8-CH Electroencephalography Amplifier
Device Facts
| Record ID | K201747 |
|---|---|
| Device Name | 8-CH Electroencephalography Amplifier |
| Applicant | Hipposcreen Neurotech Corp. |
| Product Code | GWL · Neurology |
| Decision Date | Dec 27, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1835 |
| Device Class | Class 2 |
Indications for Use
The 8-CH Electroencephalography Amplifier is intended to be used by or under the direction of a physician for acquisition of EEG signals, to transmit them digitally to a computer, and display waveform in real-time. The device is intended for use on humans. The device is intended for use in a clinical environment (e.g., hospital, physician's office, etc). The device is not intended for use in life support systems.
Device Story
8-CH Electroencephalography Amplifier captures brain wave signals via non-invasive electrodes; amplifies analog signals; converts to digital format for computer transmission. Device features EEG monitoring panel for immediate real-time waveform display to verify signal quality; green light indicator signals readiness for testing. Used in clinical environments (hospitals, physician offices) by physicians or under their direction. Output allows healthcare providers to visualize brain activity for diagnostic assessment. Benefits include non-invasive brain wave monitoring and real-time signal quality assurance.
Clinical Evidence
No clinical data was used to support substantial equivalence. Evidence consists of bench testing, including software validation, electromagnetic compatibility, electrical safety, and performance/usability testing.
Technological Characteristics
8-channel EEG amplifier; 24-bit resolution; 500Hz sampling rate; active shielding for noise protection; >109 Ω input impedance; 94 dB CMRR (DC to 60 Hz). Powered by AC 100V-240V. Connectivity via USB. Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-26. Non-invasive patient contact via external electrodes.
Indications for Use
Indicated for humans requiring EEG signal acquisition, digital transmission to a computer, and real-time waveform display. Intended for use in clinical environments (hospitals, physician offices) by or under the direction of a physician. Not for use in life support systems.
Regulatory Classification
Identification
A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).
Predicate Devices
- eego™ amplifiers (K172312)
Reference Devices
- Waveguard™ EEG Cap (K110223)
Submission Summary (Full Text)
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December 27, 2020
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HippoScreen Neurotech Corp. William Lan R&D Manager 2F., No. 578, Ruiguang Rd., Neihu District Taipei City, 11492 Taiwan
Re: K201747
Trade/Device Name: 8-CH Electroencephalography Amplifier Regulation Number: 21 CFR 882.1835 Regulation Name: Physiological Signal Amplifier Regulatory Class: Class II Product Code: GWL, OMC Dated: November 25, 2020 Received: November 27, 2020
Dear William Lan:
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 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) for
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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 mediation-emitting products, including information about labeling regulations, please see Device Advice (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.
for 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 Quality Center for Devices and Radiological Health
Enclosure
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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
510(k) Number (if known) K201747
Device Name
8-CH Electroencephalography Amplifier
#### Indications for Use (Describe)
The 8-CH Electroencephalography Amplifier is intended to be used by or under the direction of a physician for acquisition of EEG signals, to transmit them digitally to a computer, and display waveform in real-time. The device is intended for use on humans. The device is intended for use in a clinical environment (e.g., hospital, s office, etc). The device is not intended for use in life support systems.
| Type of Use (Select one or both, as applicable) | <span> <span style="padding-right: 20px;"> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |
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Traditional 510(k) 510 (k) Summary
# 510(k) Summary
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Traditional 510(k) 510 (k) Summary
# 510(k) SUMMARY
| 1 | Type of Submission: | Traditional |
|---|---------------------|---------------------------------------------------------------------------------|
| 2 | Date of Summary: | 06/15/2020 |
| 3 | Submitter: | HippoScreen Neurotech Corp. |
| | Address: | 2F., No. 578, Ruiguang Rd., Neihu District, Taipei<br>City 11492, Taiwan, R.O.C |
| | Phone: | +886-2-87978060 |
| | Fax: | +886-2-87978090 |
| | Contact: | William Lan<br>(william_lan@Hipposcreen-nc.com) |
#### 4 Identification of the Device:
| Proprietary/Trade name: | 8-CH Electroencephalography<br>Amplifier |
|------------------------------|------------------------------------------|
| Classification Product Code: | |
| Primary Product Code: | GWL |
| Additional Product Code: | OMC |
| Regulation Number: | 882.1835 |
| Regulation Description: | Physiological signal amplifier |
| Review Panel: | Neurology |
| Device Class: | II |
#### 5 Identification of the Predicate Device:
| Predicate Device Name: | eego™ amplifiers |
|------------------------------|--------------------------------------------|
| Manufacturer: | Eemagine Medical Imaging Solutions<br>GmbH |
| Classification Product Code: | |
| Primary Product Code: | GWL |
| Additional Product Code: | GWQ, OMC |
| Regulation number: | 882.1835 |
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Traditional 510(k) 510 (k) Summary
| Device Class: | II |
|----------------|---------|
| 510(k) Number: | K172312 |
# 6 Intended Use
Used to electrically amplify signals derived from electroencephalogram.
# 7 Indications for Use of the Device
The 8-CH Electroencephalography Amplifier is intended to be used by or under the direction of a physician for acquisition of EEG signals, to transmit them digitally to a computer, and display waveform in real-time. The device is intended for use on humans. The device is intended for use in a clinical environment (e.g., hospital, physician's office, etc). The device is not intended for use in life support systems.
# 8 Device Description
8-CH Electroencephalography Amplifier capture brain wave signals through non-invasive electrodes, amplify the analog signals and convert to digital signals for computer use. The EEG monitoring panel can immediately display patient's brain wave to assure signal quality of testing requirements. Begin to test when signal quality lamp on EEG monitoring panel shows green light.
# 9 Non-clinical Testing
A series of safety and performance tests were conducted on the subject device, 8-CH Electroencephalography Amplifier.
- . Software Validation
- Electromagnetic compatibility and electrical safety
- Performance
- Usability
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All the test results demonstrate 8-CH Electroencephalography Amplifier meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device.
# 10 Clinical and Usability Testing
No clinical test data was used to support the decision of substantial equivalence.
# 11 Substantial Equivalence Determination
The 8-CH Electroencephalography Amplifier submitted in this 510(k) file is substantially equivalent in intended use, has similar technology/principles of operation, and similar performance to the cleared eego™ amplifiers (K172312). Differences between the devices cited in this section do not raise any new issue of substantial equivalence.
| Item<br>Feature | Subject device | Predicate device | Substantial<br>equivalence<br>determination |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Submitter | HippoScreen Neurotech Corp. | Eemagine Medical Imaging Solutions<br>GmbH | |
| Proprietary Name | 8-CH Electroencephalography<br>Amplifier | eegoTM amplifiers | |
| 510(k) No. | K201747 | K172312 | |
| Model Name | EAmp-0001 | EE-2XX series (EE-211, EE-212,<br>EE-213, EE-221, EE-222, EE-224)<br>and<br>EE-4XX series (EE-411, EE-430) | N/A |
| Intended Use | Used to electrically amplify signals<br>derived from electroencephalogram. | Used to electrically amplify signals<br>derived from electroencephalogram. | Same.<br>Both devices are<br>amplifiers of<br>EEG signals. |
| Item<br>Feature | Subject device | Predicate device | Substantial<br>equivalence<br>determination |
| Submitter | HippoScreen Neurotech Corp. | Eemagine Medical Imaging Solutions GmbH | |
| Proprietary Name | 8-CH Electroencephalography<br>Amplifier | eegoTM amplifiers | |
| 510(k) No. | K201747 | K172312 | |
| Indication for Use | The 8-CH Electroencephalography<br>Amplifier is intended to be used by or<br>under the direction of a physician for<br>acquisition of EEG signals, to<br>transmit them digitally to a computer,<br>and display waveform in real-time.<br>The device is intended for use on<br>humans. The device is intended for<br>use in a clinical environment (e.g.,<br>hospital, physician's office, etc). The<br>device is not intended for use in life<br>support systems. | The eego amplifier is intended to be<br>used by or under the direction of a<br>physician for acquisition of EEG<br>signals and to transmit them digitally<br>to a computer. The device is intendedfor use on humans. The device is<br>intended for use in a clinical<br>environment (e.g., hospital,<br>physician's office, etc). The device is<br>not intended for use in life support<br>systems. | Same.<br>Both devices are<br>intended for<br>acquisition of<br>EEG signals to a<br>computer. |
| Type of use | Prescription Use | Prescription Use | Same |
| Modes of<br>Operation | Electroencephalography (EEG) | Electroencephalography (EEG) | Same |
| Environment of<br>Use | Clinical environment<br>(Example: hospital, physician's<br>office, etc) | Clinical environment<br>(Example: hospital, physician's<br>office, etc) | Same |
| Size | 220 x 50 x 153 mm | 205 x 22 x 160 mm | Different but<br>does not impact<br>safety and<br>effectiveness of<br>subject device |
| Weight | 600g | < 500g | Different but |
| Item<br>Feature | Subject device | Predicate device | Substantial<br>equivalence<br>determination |
| Submitter | HippoScreen Neurotech Corp. | Eemagine Medical Imaging Solutions<br>GmbH | |
| Proprietary Name | 8-CH Electroencephalography<br>Amplifier | eegoTM amplifiers | |
| 510(k) No. | K201747 | K172312 | does not impact<br>safety and<br>effectiveness of<br>subject device |
| Resolution | 24 bit | 24 bit | Same |
| Data Storage | Yes | Yes | Same |
| Electrode<br>impedance<br>measurement | No | Yes | Different but<br>does not impact<br>safety and<br>effectiveness of<br>subject device |
| Filter | Low pass filtering in amplifier | Low pass filtering in amplifier | Same |
| Patient Contact | No<br>Patient contact is made by<br>commercially available electrodes<br>and transducers | No<br>Patient contact is made by the<br>WaveguardTM EEG Cap (K110223). | Same.<br>Both contacts are<br>made by EEG<br>cap. |
| Sampling rate | 500Hz | EE-2XX Series:<br>Up to 16384 Hz Set through the user<br>interface of the Software<br>Development<br>Kit (SDK) software | Same as eego<br>EE-430<br>(EE-430 is<br>500Hz) |
| Video | No | EE-4XX Series: 500 to 2048 Hz<br>Optional | Different but |
| Item | Subject device | Predicate device | Substantial<br>equivalence<br>determination |
| Feature | | | |
| Submitter | HippoScreen Neurotech Corp. | Eemagine Medical Imaging Solutions<br>GmbH | |
| Proprietary Name | 8-CH Electroencephalography<br>Amplifier | eegoTM amplifiers | |
| 510(k) No. | K201747 | K172312 | |
| | | | does not impact<br>safety and<br>effectiveness of<br>subject device |
| Amplifier active<br>shielding<br>technique | Yes<br>(Protects the referential EEG inputs<br>from environmental noise) | Yes<br>(Protects the referential EEG inputs<br>from environmental noise) | Same |
| Amplifier CMRR<br>(referential) | 94 db at dc to 60 Hz | >100 dB | Similar<br>(Subject device<br>had meet the<br>requirement of<br>IEC 60601-2-26) |
| Amplifier Input<br>Channels | 8 | Up to 64 | Same as eego<br>EE-430 |
| Amplifier input<br>impedance<br>(referential) | >109 Ω | >109 Ω | Same |
| Amplifier power | AC input 100V~240V, 50-60Hz<br>DC output 5V/ 2.0A | EE-2XX Series: Rechargeable<br>integrated battery<br>EE-4XX Series: USB from Computer | Different but<br>does not impact<br>safety and<br>effectiveness of<br>subject device |
| Amplifier<br>operating time on | Not applicable | EE-2XX Series: Up to 4 hours | Different but<br>does not impact |
| Item<br>Feature | Subject device | Predicate device | Substantial<br>equivalence<br>determination |
| Submitter | HippoScreen Neurotech Corp. | Eemagine Medical Imaging Solutions<br>GmbH | |
| Proprietary Name | 8-CH Electroencephalography<br>Amplifier | eegoTM amplifiers | |
| 510(k) No. | K201747 | K172312 | |
| battery power | | | safety and<br>effectiveness of<br>subject device |
| Amplifier<br>referential<br>DC input channels | 8 | Yes<br>8, 16, 32, or 64 channels | Same as eego<br>EE-430 |
| Amplifier trigger<br>input | No | Yes,<br>EE-2XX Series: Optional 8 bit TTL<br>EE-4XX Series: Optional 2 bit TTL | Different but<br>does not impact<br>safety and<br>effectiveness of<br>subject device |
| Amplifier trigger<br>input channel | No | Yes<br>(Parallel) | Different but<br>does not impact<br>safety and<br>effectiveness of<br>subject device |
| Amplifier USB<br>interface | Yes | Yes | Same |
| Safety standards<br>applied | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-26 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-26<br>IEC 62133 | Similar<br>(Appropriate<br>standards are<br>applied on the<br>subject device.) |
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# 12 Similarity and Difference
The 8-CH Electroencephalography Amplifier has been compared with eego™ amplifiers. The subject device and predicate device has same intended use, indication for use, type of use, modes of operation, environment of use, resolution, data storage function, filter, patient contact, sampling rate, amplifier active shielding technique, amplifier input channels, amplifier input impedance (referential), amplifier referential DC input channels, and amplifier USB interface.
Although there are some functions that are different between two devices, such as electrode impedance measurement, video function, amplifier power, amplifier trigger input function, and amplifier input channel, the function of subject device did not exceed that of the predicate device. Also, performance tests have been completed to demonstrate that the differences between these parameters would not impact the safety and effectiveness of the subject device.
As for amplifier CMRR (referential), subject device is a little bit lower than that of the predicated device. However, subject device had met the requirement of IEC 60601-2-26.
In conclusion, the subject device has undergone safety and performance tests, and the results complied with the test requests; therefore, the difference between the subject device and the predicate device did not raise any problem of substantial equivalence. The subject device is substantially equivalent to the predicate device in intended use, safety and performance claims.
# 13 Conclusion
In conclusion, HippoScreen Neurotech Corp. believes that 8-CH Electroencephalography Amplifier maintains the same safety and effectiveness, and thus, is substantially equivalent to the predicate device.
