Who is the manufacturer of 8-CH Electroencephalography Amplifier?

Hipposcreen Neurotech Corp. filed the 510(k) submission for 8-CH Electroencephalography Amplifier (K201747).

What is the FDA product code for 8-CH Electroencephalography Amplifier?

GWL. It is classified under 21 CFR 882.1835 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for 8-CH Electroencephalography Amplifier?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like 8-CH Electroencephalography Amplifier?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

8-CH Electroencephalography Amplifier

K201747 · Hipposcreen Neurotech Corp. · GWL · Dec 27, 2020 · Neurology

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

Intended 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)

Related Devices

K170363 — Ceribell Pocket EEG Device · Ceribell, Inc. · May 8, 2017
K172312 — eego amplifiers · Eemagine Medical Imaging Solutions GmbH · Mar 30, 2018
K014147 — 80 CHANNEL EEG · Xltek · Jan 14, 2002
K092477 — NeuroWave NeuroFAST MONITORING SYSTEM, MODEL NF-701 · Neurowave Systems, Inc. · Oct 29, 2010
K130238 — NIHON KOHDEN AE-918P NEURO UNIT · Nihon Kohden Corp. · Mar 4, 2015

Submission Summary (Full Text)

{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 {2}------------------------------------------------ #### 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) | |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| 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 "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}------------------------------------------------ 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 | {5}------------------------------------------------ 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 {6}------------------------------------------------ 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 | < 500g | Different but | | 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 | does not impact safety and effectiveness of subject device | | Resolution | 24 bit | 24 bit | Same | | Data Storage | Yes | Yes | Same | | Electrode impedance measurement | No | Yes | Different but does not impact safety and effectiveness of subject device | | Filter | Low pass filtering in amplifier | Low pass filtering in amplifier | Same | | Patient Contact | No Patient contact is made by commercially available electrodes and transducers | No Patient contact is made by the WaveguardTM EEG Cap (K110223). | Same. Both contacts are made by EEG cap. | | Sampling rate | 500Hz | EE-2XX Series: Up to 16384 Hz Set through the user interface of the Software Development Kit (SDK) software | Same as eego EE-430 (EE-430 is 500Hz) | | Video | No | EE-4XX Series: 500 to 2048 Hz Optional | Different but | | Item | Subject device | Predicate device | Substantial equivalence determination | | Feature | | | | | Submitter | HippoScreen Neurotech Corp. | Eemagine Medical Imaging Solutions GmbH | | | Proprietary Name | 8-CH Electroencephalography Amplifier | eegoTM amplifiers | | | 510(k) No. | K201747 | K172312 | | | | | | does not impact safety and effectiveness of subject device | | Amplifier active shielding technique | Yes (Protects the referential EEG inputs from environmental noise) | Yes (Protects the referential EEG inputs from environmental noise) | Same | | Amplifier CMRR (referential) | 94 db at dc to 60 Hz | >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.) | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ {11}------------------------------------------------ # 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.