(184 days)
Not Found
No
The description focuses on signal acquisition, amplification, and display, with no mention of AI/ML for analysis or interpretation.
No
The device is described as an amplifier for acquiring and displaying EEG signals, not for treating conditions.
Yes
The device is described as an "Electroencephalography Amplifier" that aims to "display waveform in real-time" and "immediately display patient's brain wave." This information (brain wave signals) is typically used by physicians for diagnostic purposes, making it a diagnostic device.
No
The device description explicitly states it is an "8-CH Electroencephalography Amplifier" which captures, amplifies, and converts analog signals to digital. This describes hardware components, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "acquisition of EEG signals, to transmit them digitally to a computer, and display waveform in real-time." This describes a device that measures physiological signals from the body.
- Device Description: The description reinforces this by explaining how it "capture brain wave signals through non-invasive electrodes, amplify the analog signals and convert to digital signals." This is a description of a medical device that interacts with the patient's body to collect data.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic purposes. This device does not process or analyze such specimens. It directly measures electrical activity from the brain.
Therefore, the 8-CH Electroencephalography Amplifier is a medical device used for physiological monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
GWL, OMC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Used by or under the direction of a physician in a clinical environment (e.g., hospital, physician's office, etc).
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)
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
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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.1835 Physiological signal amplifier.
(a)
Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).(b)
Classification. Class II (performance standards).
0
December 27, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
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Traditional 510(k) 510 (k) Summary
510(k) Summary
4
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 | |
| City 11492, Taiwan, R.O.C | ||
| Phone: | +886-2-87978060 | |
| Fax: | +886-2-87978090 | |
| Contact: | William Lan | |
| (william_lan@Hipposcreen-nc.com) |
4 Identification of the Device:
| Proprietary/Trade name: | 8-CH Electroencephalography
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 |
| 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
Feature | Subject device | Predicate device | Substantial
equivalence
determination |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Submitter | HippoScreen Neurotech Corp. | Eemagine Medical Imaging Solutions
GmbH | |
| Proprietary Name | 8-CH Electroencephalography
Amplifier | eegoTM amplifiers | |
| 510(k) No. | K201747 | K172312 | |
| Model Name | EAmp-0001 | EE-2XX series (EE-211, EE-212,
EE-213, EE-221, EE-222, EE-224)
and
EE-4XX series (EE-411, EE-430) | N/A |
| Intended Use | Used to electrically amplify signals
derived from electroencephalogram. | Used to electrically amplify signals
derived from electroencephalogram. | Same.
Both devices are
amplifiers of
EEG signals. |
| Item
Feature | Subject device | Predicate device | Substantial
equivalence
determination |
| Submitter | HippoScreen Neurotech Corp. | Eemagine Medical Imaging Solutions GmbH | |
| Proprietary Name | 8-CH Electroencephalography
Amplifier | eegoTM amplifiers | |
| 510(k) No. | K201747 | K172312 | |
| Indication 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. | The eego amplifier is intended to be
used by or under the direction of a
physician for acquisition of EEG
signals and to transmit them digitally
to a computer. The device is intendedfor 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. | Same.
Both devices are
intended for
acquisition of
EEG signals to a
computer. |
| Type of use | Prescription Use | Prescription Use | Same |
| Modes of
Operation | Electroencephalography (EEG) | Electroencephalography (EEG) | Same |
| Environment of
Use | Clinical environment
(Example: hospital, physician's
office, etc) | Clinical environment
(Example: hospital, physician's
office, etc) | Same |
| Size | 220 x 50 x 153 mm | 205 x 22 x 160 mm | Different but
does not impact
safety and
effectiveness of
subject device |
| Weight | 600g | 100 dB | Similar
(Subject device
had meet the
requirement of
IEC 60601-2-26) |
| Amplifier Input
Channels | 8 | Up to 64 | Same as eego
EE-430 |
| Amplifier input
impedance
(referential) | >109 Ω | >109 Ω | Same |
| Amplifier power | AC input 100V~240V, 50-60Hz
DC output 5V/ 2.0A | EE-2XX Series: Rechargeable
integrated battery
EE-4XX Series: USB from Computer | Different but
does not impact
safety and
effectiveness of
subject device |
| Amplifier
operating time on | Not applicable | EE-2XX Series: Up to 4 hours | Different but
does not impact |
| Item
Feature | Subject device | Predicate device | Substantial
equivalence
determination |
| Submitter | HippoScreen Neurotech Corp. | Eemagine Medical Imaging Solutions
GmbH | |
| Proprietary Name | 8-CH Electroencephalography
Amplifier | eegoTM amplifiers | |
| 510(k) No. | K201747 | K172312 | |
| battery power | | | safety and
effectiveness of
subject device |
| Amplifier
referential
DC input channels | 8 | Yes
8, 16, 32, or 64 channels | Same as eego
EE-430 |
| Amplifier trigger
input | No | Yes,
EE-2XX Series: Optional 8 bit TTL
EE-4XX Series: Optional 2 bit TTL | Different but
does not impact
safety and
effectiveness of
subject device |
| Amplifier trigger
input channel | No | Yes
(Parallel) | Different but
does not impact
safety and
effectiveness of
subject device |
| Amplifier USB
interface | Yes | Yes | Same |
| Safety standards
applied | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-26 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-26
IEC 62133 | Similar
(Appropriate
standards are
applied on the
subject device.) |
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10
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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.