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 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.

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.

AI/ML Overview

For the Neurosteer EEG Recorder (K221563), the acceptance criteria and the study proving the device meets these criteria are outlined below, primarily focusing on its technical performance rather than a diagnostic accuracy study involving human readers. This device is an EEG recorder, not a diagnostic AI tool, and thus the performance evaluation is centered on its ability to accurately record and present EEG signals.

1. Table of Acceptance Criteria and Reported Device Performance

The Neurosteer EEG Recorder's performance was assessed against established standards for EEG devices and electrodes. The table below summarizes the key acceptance criteria and the corresponding reported performance.

Test Category	Specific Test / EC12 Clause	Acceptance Criteria	Reported Device Performance
Biocompatibility	ISO 10993-1 (Cytotoxicity, Irritation, Sensitization)	All endpoints (Cytotoxicity, Irritation, Sensitization) within acceptable limits.	All samples passed the acceptance criteria.
Electrical Safety	IEC 60601-1 (on Electrode Strip, Sensor, Brain Activity Monitor, charger, power adapter)	All electrical safety parameters within acceptable limits.	All samples passed the acceptance criteria.
Electromagnetic Compatibility (EMC)	IEC 60601-1-2 and ETSI EN 301 489-1 (on Electrode Strip and Sensor)	All EMC emissions and immunity parameters within acceptable limits.	All samples passed the acceptance criteria for each test.
Battery Safety	IEC 62133 (Sensor's rechargeable lithium-ion polymer battery)	All battery safety parameters within acceptable limits.	All samples passed the acceptance criteria.
EEG Essential Performance	IEC 80601-2-26 (on Sensor and Brain Activity Monitor)	All essential EEG performance parameters within acceptable limits.	All samples passed the acceptance criteria.
Electrode Performance (ANSI/AAMI EC12)
	5.2.2.1 (AC Impedance of electrode pairs)	≤ 3,000 ohm	All samples passed the acceptance criteria.
	5.2.2.2 (DC Offset Voltage of electrode pairs)	≤ 100 mV (following a 1 min stabilization period)	All samples passed the acceptance criteria.
	5.2.2.3 (Combined Offset Instability and Internal Noise)	≤ 150 uV (peak-to-peak passband voltage, measured for 5 min after 1 min stabilization)	All samples passed the acceptance criteria.
	5.2.2.4 (Defibrillation Overload Recovery)	- Discharge time to 2V ≤ 2,000ms - Recovery to < 200mV - Electrode voltage decreases at rate < 1mV/s	All samples passed the acceptance criteria.
	5.2.2.5 (Bias Current Tolerance)	≤ 100 mV (DC offset voltage over 8 hours with 200 nA applied bias current)	All samples passed the acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a numerical "sample size" in terms of number of patients or recordings for the performance data. Instead, it indicates that "All samples" passed the acceptance criteria for each test. For tests like Biocompatibility, Electrical Safety, EMC, Battery Safety, and EEG Essential Performance, the "samples" would typically refer to a statistically representative number of manufactured units or components tested according to the specific standard's requirements. For Electrode Performance (ANSI/AAMI EC12), the samples were "final finished Electrode Strips," implying multiple strips were tested.

Test Set Sample Size: Not explicitly stated as a number of patients or EEG recordings. For physical and electrical tests, it refers to "samples" of the device components (Electrode Strip, Sensor, Brain Activity Monitor, battery) or the entire device.
Data Provenance: The tests were conducted according to recognized international and national standards (e.g., ISO 10993-1, IEC 60601-1, IEC 60601-1-2, IEC 62133, IEC 80601-2-26, ANSI/AAMI EC12). This indicates the testing was performed in a controlled, standardized environment, likely by accredited testing laboratories. The document does not specify country of origin for the data, nor does it distinguish between retrospective or prospective, as these are technical performance tests on the device itself rather than clinical studies on patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not applicable and not provided in the document. The Neurosteer EEG Recorder is intended to record and present EEG signals for trained medical staff to make diagnoses. It does not provide any diagnostic conclusion itself. Therefore, its performance evaluation is based on technical specifications and adherence to standards for signal integrity and electrical safety, not on diagnostic accuracy against a ground truth established by medical experts for specific clinical conditions.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Given that the performance data pertain to technical compliance with standards (e.g., impedance, voltage, safety parameters), there is no adjudication process involving human interpretation or consensus for a "test set" in the diagnostic sense. The results are objective measurements against defined numerical thresholds.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not conducted and is not applicable for this device. The Neurosteer EEG Recorder is not an AI diagnostic tool that assists human readers. Its function is to acquire and display EEG signals. The document explicitly states: "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." Therefore, there is no human-in-the-loop performance to compare or improve with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

A standalone performance study focused on diagnostic accuracy of an algorithm was not done and is not applicable. The device's primary function is signal acquisition and presentation, not automated diagnosis or interpretation. The "data processing performed in the cloud transforms the raw electrical brain activity signal into a display representation of the signal," but this is for visualization, not automated diagnostic output.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of the Neurosteer EEG Recorder is primarily derived from objective technical standards and specifications. For instance:

For Biocompatibility, the ground truth is defined by the absence of toxicity, irritation, or sensitization as per ISO 10993-5 and -10.
For Electrical Safety, EMC, and Battery Safety, the ground truth is compliance with the limits and requirements specified in the respective IEC and ETSI standards.
For EEG Essential Performance and Electrode Performance, the ground truth is meeting the defined electrical and signal integrity parameters (e.g., AC impedance ≤ 3,000 ohm, DC offset voltage ≤ 100 mV) specified in standards like ANSI/AAMI EC12 and IEC 80601-2-26.

There is no "ground truth" derived from expert consensus, pathology, or outcomes data in the conventional sense of a diagnostic device, because this device does not provide diagnostic conclusions.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The Neurosteer EEG Recorder is not described as an AI/ML algorithm that requires a training set for diagnostic or predictive purposes. The "data processing performed in the cloud" is described as transforming raw signals into display representations, which typically involves signal processing techniques rather than machine learning requiring a training set in the AI sense.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no mention of a training set for an AI/ML algorithm in the context of this device.

Summary

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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)

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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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

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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:Neurosteer EEG Recorder	Predicate Devices: Ceribell PocketEEG Device (K170363) & CeribellInstant EEG Headband (K171459)	Comparison
Device class andregulation	Class II per 882.1400; 882.1320,	Class II per 882.1400 (K170363);882.1320 (K171459)	Same
Product codes	OMC and GXY	OMC (K170363) and GXY (K171459)	Same
Indications for use	The Neurosteer EEG Recorder isintended to record and store EEGsignals, and to present the EEGsignals in visual formats in real time.The visual signals assist trainedmedical staff to make neurologicaldiagnoses. The EEG Recorder doesnot provide any diagnostic conclusionabout the subject's condition anddoes not provide any automatedalerts of an adverse clinical event.The EEG Recorder is intended to beused in a professional healthcarefacility environment.	The Ceribell Pocket EEG Device isintended to record and store EEGsignals, and to present the EEGsignals in visual and audible formatsin real time. The visual and audiblesignals assist trained medical staff tomake neurological diagnoses. ThePocket EEG Device does not provideany diagnostic conclusion about thesubject's condition and does notprovide any automated alerts of anadverse clinical event. The PocketEEG Device is intended to be used ina professional healthcare facilityenvironment.The Ceribell Instant EEG Headbandis an electroencephalogram (EEG)electrode array intended for singlepatient use in the recording of EEGsin patients of 6 years and older. TheInstant EEG Headband is intended forprescription use in the home,healthcare facility, or clinical researchenvironment.	Substantially equivalent
Attribute	Subject Device:Neurosteer EEG Recorder	Predicate Devices: Ceribell PocketEEG Device (K170363) & CeribellInstant 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[OMC]
Montage	10/20	10/20	Same
Channels	1	8	Substantially equivalent
EEG presentationformat(s)	Visual only (raw EEG waveform, spectrogram, metrics and bar graph views)	Visual (raw EEG waveform) and auditory	Substantially equivalent
Data transfermethod(s)	Bluetooth 2.4 GHz and internetconnection (ethernet or Wi-Fi)	Wired micro-USB or wireless Wi-Ficonnection	Substantially equivalent
Data file format	Edf	Edf	Same
Type of use	Reusable	Reusable	Same
Power source	Lithium polymer battery –rechargeable with 100-240 V ACpower adapter (device does not workwhen connected to AC to recharge)	Lithium ion batteries - rechargeablewith 100-240 V AC power adapter(device does not work whenconnected to AC to recharge)	Same
Charging	Micro-USB charging cable; ifconnected to a computer, all EEGacquisition functions are automaticallydisabled	Micro-USB charging cable; ifconnected to a computer, all EEGacquisition functions are automaticallydisabled	Same
Cutaneous electrodespecifications [GXY]
Electrode type	Passive silver/silver-chloride(Ag/AgCl)	Passive silver/silver-chloride(Ag/AgCl)	Same
Number / locationsof electrodes	3 (Locations: Fp1, Fpz, Fp2)	10 (Locations: Fp1, Fp2, F7, F8, T3,T4, T5, T6, O1, O2)	Substantially equivalent
Conductiveelectrolyte gel	Semi-solid hydrogel is included in alayer integrated into each electrodeassembly.	Liquid gel is included in a packet gelreservoir integrated into eachelectrode assembly. User can applyadditional gel if needed.	Substantially equivalent
Patient contact	Patient forehead (intact skin)	Patient scalp and forehead (intactskin)	Same
Securing method	Integrated adhesive layer	Spandex blend fabric headband	Substantially equivalent
Available sizes anddimensions	One size (10.5 cm)	Small (48.4 - 53.6 cm)Medium (53.3 – 56.5 cm)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 toconnect to an EEG recording device	Integrated single-cable connector toconnect to an EEG recording device	Same
Compatibility	Compatible with the Neurosteer EEGRecorder only	Compatible with the Ceribell PocketEEG Device only	Both the subject andpredicate device areintended to connect toexternal EEG recordingdevices

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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 10993-1and was tested in its final finished form for the following endpoints:- Cytotoxicity (ISO MEM elution method per ISO 10993-5:2009);- Irritation (rabbit irritation test per ISO 10993-10:2010);- Sensitization (guinea pig maximization per ISO 10993-10:2010)	All samples passed theacceptance criteria. Thesubject device is as safe asthe predicates with respect tobiocompatibility.
Electrical Safety	Electrical safety testing was performed on the final finishedElectrode Strip, Sensor, and Brain Activity Monitor, including thecharger for the Sensor and the power adaptor for the Brain ActivityMonitor. Testing was performed in accordance with IEC 60601-1.	All samples passed theacceptance criteria. Thesubject device is as safe asthe predicates with respect toelectrical safety.
ElectromagneticCompatibility(EMC)	Electromagnetic compatibility, emissions and immunity testing wasperformed on the final finished Electrode Strip and Sensor. Testingwas performed in accordance with IEC 60601-1-2. The test alsoincluded conformance to ETSI EN 301 489-1.	All samples passed theacceptance criteria for eachtest. The subject device is assafe as the predicates withrespect to EMC.
Battery Safety	The Sensor's rechargeable lithium-ion polymer battery was testedin accordance with IEC 62133. The battery is not modified in anyway for the Neurosteer EEG Recorder, so the testing wasperformed using samples from the original battery manufacturer.	All samples passed theacceptance criteria. Thesubject device is as safe asthe predicates with respect tobattery safety.
EEG EssentialPerformance	The essential performance of the Neurosteer EEG Recorder'sEEG components (i.e., Sensor and Brain Activity Monitor) wasassessed via IEC 80601-2-26.	All samples passed theacceptance criteria. Thesubject device is as effectiveas the predicates with respectto EEG performance.
ElectrodePerformance	The performance of the Electrode Strip was assessed viaANSI/AAMI EC12 in accordance with the clauses and acceptancecriteria shown below. The test samples were final finishedElectrode Strips. An off-the-shelf, standard industry electrode wasused as a reference comparator.	All samples passed theacceptance criteria. Thesubject device is as effectiveas the predicates with respectto electrode performance.
	EC12 Clause / Test Description	Acceptance Criteria
	5.2.2.1 (AC Impedance): AC impedanceof electrode pairs of Electrode Stripconnected hydrogel-to-hydrogel	≤3,000 ohm
	5.2.2.2 (DC Offset Voltage): DC offsetvoltage of electrode pairs of ElectrodeStrip connected hydrogel-to-hydrogelfollowing a 1 min stabilization period	≤100 mV
	5.2.2.3 (Combined Offset Instability andInternal Noise): Peak-to-peak passbandvoltage measured between electrodepairs of Electrode Strip connectedhydrogel-to-hydrogel measured for a 5min period following a 1 min stabilization	≤150 uV
	5.2.2.4 (Defibrillation OverloadRecovery): DC offset voltage and ACimpedance of electrode pairs ofElectrode Strip connected gel-to-gelfollowing 4 simulated defibrillationdischarge events	· Discharge time to 2V≤2,000ms· Recovery to <200mV· Electrode voltagedecreases at rate<1mV/s
	5.2.2.5 (Bias Current Tolerance): DCoffset voltage of electrode pairs ofElectrode Strip connected gel-to-gel overthe course of 8 hours with an appliedbias 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.

Regulation Number and Section

§ 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).