(238 days)
No
The device description focuses on the physical sensors and user interface for displaying measured physiological parameters (ICP, temperature, oxygen). There is no mention of AI, ML, or any algorithms that would process or interpret the data beyond basic display and alerting. The performance studies also focus on sensor accuracy and compliance with standards, not on algorithmic performance.
No
The device is described as an "adjunct monitor of trends" for intracranial parameters and its values "should not be used as the sole basis for decisions as to diagnosis or therapy." This indicates it's a diagnostic/monitoring device, not a therapeutic one.
Yes
The device measures intracranial pressure, temperature, and oxygen to provide information that indicates the perfusion status of cerebral tissue. This information is intended to be used as an "adjunct monitor of trends" and to provide "data additional" to current clinical practice in cases where hypoxia or ischemia are a concern, which supports the diagnostic process.
No
The device description explicitly lists multiple hardware components including intracranial catheters, a cranial bolt kit, a user interface unit (EASY logO), and various cables.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as measuring physiological parameters (intracranial pressure, temperature, and oxygen) within the body (parenchyma). It is used as an "adjunct monitor of trends in these parameters, indicating the perfusion status of cerebral tissue local to sensor placement." This is a direct measurement of physiological conditions in vivo.
- Device Description: The device consists of intracranial catheters that are implanted in the parenchyma. The sensors are placed directly within the tissue.
- 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. This device does not analyze samples taken from the body; it measures parameters directly within the body.
Therefore, the RAUMEDIC® - PTO-Monitoring-System is an in vivo monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The RAUMEDIC® - PTO-Monitoring-System measures intracranial pressure, temperature and oxygen and is intended as an adjunct monitor of trends in these parameters, indicating the perfusion status of cerebral tissue local to sensor placement. RAUMEDIC® - PTO-Monitoring-System values are relative within an individual, and should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide data additional to that obtained by current clinical practice, in cases where hypoxia or ischemia is a concem.
Use of the parenchymal intracranial pressure monitoring kit with bolt is indicated for children who are at least one year old.
Product codes
GWM
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Brain parenchyma
Indicated Patient Age Range
children who are at least one year old
Intended User / Care Setting
qualified neurosurgeon
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
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.
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.
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.
Internal Performance testing was performed on the RAUMEDIC® PTO-Monitoring-System. Table 7 provides the testing performed to evaluate the PTO-Monitoring System.
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.
Key Metrics
ICP - Accuracy: ± 1 mmHg
ICP - Resolution: 0.1 mmHg
ICP - Zero Point Stability: Less than 1 mmHg during first 24 hours Less than 2 mmHg during the first 7 days
ICP - Dynamic Response Time: 120 mmHg**: 146.9 mmHg - 152.3 mmHg (requirement 150.00+/-15 mmHg)
Response time T90: ≤ 51 s (requirement
§ 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
Image /page/0/Picture/0 description: The image shows a handwritten string of characters, which appears to be an identifier or code. The string reads 'K1305-29'. The characters are written in a cursive style with varying stroke thicknesses, and the overall impression is that of a quickly jotted down note.
Image /page/0/Picture/1 description: The image shows the logo for RAUMEDIC, a company that provides lifeline to health. The logo consists of a circular symbol on the left, followed by the company name in bold, sans-serif font. Below the name is the tagline "Lifeline to Health" in a smaller, lighter font. The overall design is clean and professional, conveying a sense of reliability and trustworthiness.
RAUMEDIC AG · Postfach 5 01 · D - 95205 Münchberg
Food and Drug Administration Center for Devices and Radiological Health Document Mail Center - W066-0609 10903 New Hampshire Avenue Silver Spring, MD 20993-0002
Regulatory Affairs
Telefon: (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
1
Image /page/1/Picture/0 description: The image shows the logo for RAUMEDIC. The logo consists of a circular graphic on the left and the word "RAUMEDIC" in bold, sans-serif font on the right. Below the word "RAUMEDIC" is the tagline "Lifeline to Health" with a line on either side of the text. The circular graphic appears to be a stylized representation of a globe or sphere.
4. Name of the device
The RAUMEDIC® -PTO-Monitoring-System is composed of the following components:
- NEUROVENT -PTO .
- NEUROVENT®-TO .
- NEUROVENT®-PTO 2L .
- EASY logO .
- BOLT KIT PTO .
- BOLT KIT PTO 2L .
- Cable LWL .
- Cable PTO .
- Cable DATALOGGER GE/MARQUETTE .
- Cable DATALOGGER Philips/HP .
- Cable DATALOGGER Siemens/Dräger Infinity .
- Cable DATALOGGER Datex-Ohmeda .
- Cable DATALOGGER Hellige .
- Cable DATALOGGER SpaceLabs �
- Cable DATALOGGER Nihon Kohden .
Device Classification Name:
Classification Panel: CFR Section: Device Class: Product Code:
Device, Monitoring, Intracranial Pressure, Temperature and Oxygen Neurology 21 CFR §882.1620 Class II GWM
5. Device Description
The RAUMEDIC® -PTO-Monitoring-System determines the level and change in intracranial pressure (ICP) by using semi-conductor pressure sensors, in temperature using thermistors, and in partial oxygen pressure ptiO2 using a luminescence optical sensor fibre.
The PTO-Monitoring-System consists of intracranial catheters, a cranial bolt kit, the user interface unit (EASY logO), cables to connect the catheters to the EASY logO and cables for the EASY logO to send the measurements to specific patient monitoring units.
Three intracranial catheters are provided: NEUROVENT®-PTO, NEUROVENT® TO and NEUROVENT® PTO 2L. The NEUROVENT®-PTO measures three physiological parameters - ICP, temperature and partial oxygen pressure. The application has to be made with a single lumen Bolt (BOLT-KIT PTO). The NEUROVENT -PTO 2L also measures these three parameters, but has to be placed with a multi lumen Bolt (BOLT KIT PTO 2L) or via tunneling process. The NEUROVENT® TO measures two physiological parameters – temperature and partial oxygen pressure. The application has to be made with a single lumen Bolt (BOLT-KIT PTO).
The NEUROVENT®-PTO or the NEUROVENT®-TO is implanted in the parenchyma using a BOLT KIT PTO. The NEUROVENT®-PTO 2L is implanted in the parenchyma using a BOLT KIT PTO 2L or using a RAUMEDIC® spliceable tunnelling sleeve CH8 (already cleared for market under 510(k) K112017).
Device #:
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For connecting the catheters to the EASY logO two cables – cable PTO and cable LWL - are needed. The cable PTO transfers the electrical signal for ICP and temperature. The cable LWL transfers the optical signal for oxygen pressure.
The EASY logO is the user interface that displays the measurements and alerts the user to the status of the intracranial catheters. The EASY logO displays: oxygen partial pressure pO2, intracranial pressure ICP, pulse amplitude ICPA and temperature T. ICP is a pulsatile signal that consists of the ICP average value and a pulsatile ICPA component, which is superimposed over the ICP average value.
DATALOGGER cables allows the EASY logO to send the measurements to specific patient monitoring units.
6. Indications of Use
The RAUMEDIC® - PTO-Monitoring-System measures intracranial pressure, temperature and oxygen and is intended as an adjunct monitor of trends in these parameters, indicating the perfusion status of cerebral tissue local to sensor placement. RAUMEDIC® - PTO-Monitoring-System values are relative within an individual, and should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide data additional to that obtained by current clinical practice, in cases where hypoxia or ischemia is a concern.
Use of the parenchymal intracranial pressure monitoring kit with bolt is indicated for children who are at least one year old.
7. Substantial Equivalence Summary
The RAUMEDIC® - PTO-Monitoring-System is substantially equivalent to the DIAMETRIC MEDICAL LTD. NEUROTREND MULTIPARAMETER SENSOR which was cleared for market under 510(k) K980380 on 14" of July 1999, the LICOX Brain Oxygen Monitoring System which was cleared for market under 510(k) K002765 on 24th of November 2000, the RAUMEDIC® ICP-TEMP- MONITORING-SYSTEM which was cleared for market under 510(k) K120252 on 110 of April 2012 and the RAUMEDIC® ICP-MONITORING-SYSTEM which was cleared for market under 510(k) K103206 on 04* of March 2011.
For further information see device comparison tables below.
3
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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 For
Use | The RAUMEDIC® -PTO-
Monitoring-System 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 RAUMEDIC® -ICP-TEMP-
Monitoring-System is indicated for
use by a qualified neurosurgeon for
direct measurement of intracranial
pressure and temperature in the
parenchyma and in the ventricle
and cerebrospinal fluid drainage
applications. | YES - for
measurement
of intracranial
pressure and
temperature; for
oxygen
measurement
see SE-List with
predicate
device:
K880380 |
| Anatomical Site | Brain parenchyma | Brain parenchyma / ventricle | YES |
| Catheter
Sensors Location | Catheter Tip | Catheter Tip | YES |
| Tip Diameter | SF | SF | YES |
| Single-use- | YES | YES | |
| Catheter | | | YES |
| Sterilization
Process | With Ethylene Oxide | With Ethylene Oxide | YES |
| Bolt | Bolt with compression cap | Bolt with compression cap | YES |
| Spliceable
Tunnelling Sleeve | Spliceable Tunnelling Sleeve with
Trocar | Splicable Tunnelling Sleeve with
Trocar | YES |
| Size Of Access
Hole | for Bolt:
4.2 mm >> NEUROVENT®-PTO,
NEUROVENT®-TO
6.3 mm → NEUROVENT®-PTO 2L
for Tunnelling:
6 mm → NEUROVENT®-PTO 2L | for Bolt:
4.2 mm > NEUROVENT®-P-
TEMP.
6.3 mm -> NEUROVENT -TEMP-
IFD-S,
NEUROVENT®-TEMP-
IFD-R
for Tunnelling:
≥ 6 mm → NEUROVENT®-TEMP-
IFD-S,
NEUROVENT®-TEMP-
IFD-R | YES |
| Fixation Of
Catheter | Fixation wing (sutured to skin) | Fixation wing (sutured to skin) | YES |
| Non-fluid
Coupling Catheter | YES | YES | YES |
| ICP - Sensor
Design Catheter | Piezoresistive pressure sensor
(Semi-conductor / Wheatstone
Bridge) | Piezoresistive pressure sensor
( Semi-conductor / Wheatstone
Bridge) | YES |
| ICP - Pressure
Range | -50 to +250 mmHg | -50 to +250 mmHg | YES |
| ICP - Maximum
Pressure | 1,250 mmHg | 1,250 mmHg | YES |
| ICP - Accuracy | ± 1 mmHg | ± 1 mmHg | YES |
| ICP - Resolution | 0.1 mmHg | 0.1 mmHg | |
| ICP - Zero Point
Stability | Less than 1 mmHg during first 24
ours
Less than 2 mmHg during the first
7 days | Less than 1mmHg during first 24
hours
Less than 2mmHg during the first 7
days | YES |
| ICP - Dynamic
Response Time | 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;
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
| Performance
Testing
ASTM E1112-00
(2006) | Test conditions;
requirements | Results | Meet
Standard? |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Cleaning | Point 5.2 PB_08.12.11
No visible of technical changes | No visible of technical changes | yes |
| Toxicity | Point 5.3 PB_08.12.11
Toxicity Test | Toxicity Test | yes |
| Accuracy | Point 5.4 PB_08.12.11
No difference between the in vivo and
in vitro accuracy | No difference between the in vivo and in vitro accuracy | yes |
| Operating
Environment | Point 5.5 PB_08.12.11
40 °C, 15 % RH
120 mmHg | 150.00+/-15 mmHg | 146.9 mmHg
152.3 mmHg | 135.0 mmHg
165.0 mmHg | yes |
| Response time T90 | 13 mm² | ≥ 15.1 mm² | ≥ 5 mm² | yes
5mm²
is o.k. in brain |
| Length of the ptiO2
sensitive area | > 4mm | > 4.9 mm | > 4 mm | yes |
| Outer catheter
diameter | 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
15
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
16
Indications for Use
510(k) Number (if known): _ K130529
Device Name: RAUMEDIC® -PTO-Monitoring-System
Indications For Use:
The RAUMEDIC® - PTO-Monitoring-System measures intracranial pressure, temperature and oxygen and is intended as an adjunct monitor of trends in these parameters, indicating the perfusion status of cerebral tissue local to sensor placement. RAUMEDIC® - PTO-Monitoring-System values are relative within an individual, and should not be used as the sole basis for decisions as to diagnosis or therapy. It is intended to provide data additional to that obtained by current clinical practice, in cases where hypoxia or ischemia is a concem.
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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