The RAUMEDIC® MPR2 is indicated for use by qualified neurosurgeons or neurointensivists for measurement of intracranial pressure, temperature as well as to determine the partial oxygen pressure ptiO2 of the interstitial fluid.

Device Description

The MPR2 is a small bedside monitor for measuring, displaying and monitoring of physiological parameters in the human brain which is used only in conjunction with RAUMEDIC ® -catheters. Analog signals can be relayed to a series-connected bedside monitor via its 2 analog outputs. Optionally, the device can be operated in stand-alone mode. The power is supplied by either the internal rechargeable battery or by an external, medically approved wide range wall plug transformer.

The MPR2 is a diagnostic device with physiological limit value monitor for measuring, displaying and monitoring the following physiological parameters: oxygen partial pressure (pO2), intracranial pressure (ICP) and brain temperature (T). These parameters are determined exclusively by connecting RAUMEDIC® catheters for single channel ICP measurement or with RAUMEDIC® multi-parameter catheters for combined measurement of ICP, pO2 and temperature (thermistor-based with YSI400 characteristic) or combinations derived from them such as pO2 and temperature. Optionally the pO2 and ICP signals can be relayed via the 2 analog outputs to a bedside monitor with limit value monitoring.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA regarding the RAUMEDIC® MPR2 logO DATALOGGER. This document is focused on demonstrating substantial equivalence to previously marketed predicate devices, rather than presenting a performance study against a defined set of acceptance criteria for a new AI/Machine Learning device.

Therefore, many of the typical acceptance criteria and study design elements requested for an AI/ML device (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance, etc.) are not present in this type of regulatory submission.

Instead, the document focuses on:

Intended Use/Indications for Use: Comparing the intended use of the new device to predicates.
Technological Characteristics: Comparing features, materials, and form/function.
Performance Testing: Stating that "extensive performance testing" was conducted and results showed the device is "safe for its intended use," but without providing specific test data, methodologies, or acceptance criteria in the format typically used for AI/ML device validation. The performance parameters listed in Table 1 (Accuracy of ICP Measurement, Temperature Measurement, etc.) are characteristics of the device itself and are compared to the predicate devices, serving as a form of "acceptance criteria" for substantial equivalence.

Given this context, I will extract the information that is available and clearly state what information is not present.

Acceptance Criteria and Device Performance (Derived from Substantial Equivalence Comparison)

The acceptance criteria are not explicitly stated as pass/fail thresholds in the traditional sense for a de novo device. Instead, they are implied through the comparison to predicate devices, where the new device's performance characteristics must be "substantially equivalent" or better. The reported device performance is listed alongside the predicate devices.

Table 1: Device Performance Comparison (Acting as Acceptance Criteria Check)

Feature	Acceptance Criteria (Predicate)	Reported Device Performance (MPR2 logO)	Met?
Intended Use	RAUMEDIC® EASY logO: measurement of intracranial pressure, temperature, and ptiO2. Integra® Camino® ICP Monitor: measurement of intracranial pressure and temperature.	The RAUMEDIC® MPR2 is indicated for use by qualified neurosurgeons or neurointensivists for measurement of intracranial pressure, temperature as well as to determine the partial oxygen pressure ptiO2 of the interstitial fluid.	YES (Substantially Equivalent - see SE-Discussion 1)
ICP Measurement	YES (both predicates)	YES	YES
Pressure Measurement Range (ICP)	EASY logO: -40 to +100 mmHg. Integra® Camino®: -10 to 125 mmHg.	-20 to +100 mmHg	YES (Within physiological range & EASY logO's - see SE-Discussion 2)
Accuracy of ICP Measurement	EASY logO: ±1 mmHg (-20 to 20 mmHg), ±5% (<-20 mmHg, >20 mmHg). Integra® Camino®: ±2 mmHg (-10 to 10 mmHg), ±3 mmHg (11 to 33 mmHg), ±(6% + 1 mmHg) (34 to 125 mmHg).	• Accuracy -20 to 20 mmHg: ±1 mmHg for measuring instrument and ±1 mmHg for catheter • Accuracy <-20 mmHg and >20 mmHg: ±5% for measuring instrument and ±5% for catheter	YES (Similar to EASY logO, effectively equivalent to Integra Camino)
Temperature Measurement	YES (both predicates)	YES	YES
Temperature Measurement Range	15°C - 45°C (both predicates)	15°C - 45°C	YES
Accuracy of Temperature Measurement	EASY logO: Detailed range-specific accuracies similar to MPR2. Integra® Camino®: ±0.3 °C.	15 ... 25°C: ±0.2 K (+sensor); 25 ... 45°C: ±0.1 K (+sensor); 37 ... 39°C: ± 0.05 K (+sensor); 39 ... 45°C: ± 0.1 K (+sensor)	YES (Similar to EASY logO, effectively equivalent to Integra Camino)
pO2 Measurement	EASY logO: YES. Integra® Camino®: NO.	YES	YES
pO2 Measurement Range	EASY logO: 0 to 150 mmHg.	0 to 150 mmHg	YES
Accuracy of pO2 Measurement	EASY logO: ±3 % of measured value or ±2.5 mmHg (< 120 mmHg), < 10 % (120 mmHg to 150 mmHg).	±3 % of the measured value or ±2.5 mmHg - the higher value is applicable for the partial oxygen pressure < 120 mmHg < 10 % of the measured value for the partial oxygen pressure 120 mmHg to 150 mmHg	YES
User Interface	EASY logO: alphanumeric display. Integra® Camino®: graphic display, touch screen.	Multi Parameter Monitor with graphic display, Membrane Buttons	YES (Equivalent or better)
Monitoring	Continuous (both predicates)	Continuous	YES
Data Storage	EASY logO: NO. Integra® Camino®: YES.	YES	YES (Equivalent or better)
Power Source	EASY logO: A/C wall outlet. Integra® Camino®: A/C wall outlet or D/C battery.	A/C wall outlet or D/C battery	YES
Battery Operating Time	Integra® Camino®: 1.5 hours.	Min. 4 hours	YES (Better - see SE-Discussion 3)
Analog Output to Bedside Monitor	EASY logO: 2 pcs. for ICP and ptO2. Integra® Camino®: 2 pcs. for ICP and Temperature.	2 pcs. analog outputs for ICP and ptO2	YES
Digital Interface	RS 232 (both predicates)	RS 232	YES
Data Extraction	Integra® Camino®: USB 1.1.	USB 1.1	YES (Equivalent or better)
Calibration	Auto Zero (both predicates)	Auto Zero	YES
Alarms	EASY logO: Technical Alarms only. Integra® Camino®: Technical and Physiological Alarms for ICP.	Technical Alarms and Physiological Alarms for ICP, Temperature and ptO2	YES (Equivalent or better - see SE-Discussion 4)
Safety Measures (electrical)	Defibrillation-proof type CF applied parts (both predicates)	Defibrillation-proof type CF applied parts	YES
Safety Measures (functional)	EASY logO: Control system and 2 watch dog timers. Integra® Camino®: unknown (but assumed to have adequate safety)	Control system and 2 watchdog timers	YES
Accessories	Listed accessories for both predicates.	All cables and catheters listed in chapter 9 of the IFU zwo-459 (includes EASY logO accessories and previously cleared RAUMEDIC accessories).	YES (Substantially Equivalent - see SE-Discussion 5)
Case Material	Plastic (both predicates)	Plastic	YES

Study Details (Information Not Provided/Applicable for this Type of Submission)

This document is a 510(k) submission for a non-AI/ML medical device, focusing on substantial equivalence to predicate devices. As such, the typical detailed study information requested for a novel AI/ML device is not included.

Sample size used for the test set and the data provenance: Not applicable/not provided for this type of device. The performance testing mentioned is likely bench testing or pre-clinical validation, not clinical data for an AI model.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physiological measurements is based on reference methods and calibration, not expert consensus on images.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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, as this is not an AI/ML device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a measurement device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a medical device measuring physiological parameters (ICP, temp, ptiO2), "ground truth" is established through:
- Calibration Standards: Using known physical standards for pressure, temperature, and gas concentration.
- Reference Devices: Comparing measurements to established, highly accurate reference instruments.
- Controlled Bench Testing: Testing device accuracy and performance under controlled laboratory conditions, including simulated physiological ranges.
  The document states "extensive performance testing" was done, and the specific accuracy values in the table are the results of such testing.
The sample size for the training set: Not applicable, as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

Summary

{0}------------------------------------------------

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure in profile, with flowing lines suggesting movement or transformation.

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

July 6, 2017

Raumedic AG % Dawn Tibodeau Third Party 510(k) Project Coordinator TUV SUD America Inc. 1775 Old Highway 8 NW New Brighton, Minnesota 55112-1891

Re: K171666

Trade/Device Name: MPR2 logO DATALOGGER Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial Pressure Monitoring Device Regulatory Class: Class II Product Code: GWM Dated: March 22, 2017 Received: June 5, 2017

Dear Dawn Tibodeau:

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

{1}------------------------------------------------

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.

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

for

Carlos L. Peña. PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Image /page/2/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 "RAUMEDIC" is the tagline "Lifeline to Health" with a line above it. The circular symbol on the left contains a stylized "C" shape and two horizontal lines.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K171666

Device Name MPR2 logO DATALOGGER

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

[ ] Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the Raumedic logo. The logo consists of a blue circle on the left, with a stylized "C" and two horizontal lines inside. To the right of the circle is the word "RAUMEDIC" in bold, black letters. Below the word is the tagline "Lifeline to Health" in a smaller, thinner font.

Image /page/3/Picture/1 description: The image shows the logo for RAUMEDIC. The logo consists of a blue circle with a white swirl and two horizontal lines inside, followed by the word "RAUMEDIC" in black, and the tagline "Lifeline to Health" in a smaller font below the word "RAUMEDIC". The logo is simple and modern, and the colors are calming and professional.

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: (0049 92 52) 359-2782

Reiner.Thiem@RAUMEDIC.com

Ihre Nachricht vom Ihre Zeichen

Sachbearbeiter H Thiem Unsere Zeichen thi

Tag 30th of August 2016

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.: 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

August, the 30th 2016

Device #:	K171666
Page	1 of 3

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the Raumedic logo. The logo consists of a blue circle with a white "C" inside, followed by the word "RAUMEDIC" in black, bold letters. Below the word "RAUMEDIC" is the tagline "Lifeline to Health" in a smaller, black font.

Image /page/4/Picture/1 description: The image is a logo for RAUMEDIC. The logo consists of a blue circle on the left with a white "C" inside and two horizontal lines below it. To the right of the circle is the word "RAUMEDIC" in black, with the tagline "Lifeline to Health" in a smaller font below it.

4. Name of the device

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

MPR2 logO DATALOGGER Neurology 21 CFR §882.1620 Class II GWM

5. Device Description

6. Device Intended Use

7. Substantial Equivalence Summary

The MPR2 logO DATALOGGER is substantially equivalent to those of the legally marketed predicate devices, the EASY logO as part of the RAUMEDIC® -PTO-Monitoring-System which was cleared to market under 510 (k) K130529 on 25th of October 2013 and the INTEGRA CAMINO ICP MONITOR which was cleared to market under 510 (k) K121573 on 10th of September 2012.

Fur further information see device comparison tables attached.

Based on performance testing and the available information concerning the referenced comparison devices, the MPR2 logO DATALOGGER is equivalent 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.
Performance characteristics are suitable for designated indications for use

Device #: ___ K171666

Page 2 of 3

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the Raumedic logo. The logo consists of a blue circle on the left, with a stylized "C" shape inside, along with two horizontal lines. To the right of the circle is the word "RAUMEDIC" in bold, black letters. Below the word is the tagline "Lifeline to Health" in a smaller, thinner font.

Image /page/5/Picture/1 description: The image shows the logo for RAUMEDIC, a company that provides medical devices and solutions. The logo consists of a blue circle with a white stylized "C" inside, followed by the company name in black, bold letters. Below the name is the tagline "Lifeline to Health" in a smaller, thinner font, with a horizontal line on either side.

Based on this, the anticipated clinical performance of the MPR2 logO DATALOGGER is equivalent to the referenced systems.

8. Device Testing

The mentioned MPR2 logO DATALOGGER was subjected to extensive performance testing. Results of the testing showed that the MPR2 logo DATALOGGER is safe for its intended use.

Finally, the manufacturing process of the MPR2 logO DATALOGGER complies with the United States Food and Drug Administration and European Standards for the manufacturing of medical devices.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the Raumedic logo. The logo consists of a blue circle on the left, with a stylized "C" and two horizontal lines inside. To the right of the circle is the word "RAUMEDIC" in bold, black letters. Below the word is the tagline "Lifeline to Health" in a smaller, italicized font.

See attachment 2: Device comparison tables.

Table 1:

Feature	RAUMEDIC® MPR2 logo	RAUMEDIC® EASY logo (TheRAUMEDIC® EASY logo is acomponent of the RAUMEDIC®-PTO- Monitoring-System)K130529	Integra® Camino® ICPMonitorK121573	SE?
Trade Name	MPR2 logo	EASY logo	Integra Camino ICP Monitor	N/A
Indications for Use	The RAUMEDIC® MPR2 isindicated for use by qualifiedneurosurgeons or neurointensivistsfor measurement of intracranialpressure, temperature as well as todetermine the partial oxygenpressure ptiO2 of the interstitialfluid.	The RAUMEDIC® EASY logo isindicated for use by a qualifiedneurosurgeon for directmeasurement of intracranialpressure and temperature in theparenchyma as well as to determinethe partial oxygen pressure ptiO2 ofthe interstitial fluid.	The Integra® Camino® ICPMonitor is indicated for use byqualified neurosurgeons orneurointensivists formeasurement of intracranialpressure and temperature.	NO - see SE-discussion 1below table
ICP Measurement	YES	YES	YES	YES
Pressure MeasurementRange ICP	-20 to +100 mmHg	-40 to +100 mmHg	-10 to 125 mmHg	NO - see SE-discussion 2below table
Accuracy of ICPMeasurement	• Accuracy -20 to 20 mmHg:±1 mmHg for measuring instrumentand ±1 mmHg for catheter• Accuracy <-20 mmHg and >20mmHg:±5% for measuring instrument and±5% for catheter	• Accuracy -20 to 20 mmHg:±1 mmHg for measuring instrumentand ±1 mmHg for catheter• Accuracy <-20 mmHg and >20mmHg:±5% for measuring instrument and±5% for catheter	• Range -10 to 10 mmHg:±2 mmHg• Range 11 to 33 mmHg:±3 mmHg• Range 34 to 125 mmHg:± (6% + 1 mmHg)	YES
TemperatureMeasurement	YES	YES	YES	YES
TemperatureMeasurement Range	15°C - 45°C	15°C - 45°C	15°C - 45°C	YES
Accuracy of TemperatureMeasurement	15 ... 25°C: ±0.2 K (plus ±0.2K ofthe sensor)25 ... 45°C: ±0.1 K (plus ±0.1K ofthe sensor)37 ... 39°C: ± 0.05 K (plus ±0.05 Kof the sensor)39 ... 45°C: ± 0.1 K (plus ±0.1 K ofthe sensor)	15 ... 25°C: ±0.2 K (plus ±0.2K ofthe sensor)25 ... 45°C: ±0.1 K (plus ±0.1K ofthe sensor)37 ... 39°C: ± 0.05 K (plus ±0.05 Kof the sensor)39 ... 45°C: ± 0.1 K (plus ±0.1 K ofthe sensor)	±0.3 °C	YES

Feature	RAUMEDIC® MPR2 logO	RAUMEDIC® EASY logO (TheRAUMEDIC® EASY logo is acomponent of the RAUMEDIC®-PTO- Monitoring-System)K130529	Integra® Camino® ICPMonitorK121573	SE?
ptO2 Measurement	YES	YES	---	YES
ptO2 MeasurementRange	0 to 150 mmHg	0 to 150 mmHg	---	YES
Accuracy of ptO2Measurement	±3 % of the measured value or±2.5 mmHg - the higher value isapplicable for the partial oxygenpressure < 120 mmHg< 10 % of the measured value forthe partial oxygen pressure 120mmHg to 150 mmHg	±3 % of the measured value or±2.5 mmHg - the higher value isapplicable for the partial oxygenpressure < 120 mmHg< 10 % of the measured value forthe partial oxygen pressure 120mmHg to 150 mmHg	---	YES
User interface	Multi Parameter Monitor withgraphic display, MembraneButtons	Multi Parameter Monitor withalphanumeric display, MembraneButtons	Multi Parameter Monitor withgraphic display, Touch screen	YES
Monitoring	Continuous	Continuous	Continuous	YES
Data Storage	YES	NO	YES	YES
Power Source	A/C wall outlet or D/C battery	A/C wall outlet	A/C wall outlet or D/C battery	YES
Battery operating time	Min. 4 hours	---	1.5 hours	NO - see SE-discussion 3below table
Analog Output to BedsideMonitor	2 pcs. analog outputs for ICP andptO2	2 pcs. analog outputs for ICP andptO2	2 pcs. analog outputs for ICPand Temperature	YES
Digital Interface	RS 232	RS 232 (intern)	RS 232	YES
Data Extraction (forconnection with otherdevices, such as PC, andfurther Software)	USB 1.1	---	USB 1.1	YES
Calibration of the analogsignal inputs	Auto Zero	Auto Zero	Auto Zero	YES
Alarms	Technical Alarms and PhysiologicalAlarms for ICP, Temperature andptO2	Only Technical Alarms	Technical Alarms andPhysiological Alarms for ICP	NO - see SE-discussion 4below table

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image contains the logo for RAUMEDIC, a company that provides medical products. The logo consists of a blue circular icon on the left, followed by the company name in bold, black letters. Below the name is the tagline "Lifeline to Health" in a smaller font. The logo is clean and professional, conveying a sense of trust and reliability.

Feature	RAUMEDIC® MPR2 logO	RAUMEDIC® EASY logO (TheRAUMEDIC® EASY logO is acomponent of the RAUMEDIC®-PTO- Monitoring-System)	Integra® Camino® ICPMonitor	SE?
Safety Measures(electrical safety)	Defibrillation-proof type CFapplied parts	Defibrillation-proof type CF appliedparts	Defibrillation-proof type CFapplied parts	YES
Safety Measures(functional safety)	Control system and 2 watchdogtimers	Control system and 2 watch dogtimers	unknown	YES
Accessories	All cables and catheters listed inchapter 9 of the IFU zwo-459	All cables and catheters listed inchapter 9 of the IFU zwo-380	unknown	NO - see SE-discussion 5below table
Case Material	Plastic	Plastic	Plastic	YES
Product Code	GWM	GWM	GWM	YES
Registration #	Pending	K130529	K121573	N/A
Applicant	RAUMEDIC AGHermann-Staudinger-Str. 295233 HelmbrechtsGermany	RAUMEDIC AGHermann-Staudinger-Str. 295233 HelmbrechtsGermany	Integra LifeSciencesCorporation311 Enterprise DrivePlainsboro NJ 08536USA	N/A

SE-Discussion:

1. A) The indications for use of the MPR2 logO and the Interefore substantial equivalent, with the following differences: "as well as to determine the partial oxygen pressure ptio2 of the interstitial fluid": Integra Camino is not able to determine the partial oxygen pressure, therefore a second predicate device (Easy logo) was selected (see below),
- B) The indications for use of the Easy logo are identical and therefore sybstantial equivalent, with the following differences "indicated for use by qualified neurosurgeons or neurointensivists": the indications for use of the Easy logo do not mention neurointensivists. Both devices are to be applied by trained healthcare professionals as defined in the relevant fiUs. This includes both neurosurgeons and neurointensivists. Therefore the two devices are substantial equivalent also in this point.
- ffor measurement of intracranial presure, the indications for use of the Easy logO state "for direct measurement" instead. Further it says "temperature in the parenchyna" the measurements (direst and in the parenchyma) are the same for MPR2 and Easy logo as the applied catheters, which perform the actual measurement, are the same for both devices are substantial equivalent also in these points.
1. The pressure-range of the RAUMEDIC® MPR2 logO covers the physiological intracranial pressure-range measurable in the brain (0 < ICP < 100 mmHg, see literature) and is within the range of the RAUMEDIC® EASY logO.

"3.2 Safety and Performance Requirements Literature 1: 3.2.1 Pressure Range

The minimum pressure range of the ICP monitoring system and of the pressure display module shall be 0 to 100 tor of water ..

ANSI/AAMI NS28:1988/(R)2010 Intracranial pressure monitoring devices AAMI Association for the Advancement of Medical Instrumentation

1. The Battery operating time of both devices are similar. Both devices use a rechargeable battery operating time is greater than 1.5 hours. Both devices are used in a professional health care environment from a standard. The Battery operating must be sufficient for operation of the device twithin the specified operating environment. This requirement is met by the MPR2 logO
1. All 3 devices have an alarm system for technical alarms

Only the MPR2 logO and the Integra Camino ICP montor additionally have physiological alarms of both devices are similar but not identical. The physiological limit values can be set for both devices have the possibility of monitoring the alarm imit value of the ICP for example and therefore both devices are substantial equivalent on the alarm system.

1. All accessories for the EASY logO (exception main power adapter) can be used without limitation as accessories for the MPR2 logO and are therefore listed as accessories for the MPR2 logo (cf. IFU zwo-459 chapter 9. Accessories and IFU zwo-380 chapter 9. In addition, there are the following accessories for the MPR2 logO which are not accessories for the EASY logO:
  094268-002 NEUROVENT-P-TEMP 1) NEUROVENT-TEMP 1) 094278-002 NEUROVENT-TEMP-IFD-S 17 094288-002 neurovent-temp-ifd-r 11 095327-002 094323-001 ICP-TEMP-Adapter: length 0.70 m 1) 094328-001 ICP-TEMP-Cable; length 2.00 m

This accessory has already been tested within 510 (k) –registration K120252 RAUMEDIC® -ICP-TEMP-Monitoring-System.

This accessory has already been tested within 510 (k) –registration K03206 RAUMEDIC® -ICP-Monitoring System.

The accessories for the MPR2 logO are either identical to the EASY logO or they were already accessories of earlier RAUMEDIC 510 (k) registrations and have therefore alreared. Therefore the accessories of the MPR2 logO and the EASY logO are substantial equivalent.

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).