(252 days)
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No
The summary describes a device for monitoring neurophysiological signals (EEG, FEMG, AEP) and performing basic signal processing. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No
The device is described as being for "monitoring of electroencephalograph (EEG), frontal electromyograph (FEMG), and auditory evoked potentials (AEP)" which are diagnostic measurements, not treatments.
Yes
The device is intended for monitoring electroencephalograph (EEG), frontal electromyograph (FEMG), and auditory evoked potentials (AEP), which are measurements used to assess a patient's neurophysiological status. These measurements provide information that aids in diagnosis.
No
The device description clearly outlines hardware components (E-EEGX module, N-EEGX headbox, accessories) that are essential for the device's function of measuring and transferring physiological data. It is not solely software.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes.
- Device Function: The GE EEG module, E-EEGX, and its accessories are used for monitoring electroencephalograph (EEG), frontal electromyograph (FEMG), and auditory evoked potentials (AEP) directly from the patient's body. This involves measuring electrical activity and responses within the patient, not analyzing samples taken from the patient.
- Intended Use: The intended use clearly states "monitoring of electroencephalograph (EEG), frontal electromyograph (FEMG), and auditory evoked potentials (AEP) of all hospital patients." This is a direct physiological measurement, not an in vitro test.
Therefore, the device falls under the category of a physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The GE EEG module, E-EEGX, the GE EEG headbox, N-EEGX, and accessories are intended to be used with the compatible CARESCAPE monitors for the monitoring of electroencephalograph (EEG), frontal electromyograph (FEMG), and auditory evoked potentials (AEP) of all hospital patients. The device is intended for use by qualified medical personnel only.
Product codes
OLT, GWJ, MHX, MLD, OMC, ORT
Device Description
The E-EEGX module is a single-width plug-in interface module to be used with CARESCAPE Bx50 V3 patient monitors. It is used with N-EEGX headbox and accessories for monitoring neurophysiological status of all hospital patients by measuring the electroencephalogram (EEG), frontal electromyogram (FEMG) and auditory evoked potentials (AEP).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
All hospital patients
Intended User / Care Setting
Qualified medical personnel only.
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)
For the E-EEGX module, N-EEGX headbox and accessories the following quality assurance measures were applied to the development of the system.
-
- Risk Analysis
-
- Requirements Reviews
-
- Design Reviews
-
- Testing on unit level (Module verification)
-
- Integration testing (System verification)
-
- Final acceptance testing (Validation)
-
- Performance testing (Verification)
- Safety testing (Verification) 8.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows 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 is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
Joel Kent Senior Regulatory Affairs Manager GE Healthcare Finland Oy Kuortaneenkatu 2 00510 Helsinki, Finland
Re: K191322
Trade/Device Name: E-EEGX module, N-EEGX headbox and accessories Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLT, GWJ, MHX, MLD, OMC, ORT Dated: December 19, 2019 Received: December 23, 2019
Dear Joel Kent:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and probibitions 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
1
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191322
Device Name
E-EEGX module, N-EEGX headbox and accessories
Indications for Use (Describe)
The GE EEG module, E-EEGX, the GE EEG headbox, N-EEGX, and accessories are intended to be used with the compatible CARESCAPE monitors for the monitoring of electroencephalograph (EEG), frontal electromyograph (FEMG), and auditory evoked potentials (AEP) of all hospital patients. The device is intended for use by qualified medical personnel only.
| 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) |
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3
Image /page/3/Picture/1 description: The image shows the General Electric (GE) logo, which consists of the letters 'GE' intertwined in a stylized monogram. The monogram is enclosed within a circle, and there are decorative flourishes or 'teardrops' around the circle's perimeter. The logo is presented in black and white, with the monogram and circle being black against a white background.
GE Healthcare Finland Oy Kuortaneenkatu 2, P.O. Box 900 00031 GE
Finland
T: +358 10 39411
F: +358 9 1463310
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Owner/Contact/Date
| (807.92(a)(1): | ||
|---|---|---|
| Date: | January 16, 2020 | |
| Owner/Submitter: | GE Healthcare Finland Oy. | |
| Kuortaneenkatu 2 | ||
| 00510 Helsinki | ||
| FINLAND | ||
| Phone: +358 10 39411 | ||
| Primary Contact Person: | Joel Kent | |
| Senior Regulatory Affairs Manager | ||
| GE Healthcare | ||
| Phone: 617-851-0943 | ||
| E-mail: joel.kent@ge.com | ||
| Secondary Contact Person: | Anna Pehrsson | |
| Regulatory Affairs Leader | ||
| GE Healthcare Finland Oy | ||
| Kuortaneenkatu 2 | ||
| 00510 Helsinki | ||
| Finland | ||
| Phone: + 358 40 569 5108 | ||
| E-mail: anna.pehrsson@ge.com | ||
| Device names (807.92(a)(2)): | ||
| Trade Name: | E-EEGX module, N-EEGX headbox and accessories | |
| Common/Usual Name: | EEG measurement module, headbox and accessories | |
| Classification Name: | 21 CFR 882.1400 electroencephalograph |
4
Product Code OLT
Subsequent Product Codes: GWJ, MHX, MLD, OMC, ORT
- Predicate Device(s) K051883 Datex-Ohmeda S/5 EEG Module, E-EEG and Datex-(807.92(a)(3): Ohmeda S/5 EEG Headbox, N-EEG and Accessories
The E-EEGX module is a single-width plug-in interface module Device Description (807.92(a)(4)): to be used with CARESCAPE Bx50 V3 patient monitors. It is used with N-EEGX headbox and accessories for monitoring neurophysiological status of all hospital patients by measuring the electroencephalogram (EEG), frontal electromyogram (FEMG) and auditory evoked potentials (AEP).
Intended Use: (807.92(a)(5): The GE EEG module, E-EEGX, the GE EEG headbox, N-EEGX, and accessories are intended to be used with the compatible CARESCAPE monitors for the monitoring of electroencephalograph (EEG), frontal electromyograph (FEMG), and auditory evoked potentials (AEP) of all hospital patients. The device is intended for use by qualified medical personnel only.
The E-EEGX module is used with the N-EEGX headbox for Technology (807.92(a)(6)): monitoring of EEG. FEMG. to stimulate the brain with auditory stimuli, and to measure AEP. The E-EEGX module connects to a N-EEGX headbox which further connects to accessories that connect to the patient.
The EEG, FEMG and AEP measurements are performed by the N-EEGX headbox. The N-EEGX headbox measures the raw EEG waveform data from four real-time EEG waveform channels, FEMG from one channel and AEP from two channels. The N-EEGX headbox is connected to the patient with EEG accessories.
The E-EEGX module transfers the digitized EEG data received from the N-EEGX headbox to the host monitor. The module also generates the stimuli used in the AEP measurement and performs part of the AEP measurement data processing.
The fundamental function and operation of the device remains unchanged compared to the predicate. A summary of the main changes compared to the predicate is listed below.
5
| Specification | Datex-Ohmeda S/5 EEG Module, E-EEG and
Datex-Ohmeda S/5 EEG Headbox, N-EEG and
Accessories (K051883) | E-EEG X module, N-EEGX headbox and EEG
accessories | Discussion of differences |
|-------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The Datex-Ohmeda EEG module, E-EEG and the
Datex-Ohmeda EEG headbox, N-EEG and
accessories are indicated for monitoring of
electroencephalograph (EEG), frontal
electromyograph (FEMG) and auditory evoked
potentials (AEP) of all hospital patients.
The device is indicated for use by qualified
medical personnel only. | The GE EEG module, E-EEGX, the GE EEG
headbox, N-EEGX, and accessories are intended
to be used with the compatible CARESCAPE
monitors for the monitoring of
electroencephalograph (EEG), frontal
electromyograph (FEMG), and auditory evoked
potentials (AEP) of all hospital patients. The
device is intended for use by qualified medical
personnel only. | Equivalent
The changes from previously cleared
indications are:
Company name "Datex" has been
replaced by "GE".
The indications refer to compatible
monitors.
Some minor text edits and changes
for added clarity.
The changes have been made to
improve clarity of labeling.
Therefore, they do not significantly
affect safety and/or effectiveness. |
| Physical Properties
Module Size(H x W x
D)
Module Weight | E-EEG module
112 x 37 x 186 mm
(4.4 x 1.5 x 7.3 in)
0.3 kg (0.7 lb)
N-EEG headbox
34 x 97 x 174 mm
(1.3 x 3.8 x 6.8 in)
0.44 kg (1.1 lb) | E-EEGX module
112 x 37 x 187 mm
(4.4 x 1.5 x 7.3 in)
0.3 kg (0.7 lb)
N-EEGX headbox
34 x 97 x 174 mm
(1.3 x 3.8 x 6.8 in)
0.5 kg (1.1 lb) | Equivalent
The N-EEGX headbox weight has
slightly changed due to a new
hardware design.
This change does not significantly
affect safety and/or effectiveness. |
| Host device
compatibility | E-EEG module is compatible with S/5 AM,
CAM, S/5 CCM, CARESCAPE B450 Monitor
with software ESP V1 or V2, CARESCAPE
Monitor B650 with software ESP V1 or V2 and
CARESCAPE Monitor B850 with software ESP
V1 or V2 | E-EEGX module and N-EEGX headbox are
compatible with the CARESCAPE Bx50 V3
patient monitors | Equivalent
The E-EEGX module and N-EEGX
headbox are only compatible with
CARESCAPE Bx50 V3 patient
monitors.
This change has been verified and the
overall functionality remains
equivalent.
This change does not significantly
affect safety and/or effectiveness. |
| Parameter Specifications | | | |
| Measured parameters | EEG, Auditory Evoked Potentials, EMG | EEG, Auditory Evoked Potentials, EMG | Identical |
| Mode | Referential or Bipolar | Referential or Bipolar | Identical |
| Processing of the EEG | Spectral analysis: Spectral Edge Frequency
(SEF), Median frequency, Relative power in
Delta, Theta, Alpha and Beta bands
Burst suppression detection
Total power | Spectral analysis: Spectral Edge Frequency
(SEF), Median frequency, Relative power in
Delta, Theta, Alpha and Beta bands
Burst suppression detection
Total power | Identical |
| EEG parameter specifications | | | |
| EEG Measurement
method | 1, 2, 3 or 4 channels of EEG | 1, 2, 3 or 4 channels of EEG | Identical |
| Range | $\pm$ 400 μV | $\pm$ 500 μV | Equivalent
Range has been expanded to meet the
requirements of IEC 60601-2-
26:2012.
This change has been verified and the
overall functionality remains
equivalent.
This change does not significantly
affect safety and/or effectiveness. |
| Measurement range
frequency | 0.5 ... 30 Hz | 0.5 ... 50 Hz | Equivalent
Range has been expanded to meet the
requirements of IEC 60601-2-
26:2012.
This change has been verified and the
overall functionality remains
equivalent.
This change does not significantly
affect safety and/or effectiveness. |
| AEP parameter specifications | | | |
| Evoked potentials | Auditory evoked potentials: brain stem and mid-latency | Auditory evoked potentials: brain stem and mid-latency | Identical |
| Measurement Sampling
frequency | Brainstem Auditory Evoked Potentials (BAEP):
4800 Hz
Middle Latency Auditory Evoked Potential
(MLAEP): 2400 Hz | Brainstem Auditory Evoked Potentials (BAEP):
4800 Hz
Middle Latency Auditory Evoked Potential
(MLAEP): 2400 Hz | Identical |
| Frequency range | 0.5 Hz - 1000 hz | 0.5 Hz - 1000 Hz | Identical |
| Stimulation type | Condensating click | Condensating click | Identical |
| Stimulation frequency | 1.1 to 9.1 Hz(1 Hz steps) @ 10 ms sweep
1.1 to 8.1 Hz(1 Hz steps) @ 100 ms sweep | 1.1 to 9.1 Hz(1 Hz steps) @ 10 ms sweep
1.1 to 8.1 Hz(1 Hz steps) @ 100 ms sweep | Identical |
| EMG parameter specifications | | | |
| EMG measurement
frequency range | 60 to 300 Hz | 60 to 300 Hz | Identical |
6
Determination of Substantial Equivalence (807.92(b)(1))
Summary of Non-Clinical Tests:
For the E-EEGX module, N-EEGX headbox and accessories the following quality assurance measures were applied to the development of the system.
-
- Risk Analysis
-
- Requirements Reviews
-
- Design Reviews
-
- Testing on unit level (Module verification)
-
- Integration testing (System verification)
-
- Final acceptance testing (Validation)
-
- Performance testing (Verification)
- Safety testing (Verification) 8.
-
- The following list contains applicable standards regarding performance testing related to E-EEGX module, N-EEGX headbox and accessories:
- ANSI/AAMI ES60601-1:2005/(R)2012 and ● A1:2012: Medical electrical equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1: 2012)
- . IEC 60601-1-2: 2014: Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
- IEC 60601-2-26:2012: Medical electrical equipment Part 2-26: Particular requirements for
7
the safety and essential performance of electroencephalographs
- IEC 60601-2-40: 2016: Medical Electrical ● Equipment Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment
- IEC 60601-2-49: 2011: Medical electrical ● equipment Part 2-49: Particular requirements for the safety essential performance of multifunction patient monitoring equipment
Clinical (807.92(b)(2)): Summary of Clinical Tests:
The subject of this premarket submission, the E-EEGX module, N-EEGX headbox and accessories did not require clinical studies to support substantial equivalence.
- Conclusion (807.92(b)(3)): GE Healthcare considers the E-EEGX module, N-EEGX headbox and accessories to be as safe, as effective, and performance is substantially equivalent to the predicate device.