comment | |
|---|---|---|---|---|---|
| location | Single Use catheter | Yes | Yes | Yes | Same |
| Sterilizationprocess | With ethylene Oxide | With ethylene oxide | With ethylene oxide | Same | |
| Drainage | No | No | No | Same | |
| ICP - sensordesigncatheter | Piezoresistivepressure sensor | Piezoresistivepressure sensor | Piezoresistivepressure sensor | Same | |
| ICT- sensordesign | Thermistor | - | Thermistor | Same - forRaumedic.The Pressio®PSO-PT andPSO-PB donot readintracranialtemperature. | |
| MRIconditional | Yes | Yes | Yes | Same | |
| Product code | GWM | GWM | GWM | Same | |
| Biocompatibility ofpatientcontactingcomponents | ISO 10993-1 | ISO 10993-1 | ISO 10993-1 | Same | |
| Sterilization | EN ISO 11135-1ISO 11607 | EN ISO 11135-1ISO 11607 | EN ISO 11135-1ISO 11607 | Same |
Table 5: Predicate Comparison: Ventricular Implantable catheters
| Item | Raumedic® ICP-TEMP MonitoringSystemK120252 | Pressio® ICPMonitoring systemK062584 | Pressio® 2 ICPMonitoring SystemK162108 | Comment |
|---|---|---|---|---|
| Trade Name | NEUROVENT®-TEMP-IFD-S | SOPHYSA®-PSO-VT | SOPHYSA®-PSO-VTT | N/A |
| Indication foruse | The Raumedic®-PTO MonitoringSystem is indicatedfor use by aqualifiedneurosurgeon fordirect measurementof intracranialpressure andtemperature in theventricle andcerebrospinal | The Pressio® PSO-VT IntracranialPressure MonitoringKit with tunneling isindicated forcontinuous invasivemonitoring ofintracranialventricular pressure(ICP) by trainedpersonnel of (neuro)intensive care units | The Pressio® PSO-VTT IntracranialPressure MonitoringKit with tunneling isindicated forcontinuous invasivemonitoring ofintracranial ventricularpressure (ICP) andtemperature (ICT) bytrained personnel of(neuro) intensive care | Same forRaumedic.The PSO-VT does notreadintracranialtemperature. |
{10}------------------------------------------------
| Item | Raumedic® ICP-TEMP MonitoringSystemK120252 | Pressio® ICPMonitoring systemK062584 | Pressio® 2 ICPMonitoring SystemK162108 | Comment |
|---|---|---|---|---|
| applications | and neurosurgerydepartments withcerebrospinal fluiddrainage application. | units and neurosurgerydepartments withcerebrospinal fluiddrainage application. | ||
| MRIconditional | Yes | Yes | Yes | Same |
| AnatomicalSite Catheter | Brain ventricle | Brain ventricle | Brain ventricle | Same |
| Single Usecatheter | Yes | Yes | Yes | Same |
| Sterilizationprocess | With ethyleneOxide | With ethylene oxide | With ethylene oxide | Same |
| Drainage | Yes | Yes | Yes | Same |
| ICP - sensordesigncatheter | Piezoresistivepressure sensor | Piezoresistivepressure sensor | Piezoresistive pressuresensor | Same |
| ICT- sensordesign | Thermistor | - | Thermistor | SameThePressio®PSO-VTdoes notreadintracranialtemperature. |
| Product code | GWM | GWM | GWM | Same |
| Biocompatibility of patientcontactingcomponents | ISO 10993-1 | ISO 10993-1 | ISO 10993-1 | Same |
| Sterilization | EN ISO 11135-1ISO 11607 | EN ISO 11135-1ISO 11607 | EN ISO 11135-1ISO 11607 | Same |
Table 6: Predicate comparison: Implantable catheters safety (summary)
| Safety –Implantablecatheters | Pressio®2 ICPMonitoring System | Pressio® ICPMonitoring systemK062584 | Raumedic®Monitoring systemK130529, K120252 | Comment |
|---|---|---|---|---|
| Biocompatibilityof patientcontactingcomponents | ISO 10993-1 | ISO 10993-1 | ISO 10993-1 | Same |
| Sterilization | EN ISO 11135-1ISO 11607 | EN ISO 11135-1ISO 11607 | EN ISO 11135-1ISO 11607 | Same |
{11}------------------------------------------------
| Devices | Raumedic®PTO MonitoringSystemK130529 | Pressio® ICPMonitoringsystemK062584 | Pressio® 2 ICPMonitoringSystemK162108 | Comment |
|---|---|---|---|---|
| Bolt forintroduction andfixation | 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® PTOMonitoring SystemK130529 | Pressio® ICPMonitoring systemK062584 | Pressio® 2 ICPMonitoring SystemK162108 | Comment |
|---|---|---|---|---|
| ACCESSORIES OF IMPLANTATION | ||||
| Type ofinstallation –ICPmonitoringwithtunneling | Spliceable TunnelingSleeve CH8:- Trocar- Tunneling sleeve | Monitoring kit withtunneling (PSO-PT)- Trocar- Tunneling needlewith stylet- Drill withadjustable stop- Allen key | Monitoring kit withbolt (PSO-PBT):- Trocar- Tunneling needlewith stylet- Drill withadjustable stop- Allen key | Similar - forRaumedickitSame – forSophysa®monitoring |
| Type ofinstallation –Ventricularpressuremonitoring | Spliceable Tunnelingsleeve CH12:- Trocar- Tunneling sleeve | Monitoring kit withtunneling (PSO-VT):- Trocar- Tunneling sheath- Drill withadjustable stop- Allen key | Monitoring kit withtunneling (PSO-VT):- Trocar- Tunneling sheath- Drill withadjustable stop- Allen key | Similar - forRaumedickitSame – forSophysa®monitoringkit |
| PERFORMANCE TESTING | ||||
| Placement insubduralspace -PressureMeasurement | No alteration ofpressure measuredwith a Raumedic®catheter wheninserted in a subduralspace | No alteration ofpressure measuredwith a Pressio®catheter wheninserted in a subduralspace | No alteration ofpressure measuredwith a Pressio®catheter wheninserted in a subduralspace | Sameperformanceresultsreached. |
| Biocompatibility of patientcontactingcomponents | ISO 10993-1 | ISO 10993-1 | ISO 10993-1 | Same |
| Sterilization | EN ISO 11135-1ISO 11607 | EN ISO 11135-1ISO 11607 | EN ISO 11135-1ISO 11607 | Same |
{12}------------------------------------------------
| Devices | Camino ParenchymalBolt ICP Monitoringcatheter - 110-4BK102875 | Pressio® 2 ICPMonitoring SystemK162108 | Comment |
|---|---|---|---|
| Implantation | Parenchymal bone | Parenchymal bone | Same |
| Number of lumens | 1 | 1 | Same |
| Type of catheterused with | Parenchymal catheter forICP monitoring | Parenchymal catheter forICP 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 kitcomposition | Drill | Drill | Same |
| Adjustable safety stop | Adjustable Drill stopper | Same | |
| Hex wrench foradjustable safety stop | Allen key for adjustableDrill 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.
§ 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).