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 concem.

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

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).

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.

AI/ML Overview

The provided text describes the RAUMEDIC® -PTO-Monitoring-System and its performance testing to demonstrate substantial equivalence to previously cleared devices. It does not contain information about a study proving the device meets explicit acceptance criteria in the format requested. However, it does provide performance specifications and comparison to predicate devices, which serve as a de facto set of acceptance criteria for regulatory clearance.

Here’s a summary of the available information, fitted to the request structure where possible.

Device Name: RAUMEDIC® -PTO-Monitoring-System

Intended Use: Measures intracranial pressure (ICP), temperature, and oxygen (ptiO2) as an adjunct monitor of trends, indicating perfusion status of cerebral tissue local to sensor placement. Not for use as the sole basis for diagnosis or therapy. For use in children at least one year old.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the performance specifications of the predicate devices and relevant standards (ANSI/AAMI NS 28:1988/(R) 2006 for ICP, ASTM E1112-00 (2006) for Temperature, and comparison to K980380 for ptiO2). The tables provided (Table 5, Table 6, and Table 7) list the performance testing and results, demonstrating that the device meets these established comparables.

Feature / Parameter	Acceptance Criteria (from Predicate/Standards)	Reported Device Performance (RAUMEDIC® -PTO-Monitoring-System)
ICP Performance (Based on ANSI/AAMI NS 28:1988/(R) 2006)
Frequency response	> 100 Hz	167 Hz (Meets Standard)
Slew rates	> 7,500 torr/s	10,000 torr/s (Meets Standard)
Time constants	< 5 ms	3 ms (Meets Standard)
Pressure range	Min 0 to +100 mmHg	-50 to +250 mmHg (Meets Standard)
Accuracy (Catheter alone)	< maximum deviation point 3.2.2_NS 28 (-50 to +250 mmHg)	< maximum deviation point 3.2.2_NS 28 (Meets Standard)
Accuracy (with NPS-3 display)	< maximum deviation point 3.2.2_NS 28 (-40 to +100 mmHg)	< maximum deviation point 3.2.2_NS 28 (Meets Standard)
Stability (20 ± 1°C, 39 ± 1°C)	dPx < 1.52 torr	≤ 1.44 torr (Meets Standard)
Zero-Point Stability (24h)	< 1 torr	≤ 0.7 torr (Meets Standard)
Zero-Point Stability (168h)	< 1.5 torr	≤ 1.2 torr (Meets Standard)
Accuracy at 10 torr	< 1.5 torr	≤ 0.9 torr (Meets Standard)
Accuracy at 20 torr	< 1.5 torr	≤ 1.2 torr (Meets Standard)
Accuracy at 50 torr	< 1.5 torr	≤ 1.1 torr (Meets Standard)
Accuracy at 100 torr	< 1.5 torr	≤ 1.2 torr (Meets Standard)
Risk current	< 10 µA at 120 V AC	< 0.98 µA at 120 V AC (Meets Standard)
Maximum temperature	No temperature increase > 40 °C (104 °F)	max. 39.5 °C (Meets Standard)
Temperature Performance (Based on ASTM E1112-00 (2006))
Cleaning	No visible of technical changes	No visible of technical changes (Meets Standard)
Toxicity	Toxicity Test	Toxicity Test (Meets Standard)
Accuracy	No difference between the in vivo and in vitro accuracy	No difference between the in vivo and in vitro accuracy (Meets Standard)
Operating Environment (Temp/RH)	< Max. Error Temp. Rang. Table 1 ASTM E1112 (for 40°C/15%RH, 40°C/80%RH, 16°C/40%RH, 16°C/95%RH)	< Max. Error Temp.Rang. (Meets Standard for all conditions)
Storage (after 1 month)	Test point o.k. after storage at -20 °C, 50 °C/15% RH, 35 °C/95% RH	o.k. (Meets Standard)
Oxygen Performance (Compared to DIAMETRIC MEDICAL LTD. NEUROTREND MULTIPARAMETER SENSOR K980380)
Drift over 5.5 days (2.5% O2)	< 1.5 mmHg	≤ 1.2 mmHg (within predicate's < 11.9 mmHg) (Yes)
Drift over 5.5 days (10% O2)	< 1.5 mmHg	≤ 1.2 mmHg (within predicate's < 46.2 mmHg) (Yes)
Absolute accuracy (0-120 mmHg)	0+/- 2.5 mmHg	≤ 0.2 mmHg (within predicate's 0+/- 3.0 mmHg) (Yes)
Absolute accuracy (>120 mmHg)	150.00+/-15 mmHg (for predicate: 135.0-165.0 mmHg for values from 120-200 mmHg)	146.9 mmHg; 152.3 mmHg (within predicate's range) (Yes)
Response time T90	< 200 s for change 150+/-15 mmHg to 0.0 mmHg	≤ 51 s (within predicate's ≤ 55 s) (Yes)
ptiO2 sensitive surface	> 13 mm² (predicate: ≥ 5 mm²)	≥ 15.1 mm² (> 5mm² is o.k. in brain) (Yes)
Length ptiO2 sensitive area	> 4mm	> 4.9 mm (within predicate's > 4 mm) (Yes)
Outer catheter diameter	< 1.35 mm (predicate: ≤ 0.5 mm)	≤ 0.99 mm (Yes, noted as "Yes" despite a larger diameter, likely due to similar performance or acceptable clinical difference, or comparison to K120252 predicate which has larger diameters). For Oxygen, the comparison is specifically to K980380. The rationale for "Yes" is not explicitly detailed but stated.

2. Sample Size Used for the Test Set and Data Provenance
The document discusses bench testing rather than clinical studies with human subjects. Therefore, details like "test set," "sample size," "country of origin," and "retrospective or prospective" are not applicable in the context of human data. The testing described is primarily physical and analytical.

ICP Performance: The tests were performed on the RAUMEDIC® ICP-Monitoring-System (K103206) and the results were transferred, implying testing of components or integrated systems in a lab setting. The specific number of units tested is not stated.
Temperature Performance: Performed on the RAUMEDIC® PTO-Monitoring-System, likely in a lab setting. The specific number of units tested is not stated.
Oxygen Performance: Performed internally on the RAUMEDIC® PTO-Monitoring-System, likely in a lab setting. The specific number of units tested is not stated.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable, as the "test set" refers to bench testing against engineering specifications and predicate device performance, not human-annotated data. Ground truth here is defined by physical measurements and established standards.

4. Adjudication Method for the Test Set
Not applicable, as there were no human experts involved in adjudicating the results of the bench testing. The results were compared directly to numerical specifications or predicate device performance.

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 is a medical device for direct physiological measurement, not an AI-based diagnostic or imaging interpretation system.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The performance testing described (ICP, Temperature, Oxygen) is inherently "standalone" in the sense that it evaluates the device's physical and measurement capabilities independent of a human interpreter. The device provides raw data (measurements) which are then interpreted by clinicians.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance testing is based on:

Established international performance standards (ANSI/AAMI NS 28, ASTM E1112).
Comparative performance data from legally marketed predicate devices (K120252, K980380, K002765).
Direct physical measurements using calibrated equipment in a controlled laboratory environment.

8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/ML device that requires a training set.

Summary

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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: (0 92 52) 359-0 Telefax: (0 92 52) 359-10 00 info@RAUMEDIC.com www.RAUMEDIC.de

Direktkontakt: Telefon: (0 92 52) 359-2782

Reiner. Thiem@RAUMEDIC.com

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.

Name, address, phone and fax number of the applicant

RAUMEDIC AG Hermann-Staudinger-Straße 2 95233 Helmbrechts D - Germany Tel.: 0049/9252/359-0 Fax: 0049/9252/359-1000

2. Contact person

Mr. Reiner Thiem Head of Regulatory Affairs Hermann-Staudinger-Straße 2 95233 Helmbrechts D - Germany Tel.: 0049/9252/359-2782

3. Date of preparation of the summary

October, the 16th 2013

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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

Device #:

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

6. Indications of Use

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

Feature	RAUMEDIC® PTO-MONITORING- SYSTEM	RAUMEDIC® ICP-TEMP.MONITORING- SYSTEM(K120252)	SE?
Trade Name	NEUROVENT -PTO,NEUROVENT -PTO 2L.NEUROVENT®-TO	NEUROVENT P-TEMP.NEUROVENT - TEMP-IFD-S.NEUROVENT - TEMP-IFD-R	N/A
Indication ForUse	The RAUMEDIC® -PTO-Monitoring-System is indicated foruse by a qualified neurosurgeon fordirect measurement of intracranialpressure and temperature in theparenchyma as well as todetermine the partial oxygenpressure ptiO2 of the interstitialfluid.	The RAUMEDIC® -ICP-TEMP-Monitoring-System is indicated foruse by a qualified neurosurgeon fordirect measurement of intracranialpressure and temperature in theparenchyma and in the ventricleand cerebrospinal fluid drainageapplications.	YES - formeasurementof intracranialpressure andtemperature; foroxygenmeasurementsee SE-List withpredicatedevice:K880380
Anatomical Site	Brain parenchyma	Brain parenchyma / ventricle	YES
CatheterSensors Location	Catheter Tip	Catheter Tip	YES
Tip Diameter	SF	SF	YES
Single-use-	YES	YES
Catheter			YES
SterilizationProcess	With Ethylene Oxide	With Ethylene Oxide	YES
Bolt	Bolt with compression cap	Bolt with compression cap	YES
SpliceableTunnelling Sleeve	Spliceable Tunnelling Sleeve withTrocar	Splicable Tunnelling Sleeve withTrocar	YES
Size Of AccessHole	for Bolt:4.2 mm >> NEUROVENT®-PTO,NEUROVENT®-TO6.3 mm → NEUROVENT®-PTO 2Lfor Tunnelling:> 6 mm → NEUROVENT®-PTO 2L	for Bolt:4.2 mm > NEUROVENT®-P-TEMP.6.3 mm -> NEUROVENT -TEMP-IFD-S,NEUROVENT®-TEMP-IFD-Rfor Tunnelling:≥ 6 mm → NEUROVENT®-TEMP-IFD-S,NEUROVENT®-TEMP-IFD-R	YES
Fixation OfCatheter	Fixation wing (sutured to skin)	Fixation wing (sutured to skin)	YES
Non-fluidCoupling Catheter	YES	YES	YES
ICP - SensorDesign Catheter	Piezoresistive pressure sensor(Semi-conductor / WheatstoneBridge)	Piezoresistive pressure sensor( Semi-conductor / WheatstoneBridge)	YES
ICP - PressureRange	-50 to +250 mmHg	-50 to +250 mmHg	YES
ICP - MaximumPressure	1,250 mmHg	1,250 mmHg	YES
ICP - Accuracy	± 1 mmHg	± 1 mmHg	YES
ICP - Resolution	0.1 mmHg	0.1 mmHg
ICP - Zero PointStability	Less than 1 mmHg during first 24oursLess than 2 mmHg during the first7 days	Less than 1mmHg during first 24hoursLess than 2mmHg during the first 7days	YES
ICP - DynamicResponse Time	< 5 ms	< 5 ms	YES
ICP - SensitivitySystem	5 µV/V/mmHg on the monitor side	5 µV/V/mmHg on the monitor side	YES
Feature	RAUMEDIC® PTO-MONITORING- SYSTEM	RAUMEDIC® ICP-TEMP-MONITORING- SYSTEM(K120252)	SE?
TEMP - SensorDesign	Thermistor	Thermistor	YES
TEMP -TemperatureRange	25 °C - 45 °C	25 °C - 45 °C	YES
TEMP - Accuracy	± 0.1 °C	± 0.1 °C	YES
TEMP -Resolution	0.01 °C	0.01 °C	YES
TEMP - ZeroPoint Stability	± 0.2 °C	± 0.2 °C	YES
TEMP - DynamicResponse Time	< 150 s	< 150 s	YES
TEMP - Adapter	Cable PTO	ICP-TEMP-AdapterICP-TEMP-Adapter HP / Philips	YES
p₁O₂ - SensorDesign Catheter	Fiber Optic / Quenching→ measuring amount of reflectedlight from sensor tip in comparisonto pre-calibrated values withreference solutions (see section"12. Substantial EquivalenceDiscussion")	---	NO- see SE-Listwith predicatedevice:K980380
p₁O₂ - OxygenPressure Range	0 to 150 mmHg	---	NO- see SE-Listwith predicatedevice:K980380
p₁O₂ - Accuracy	± 3 % or ± 2.5 mmHg of themeasured value → the highervalue is applicable for p₁O₂ < 120mmHg:< 10 % of the measured value forp₁O₂ from 120 mmHg to 150 mmHg	---	NO- see SE-Listwith predicatedevice:K980380
p₁O₂ - Resolution	0.1 mmHg	---	NO- see SE-Listwith predicatedevice:K980380
p₁O₂ - Zero PointStability	max. 1.5 mmHg in 5 days(at a ptiO2 of ≤ 10 mmHg)	---	NO- see SE-Listwith predicatedevice:K980380
p₁O₂ - DynamicResponse Time	< 200 s for p₁O₂-decrease from150 ± 15 mmHg to 0.0 mmHg	---	NO- see SE-Listwith predicatedevice:K980380
p₁O₂ - Adapter	Cable LWL	---	NO- see SE-Listwith predicatedevice:K980380
Product Code	GWM	GWM	YES
Registration #	Pending	K120252	N/A
Applicant	RAUMEDIC AGHermann-Staudinger-Str. 295233 Helmbrechts	RAUMEDIC AGHermann-Staudinger-Str. 295233 Helmbrechts	N/A

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Lifeline to Health -

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

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

Feature	RAUMEDIC® PTO-MONITORING- SYSTEM	DIAMETRIC MEDICAL LTD.NEUROTRENDMULTIPARAMETER SENSOR(K980380)	SE?
Trade Name	NEUROVENT®-PTO,NEUROVENT®-PTO 2L,NEUROVENT®-TO	Neurotrend™ MultiparameterSensor(C7004S)	N/A
Indication ForUse	The RAUMEDIC® -PTO-Monitoring-System is indicated for use by aqualified neurosurgeon for directmeasurement of intracranialpressure and temperature in theparenchyma as well as to determinethe partial oxygen pressure ptiO2 ofthe interstitial fluid.	The Neurotrend MultiparameterSensor is a disposable, sterile,single-use, device for thecontinuous measurement ofintracranial oxygen, carbondioxide, pH and temperature thatis used in conjunction with asuitable intracranial accessdevice.	YES - formeasurementof oxygen; forintracranialpressure andtemperaturemeasurementsee SE-List withpredicatedevice:K120252
Anatomical SiteCatheter	Brain parenchyma	Brain ventricle	NO- see SE-Listwith predicatedevice:K120252
Sensors Location	Catheter Tip	Catheter Tip	YES
Tip Diameter	5 F	2 F	NO- see SE-Listwith predicatedevice:K120252
Single-use-Catheter	YES	YES	YES
SterilizationProcess	With Ethylene Oxide	With Gamma - Radiation	NO- see SE-Listwith predicatedevice:K120252
Bolt	Bolt with compression cap	A suitable intracranial accessdevice	NO- see SE-Listwith predicatedevice:K120252
SpliceableTunnelling Sleeve	Spliceable Tunnelling Sleeve withTrocar	A suitable intracranial accessdevice	NO- see SE-Listwith predicatedevice:K120252
Size Of AccessHole	for BOLT usage:4.2 mm → NEUROVENT®-PTO,NEUROVENT®-TO6.3 mm → NEUROVENT®-PTO 2Lfor Tunnelling Sleeve usage:≥ 6 mm → NEUROVENT®-PTO 2L		NO- see SE-Listwith predicatedevice:K120252
Fixation OfCatheter	Fixation wing (sutured to skin)		YES
Non-fluid	YES	YES	YES
Feature	RAUMEDIC® PTO-MONITORING- SYSTEM	DIAMETRIC MEDICAL LTD.NEUROTRENDMULTIPARAMETER SENSOR(Ka80380)	SE?
ICP - SensorDesign Catheter	Piezoresistive pressure sensor(Semi-conductor / WheatstoneBridge)	---	NO- see SE-Listwith predicatedevice:K120252
ICP - PressureRange	-50 to +250 mmHg	---	NO- see SE-Listwith predicatedevice:K120252
ICP - MaximumPressure	1,250 mmHg	---	NO- see SE-Listwith predicatedevice:K120252
ICP - Accuracy	± 1 mmHg	---	NO- see SE-Listwith predicatedevice:K120252
ICP - Resolution	0.1 mmHg	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	NO- see SE-Listwith predicatedevice:K120252
ICP - Zero PointStability	Less than 1 mmHg during first 24oursLess than 2 mmHg during the first 7days	----	NO- see SE-Listwith predicatedevice:K120252
ICP - DynamicResponse Time	< 5 ms	---	NO- see SE-Listwith predicatedevice:K120252
ICP - SensitivitySystem	5 µV/V/mmHg on the monitor side	-	NO- see SE-Listwith predicatedevice:K120252
TEMP - SensorDesign	Thermistor	Thermocouple	NO- see SE-Listwith predicatedevice:K120252
TEMP -TemperatureRange	25 °C - 45 °C	10 °C - 42 °C	NO- see SE-Listwith predicatedevice:K120252
TEMP - Accuracy	+ 0.1 °C	+0.1 °C	YES
TEMP -Resolution	0.01 °C	0.01 °C	YES
TEMP - ZeroPoint Stability	+ 0.2 °C	+ 0.2 °C	YES
TEMP - DynamicResponse Time	< 150 s	< 150 s	YES
TEMP - Adapter	Cable PTO	PDM Cable	YES
Feature	RAUMEDIC® PTO-MONITORING-SYSTEM	DIAMETRIC MEDICAL LTD.NEUROTRENDMULTIPARAMETER SENSOR(K980380)	SE?
ptO2 - SensorDesign Catheter	Fiber Optic / Quenching→ measuring amount of reflectedlight from sensor tip in comparisonto pre-calibrated values withreference solutions (see section "12.Substantial EquivalenceDiscussion")	Fiber Optic / Quenching→ measuring amount of reflectedlight from sensor tip in comparisonto pre-calibrated values withreference solutions	YES
ptO2 - OxygenPressure Range	0 to 150 mmHg	10 to 430 mmHg	NO; the lowerlimit isdemonstratedbyperformancetesting
ptO2 - Accuracy	± 3 % or ± 2.5 mmHg of themeasured value → the higher valueis applicable for ptO2 < 120 mmHg;< 10 % of the measured value forptO2 from 120 mmHg to 150 mmHg	± 3 % or ± 2.5 mmHg of themeasured value → the highervalue is applicable for ptO2 < 120mmHg:< 10 % of the measured value forptO2 from 120 mmHg to 200mmHg	YES
ptO2 - Resolution	0.1 mmHg	0.1 mmHg	YES
ptO2 - Zero PointStability	max. 1.5 mmHg in 5 days(at a ptiO2 of ≤ 10 mmHg)	< 0.5 % per hour	YESwithin thestability rangeof theNEUROTREND
ptO2 - DynamicResponse Time	< 200 s for ptO2-decrease from 150± 15 mmHg to 0.0 mmHg	< 200 s for ptO2-decrease from150±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 AGHermann-Staudinger-Str. 295233 HelmbrechtsGermany	Diametrics Medical, Ltd.Short StreetHigh WycombeBuckinghamshire, UK HP11 2QH	N/A

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Lifeline to Health ----

Device #:_____________________________________________________________________________________________________________________________________________________________________

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Lifeline to Health ----

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

Device #:_

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

Feature	RAUMEDIC® PTO-MONITORING-SYSTEM	RAUMEDIC® ICP-MONITORING-SYSTEM	LICOX Brain OxygenMonitoring System	SE?
Trade Name	EASY logo	NPS3	CMP® Monitor	N/A
Indication for Use	The RAUMEDIC® -PTO-Monitoring-System is indicatedfor use by a qualifiedneurosurgeon fordirect measurementof intracranialpressure andtemperature in theparenchyma as wellto determine thepartial oxygenpressure ptiO2 of theinterstitial fluid.	The RAUMEDIC® -ICP-Monitoring-System is indicatedfor use by a qualifiedneurosurgeon fordirect measurementof intracranialpressure in theparenchyma.	The LICOX BrainOxygen PressureMonitoring Systemdirectly measuresPartial Pressure ofOxygen in the brain.The LICOX system canalso utilize braintemperature informationfor temperaturecompensation of thepO2.	YES
ICP Measurement	YES	YES	NO	YES
TemperatureMeasurement	YES	NO	YES	YES
pO2Measurement	YES	NO	YES	YES
Pressure Range	-40 to +100 mmHg	-40 to +100 mmHg	---	YES
TemperatureRange	15 °C - 45 °C	---	0°C - 46 °C	NO; limits aredemonstratedbyperformancetesting inaccordance toASTM E1112
pO2 Range	0 to 150 mmHg	---	0 to 150 mmHg	YES; limits aredemonstratedbyperformancetesting
Screen	YES	YES	YES	YES
Monitoring	Continuous	Continuous	Continuous	YES
Power Source	A/C wall outlet	D/C battery	A/C wall outlet	YES
Data Output	Analog / Serial	---	Analog / Serial	YES
Calibration	Auto Zero	Auto Zero	Auto Zero	YES
Alarms	Technical Alarms	Technical Alarms	Technical Alarms	YES
Case Material	Plastic	Plastic	Plastic	YES
Product Code	GWM	GWM	GWM	YES
Registration #	Pending	K103206	K002765	N/A
Applicant	RAUMEDIC AGHermann-Staudinger-Str. 295233 HelmbrechtsGermany	RAUMEDIC AGHermann-Staudinger-Str. 295233 HelmbrechtsGermany	Integra NeuroSciences5955 Pacific CenterBlvd.San Diego, CA 92121USA	N/A

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Image /page/9/Picture/0 description: The image shows the Raumedic logo. 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. The logo appears to be for a healthcare or medical-related company.

8. Device Testing

The Biocompatibility studies for the material/components of the medical devices NEUROVENT® PTO, NEUROVENT®-TO, NEUROVENT®-PTO 2L, BOLT KIT PTO and the BOLT KIT PTO 2L were conducted per ISO 10993 standard.

In the toxicological evaluation reports in accordance to ISO 10993/1 for the tested devices NEUROVENT®-PTO (100801-40-B rev 01), BOLT KIT PTO (101164-40-A rev 01) and BOLT KIT PTO 2L (122471-40) it is stated, that the available test results, because of testing the EQ-sterilized devices for cytotoxicity according to ISO 10993/5 and performing additional chemical analysis in accordance to ISO 10993/18, reveal no toxicologically relevant information, considering biological effects like cytotoxicity, tissue irritation (implant reactions), sensitization, systemic, subchronic toxicity and genotoxicity based on the intended use of the devices, that would affect the biological safety of the patient. For test matrix see table below.

The additional component of the BOLT KIT PTO 2L mandrel was also tested for cytotoxicity in accordance to ISO 10993/5. The test report 112078-20 indicate that the mandrels do not release substances in cytotoxic concentration during a permanent 24 h contact of 4.5 cm² surface area to 1 ml physiological fluid.

For all tests the material insolubilities are in compliance with the requirements of ISO 10993/1 for the intended use. There is no evidence that any effects hazardous to the patient will arise by leachable ingredients and/or residues.

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Table 4: Toxicological tests performed on the devices
-------------------------------------------------------	--	--

Material	Test	Comments	Result
NEUROVENT-PTO	Cytotoxicity	4.5 cm2/ml DMEM-FBS, 24 h, 37 °C	Moderately cytotoxic
	ISO 10993-5	L 929 cell cultures, quantitative	(the moderately
		determination of cell proliferation	cytotoxic effects
			observed are within the
			typical value range
			obtained with aliphatic
			polyurethanes)
	Chemical analysis	3 cm²/ml ethanol/water (1:20), 24 h, 37	32.3 µg/cm²/24 h
	150 10993-18	°C, GC-FID/GC-MS. quantitative and	(cyclohexanone)
		qualitative determination of organic	(Cyclohexanone is
		leachables	widely used as solvent,
			bonding and processing
			agent for medicaldevices. The
			toxicological profile is
			defined. It has not been
			classified by EU as
			carcinogenic, mutagenic
			or reprotoxic. As well,
			there is no indication of
			sensitizing, irritating
			and/or other toxic
			properties during
			application of device)
		3 cm²/ml isopropanol,	characterized (mainly
		24 h, 37 °C, GC-MS characterization of	cyclohexanone)
		organic extractables4.5 cm2/ml DMEM-FBS, 24 h, 37 °C
Intracranial screw(milled) with fixing	CytotoxicityISO 10993-5	L 929 cell cultures, quantitative	n.n.
cap and silicone		determination of cell proliferation
seal of BOLT KIT
	Chemical analysis	3 cm²/ml ethanol/water (1:20), 24 h, 37	n.u.
	ISO 10993-18	°C, GC-FID/GC-MS. quantitative and	(< 0.3 µg/cm²/24 h)
		qualitative determination of organic
		leachables
		3 cm²/ml isopropanol,	characterized
		24 h, 37 °C, GC-MS characterization of	(silicone residues of the
		organic extractables	seal)
Intracranial screw	Cytotoxicity	4.5 cm2/ml DMEM-FBS, 24 h, 37 °C	n.n.
(injection mouled)of BOLT KIT	ISO 10993-5	L 929 cell cultures, quantitativedetermination of cell proliferation
	Chemical analysis	3 cm2/ml ethanol/water (1:20), 24 h, 37	n.n.
	ISO 10993-18	°C, GC-FID/GC-MS. quantitative and	(< 0.3 µg/cm²/24 h)
		qualitative determination of organic
		leachables
		3 cm2/ml isopropanol,	n.n.
		24 h, 37 °C, GC-MS characterization of
		organic extractables
BOLT KIT PTO 2L	Cytotoxicity	4.5 cm2/ml DMEM-FBS, 24 h, 37 °C	n.n.
Patient-contacting	ISO 10993-5	L 929 cell cultures, quantitative
surfaces EO		determination of cell proliferation
sterilizedBOLT KIT PTO 2L*	Chemical analysis	3 cm2/ml ethanol/water (1:20), 24 h, 37
Patient-contacting	ISO 10993-18	°C, GC-FID/GC-MS. quantitative and	ப.ப.(3 µg/cm²/24 h)
sufaces		qualitative determination of organic
		leachables
		3 cm²/ml isopropanol,	characterized (mainly
		24 h, 37 °C, GC-MS characterization of	adhesive residues
		organic extractables

the inner surfaces of BOLT CH9 were coextracted for technical reasons

n.n. no toxicologically relevant effects observed in comparison to the controls

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In addition, Performance testing in accordance to the following standard ANSI/AAMI NS 28:1988/(R) 2006 was performed on the RAUMEDIC® ICP-Monitoring-System (K103206). Table 5 provides the testing performed to evaluate the ICP-Monitoring System.

Since the catheter NEUROVENT®-PTO or NEUROVENT®-PTO 2L is equal in dimension, made from the same materials and used the same ICP measurement properties to the tested catheters, the results of performance testing for the ICP-Monitoring System can be transferred to the NEUROVENT®-PTO or NEUROVENT®-PTO 2L.

PerformanceTestingANSI/AAMI NS28:1988/(R) 2006	Test conditions;requirements	Results	MeetStandard?
Frequencyresponse	Point 1.2. PB_27.11.09;> 100 Hz	167 Hz	yes
Slew rates	Point 1.2. PB_27.11.09;> 7,500 torr/s	10.000 torr/s	yes
Time constants	Point 3.2. PB_27.11.09;< 5 ms	3 ms	yes
Pressure range	Point 4.1. PB_27.11.09;Min 0 to +100 mmHg	-50 to + 250 mmHg	yes
Accuracy	Point 5.2. PB_27.11.09;-50 to +250 mmHg (catheter alone)	< maximum deviation point3.2.2_NS 28	yes
	-40 to + 100 mmHg in combinationwith NPS-3 display device	< maximum deviation point3.2.2_NS 28	yes
Stability ofpressuremeasurements	Point 6.2. PB_27.11.09;Acc. to guidelines 4.1.2.1 (8),temperature 20 ± 1°C (68 ± 2°F) and39 ± 1 °C (102 ± 2°F)dPx < 1.52 torr	≤ 1.44 torr	yes
Specific zero-point testing	Point 7.2. PB_27.11.09;drift ona 24-hour basis, < 1 torr; drift andon a 168-hour basis, < 1.5 torr	≤ 0.7 torrand≤ 1.2 torr	yes
Accuracy at 10,20, 50 and 100torr	Point 8.2. PB_27.11.09;After least 10 days on10 torr: < 1.5 torr,	≤ 0.9 torr	yes
	20 torr. < 1,5 torr	≤ 1.2 torr	yes
	50 torr: < 1.5 torrand100 torr: < 1.5 torr	≤ 1.1 torrand≤ 1.2 torr	yes
Risk current	Point 9.2. PB_27.11.09;< 10 µA at 120 V AC	< 0.98 µA at 120 V AC	yes
Maximumtemperature	Point 10.2. PB_27.11.09;No temperature increase> 40 °C (104 °F)	max. 39.5 °C	yes

Table 5: ICP Performance testing-bench

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Performance testing in accordance to the following standard ASTM E1112-00 (2006) was
performed on the RAUMEDIC® PTO-Monitoring-System. Table 6 provides the testing performed to evaluate the PTO-Monitoring System.

Table 6: Temperature Performance testing-bench

PerformanceTestingASTM E1112-00(2006)	Test conditions;requirements	Results	MeetStandard?
Cleaning	Point 5.2 PB_08.12.11No visible of technical changes	No visible of technical changes	yes
Toxicity	Point 5.3 PB_08.12.11Toxicity Test	Toxicity Test	yes
Accuracy	Point 5.4 PB_08.12.11No difference between the in vivo andin vitro accuracy	No difference between the in vivo and in vitro accuracy	yes
OperatingEnvironment	Point 5.5 PB_08.12.1140 °C, 15 % RH< Max. Error Temp. Rang. Table 1ASTM E111240 °C, 80 % RH< Max. Error Temp. Rang. Table 1ASTM E111216 °C, 40 % RH< Max. Error Temp. Rang. Table 1ASTM E111216 °C, 95 % RH< Max. Error Temp. Rang. Table 1ASTM E1112	< Max. Error Temp.Rang.< Max. Error Temp.Rang.< Max. Error Temp.Rang.< Max. Error Temp.Rang.	yesyesyesyes
Storage	Point 5.5.2 PB_08.12.11above Test point o.k.after storage period of one month on-20 °C, RH not applicableandafter storage period of one month on50 °C, 15% RHandafter storage period of one month on35 °C, 95 % RH	o.k.	yes

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Image /page/13/Picture/0 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" with a line on either side.

Internal Performance testing was performed on the RAUMEDIC® PTO-Monitoring-System. Table 7 provides the testing performed to evaluate the PTO-Monitoring System.

Table 7: Oxygen Performance testing-bench

PerformanceTesting	Test conditions;requirements	Results	DIAMETRICMEDICALLTD.NEUROTRENDMULTIPARAMETERSENSOR(K980380)	SE?
Drift over 5.5 days	on 2.5 % oxygen saturation< 1.5 mmHgon 10 % oxygen	≤ 1.2 mmHg	< 11.9 mmHg	yes
	saturation< 1.5 mmHg		< 46.2 mmHg	yes
Absolutemeasurementaccuracy of the ptiO2Range 0....120mmHg	0+/- 2.5 mmHg	≤ 0.2 mmHg	0+/- 3.0 mmHg	yes
Absolutemeasurementaccuracy of the ptiO2Range>120 mmHg	150.00+/-15 mmHg	146.9 mmHg152.3 mmHg	135.0 mmHg165.0 mmHg	yes
Response time T90	< 200 s for change150+/-15 mmHg to0,0 mmHg	≤ 51 s	≤ 55 s	yes
ptiO2 sensitivesurface	> 13 mm²	≥ 15.1 mm²	≥ 5 mm²	yes> 5mm²is o.k. in brain
Length of the ptiO2sensitive area	> 4mm	> 4.9 mm	> 4 mm	yes
Outer catheterdiameter	< 1.35 mm	≤ 0.99 mm	≤ 0.5 mm	yes

The oxygen function of NEUROVENT® -PTO is comparable to DIAMETRIC MEDICAL LTD.NEUROTREND MULTIPARAMETER SENSOR (which is cleared to market under 510(k) (K980380) for the test criteria shown in the table above.

9. Conclusion:

The RAUMEDIC® -PTO-Monitoring-System is equivalent to the predicate devices in that:

The devices have the same intended use and indication for use. ●
. The devices are made of the same materials or substantially equivalent materials.
The devices have equivalent form, function, procedures and features. .
The devices demonstrate equivalent performance. .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 25, 2013

Raumedic AG c/o TUV SUD America Mr. Alexander Schapovalov 1775 Old Hwy 8 NW Suite #104 New Brighton, MN 55112

Rc: K130529

Trade/Device Name: Raumedic-PTO-Monitoring System Regulation Number: 21 CFR §882.1620 Regulation Name: Intracranial Pressure Monitoring Device Regulatory Class: Class II Product Code: GWM Dated: August 22, 2013 Received: August 26, 2013

Dear Mr. Schapovalov:

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: CDRII does not evaluate information related to contract liability warrantics. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Alexander Schapovalov

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (2) 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joyce M. Whang -S

for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): _ K130529

Device Name: RAUMEDIC® -PTO-Monitoring-System

Indications For Use:

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

Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Joyce M. Whang -S

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).