MPR2 logO DATALOGGER

K171666 · Raumedic AG · GWM · Jul 6, 2017 · Neurology

Device Facts

• Record ID: K171666
• Device Name: MPR2 logO DATALOGGER
• Applicant: Raumedic AG
• Product Code: GWM · Neurology
• Decision Date: Jul 6, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1620
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

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 Story

Bedside monitor for measuring, displaying, and monitoring intracranial pressure (ICP), brain temperature, and interstitial fluid oxygen partial pressure (ptiO2). Device operates exclusively with RAUMEDIC catheters (single-channel ICP or multi-parameter ICP/pO2/temperature). Inputs are analog signals from catheters; device processes these for display and provides two analog outputs for relaying signals to external bedside monitors. Features include physiological limit value monitoring with alarms, data storage, and digital interface (RS 232, USB 1.1). Used in clinical settings (e.g., neuro-ICU) by neurosurgeons or neurointensivists. Power supplied by internal rechargeable battery or external medically approved wall transformer. Provides real-time physiological data to assist clinicians in monitoring neurological status and making clinical decisions regarding patient care.

Clinical Evidence

Bench testing only. Performance testing confirmed the device is safe for its intended use and complies with FDA and European standards for medical device manufacturing. Performance characteristics (accuracy, range) were compared against predicate devices and found to be equivalent.

Technological Characteristics

Bedside monitor with graphic display and membrane buttons. Sensing via RAUMEDIC catheters (thermistor-based temperature). Power: internal rechargeable battery or external wall transformer. Connectivity: RS 232, USB 1.1, 2 analog outputs. Safety: Defibrillation-proof type CF applied parts, control system with dual watchdog timers. Materials: Plastic housing.

Indications for Use

Indicated for qualified neurosurgeons or neurointensivists to measure intracranial pressure, temperature, and interstitial fluid partial oxygen pressure (ptiO2) in patients requiring such monitoring.

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

• EASY logO (K130529)
• INTEGRA CAMINO ICP MONITOR (K121573)

Submission Summary (Full Text)

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Public Health Service

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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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)

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.

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)

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FORM FDA 3881 (8/14)

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

Direktkontakt: Telefon: [phone]

[e-mail]

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.: [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

August, the 30th 2016

| Device #: | K171666 |
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| Page | 1 of 3 |

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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

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.

### 6. Device Intended Use

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.

### 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

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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.

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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 (The<br>RAUMEDIC® EASY logo is a<br>component of the RAUMEDIC®-<br>PTO- Monitoring-System)<br>K130529 | Integra® Camino® ICP<br>Monitor<br>K121573 | SE? |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Trade Name | MPR2 logo | EASY logo | Integra Camino ICP Monitor | N/A |
| Indications for Use | The RAUMEDIC® MPR2 is<br>indicated for use by qualified<br>neurosurgeons or neurointensivists<br>for measurement of intracranial<br>pressure, temperature as well as to<br>determine the partial oxygen<br>pressure ptiO2 of the interstitial<br>fluid. | The RAUMEDIC® EASY logo is<br>indicated for use by a qualified<br>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 Integra® Camino® ICP<br>Monitor is indicated for use by<br>qualified neurosurgeons or<br>neurointensivists for<br>measurement of intracranial<br>pressure and temperature. | NO - see SE-<br>discussion 1<br>below table |
| ICP Measurement | YES | YES | YES | YES |
| Pressure Measurement<br>Range ICP | -20 to +100 mmHg | -40 to +100 mmHg | -10 to 125 mmHg | NO - see SE-<br>discussion 2<br>below table |
| Accuracy of ICP<br>Measurement | • Accuracy -20 to 20 mmHg:<br>±1 mmHg for measuring instrument<br>and ±1 mmHg for catheter<br><br>• Accuracy <-20 mmHg and >20<br>mmHg:<br>±5% for measuring instrument and<br>±5% for catheter | • Accuracy -20 to 20 mmHg:<br>±1 mmHg for measuring instrument<br>and ±1 mmHg for catheter<br><br>• Accuracy <-20 mmHg and >20<br>mmHg:<br>±5% for measuring instrument and<br>±5% for catheter | • Range -10 to 10 mmHg:<br>±2 mmHg<br>• Range 11 to 33 mmHg:<br>±3 mmHg<br>• Range 34 to 125 mmHg:<br>± (6% + 1 mmHg) | YES |
| Temperature<br>Measurement | YES | YES | YES | YES |
| Temperature<br>Measurement Range | 15°C - 45°C | 15°C - 45°C | 15°C - 45°C | YES |
| Accuracy of Temperature<br>Measurement | 15 ... 25°C: ±0.2 K (plus ±0.2K of<br>the sensor)<br>25 ... 45°C: ±0.1 K (plus ±0.1K of<br>the sensor)<br>37 ... 39°C: ± 0.05 K (plus ±0.05 K<br>of the sensor)<br>39 ... 45°C: ± 0.1 K (plus ±0.1 K of<br>the sensor) | 15 ... 25°C: ±0.2 K (plus ±0.2K of<br>the sensor)<br>25 ... 45°C: ±0.1 K (plus ±0.1K of<br>the sensor)<br>37 ... 39°C: ± 0.05 K (plus ±0.05 K<br>of the sensor)<br>39 ... 45°C: ± 0.1 K (plus ±0.1 K of<br>the sensor) | ±0.3 °C | YES |

| Feature | RAUMEDIC® MPR2 logO | RAUMEDIC® EASY logO (The<br>RAUMEDIC® EASY logo is a<br>component of the RAUMEDIC®-<br>PTO- Monitoring-System)<br>K130529 | Integra® Camino® ICP<br>Monitor<br>K121573 | SE? |
|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|---------------------------------------------|
| ptO2 Measurement | YES | YES | --- | YES |
| ptO2 Measurement<br>Range | 0 to 150 mmHg | 0 to 150 mmHg | --- | YES |
| Accuracy of ptO2<br>Measurement | ±3 % of the measured value or<br>±2.5 mmHg - the higher value is<br>applicable for the partial oxygen<br>pressure < 120 mmHg<br>< 10 % of the measured value for<br>the partial oxygen pressure 120<br>mmHg to 150 mmHg | ±3 % of the measured value or<br>±2.5 mmHg - the higher value is<br>applicable for the partial oxygen<br>pressure < 120 mmHg<br>< 10 % of the measured value for<br>the partial oxygen pressure 120<br>mmHg to 150 mmHg | --- | YES |
| User interface | Multi Parameter Monitor with<br>graphic display, Membrane<br>Buttons | Multi Parameter Monitor with<br>alphanumeric display, Membrane<br>Buttons | Multi Parameter Monitor with<br>graphic 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-<br>discussion 3<br>below table |
| Analog Output to Bedside<br>Monitor | 2 pcs. analog outputs for ICP and<br>ptO2 | 2 pcs. analog outputs for ICP and<br>ptO2 | 2 pcs. analog outputs for ICP<br>and Temperature | YES |
| Digital Interface | RS 232 | RS 232 (intern) | RS 232 | YES |
| Data Extraction (for<br>connection with other<br>devices, such as PC, and<br>further Software) | USB 1.1 | --- | USB 1.1 | YES |
| Calibration of the analog<br>signal inputs | Auto Zero | Auto Zero | Auto Zero | YES |
| Alarms | Technical Alarms and Physiological<br>Alarms for ICP, Temperature and<br>ptO2 | Only Technical Alarms | Technical Alarms and<br>Physiological Alarms for ICP | NO - see SE-<br>discussion 4<br>below table |

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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 (The<br>RAUMEDIC® EASY logO is a<br>component of the RAUMEDIC®-<br>PTO- Monitoring-System) | Integra® Camino® ICP<br>Monitor | SE? |
|----------------------------------------|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|---------------------------------------------|
| Safety Measures<br>(electrical safety) | Defibrillation-proof type CF<br>applied parts | Defibrillation-proof type CF applied<br>parts | Defibrillation-proof type CF<br>applied parts | YES |
| Safety Measures<br>(functional safety) | Control system and 2 watchdog<br>timers | Control system and 2 watch dog<br>timers | unknown | YES |
| Accessories | All cables and catheters listed in<br>chapter 9 of the IFU zwo-459 | All cables and catheters listed in<br>chapter 9 of the IFU zwo-380 | unknown | NO - see SE-<br>discussion 5<br>below table |
| Case Material | Plastic | Plastic | Plastic | YES |
| Product Code | GWM | GWM | GWM | YES |
| Registration # | Pending | K130529 | K121573 | N/A |
| Applicant | RAUMEDIC AG<br>Hermann-Staudinger-Str. 2<br>95233 Helmbrechts<br>Germany | RAUMEDIC AG<br>Hermann-Staudinger-Str. 2<br>95233 Helmbrechts<br>Germany | Integra LifeSciences<br>Corporation<br>311 Enterprise Drive<br>Plainsboro NJ 08536<br>USA | 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.
- 2) 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

- 3) 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
- 4) 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.

- 5) 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.