Neurosteer EEG Recorder
Device Facts
| Record ID | K221563 |
|---|---|
| Device Name | Neurosteer EEG Recorder |
| Applicant | Neurosteer, Inc. |
| Product Code | OMC · Neurology |
| Decision Date | Oct 24, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1400 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for Use
The Neurosteer EEG Recorder is intended to record and store EEG signals, and to present the EEG signals in visual formats in real time. The visuals assist trained medical staff to make neurological diagnoses. The EEG Recorder does not provide any diagnostic conclusion about the subject's condition and does not provide any automated alerts of an adverse clinical event. The EEG Recorder is intended to be used in a professional healthcare facility environment.
Device Story
Portable single-channel EEG monitoring platform; captures brain electrical activity via adhesive electrode strip (3 Ag/AgCl electrodes) on forehead. Sensing device transmits signals via Bluetooth (BLE) to local brain activity monitor. Monitor displays raw EEG, spectrograms, and metrics; provides status indicators and auditory prompts. Data transmitted via Wi-Fi/Ethernet to cloud for storage and processing; cloud-based software transforms raw signals into visual displays. Real-time viewing available on monitor and web portal. Used in professional healthcare facilities by medical staff to assist in neurological diagnosis; does not provide diagnostic conclusions or automated clinical alerts.
Clinical Evidence
Bench testing only. No clinical data presented. Performance verified via biocompatibility (ISO 10993), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), battery safety (IEC 62133), EEG essential performance (IEC 80601-2-26), and electrode performance (ANSI/AAMI EC12). All tests met acceptance criteria.
Technological Characteristics
Single-channel EEG; 3 passive Ag/AgCl electrodes with semi-solid hydrogel; adhesive strip form factor. Connectivity: BLE (sensor to monitor), Wi-Fi/Ethernet (monitor to cloud). Power: Rechargeable Li-ion polymer battery. Standards: ISO 10993-1, IEC 60601-1, IEC 60601-1-2, IEC 62133, IEC 80601-2-26, ANSI/AAMI EC12. Software: Cloud-based processing and web-based viewing.
Indications for Use
Indicated for recording and storing EEG signals and presenting them in real-time visual formats to assist trained medical staff in neurological diagnosis. Intended for use in professional healthcare facilities. No specific patient population (age/gender) or contraindications specified.
Regulatory Classification
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.
Predicate Devices
Reference Devices
- Corscience qmBH EEG/ERP NeuroAmp (K193159)
Submission Summary (Full Text)
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October 24, 2022
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Neurosteer Inc. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, Pennsylvania 19103
Re: K221563
Trade/Device Name: Neurosteer EEG Recorder Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMC, GXY Dated: May 31, 2022 Received: May 31, 2022
Dear Janice Hogan:
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
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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 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 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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# Indications for Use
510(k) Number (if known) K221563
Device Name
Neurosteer EEG Recorder
Indications for Use (Describe)
The Neurosteer EEG Recorder is intended to record and store EEG signals, and to present the EEG signals in visual formats in real time. The visuals assist trained medical staff to make neurological diagnoses. The EEG Recorder does not provide any diagnostic conclusion about the subject's condition and does not provide any automated alerts of an adverse clinical event. The EEG Recorder is intended to be used in a professional healthcare facility environment.
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------|
| <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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## 510(k) SUMMARY Neurosteer Inc.'s Neurosteer EEG Recorder
## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Neurosteer Inc. 375 South End Avenue Suite 26C New York, NY 10280 USA Phone: +1 844-444-5601 Contact Person: Nathan Intrator
Date Prepared: September 15, 2022
#### Device Information
Trade Name: Neurosteer EEG Recorder
Common or Usual Name: Electroencephalograph
Classification: 21 CFR 882.1400
Device Class: Class II
Product Code: OMC
#### Predicate Devices
Predicate devices:
Ceribell, Inc. Ceribell Pocket EEG Device (K170363)
Ceribell, Inc. Ceribell Instant EEG Headband (K171459)
Reference device:
Corscience qmBH EEG/ERP NeuroAmp (K193159)
#### Device Description
The Neurosteer brain monitoring platform is a portable single-channel EEG that measures and records electrical activity of the brain. An adhesive electrode strip is affixed to the subject's forehead to capture the brain activity signal. The strip is attached to a sensing device that transmits the signal via low-energy Bluetooth (BLE) to a local brain activity monitor.
The brain activity monitor provides technical status indicators about the recording (such as battery level, connection status, and electrode disconnection alert). It can also be used to provide auditory prompt sequences (using an external speaker) during monitoring.
The signal is sent via a secure Internet connection to the cloud (either wireless Wi-Fi or physical Ethernet) where the data is stored according to HIPAA quidelines. Data processing performed in the cloud transforms the raw electrical brain activity signal into a display representation of the signal.
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When the Internet connection is available, both the raw and processed data can be viewed in real-time on the brain activity monitor and through the web portal. When the connection is not available, only the raw data can be viewed in real-time on the brain activity monitor.
## Intended Use / Indications for Use
The Neurosteer EEG Recorder is intended to record and store EEG signals, and to present the EEG signals in visual formats in real time. The visual signals assist trained medical staff to make neurological diagnoses. The EEG Recorder does not provide any diagnostic conclusion about the subject's condition and does not provide any automated alerts of an adverse clinical event. The EEG Recorder is intended to be used in a professional healthcare facility environment.
## Substantial Equivalence
The Neurosteer EEG Recorder and the predicate devices have the same intended use and very similar technological features, including an integrated array of cutaneous electrodes, a sensor, portable monitor, and software intended for recording and viewing EEG signals. The differences between the Neurosteer EEG Recorder and its predicate devices raise no new issues of safety or effectiveness. Performance testing confirms that the device functions as intended, supporting substantial equivalence. The characteristics of the subject and predicate device are summarized in the following table:
| Attribute | Subject Device:<br>Neurosteer EEG Recorder | Predicate Devices: Ceribell Pocket<br>EEG Device (K170363) & Ceribell<br>Instant EEG Headband (K171459) | Comparison |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Device class and<br>regulation | Class II per 882.1400; 882.1320, | Class II per 882.1400 (K170363);<br>882.1320 (K171459) | Same |
| Product codes | OMC and GXY | OMC (K170363) and GXY (K171459) | Same |
| Indications for use | The Neurosteer EEG Recorder is<br>intended to record and store EEG<br>signals, and to present the EEG<br>signals in visual formats in real time.<br>The visual signals assist trained<br>medical staff to make neurological<br>diagnoses. The EEG Recorder does<br>not provide any diagnostic conclusion<br>about the subject's condition and<br>does not provide any automated<br>alerts of an adverse clinical event.<br>The EEG Recorder is intended to be<br>used in a professional healthcare<br>facility environment. | The Ceribell Pocket EEG Device is<br>intended to record and store EEG<br>signals, and to present the EEG<br>signals in visual and audible formats<br>in real time. The visual and audible<br>signals assist trained medical staff to<br>make neurological diagnoses. The<br>Pocket EEG Device does not provide<br>any diagnostic conclusion about the<br>subject's condition and does not<br>provide any automated alerts of an<br>adverse clinical event. The Pocket<br>EEG Device is intended to be used in<br>a professional healthcare facility<br>environment.<br>The Ceribell Instant EEG Headband<br>is an electroencephalogram (EEG)<br>electrode array intended for single<br>patient use in the recording of EEGs<br>in patients of 6 years and older. The<br>Instant EEG Headband is intended for<br>prescription use in the home,<br>healthcare facility, or clinical research<br>environment. | Substantially equivalent |
| Attribute | Subject Device:<br>Neurosteer EEG Recorder | Predicate Devices: Ceribell Pocket<br>EEG Device (K170363) & Ceribell<br>Instant EEG Headband (K171459) | Comparison |
| System components | EEG electrodes with conductive hydrogel EEG sensor Portable EEG monitor to display EEG data in real time in visual format and transfer EEG recording files to cloud storage platform via internet connection Cloud storage platform Browser-based EEG viewing software | EEG electrodes with conductive gel EEG sensor (included in same housing as portable EEG monitor) Portable EEG monitor to display EEG data in real time in visual and auditory formats and transfer EEG recording files to a computer via wired connection Application-based EEG viewing software | Same |
| EEG specifications<br>[OMC] | | | |
| Montage | 10/20 | 10/20 | Same |
| Channels | 1 | 8 | Substantially equivalent |
| EEG presentation<br>format(s) | Visual only (raw EEG waveform, spectrogram, metrics and bar graph views) | Visual (raw EEG waveform) and auditory | Substantially equivalent |
| Data transfer<br>method(s) | Bluetooth 2.4 GHz and internet<br>connection (ethernet or Wi-Fi) | Wired micro-USB or wireless Wi-Fi<br>connection | Substantially equivalent |
| Data file format | Edf | Edf | Same |
| Type of use | Reusable | Reusable | Same |
| Power source | Lithium polymer battery –<br>rechargeable with 100-240 V AC<br>power adapter (device does not work<br>when connected to AC to recharge) | Lithium ion batteries - rechargeable<br>with 100-240 V AC power adapter<br>(device does not work when<br>connected to AC to recharge) | Same |
| Charging | Micro-USB charging cable; if<br>connected to a computer, all EEG<br>acquisition functions are automatically<br>disabled | Micro-USB charging cable; if<br>connected to a computer, all EEG<br>acquisition functions are automatically<br>disabled | Same |
| Cutaneous electrode<br>specifications [GXY] | | | |
| Electrode type | Passive silver/silver-chloride<br>(Ag/AgCl) | Passive silver/silver-chloride<br>(Ag/AgCl) | Same |
| Number / locations<br>of electrodes | 3 (Locations: Fp1, Fpz, Fp2) | 10 (Locations: Fp1, Fp2, F7, F8, T3,<br>T4, T5, T6, O1, O2) | Substantially equivalent |
| Conductive<br>electrolyte gel | Semi-solid hydrogel is included in a<br>layer integrated into each electrode<br>assembly. | Liquid gel is included in a packet gel<br>reservoir integrated into each<br>electrode assembly. User can apply<br>additional gel if needed. | Substantially equivalent |
| Patient contact | Patient forehead (intact skin) | Patient scalp and forehead (intact<br>skin) | Same |
| Securing method | Integrated adhesive layer | Spandex blend fabric headband | Substantially equivalent |
| Available sizes and<br>dimensions | One size (10.5 cm) | Small (48.4 - 53.6 cm)<br>Medium (53.3 – 56.5 cm)<br>Large (55.5 - 62 cm) | Substantially equivalent |
| Type of use | Single use, non-sterile, disposable | Single use, non-sterile, disposable | Same |
| Connector | Integrated single-cable connector to<br>connect to an EEG recording device | Integrated single-cable connector to<br>connect to an EEG recording device | Same |
| Compatibility | Compatible with the Neurosteer EEG<br>Recorder only | Compatible with the Ceribell Pocket<br>EEG Device only | Both the subject and<br>predicate device are<br>intended to connect to<br>external EEG recording<br>devices |
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## Performance Data
The following test data were submitted in support of substantial equivalence. All tests showed passing results.
| Test | Test Method Summary | Results |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | The Electrode Strip was assessed in accordance with ISO 10993-1<br>and was tested in its final finished form for the following endpoints:<br>- Cytotoxicity (ISO MEM elution method per ISO 10993-5:2009);<br>- Irritation (rabbit irritation test per ISO 10993-10:2010);<br>- Sensitization (guinea pig maximization per ISO 10993-10:2010) | All samples passed the<br>acceptance criteria. The<br>subject device is as safe as<br>the predicates with respect to<br>biocompatibility. |
| Electrical Safety | Electrical safety testing was performed on the final finished<br>Electrode Strip, Sensor, and Brain Activity Monitor, including the<br>charger for the Sensor and the power adaptor for the Brain Activity<br>Monitor. Testing was performed in accordance with IEC 60601-1. | All samples passed the<br>acceptance criteria. The<br>subject device is as safe as<br>the predicates with respect to<br>electrical safety. |
| Electromagnetic<br>Compatibility<br>(EMC) | Electromagnetic compatibility, emissions and immunity testing was<br>performed on the final finished Electrode Strip and Sensor. Testing<br>was performed in accordance with IEC 60601-1-2. The test also<br>included conformance to ETSI EN 301 489-1. | All samples passed the<br>acceptance criteria for each<br>test. The subject device is as<br>safe as the predicates with<br>respect to EMC. |
| Battery Safety | The Sensor's rechargeable lithium-ion polymer battery was tested<br>in accordance with IEC 62133. The battery is not modified in any<br>way for the Neurosteer EEG Recorder, so the testing was<br>performed using samples from the original battery manufacturer. | All samples passed the<br>acceptance criteria. The<br>subject device is as safe as<br>the predicates with respect to<br>battery safety. |
| EEG Essential<br>Performance | The essential performance of the Neurosteer EEG Recorder's<br>EEG components (i.e., Sensor and Brain Activity Monitor) was<br>assessed via IEC 80601-2-26. | All samples passed the<br>acceptance criteria. The<br>subject device is as effective<br>as the predicates with respect<br>to EEG performance. |
| Electrode<br>Performance | The performance of the Electrode Strip was assessed via<br>ANSI/AAMI EC12 in accordance with the clauses and acceptance<br>criteria shown below. The test samples were final finished<br>Electrode Strips. An off-the-shelf, standard industry electrode was<br>used as a reference comparator. | All samples passed the<br>acceptance criteria. The<br>subject device is as effective<br>as the predicates with respect<br>to electrode performance. |
| | EC12 Clause / Test Description | Acceptance Criteria |
| | 5.2.2.1 (AC Impedance): AC impedance<br>of electrode pairs of Electrode Strip<br>connected hydrogel-to-hydrogel | ≤3,000 ohm |
| | 5.2.2.2 (DC Offset Voltage): DC offset<br>voltage of electrode pairs of Electrode<br>Strip connected hydrogel-to-hydrogel<br>following a 1 min stabilization period | ≤100 mV |
| | 5.2.2.3 (Combined Offset Instability and<br>Internal Noise): Peak-to-peak passband<br>voltage measured between electrode<br>pairs of Electrode Strip connected<br>hydrogel-to-hydrogel measured for a 5<br>min period following a 1 min stabilization | ≤150 uV |
| | 5.2.2.4 (Defibrillation Overload<br>Recovery): DC offset voltage and AC<br>impedance of electrode pairs of<br>Electrode Strip connected gel-to-gel<br>following 4 simulated defibrillation<br>discharge events | · Discharge time to 2V<br>≤2,000ms<br>· Recovery to <200mV<br>· Electrode voltage<br>decreases at rate<br><1mV/s |
| | 5.2.2.5 (Bias Current Tolerance): DC<br>offset voltage of electrode pairs of<br>Electrode Strip connected gel-to-gel over<br>the course of 8 hours with an applied<br>bias current of 200 nA | ≤100 mV |
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## Conclusions
The Neurosteer EEG Recorder has the same intended use and similar indications for use, technological characteristics, and principles of operation as the predicate devices. The minor technological differences between the Neurosteer EEG Recorder and its predicate devices raise no new or different questions of safety or effectiveness. Performance data demonstrate that the Neurosteer EEG Recorder is as safe and effective as the predicate devices. Thus, the Neurosteer EEG Recorder is substantially equivalent.
