RAUMEDIC-PTO-MONITORING-SYSTEM

K130529 · Raumedic AG · GWM · Oct 25, 2013 · Neurology

Device Facts

• Record ID: K130529
• Device Name: RAUMEDIC-PTO-MONITORING-SYSTEM
• Applicant: Raumedic AG
• Product Code: GWM · Neurology
• Decision Date: Oct 25, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1620
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The RAUMEDIC® - PTO-Monitoring-System measures intracranial pressure, temperature and oxygen and is intended as an adjunct monitor of trends in these parameters, indicating the perfusion status of cerebral tissue local to sensor placement. RAUMEDIC® - PTO-Monitoring-System values are relative within an individual, and should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide data additional to that obtained by current clinical practice, in cases where hypoxia or ischemia is a concern. Use of the parenchymal intracranial pressure monitoring kit with bolt is indicated for children who are at least one year old.

Device Story

The RAUMEDIC PTO-Monitoring-System is a multi-parameter intracranial monitoring device used in clinical settings by neurosurgeons. It utilizes implanted catheters (NEUROVENT series) containing piezoresistive pressure sensors for ICP, thermistors for temperature, and luminescence optical fiber sensors for ptiO2. The system includes a user interface unit (EASY logO) that processes signals from the catheters via dedicated cables (PTO and LWL). The EASY logO displays real-time measurements of ICP (including pulsatile ICPA), temperature, and oxygen, and provides technical alarms. Data can be exported to external patient monitoring units via specialized cables. The system provides trend data to assist clinicians in assessing cerebral perfusion status; it is not intended as the sole basis for diagnosis or therapy. Benefits include continuous, localized monitoring of physiological parameters in patients at risk of cerebral hypoxia or ischemia.

Clinical Evidence

Bench testing only. Performance evaluated against ANSI/AAMI NS 28:1988/(R) 2006 for ICP monitoring and ASTM E1112-00 (2006) for temperature. Oxygen sensor performance compared to predicate (K980380) regarding drift, accuracy, and response time. Biocompatibility testing conducted per ISO 10993-1, -5, and -18.

Technological Characteristics

System comprises intracranial catheters (piezoresistive pressure sensor, thermistor, luminescence optical fiber), cranial bolt kits, and EASY logO interface. Materials comply with ISO 10993. Connectivity via dedicated cables to external patient monitors. Sterilization via Ethylene Oxide. ICP sensor: Wheatstone bridge/piezoresistive. Temperature sensor: thermistor. Oxygen sensor: fiber optic quenching.

Indications for Use

Indicated for children (≥1 year) and adults requiring adjunct monitoring of intracranial pressure, temperature, and interstitial fluid oxygen partial pressure (ptiO2) to assess cerebral tissue perfusion status in cases where hypoxia or ischemia is a concern.

Regulatory Classification

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.

Predicate Devices

• DIAMETRIC MEDICAL LTD. NEUROTREND MULTIPARAMETER SENSOR (K980380)
• LICOX Brain Oxygen Monitoring System (K002765)
• RAUMEDIC® ICP-TEMP- MONITORING-SYSTEM (K120252)
• RAUMEDIC® ICP-MONITORING-SYSTEM (K103206)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a handwritten string of characters, which appears to be an identifier or code. The string reads 'K1305-29'. The characters are written in a cursive style with varying stroke thicknesses, and the overall impression is that of a quickly jotted down note.

Image /page/0/Picture/1 description: The image shows the logo for RAUMEDIC, a company that provides lifeline to health. The logo consists of a circular symbol on the left, followed by the company name in bold, sans-serif font. Below the name is the tagline "Lifeline to Health" in a smaller, lighter font. The overall design is clean and professional, conveying a sense of reliability and trustworthiness.

RAUMEDIC AG · Postfach 5 01 · D - 95205 Münchberg

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center - W066-0609 10903 New Hampshire Avenue Silver Spring, MD 20993-0002

#### Regulatory Affairs

Telefon: [phone] Telefax: (0 92 52) 359-10 00 [e-mail] www.RAUMEDIC.de

Direktkontakt: Telefon: [phone]

Reiner. [e-mail]

Tag 16th of October 2013

Ihre Nachricht vom Ihre Zeichen

H Thiem Sachbearbeiter Unsere Zeichen thi

510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

1. Name, address, phone and fax number of the applicant

RAUMEDIC AG Hermann-Staudinger-Straße 2 95233 Helmbrechts D - Germany Tel.: [phone] Fax: [phone]

#### 2. Contact person

Mr. Reiner Thiem Head of Regulatory Affairs Hermann-Staudinger-Straße 2 95233 Helmbrechts D - Germany Tel.: [phone]

#### 3. Date of preparation of the summary

October, the 16th 2013

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Image /page/1/Picture/0 description: The image shows the logo for RAUMEDIC. The logo consists of a circular graphic on the left and the word "RAUMEDIC" in bold, sans-serif font on the right. Below the word "RAUMEDIC" is the tagline "Lifeline to Health" with a line on either side of the text. The circular graphic appears to be a stylized representation of a globe or sphere.

#### 4. Name of the device

The RAUMEDIC® -PTO-Monitoring-System is composed of the following components:

- NEUROVENT -PTO .
- NEUROVENT®-TO .
- NEUROVENT®-PTO 2L .
- EASY logO .
- BOLT KIT PTO .
- BOLT KIT PTO 2L .
- Cable LWL .
- Cable PTO .
- Cable DATALOGGER GE/MARQUETTE .
- Cable DATALOGGER Philips/HP .
- Cable DATALOGGER Siemens/Dräger Infinity .
- Cable DATALOGGER Datex-Ohmeda .
- Cable DATALOGGER Hellige .
- Cable DATALOGGER SpaceLabs �
- Cable DATALOGGER Nihon Kohden .

Device Classification Name:

Classification Panel: CFR Section: Device Class: Product Code:

Device, Monitoring, Intracranial Pressure, Temperature and Oxygen Neurology 21 CFR §882.1620 Class II GWM

#### 5. Device Description

The RAUMEDIC® -PTO-Monitoring-System determines the level and change in intracranial pressure (ICP) by using semi-conductor pressure sensors, in temperature using thermistors, and in partial oxygen pressure ptiO2 using a luminescence optical sensor fibre.

The PTO-Monitoring-System consists of intracranial catheters, a cranial bolt kit, the user interface unit (EASY logO), cables to connect the catheters to the EASY logO and cables for the EASY logO to send the measurements to specific patient monitoring units.

Three intracranial catheters are provided: NEUROVENT®-PTO, NEUROVENT® TO and NEUROVENT® PTO 2L. The NEUROVENT®-PTO measures three physiological parameters - ICP, temperature and partial oxygen pressure. The application has to be made with a single lumen Bolt (BOLT-KIT PTO). The NEUROVENT -PTO 2L also measures these three parameters, but has to be placed with a multi lumen Bolt (BOLT KIT PTO 2L) or via tunneling process. The NEUROVENT® TO measures two physiological parameters – temperature and partial oxygen pressure. The application has to be made with a single lumen Bolt (BOLT-KIT PTO).

The NEUROVENT®-PTO or the NEUROVENT®-TO is implanted in the parenchyma using a BOLT KIT PTO. The NEUROVENT®-PTO 2L is implanted in the parenchyma using a BOLT KIT PTO 2L or using a RAUMEDIC® spliceable tunnelling sleeve CH8 (already cleared for market under 510(k) K112017).

Device #:

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Image /page/2/Picture/0 description: The image shows the logo for RAUMEDIC. The logo consists of a circular graphic on the left, followed by the word "RAUMEDIC" in bold, sans-serif font. Below the word is the tagline "Lifeline to Health" in a smaller, italicized font, flanked by horizontal lines.

For connecting the catheters to the EASY logO two cables – cable PTO and cable LWL - are needed. The cable PTO transfers the electrical signal for ICP and temperature. The cable LWL transfers the optical signal for oxygen pressure.

The EASY logO is the user interface that displays the measurements and alerts the user to the status of the intracranial catheters. The EASY logO displays: oxygen partial pressure pO2, intracranial pressure ICP, pulse amplitude ICPA and temperature T. ICP is a pulsatile signal that consists of the ICP average value and a pulsatile ICPA component, which is superimposed over the ICP average value.

DATALOGGER cables allows the EASY logO to send the measurements to specific patient monitoring units.

#### 6. Indications of Use

The RAUMEDIC® - PTO-Monitoring-System measures intracranial pressure, temperature and oxygen and is intended as an adjunct monitor of trends in these parameters, indicating the perfusion status of cerebral tissue local to sensor placement. RAUMEDIC® - PTO-Monitoring-System values are relative within an individual, and should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide data additional to that obtained by current clinical practice, in cases where hypoxia or ischemia is a concern.

Use of the parenchymal intracranial pressure monitoring kit with bolt is indicated for children who are at least one year old.

#### 7. Substantial Equivalence Summary

The RAUMEDIC® - PTO-Monitoring-System is substantially equivalent to the DIAMETRIC MEDICAL LTD. NEUROTREND MULTIPARAMETER SENSOR which was cleared for market under 510(k) K980380 on 14" of July 1999, the LICOX Brain Oxygen Monitoring System which was cleared for market under 510(k) K002765 on 24th of November 2000, the RAUMEDIC® ICP-TEMP- MONITORING-SYSTEM which was cleared for market under 510(k) K120252 on 110 of April 2012 and the RAUMEDIC® ICP-MONITORING-SYSTEM which was cleared for market under 510(k) K103206 on 04* of March 2011.

For further information see device comparison tables below.

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Image /page/3/Picture/0 description: The image shows the logo for RAUMEDIC, a company that provides medical products. The logo consists of a circular symbol on the left and the word "RAUMEDIC" in bold letters on the right. Below the word "RAUMEDIC" is the tagline "Lifeline to Health".

Table 1: Comparison to Predicate RAUMEDIC® ICP-TEMP- MONITORING- SYSTEM (K120252)

| Feature | RAUMEDIC® PTO-<br>MONITORING- SYSTEM | RAUMEDIC® ICP-TEMP.<br>MONITORING- SYSTEM<br>(K120252) | SE? |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | NEUROVENT -PTO,<br>NEUROVENT -PTO 2L.<br>NEUROVENT®-TO | NEUROVENT P-TEMP.<br>NEUROVENT - TEMP-IFD-S.<br>NEUROVENT - TEMP-IFD-R | N/A |
| Indication For<br>Use | The RAUMEDIC® -PTO-<br>Monitoring-System is indicated for<br>use by a qualified neurosurgeon for<br>direct measurement of intracranial<br>pressure and temperature in the<br>parenchyma as well as to<br>determine the partial oxygen<br>pressure ptiO2 of the interstitial<br>fluid. | The RAUMEDIC® -ICP-TEMP-<br>Monitoring-System is indicated for<br>use by a qualified neurosurgeon for<br>direct measurement of intracranial<br>pressure and temperature in the<br>parenchyma and in the ventricle<br>and cerebrospinal fluid drainage<br>applications. | YES - for<br>measurement<br>of intracranial<br>pressure and<br>temperature; for<br>oxygen<br>measurement<br>see SE-List with<br>predicate<br>device:<br>K880380 |
| Anatomical Site | Brain parenchyma | Brain parenchyma / ventricle | YES |
| Catheter<br>Sensors Location | Catheter Tip | Catheter Tip | YES |
| Tip Diameter | SF | SF | YES |
| Single-use- | YES | YES | |
| Catheter | | | YES |
| Sterilization<br>Process | With Ethylene Oxide | With Ethylene Oxide | YES |
| Bolt | Bolt with compression cap | Bolt with compression cap | YES |
| Spliceable<br>Tunnelling Sleeve | Spliceable Tunnelling Sleeve with<br>Trocar | Splicable Tunnelling Sleeve with<br>Trocar | YES |
| Size Of Access<br>Hole | for Bolt:<br>4.2 mm >> NEUROVENT®-PTO,<br>NEUROVENT®-TO<br>6.3 mm → NEUROVENT®-PTO 2L<br>for Tunnelling:<br>> 6 mm → NEUROVENT®-PTO 2L | for Bolt:<br>4.2 mm > NEUROVENT®-P-<br>TEMP.<br>6.3 mm -> NEUROVENT -TEMP-<br>IFD-S,<br>NEUROVENT®-TEMP-<br>IFD-R<br>for Tunnelling:<br>≥ 6 mm → NEUROVENT®-TEMP-<br>IFD-S,<br>NEUROVENT®-TEMP-<br>IFD-R | YES |
| Fixation Of<br>Catheter | Fixation wing (sutured to skin) | Fixation wing (sutured to skin) | YES |
| Non-fluid<br>Coupling Catheter | YES | YES | YES |
| ICP - Sensor<br>Design Catheter | Piezoresistive pressure sensor<br>(Semi-conductor / Wheatstone<br>Bridge) | Piezoresistive pressure sensor<br>( Semi-conductor / Wheatstone<br>Bridge) | YES |
| ICP - Pressure<br>Range | -50 to +250 mmHg | -50 to +250 mmHg | YES |
| ICP - Maximum<br>Pressure | 1,250 mmHg | 1,250 mmHg | YES |
| ICP - Accuracy | ± 1 mmHg | ± 1 mmHg | YES |
| ICP - Resolution | 0.1 mmHg | 0.1 mmHg | |
| ICP - Zero Point<br>Stability | Less than 1 mmHg during first 24<br>ours<br>Less than 2 mmHg during the first<br>7 days | Less than 1mmHg during first 24<br>hours<br>Less than 2mmHg during the first 7<br>days | YES |
| ICP - Dynamic<br>Response Time | < 5 ms | < 5 ms | YES |
| ICP - Sensitivity<br>System | 5 µV/V/mmHg on the monitor side | 5 µV/V/mmHg on the monitor side | YES |
| Feature | RAUMEDIC® PTO-<br>MONITORING- SYSTEM | RAUMEDIC® ICP-TEMP-<br>MONITORING- SYSTEM<br>(K120252) | SE? |
| TEMP - Sensor<br>Design | Thermistor | Thermistor | YES |
| TEMP -<br>Temperature<br>Range | 25 °C - 45 °C | 25 °C - 45 °C | YES |
| TEMP - Accuracy | ± 0.1 °C | ± 0.1 °C | YES |
| TEMP -<br>Resolution | 0.01 °C | 0.01 °C | YES |
| TEMP - Zero<br>Point Stability | ± 0.2 °C | ± 0.2 °C | YES |
| TEMP - Dynamic<br>Response Time | < 150 s | < 150 s | YES |
| TEMP - Adapter | Cable PTO | ICP-TEMP-Adapter<br>ICP-TEMP-Adapter HP / Philips | YES |
| p₁O₂ - Sensor<br>Design Catheter | Fiber Optic / Quenching<br>→ measuring amount of reflected<br>light from sensor tip in comparison<br>to pre-calibrated values with<br>reference solutions (see section<br>"12. Substantial Equivalence<br>Discussion") | --- | NO<br>- see SE-List<br>with predicate<br>device:<br>K980380 |
| p₁O₂ - Oxygen<br>Pressure Range | 0 to 150 mmHg | --- | NO<br>- see SE-List<br>with predicate<br>device:<br>K980380 |
| p₁O₂ - Accuracy | ± 3 % or ± 2.5 mmHg of the<br>measured value → the higher<br>value is applicable for p₁O₂ < 120<br>mmHg:<br>< 10 % of the measured value for<br>p₁O₂ from 120 mmHg to 150 mmHg | --- | NO<br>- see SE-List<br>with predicate<br>device:<br>K980380 |
| p₁O₂ - Resolution | 0.1 mmHg | --- | NO<br>- see SE-List<br>with predicate<br>device:<br>K980380 |
| p₁O₂ - Zero Point<br>Stability | max. 1.5 mmHg in 5 days<br>(at a ptiO2 of ≤ 10 mmHg) | --- | NO<br>- see SE-List<br>with predicate<br>device:<br>K980380 |
| p₁O₂ - Dynamic<br>Response Time | < 200 s for p₁O₂-decrease from<br>150 ± 15 mmHg to 0.0 mmHg | --- | NO<br>- see SE-List<br>with predicate<br>device:<br>K980380 |
| p₁O₂ - Adapter | Cable LWL | --- | NO<br>- see SE-List<br>with predicate<br>device:<br>K980380 |
| Product Code | GWM | GWM | YES |
| Registration # | Pending | K120252 | N/A |
| Applicant | RAUMEDIC AG<br>Hermann-Staudinger-Str. 2<br>95233 Helmbrechts | RAUMEDIC AG<br>Hermann-Staudinger-Str. 2<br>95233 Helmbrechts | N/A |

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Image /page/4/Picture/0 description: The image shows the logo for RAUMEDIC. The logo consists of a circular graphic on the left, followed by the word "RAUMEDIC" in bold, sans-serif font. Below the word "RAUMEDIC" is the tagline "life.to health" in a smaller font size.

- Lifeline to Health -

* ICP measurement only with NEUROVENT®-PTO and NEUROVENT®-PTO 2L

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Image /page/5/Picture/0 description: The image contains the logo for RAUMEDIC, a company that provides a lifeline to health. The logo consists of a circular graphic on the left, followed by the company name in bold, sans-serif font. Below the name is the tagline "Lifeline to Health".

Table 2: Comparison to predicate DIAMETRIC MEDICAL LTD.NEUROTREND MULTIPARAMETER SENSOR (K980380)

| Feature | RAUMEDIC® PTO-<br>MONITORING- SYSTEM | DIAMETRIC MEDICAL LTD.<br>NEUROTREND<br>MULTIPARAMETER SENSOR<br>(K980380) | SE? |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | NEUROVENT®-PTO,<br>NEUROVENT®-PTO 2L,<br>NEUROVENT®-TO | Neurotrend™ Multiparameter<br>Sensor<br>(C7004S) | N/A |
| Indication For<br>Use | The RAUMEDIC® -PTO-Monitoring-<br>System is indicated for use by a<br>qualified neurosurgeon for direct<br>measurement of intracranial<br>pressure and temperature in the<br>parenchyma as well as to determine<br>the partial oxygen pressure ptiO2 of<br>the interstitial fluid. | The Neurotrend Multiparameter<br>Sensor is a disposable, sterile,<br>single-use, device for the<br>continuous measurement of<br>intracranial oxygen, carbon<br>dioxide, pH and temperature that<br>is used in conjunction with a<br>suitable intracranial access<br>device. | YES - for<br>measurement<br>of oxygen; for<br>intracranial<br>pressure and<br>temperature<br>measurement<br>see SE-List with<br>predicate<br>device:<br>K120252 |
| Anatomical Site<br>Catheter | Brain parenchyma | Brain ventricle | NO<br>- see SE-List<br>with predicate<br>device:<br>K120252 |
| Sensors Location | Catheter Tip | Catheter Tip | YES |
| Tip Diameter | 5 F | 2 F | NO<br>- see SE-List<br>with predicate<br>device:<br>K120252 |
| Single-use-<br>Catheter | YES | YES | YES |
| Sterilization<br>Process | With Ethylene Oxide | With Gamma - Radiation | NO<br>- see SE-List<br>with predicate<br>device:<br>K120252 |
| Bolt | Bolt with compression cap | A suitable intracranial access<br>device | NO<br>- see SE-List<br>with predicate<br>device:<br>K120252 |
| Spliceable<br>Tunnelling Sleeve | Spliceable Tunnelling Sleeve with<br>Trocar | A suitable intracranial access<br>device | NO<br>- see SE-List<br>with predicate<br>device:<br>K120252 |
| Size Of Access<br>Hole | for BOLT usage:<br>4.2 mm → NEUROVENT®-PTO,<br>NEUROVENT®-TO<br>6.3 mm → NEUROVENT®-PTO 2L<br><br>for Tunnelling Sleeve usage:<br>≥ 6 mm → NEUROVENT®-PTO 2L | | NO<br>- see SE-List<br>with predicate<br>device:<br>K120252 |
| Fixation Of<br>Catheter | Fixation wing (sutured to skin) | | YES |
| Non-fluid | YES | YES | YES |
| Feature | RAUMEDIC® PTO-<br>MONITORING- SYSTEM | DIAMETRIC MEDICAL LTD.<br>NEUROTREND<br>MULTIPARAMETER SENSOR<br>(Ka80380) | SE? |
| ICP - Sensor<br>Design Catheter | Piezoresistive pressure sensor<br>(Semi-conductor / Wheatstone<br>Bridge) | --- | NO<br>- see SE-List<br>with predicate<br>device:<br>K120252 |
| ICP - Pressure<br>Range | -50 to +250 mmHg | --- | NO<br>- see SE-List<br>with predicate<br>device:<br>K120252 |
| ICP - Maximum<br>Pressure | 1,250 mmHg | --- | NO<br>- see SE-List<br>with predicate<br>device:<br>K120252 |
| ICP - Accuracy | ± 1 mmHg | --- | NO<br>- see SE-List<br>with predicate<br>device:<br>K120252 |
| ICP - Resolution | 0.1 mmHg | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | NO<br>- see SE-List<br>with predicate<br>device:<br>K120252 |
| ICP - Zero Point<br>Stability | Less than 1 mmHg during first 24<br>ours<br>Less than 2 mmHg during the first 7<br>days | ---- | NO<br>- see SE-List<br>with predicate<br>device:<br>K120252 |
| ICP - Dynamic<br>Response Time | < 5 ms | --- | NO<br>- see SE-List<br>with predicate<br>device:<br>K120252 |
| ICP - Sensitivity<br>System | 5 µV/V/mmHg on the monitor side | - | NO<br>- see SE-List<br>with predicate<br>device:<br>K120252 |
| TEMP - Sensor<br>Design | Thermistor | Thermocouple | NO<br>- see SE-List<br>with predicate<br>device:<br>K120252 |
| TEMP -<br>Temperature<br>Range | 25 °C - 45 °C | 10 °C - 42 °C | NO<br>- see SE-List<br>with predicate<br>device:<br>K120252 |
| TEMP - Accuracy | + 0.1 °C | +0.1 °C | YES |
| TEMP -<br>Resolution | 0.01 °C | 0.01 °C | YES |
| TEMP - Zero<br>Point Stability | + 0.2 °C | + 0.2 °C | YES |
| TEMP - Dynamic<br>Response Time | < 150 s | < 150 s | YES |
| TEMP - Adapter | Cable PTO | PDM Cable | YES |
| Feature | RAUMEDIC® PTO-<br>MONITORING-SYSTEM | DIAMETRIC MEDICAL LTD.<br>NEUROTREND<br>MULTIPARAMETER SENSOR<br>(K980380) | SE? |
| ptO2 - Sensor<br>Design Catheter | Fiber Optic / Quenching<br>→ measuring amount of reflected<br>light from sensor tip in comparison<br>to pre-calibrated values with<br>reference solutions (see section "12.<br>Substantial Equivalence<br>Discussion") | Fiber Optic / Quenching<br>→ measuring amount of reflected<br>light from sensor tip in comparison<br>to pre-calibrated values with<br>reference solutions | YES |
| ptO2 - Oxygen<br>Pressure Range | 0 to 150 mmHg | 10 to 430 mmHg | NO; the lower<br>limit is<br>demonstrated<br>by<br>performance<br>testing |
| ptO2 - Accuracy | ± 3 % or ± 2.5 mmHg of the<br>measured value → the higher value<br>is applicable for ptO2 < 120 mmHg;<br>< 10 % of the measured value for<br>ptO2 from 120 mmHg to 150 mmHg | ± 3 % or ± 2.5 mmHg of the<br>measured value → the higher<br>value is applicable for ptO2 < 120<br>mmHg:<br>< 10 % of the measured value for<br>ptO2 from 120 mmHg to 200<br>mmHg | YES |
| ptO2 - Resolution | 0.1 mmHg | 0.1 mmHg | YES |
| ptO2 - Zero Point<br>Stability | max. 1.5 mmHg in 5 days<br>(at a ptiO2 of ≤ 10 mmHg) | < 0.5 % per hour | YES<br>within the<br>stability range<br>of the<br>NEUROTREND |
| ptO2 - Dynamic<br>Response Time | < 200 s for ptO2-decrease from 150<br>± 15 mmHg to 0.0 mmHg | < 200 s for ptO2-decrease from<br>150±15 mmHg to 0.0 mmHg | YES |
| ptO2-Adapter | Cable LWL | PDM Cable | YES |
| Product Code | GWM | GWM | YES |
| Registration # | Pending | K980380 | N/A |
| Applicant | RAUMEDIC AG<br>Hermann-Staudinger-Str. 2<br>95233 Helmbrechts<br>Germany | Diametrics Medical, Ltd.<br>Short Street<br>High Wycombe<br>Buckinghamshire, UK HP11 2QH | N/A |

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Image /page/6/Picture/0 description: The image shows the logo for RAUMEDIC. The logo consists of a circular graphic on the left, followed by the word "RAUMEDIC" in bold, sans-serif font. Underneath the word "RAUMEDIC" is the tagline "Lifeline to Health".

- Lifeline to Health ----

1

Device #:_____________________________________________________________________________________________________________________________________________________________________

,

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Image /page/7/Picture/0 description: The image shows the logo for RAUMEDIC. The logo consists of a circular graphic on the left, followed by the word "RAUMEDIC" in bold, sans-serif font. Below the word "RAUMEDIC" is the tagline "life. united. health."

- Lifeline to Health ----

* ICP measurement only with NEUROVENT®-PTO and NEUROVENT®-PTO 2L

Device #:_

:

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Image /page/8/Picture/0 description: The image shows the Raumedic logo. The logo consists of a circular symbol on the left and the word "RAUMEDIC" in bold, sans-serif font on the right. Below the word is the tagline "Lifeline to Health" with a line above and below the text.

Table 3: Comparison to Predicate LICOX Brain Oxygen Monitoring System (K002765)

| Feature | RAUMEDIC® PTO-<br>MONITORING-<br>SYSTEM | RAUMEDIC® ICP-<br>MONITORING-<br>SYSTEM | LICOX Brain Oxygen<br>Monitoring System | SE? |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Trade Name | EASY logo | NPS3 | CMP® Monitor | N/A |
| Indication for Use | The RAUMEDIC® -<br>PTO-Monitoring-<br>System is indicated<br>for use by a qualified<br>neurosurgeon for<br>direct measurement<br>of intracranial<br>pressure and<br>temperature in the<br>parenchyma as wellto determine the<br>partial oxygen<br>pressure ptiO2 of the<br>interstitial fluid. | The RAUMEDIC® -<br>ICP-Monitoring-<br>System is indicated<br>for use by a qualified<br>neurosurgeon for<br>direct measurement<br>of intracranial<br>pressure in the<br>parenchyma. | The LICOX Brain<br>Oxygen Pressure<br>Monitoring System<br>directly measures<br>Partial Pressure of<br>Oxygen in the brain.<br>The LICOX system can<br>also utilize brain<br>temperature information<br>for temperature<br>compensation of the<br>pO2. | YES |
| ICP Measurement | YES | YES | NO | YES |
| Temperature<br>Measurement | YES | NO | YES | YES |
| pO2<br>Measurement | YES | NO | YES | YES |
| Pressure Range | -40 to +100 mmHg | -40 to +100 mmHg | --- | YES |
| Temperature<br>Range | 15 °C - 45 °C | --- | 0°C - 46 °C | NO; limits are<br>demonstrated<br>by<br>performance<br>testing in<br>accordance to<br>ASTM E1112 |
| pO2 Range | 0 to 150 mmHg | --- | 0 to 150 mmHg | YES; limits are<br>demonstrated<br>by<br>performance<br>testing |
| Screen | YES | YES | YES | YES |
| Monitoring | Continuous…