(154 days)
Not Found
No
The description focuses on the hardware and software control of electrical stimulation, impedance measurement, and triggering, with no mention of AI or ML algorithms for data analysis, prediction, or adaptive stimulation.
No.
The device is used for functional brain mapping via electrical stimulation prior to cortical resections, which is a diagnostic or pre-surgical planning function, not a direct treatment.
Yes
The device is intended for "functional brain mapping via electrical stimulation prior to cortical resections in the vicinity of essential cortex," which is a diagnostic purpose to identify functional areas of the brain before surgery. While it delivers stimulation, the primary stated use is for mapping, which is a diagnostic activity.
No
The device description explicitly details hardware components including a stimulator, cables, and switches, in addition to the software.
Based on the provided information, the g.Estim PRO is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "functional brain mapping via electrical stimulation prior to cortical resections." This involves directly stimulating the brain tissue in vivo (within a living organism) to understand its function.
- Device Description: The device is described as a "neural, constant current, monophasic stimulator for electrical stimulation of the brain (cortical stimulator)." This confirms its function is to apply electrical current to the brain.
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens, including blood, urine, and tissue, taken from the human body to provide information for diagnosis, monitoring, or screening. They perform tests outside the body (in vitro).
The g.Estim PRO operates in vivo by directly interacting with the patient's brain tissue through electrical stimulation. It does not analyze specimens taken from the body.
Therefore, it falls under the category of a medical device used for therapeutic or diagnostic purposes in vivo, not an IVD.
N/A
Intended Use / Indications for Use
The g.Estim PRO is intended for functional brain mapping via electrical stimulation prior to cortical resections in the vicinity of essential cortex. The device must be used by trained and qualified personnel within a medical environment.
Product codes (comma separated list FDA assigned to the subject device)
GYC
Device Description
The g.Estim PRO is a neural, constant current, monophasic stimulator for electrical stimulation of the brain (cortical stimulator). The device is battery supplied and can be controlled via USB from a computer. It can be trigged via software or with external devices and can provide beside the stimulation pulse also trigger signals for other devices.
The system consists of the stimulator, a USB connector cable to connect the device to a host computer, trigger out cables and trigger in cables, the driver and software package (including a graphical user interface and communication interface). Additionally the device can be triggered with a hand switch and/or foot switch.
The stimulator can be programmed and is a constant-current stimulator that can deliver electrical pulses with alternating polarities, lengths, amplitudes or trains of such pulses. The device is connected via USB to a computer and on the computer stimulator settings can be performed. On the computer a graphical user interface allows to perform all settings required for the stimulator. The stimulator is battery powered and has an optical isolation from the computer for safety reasons. A LED shows the stimulus time point.
The stimulator allows to send trigger pulses to external devices to synchronize the stimulus e.g. with EEG data acquisition devices. Such a trigger pulse can be programmed to occur prior to the stimulus so that e.g. a switching unit can switch before the stimulus occurs and can last longer than the electrical pulse to switch back after the pulse. Furthermore the triggers can be perfectly aligned with the stimulus so that an accurate trigger signal can be sent to the external device. The trigger lines are TTL compatible. Two trigger lines are supported.
The stimulus can be triggered via the software running on the computer or via external inputs to the stimulator. Important is that the stimulus is triggered very accurately for perfect synchronization. A foot switch or hand switch can be used to trigger the stimulator. The trigger input is TTL compatible. One trigger line is supported.
The device can perform an impedance measurement to check the electrodes impedance before the stimulation is done and can measure the actual stimulation current when a stimulation is done. The results are shown in the graphical user interface and can be passed also to other applications via an interface. The impedance measurement is done quickly so that the stimulation can rapidly be performed. If a high impedance is detected the stimulator does not stimulate.
g. Estim PRO works in the same manner as the approved and predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain (cortical)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medically trained and qualified personnel within a medical environment.
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 stimulator was tested with a data acquisition device and provides rectangular stimulation pulses with the necessary frequency and amplitude range. Furthermore digital outputs were tested to provide trigger signals and digital inputs were tested to trigger the stimulation. The impedance measurement was tested with test impedances. The tests show that the stimulator works like the predicate device.
In g.Estim PRO medical safety is realized by isolating the applied part optically for data transmission via USB and by battery supply. The current for the impedance measurement is limited with resistors.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.1310 Cortical electrode.
(a)
Identification. A cortical electrode is an electrode which is temporarily placed on the surface of the brain for stimulating the brain or recording the brain's electrical activity.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 4, 2018
g.tec medical engineering GmbH % Olaf Teichert Responsible Third Party Official TUV SUD America Inc. 1775 Old Highway 8 NW New Brighton, Minnesota 55112-1891
Re: K173684
Trade/Device Name: g.Estim PRO Regulation Number: 21 CFR 882.1310 Regulation Name: Cortical electrode Regulatory Class: Class II Product Code: GYC Dated: April 20, 2018 Received: April 25, 2018
Dear Olaf Teichert:
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 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 forth in the quality systems (QS) regulation (21 CFR Part 820);
1
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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
Indications for Use
510(k) Number (if known) K173684
Device Name g.Estim PRO
Indications for Use (Describe)
The g.Estim PRO is intended for functional brain mapping via electrical stimulation prior to cortical resections in the vicinity of essential cortex. The device must be used by trained and qualified personnel within a medical environment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|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."
3
g.tec medical engineering GmbH
510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a).
807.92(a)(1)
Submitter Information
| g.tec medical engineering GmbH
Sierningstrasse 14
4521 Schiedlberg
| Austria | ||
|---|---|---|
| Phone: | ++43 (7251) 22240-12 | |
| Fax: | ++43 (7251) 22240-39 | |
| Contact Person: | Christoph Guger | |
| Date: | 14th November 2016 | |
| 807.92(a)(2) | ||
| Trade Name: | g.Estim PRO | |
| Common Name: | Cortical Stimulator | |
| Classification Names(s): | Cortical Electrode | |
| (per 21 CFR section 21 CFR 882.1310) | ||
| Product Code: | GYC | |
| 807.92(a)(3) | ||
| Predicate Device(s) | ||
| Chatten Associates | S12X | K082629 |
g.tec medical engineering GmbH, Sierningstrasse 14, 4521 Schiedlberg, Austria, Europe,
4
807.92(a)(4)
Device Description
The g.Estim PRO is a neural, constant current, monophasic stimulator for electrical stimulation of the brain (cortical stimulator). The device is battery supplied and can be controlled via USB from a computer. It can be trigged via software or with external devices and can provide beside the stimulation pulse also trigger signals for other devices.
The system consists of the stimulator, a USB connector cable to connect the device to a host computer, trigger out cables and trigger in cables, the driver and software package (including a graphical user interface and communication interface). Additionally the device can be triggered with a hand switch and/or foot switch.
The stimulator can be programmed and is a constant-current stimulator that can deliver electrical pulses with alternating polarities, lengths, amplitudes or trains of such pulses. The device is connected via USB to a computer and on the computer stimulator settings can be performed. On the computer a graphical user interface allows to perform all settings required for the stimulator. The stimulator is battery powered and has an optical isolation from the computer for safety reasons. A LED shows the stimulus time point.
The stimulator allows to send trigger pulses to external devices to synchronize the stimulus e.g. with EEG data acquisition devices. Such a trigger pulse can be programmed to occur prior to the stimulus so that e.g. a switching unit can switch before the stimulus occurs and can last longer than the electrical pulse to switch back after the pulse. Furthermore the triggers can be perfectly aligned with the stimulus so that an accurate trigger signal can be sent to the external device. The trigger lines are TTL compatible. Two trigger lines are supported.
The stimulus can be triggered via the software running on the computer or via external inputs to the stimulator. Important is that the stimulus is triggered very accurately for perfect synchronization. A foot switch or hand switch can be used to trigger the stimulator. The trigger input is TTL compatible. One trigger line is supported.
The device can perform an impedance measurement to check the electrodes impedance before the stimulation is done and can measure the actual stimulation current when a stimulation is done. The results are shown in the graphical user interface and can be passed also to other applications via an interface. The impedance measurement is done quickly so that the stimulation can rapidly be performed. If a high impedance is detected the stimulator does not stimulate.
g. Estim PRO works in the same manner as the approved and predicate device.
5
g.tec medical engineering GmbH
807.92(1)(5)
Intended Use(s)
The g.Estim PRO is intended for functional brain mapping via electrical stimulation prior to cortical resections in the vicinity of essential cortex. The device must be used by medically trained and qualified personnel within a medical environment.
g.tec medical engineering GmbH, Sierningstrasse 14, 4521 SchiedIberg, Austria, Europe, Tel.: +43 7251 22240, Fax: +43 7251 22240-39, office@gtec.at, www.gtec.at
6
g.tec medical engineering GmbH
807.92(a)(6)
| | Item | Chatten Associates
S12X
K082629 | g.tec medical
engineering GmbH
g.Estim PRO
This Submission | Comments |
|-----|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Intended use | The S12X Cortical
stimulator is intended for
Intraoperative cortical
stimulation mapping to aid
in cortical resections in the
vicinity of essential
cortex.
The ESAx option is
intended for use with the
S1 2X for facilitating the
switching of the patient
electrodes. | The g.Estim PRO is intended
for functional brain mapping
via electrical stimulation prior
to cortical resections in the
vicinity of essential cortex. | Reduced intended
used, no switching
unit option realized,
but equivalent in
safety and
effectiveness |
| 2. | User | The device is intended for
use only by medically
trained and qualified
personnel, with a hospital
or medical environment. | The device must be used by
medically trained and qualified
personnel within a medical
environment. | Same as predicate |
| 3. | Constant type | Constant current bi-
phasic, rectangular | Constant current, bi-phasic,
rectangular | Same as predicate |
| 4. | Maximum stimulation charge | 20 μC | 15 μC | Lower limit for
additional safety but
equivalent in
effectiveness. |
| 5. | Pulse polarity | Selectable, positive,
negative or alternating
stimulus polarity on
successive pulses | Selectable, positive, negative
or alternating stimulus polarity
on successive pulses | Same as predicate |
| 6. | Train duration | 0.2 to 20 sec in 7 steps | 0.1 to 20 sec. | Shorter minimum
train duration but
equivalent in safety
and effectiveness. |
| 7. | Pulse amplitude | 0.2 - 15 mA (peak),
constant current, 17 steps | 0.05 - 15 mA (peak), constant
current, 0.01 mA increments | Allows lower start
value, lower
increments, but
equivalent in safety
and effectiveness. |
| 8. | Stimulation frequency | 2 - 100 Hz in 7 steps | 2-100 Hz, 0,1 Hz steps | Same frequency
range and smaller
increments for more
flexibility, but
equivalent in safety
and effectiveness. |
| 9. | Stimulation pulse duration | 0.1 - 1.0 ms per phase (15
mA max); up to 2 ms per
phase (10 mA max) | 0.1 ms - 1 ms per phase | 1 ms is long enough
to achieve the
necessary
stimulation, but
equivalent in safety
and effectiveness. |
| 10. | Max. transient voltage | 34V, Zener Diode for
hardware safety | 80V, lead off via software for
safety | Higher voltage for
smaller electrode
sizes but equivalent |
| | | | | in safety and
effectiveness. |
| 11. | Power supply | 12V DC, External medical
power supply | Battery, 2 x 9 V | Battery supply to
reduce risk and
noise. |
| 12. | Electrode size | Warning that electrodes
with less than 4 sq mm
can cause tissue damage. | Electrode size defines the
safety threshold for stimulation
parameters. | The g.Estim PRO is
safe also with
smaller electrode
size, because the
stimulator calculates
the maximum
stimulation current
depending on
electrode size. So
equivalent in safety
and effectiveness. |
| 13. | Supported electrodes | Strip, grids, handheld
probe | Strip, grids, handheld probe | Same as predicate |
| 14. | Stimulus switching unit | Yes | No | Just a cortical
stimulator for 1
bipolar channel, but
equivalent in safety
and effectiveness. |
| 15. | Use standard sensors and
electrodes | Electrodes are not
included | Electrodes are not included | Same as predicate |
| 16. | User input | Stylus (touch), standard
mouse | Standard computer | Standard computer,
but equivalent in
safety and
effectiveness. |
| 17. | Graphical user interface | LCD | LCD display of computer | Same as predicate |
| 18. | Simulator parameters setting | Through displayed
controls | Through displayed controls | Same as predicate |
| 19. | Active stimulation LED | Yes | Yes | Same as predicate |
| 20. | Actual current delivered
displayed | Yes | Yes | Same as predicate |
| 21. | Dimension | 337 x 165 x 178 mm | 240 x 137 x 80 mm | Smaller and
therefore easier to
handle, but
equivalent in safety
and effectiveness. |
| 22. | Weight | 2.25 kg | 0.85 kg | Lighter and therefore
easier to carry, but
equivalent in safety
and effectiveness. |
| 23. | Trigger out for external
devices | Yes | Yes | Same as predicate |
| 24. | Digital input | Isolated | Isolated | Same as predicate |
| 25. | Patient isolation | BF | BF | Same as predicate |
| 26. | Safety standards | IEC60601-1
IEC60601-1-2 | IEC60601-1
IEC60601-1-2
IEC60601-2-40
ISO14971
IEC62304
IEC62366 | More standards
applied. |
| | | | | |
| 27. | System components | Stimulator
Switching array
Hand controller
Touchscreen Stylus
Power Supply
Portable carry case
Cable to switching array
Cable to manual probe | Stimulator with USB cable
Hand switch and foot switch
Portable carry case
1 x Trigger in cable
2 x Trigger out cable | g.Estim PRO doesnot provide a
switching array,
Touchscreen Stylus
and power supply,
additionally with
foot switch and
trigger cables.
Equivalent in safety
and effectiveness. |
| 28. | Firmware / software | Resident firmware | Resident firmware inside
g.Estim PRO
API/GUI on computer | Additional Front-end
driver to operate but
equivalent in safety
and effectiveness. |
| 29. | Log file | YES on device transferred
with USB flash stick | YES on computer | Not saved, on
device, but
equivalent in safety
and effectiveness. |
| 30. | Digital inputs/outputs | 1 external trigger input
(disabled)
1 train duration out
1 trigger out (pulse) | 1 trigger input (disabled)
1 pulse output
1 pulse output to trigger
external devices | Programmable
outputs but
equivalent in safety
and effectiveness. |
| 31. | Connectors, switches | 1 handheld controller
connector
1 handheld probe
connector
1 output connector to
switching unit
2 USB
1 external trigger input
1 train duration output
1 trigger out(pulse)
1 DC power in
1 Ethernet connector
1 on/off switch
1 HW all stop switch
1 HW stimulation switch | 1 hand/foot switch connector
2 safety sockets to connect
electrodes
1 USB connector
DIO - 1 input connector
DIO - 1 output connector 1
DIO - 1 output connector 2
2 battery housings
1 on/off switch | Different in output
for the switching
unit, reduced
connectivity with
one USB and no
Ethernet connector
and no HW-switches
, but equivalent in
safety and
effectiveness. |
| 32. | Impedance measurement | Yes | Yes | Same as predicate |
| 33. | Isolated power out | Yes | No | No isolated power
out but equal in
safety and
effectiveness. |
| 34. | Embedded controller | 1 | 2 | One additional to
ensure the equal
safety and
effectiveness. |
g.tec medical engineering GmbH, Siemingstrasse 14, 4521 Schiediberg, Austria, Europe,
7
g.tec medical engineering GmbH
g.tec medical engineering GmbH, Sierningstrasse 14, 4521 Schiediberg, Austria, Europe,
8
g.tec medical engineering GmbH
g.tec medical engineering GmbH, Sierningstrasse 14, 4521 Schiedlberg, Austria, Europe,
9
807.92(b)(1)
The stimulator was tested with a data acquisition device and provides rectangular stimulation pulses with the necessary frequency and amplitude range. Furthermore digital outputs were tested to provide trigger signals and digital inputs were tested to trigger the stimulation. The impedance measurement was tested with test impedances. The tests show that the stimulator works like the predicate device.
In g.Estim PRO medical safety is realized by isolating the applied part optically for data transmission via USB and by battery supply. The current for the impedance measurement is limited with resistors.
807.92(b)(2) Not applicable
807.92(b)(3)
The conclusion is that g.Estim PRO and the predicate device provide electrical stimuli with varying pulse width, frequency and amplitude in the same way and that the stimulator is working substantial equivalent and as effective as the marketed device. g.Estim PRO is using battery supply and optical separated USB transmission and is therefore considered to be safe.