Predicate Devices

K121573, K102875, K130529, K120252, K062584

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a system for continuous invasive monitoring of intracranial pressure and temperature. It details the hardware components (monitor, catheters, cables) and their function in measuring and displaying physiological parameters. There is no mention of any algorithms, data analysis, or features that would suggest the use of AI or ML for interpretation, prediction, or decision support. The performance studies focus on standard device testing and pressure measurement accuracy, not on the performance of any AI/ML model.

Therapeutic

No
Explanation: The device is described as a "monitoring system" designed to measure intracranial pressure and temperature, not to provide therapy or treatment. While it may aid in guiding therapeutic decisions, its primary function is diagnostic monitoring.

Diagnostic

Yes

Explanation: The device is specifically indicated for "continuous invasive monitoring of intracranial pressure" and can also "display the intracranial temperature." Monitoring these physiological parameters helps in assessing a patient's condition and guiding clinical decisions, which are key aspects of diagnostics.

SaMD (Software as a Medical Device)

No

The device description explicitly states the system is composed of a monitor (PSO-4000) with accessories and implantable catheters, which are hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Device Function: The Pressio® 2 Intracranial Pressure Monitoring system is designed for continuous invasive monitoring of intracranial pressure and temperature directly within the patient's body (in the brain parenchyma or ventricles) using implanted catheters.
Lack of Specimen Analysis: The device does not analyze any biological specimens taken from the body. It measures physical parameters (pressure and temperature) within the body.

Therefore, the Pressio® 2 Intracranial Pressure Monitoring system falls under the category of in vivo diagnostic or monitoring devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.
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.

Product codes (comma separated list FDA assigned to the subject device)

GWM

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).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Brain Parenchyma, Brain Ventricle

Indicated Patient Age Range

Not Found

Intended User / Care Setting

trained personnel of (neuro) intensive care units and neurosurgery departments.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Key Results: No alteration of pressure measured with a Pressio® catheter when inserted in a subdural space.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K121573, K102875, K130529, K120252, K062584

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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)
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 SA
5 rue Guy Moquet
91400 Orsay
FRANCE
Tel: (+33) 1 69 35 35 00
Fax: (+33) 1 69 35 36 90 |
|-------------------|-----------------------------------------------------------------------------------------------------------------|
| Contact Person: | Etienne DUHOT
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
Class II, Product Code GWM |
| Product Code: | GWM |

Predicate Devices:

| Applicant | Model | Document
number | Regulation &
Product Code | Review Panel |
|-----------|----------------------------------------------------------------|--------------------|------------------------------|----------------------|
| Integra® | Camino® ICP monitor | K121573 | 21 CFR 882.1620
GWM | Ear Nose &
Throat |
| | Camino Parenchymal Bolt
ICP Monitoring catheter –
110-4B | K102875 | | Ear Nose &
Throat |
| Raumedic® | Neurovent®-PTO 2L
Neurovent®-PTO | K130529 | 21 CFR 882.1620
GWM | Neurology |
| | Neurovent®-TEMP IFD-S | K120252 | 21 CFR 882.1620
GWM | Ear Nose &
Throat |
| Sophysa® | Sophysa® - PSO-PB
Sophysa® - PSO-PT
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
Monitoring
system | K062584Integra®
Camino® ICP
Monitoring
System K121573 | Pressio® 2 ICP
Monitoring System
K162108 | Rationale /
Comment |
|-----------------------------|--------------------------------------|----------------------------------------------------------------|------------------------------------------------|------------------------|
| Applicable
product codes | 21CFR 882.1620 | | | GWM; Same |

Table 1: Predicate comparison: Intended uses and design (ICP Monitors)

| Item | Integra® Camino® ICP
Monitoring System
K121573 | Pressio® 2 ICP Monitoring
System
K162108 | Comment |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Manufacturer | Integra® | Sophysa® | N/A |
| 510(k) no. | K121573 | K162108 | N/A |
| Classification
regulation | 21 CFR 882.1620 | 21 CFR 882.1620 | Same |
| Product no. | GWM | GWM | Same |
| Indications
for Use | The Integra® Camino ® ICP
Monitoring system is indicated for
use by qualified neurosurgeons or
neurointensivists for measurement
of intracranial pressure and
temperature | 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 | Subject device
includes the
relevant bullet
points for each
particular
catheter. |

7

| Item | Integra® Camino® ICP
Monitoring System
K121573 | Pressio® 2 ICP Monitoring
System
K162108 | Comment |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| | | 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. | |
| Prescription
use | Yes | Yes | Same |
| Anesthesia
required | Yes | Yes | Same |
| Physician
training
required | Yes | Yes | Same |
| System
components | Monitor
Power cable
Battery
Patient bedside monitor cables
Integra® Catheter
Flex extension cable
USB adapter cable | Monitor
Power cable
Battery
Patient bedside monitor cables
Sophysa® Catheter
Catheter extension cable
USB adapter cable | Same |

	Table 2: Predicate comparison: Main functions and technological specifications (ICP Monitors)
--	-----------------------------------------------------------------------------------------------

| Item | Integra® Camino® ICP
Monitoring System
K121573 | Pressio® 2 ICP Monitoring
System
K162108 | Comment |
|----------------------------------------|------------------------------------------------------|------------------------------------------------|---------|
| Intracranial Pressure
Monitoring | Yes | Yes | Same |
| Intracranial Temperature
Monitoring | Yes | Yes | Same |
| Output to patient monitor
for ICP | Yes | Yes | Same |
| Output to patient monitor
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-
TEMP Monitoring
System
K120252	Pressio® 2 ICP
Monitoring System
K162108	Comment
Electrical and EMC
standards conformity	IEC 60601-1
IEC 60601-1-2	IEC 60601-1
IEC 60601-1-2	Same
Electrical safety -
Multifunction patient
monitoring 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® ICP
Monitoring
system
K062584 | Raumedic®
ICP-TEMP
Monitoring
System
K120252 | Raumedic® PTO
Monitoring
System
K130529 | Pressio® 2 ICP
Monitoring
System
K162108 | Comment |
|--------------------------------|-------------------------------------------------|----------------------------------------------------------|--------------------------------------------------|---------------------------------------------------|--------------|
| Applicable
product
codes | 21CFR 882.1620 | | | | GWM;
Same |

Table 4: Predicate comparison: Parenchymal Implantable Catheters

| Item | Raumedic® PTO
Monitoring System
K130529 | Pressio® ICP
Monitoring system
K062584 | Pressio® 2 ICP
Monitoring System
K162108 | Comment |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Trade Name | NEUROVENT®-
PTO (tunellisable)
NEUROVENT®-
PTO 2L (with Bolt) | SOPHYSA®-
PSO-PT
(with tunneling)
PSO-PB (with bolt) | SOPHYSA®-
PSO-PTT (with
tunneling)
PSO-PBT (with bolt) | N/A |
| Indication
for use | The Raumedic®-PTO
Monitoring System is
indicated for use by a
qualified
neurosurgeon for
direct measurement
of intracranial
pressure and
temperature in the
parenchyma as well
as to determine the
partial oxygen
pressure PtiO2 of the
interstitial fluid. | The Pressio® PSO-
PB and PSO-PT
Monitoring Kit is
indicated for
continuous invasive
monitoring of
intracranial
parenchymal
pressure (ICP) by
trained personnel of
(neuro) intensive care
units and
neurosurgery
departments | The Pressio® PSO-
PBT and PSO-PTT
Monitoring Kit is
indicated for
continuous invasive
monitoring of
intracranial
parenchymal
pressure (ICP) and
temperature (ICT) by
trained personnel of
(neuro) intensive care
units and
neurosurgery
departments | Same - for
measurement
of intracranial
pressure and
temperature. |
| Anatomical
Site Catheter | Brain Parenchyma | Brain Parenchyma | Brain Parenchyma | Same |
| Sensors | Catheter tip | Catheter tip | Catheter tip | Same |

9

| Item | Raumedic® PTO
Monitoring System
K130529 | Pressio® ICP
Monitoring system
K062584 | Pressio® 2 ICP
Monitoring System
K162108 | Comment | |
|------------------------------------------------------------|-----------------------------------------------|----------------------------------------------|------------------------------------------------|----------------------------------------------------------------------------------------------------------------|------|
| location | Single Use catheter | Yes | Yes | Yes | Same |
| Sterilization
process | With ethylene Oxide | With ethylene oxide | With ethylene oxide | Same | |
| Drainage | No | No | No | Same | |
| ICP - sensor
design
catheter | Piezoresistive
pressure sensor | Piezoresistive
pressure sensor | Piezoresistive
pressure sensor | Same | |
| ICT- sensor
design | Thermistor | - | Thermistor | Same - for
Raumedic.
The Pressio®
PSO-PT and
PSO-PB do
not read
intracranial
temperature. | |
| MRI
conditional | Yes | Yes | Yes | Same | |
| Product code | GWM | GWM | GWM | Same | |
| Biocompatibility of
patient
contacting
components | ISO 10993-1 | ISO 10993-1 | ISO 10993-1 | Same | |
| Sterilization | EN ISO 11135-1
ISO 11607 | EN ISO 11135-1
ISO 11607 | EN ISO 11135-1
ISO 11607 | Same | |

Table 5: Predicate Comparison: Ventricular Implantable catheters

| Item | Raumedic® ICP-
TEMP Monitoring
System
K120252 | Pressio® ICP
Monitoring system
K062584 | Pressio® 2 ICP
Monitoring System
K162108 | Comment |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Trade Name | NEUROVENT®-
TEMP-IFD-S | SOPHYSA®-
PSO-VT | SOPHYSA®-
PSO-VTT | N/A |
| Indication for
use | The Raumedic®-
PTO Monitoring
System is indicated
for use by a
qualified
neurosurgeon for
direct measurement
of intracranial
pressure and
temperature in the
ventricle and
cerebrospinal | The Pressio® PSO-
VT Intracranial
Pressure Monitoring
Kit with tunneling is
indicated for
continuous invasive
monitoring of
intracranial
ventricular pressure
(ICP) by trained
personnel of (neuro)
intensive care units | The Pressio® PSO-
VTT Intracranial
Pressure Monitoring
Kit with tunneling is
indicated for
continuous invasive
monitoring of
intracranial ventricular
pressure (ICP) and
temperature (ICT) by
trained personnel of
(neuro) intensive care | Same for
Raumedic.
The PSO-
VT does not
read
intracranial
temperature. |

10

| Item | Raumedic® ICP-
TEMP Monitoring
System
K120252 | Pressio® ICP
Monitoring system
K062584 | Pressio® 2 ICP
Monitoring System
K162108 | Comment |
|---------------------------------------------------------|--------------------------------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| applications | | and neurosurgery
departments with
cerebrospinal fluid
drainage application. | units and neurosurgery
departments with
cerebrospinal fluid
drainage application. | |
| MRI
conditional | Yes | Yes | Yes | Same |
| Anatomical
Site Catheter | Brain ventricle | Brain ventricle | Brain ventricle | Same |
| Single Use
catheter | Yes | Yes | Yes | Same |
| Sterilization
process | With ethylene
Oxide | With ethylene oxide | With ethylene oxide | Same |
| Drainage | Yes | Yes | Yes | Same |
| ICP - sensor
design
catheter | Piezoresistive
pressure sensor | Piezoresistive
pressure sensor | Piezoresistive pressure
sensor | Same |
| ICT- sensor
design | Thermistor | - | Thermistor | Same
The
Pressio®
PSO-VT
does not
read
intracranial
temperature. |
| Product code | GWM | GWM | GWM | Same |
| Biocompatibility of patient
contacting
components | ISO 10993-1 | ISO 10993-1 | ISO 10993-1 | Same |
| Sterilization | EN ISO 11135-1
ISO 11607 | EN ISO 11135-1
ISO 11607 | EN ISO 11135-1
ISO 11607 | Same |

Table 6: Predicate comparison: Implantable catheters safety (summary)

| Safety –
Implantable
catheters | Pressio®2 ICP
Monitoring System | Pressio® ICP
Monitoring system
K062584 | Raumedic®
Monitoring system
K130529, K120252 | Comment |
|------------------------------------------------------------|------------------------------------|----------------------------------------------|----------------------------------------------------|---------|
| Biocompatibility
of patient
contacting
components | ISO 10993-1 | ISO 10993-1 | ISO 10993-1 | Same |
| Sterilization | EN ISO 11135-1
ISO 11607 | EN ISO 11135-1
ISO 11607 | EN ISO 11135-1
ISO 11607 | Same |

11

| Devices | Raumedic®
PTO Monitoring
System
K130529 | Pressio® ICP
Monitoring
system
K062584 | Pressio® 2 ICP
Monitoring
System
K162108 | Comment |
|------------------------------------------|--------------------------------------------------|-------------------------------------------------|---------------------------------------------------|---------|
| Bolt for
introduction and
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
Monitoring System
K130529 | Pressio® ICP
Monitoring system
K062584 | Pressio® 2 ICP
Monitoring System
K162108 | Comment |
|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| ACCESSORIES OF IMPLANTATION | | | | |
| Type of
installation –
ICP
monitoring
with
tunneling | Spliceable Tunneling
Sleeve CH8:

Trocar
Tunneling sleeve | Monitoring kit with
tunneling (PSO-PT)
Trocar
Tunneling needle
with stylet
Drill with
adjustable stop
Allen key | Monitoring kit with
bolt (PSO-PBT):
Trocar
Tunneling needle
with stylet
Drill with
adjustable stop
Allen key | Similar - for
Raumedic
kit
Same – for
Sophysa®
monitoring |
| Type of
installation –
Ventricular
pressure
monitoring | Spliceable Tunneling
sleeve CH12:
Trocar
Tunneling sleeve | Monitoring kit with
tunneling (PSO-VT):
Trocar
Tunneling sheath
Drill with
adjustable stop
Allen key | Monitoring kit with
tunneling (PSO-VT):
Trocar
Tunneling sheath
Drill with
adjustable stop
Allen key | Similar - for
Raumedic
kit
Same – for
Sophysa®
monitoring
kit |
| PERFORMANCE TESTING | | | | |
| Placement in
subdural
space -
Pressure
Measurement | No alteration of
pressure measured
with a Raumedic®
catheter when
inserted in a subdural
space | No alteration of
pressure measured
with a Pressio®
catheter when
inserted in a subdural
space | No alteration of
pressure measured
with a Pressio®
catheter when
inserted in a subdural
space | Same
performance
results
reached. |
| Biocompatibi
lity of patient
contacting
components | ISO 10993-1 | ISO 10993-1 | ISO 10993-1 | Same |
| Sterilization | EN ISO 11135-1
ISO 11607 | EN ISO 11135-1
ISO 11607 | EN ISO 11135-1
ISO 11607 | Same |

12

| Devices | Camino Parenchymal
Bolt ICP Monitoring
catheter - 110-4B
K102875 | Pressio® 2 ICP
Monitoring System
K162108 | Comment |
|-------------------------------|---------------------------------------------------------------------------|------------------------------------------------|---------|
| Implantation | Parenchymal bone | Parenchymal bone | Same |
| Number of lumens | 1 | 1 | Same |
| Type of catheter
used with | Parenchymal catheter for
ICP monitoring | Parenchymal catheter for
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
composition | Drill | Drill | Same |
| | Adjustable safety stop | Adjustable Drill stopper | Same |
| | Hex wrench for
adjustable safety stop | Allen key for adjustable
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.