(31 days)
K120252, K03206
No
The device description focuses on the measurement and display of physiological parameters using catheters and a bedside monitor. There is no mention of AI, ML, image processing, or any algorithms that would suggest the use of such technologies. The performance studies mentioned relate to the safety of a data logger, not the analytical capabilities of the device itself.
No
The device is described as a "diagnostic device" for "measuring, displaying and monitoring of physiological parameters" and has no mention of treating or preventing a disease or condition.
Yes
The "Device Description" explicitly states, "The MPR2 is a diagnostic device..." and further details its function in measuring physiological parameters for diagnosis.
No
The device description explicitly states it is a "small bedside monitor" and mentions hardware components like an internal rechargeable battery, external wall plug transformer, and analog outputs, indicating it is a physical device, not software-only.
Based on the provided information, the RAUMEDIC® MPR2 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- RAUMEDIC® MPR2 Function: The RAUMEDIC® MPR2 measures physiological parameters directly within the human brain (intracranial pressure, temperature, and partial oxygen pressure) using catheters. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states measurement of parameters in the human brain.
- Device Description: The description emphasizes measuring, displaying, and monitoring physiological parameters in the human brain using catheters.
Therefore, the RAUMEDIC® MPR2 is a physiological monitoring device used for direct measurement within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
GWM
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified neurosurgeons or neurointensivists
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K120252, K03206
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
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
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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)
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)
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
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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
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 |
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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
Page 2 of 3
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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 (The
RAUMEDIC® EASY logo is a
component of the RAUMEDIC®-
PTO- Monitoring-System)
K130529 | Integra® Camino® ICP
Monitor
K121573 | SE? |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Trade Name | MPR2 logo | EASY logo | Integra Camino ICP Monitor | N/A |
| Indications for 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. | The RAUMEDIC® EASY logo is
indicated for use by a qualified
neurosurgeon for direct
measurement of intracranial
pressure and temperature in the
parenchyma as well as to determine
the partial oxygen pressure ptiO2 of
the interstitial fluid. | The Integra® Camino® ICP
Monitor is indicated for use by
qualified neurosurgeons or
neurointensivists for
measurement of intracranial
pressure and temperature. | NO - see SE-
discussion 1
below table |
| ICP Measurement | YES | YES | YES | YES |
| Pressure Measurement
Range ICP | -20 to +100 mmHg | -40 to +100 mmHg | -10 to 125 mmHg | NO - see SE-
discussion 2
below table |
| Accuracy of ICP
Measurement | • Accuracy -20 to 20 mmHg:
±1 mmHg for measuring instrument
and ±1 mmHg for catheter
• Accuracy 20
mmHg:
±5% for measuring instrument and
±5% for catheter | • Accuracy -20 to 20 mmHg:
±1 mmHg for measuring instrument
and ±1 mmHg for catheter
• Accuracy 20
mmHg:
±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 |
| Temperature
Measurement | YES | YES | YES | YES |
| Temperature
Measurement Range | 15°C - 45°C | 15°C - 45°C | 15°C - 45°C | YES |
| Accuracy of Temperature
Measurement | 15 ... 25°C: ±0.2 K (plus ±0.2K of
the sensor)
25 ... 45°C: ±0.1 K (plus ±0.1K of
the sensor)
37 ... 39°C: ± 0.05 K (plus ±0.05 K
of the sensor)
39 ... 45°C: ± 0.1 K (plus ±0.1 K of
the sensor) | 15 ... 25°C: ±0.2 K (plus ±0.2K of
the sensor)
25 ... 45°C: ±0.1 K (plus ±0.1K of
the sensor)
37 ... 39°C: ± 0.05 K (plus ±0.05 K
of the sensor)
39 ... 45°C: ± 0.1 K (plus ±0.1 K of
the sensor) | ±0.3 °C | YES |
| Feature | RAUMEDIC® MPR2 logO | RAUMEDIC® EASY logO (The
RAUMEDIC® EASY logo is a
component of the RAUMEDIC®-
PTO- Monitoring-System)
K130529 | Integra® Camino® ICP
Monitor
K121573 | SE? |
|------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|---------------------------------------------|
| ptO2 Measurement | YES | YES | --- | YES |
| ptO2 Measurement
Range | 0 to 150 mmHg | 0 to 150 mmHg | --- | YES |
| Accuracy of ptO2
Measurement | ±3 % of the measured value or
±2.5 mmHg - the higher value is
applicable for the partial oxygen
pressure