(146 days)
No
The summary explicitly states the device does not provide diagnostic conclusions or automated alerts, and the data processing is described as transforming the raw signal into a display representation, not using AI/ML for interpretation or analysis. There is no mention of AI, ML, or related terms in the document.
No
The device records and displays EEG signals to assist trained medical staff in making neurological diagnoses. It explicitly states that it "does not provide any diagnostic conclusion" and "does not provide any automated alerts of an adverse clinical event." Therefore, it is a diagnostic tool, not a therapeutic one.
No
The device is intended to record and present EEG signals to assist medical staff in making diagnoses, but it explicitly states that it "does not provide any diagnostic conclusion" and "does not provide any automated alerts of an adverse clinical event."
No
The device description explicitly details hardware components including an adhesive electrode strip, a sensing device, and a brain activity monitor, and performance studies were conducted on these hardware components.
Based on the provided information, the Neurosteer EEG Recorder is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Neurosteer EEG Recorder records electrical signals directly from the patient's forehead (intact skin). It does not analyze blood, urine, tissue, or other bodily fluids or substances.
- The intended use is to record and present EEG signals visually. While this information assists trained medical staff in making diagnoses, the device itself does not perform any analysis of a specimen to provide diagnostic information.
- The device explicitly states it "does not provide any diagnostic conclusion about the subject's condition". This is a key characteristic that differentiates it from an IVD, which is designed to provide information for diagnostic purposes based on the analysis of a specimen.
The Neurosteer EEG Recorder is a medical device used for physiological monitoring and recording of electrical activity from the brain. It falls under the category of devices that measure and display physiological signals from the body, rather than analyzing specimens in vitro.
N/A
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 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.
Product codes
OMC, GXY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical staff, professional healthcare facility environment.
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)
The following test data were submitted in support of substantial equivalence. All tests showed passing results.
- Biocompatibility: The Electrode Strip was assessed in accordance with ISO 10993-1 and 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 the acceptance criteria. The subject device is as safe as the predicates with respect to biocompatibility.
- Electrical Safety: Electrical safety testing was performed on the final finished Electrode Strip, Sensor, and Brain Activity Monitor, including the charger for the Sensor and the power adaptor for the Brain Activity Monitor. Testing was performed in accordance with IEC 60601-1. All samples passed the acceptance criteria. The subject device is as safe as the predicates with respect to electrical safety.
- Electromagnetic Compatibility (EMC): Electromagnetic compatibility, emissions and immunity testing was performed on the final finished Electrode Strip and Sensor. Testing was performed in accordance with IEC 60601-1-2. The test also included conformance to ETSI EN 301 489-1. All samples passed the acceptance criteria for each test. The subject device is as safe as the predicates with respect to EMC.
- Battery Safety: The Sensor's rechargeable lithium-ion polymer battery was tested in accordance with IEC 62133. The battery is not modified in any way for the Neurosteer EEG Recorder, so the testing was performed using samples from the original battery manufacturer. All samples passed the acceptance criteria. The subject device is as safe as the predicates with respect to battery safety.
- EEG Essential Performance: The essential performance of the Neurosteer EEG Recorder's EEG components (i.e., Sensor and Brain Activity Monitor) was assessed via IEC 80601-2-26. All samples passed the acceptance criteria. The subject device is as effective as the predicates with respect to EEG performance.
- Electrode Performance: The performance of the Electrode Strip was assessed via ANSI/AAMI EC12 in accordance with the clauses and acceptance criteria shown below. The test samples were final finished Electrode Strips. An off-the-shelf, standard industry electrode was used as a reference comparator. All samples passed the acceptance criteria. The subject device is as effective as the predicates with respect to electrode performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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October 24, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name. The logo is simple and professional, reflecting the agency's role in protecting public health.
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
1
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
2
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) |
|---|
| ------------------------------------------------- |
| 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
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.
4
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:
Neurosteer EEG Recorder | Predicate Devices: Ceribell Pocket
EEG Device (K170363) & Ceribell
Instant EEG Headband (K171459) | Comparison |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| Device class and
regulation | 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 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. | The Ceribell Pocket EEG Device is
intended to record and store EEG
signals, and to present the EEG
signals in visual and audible formats
in real time. The visual and audible
signals assist trained medical staff to
make neurological diagnoses. The
Pocket EEG Device does not provide
any diagnostic conclusion about the
subject's condition and does not
provide any automated alerts of an
adverse clinical event. The Pocket
EEG Device is intended to be used in
a professional healthcare facility
environment.
The Ceribell Instant EEG Headband
is an electroencephalogram (EEG)
electrode array intended for single
patient use in the recording of EEGs
in patients of 6 years and older. The
Instant EEG Headband is intended for
prescription use in the home,
healthcare facility, or clinical research
environment. | Substantially equivalent |
| Attribute | Subject Device:
Neurosteer EEG Recorder | Predicate Devices: Ceribell Pocket
EEG Device (K170363) & Ceribell
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
[OMC] | | | |
| Montage | 10/20 | 10/20 | Same |
| Channels | 1 | 8 | Substantially equivalent |
| EEG presentation
format(s) | Visual only (raw EEG waveform, spectrogram, metrics and bar graph views) | Visual (raw EEG waveform) and auditory | Substantially equivalent |
| Data transfer
method(s) | Bluetooth 2.4 GHz and internet
connection (ethernet or Wi-Fi) | Wired micro-USB or wireless Wi-Fi
connection | Substantially equivalent |
| Data file format | Edf | Edf | Same |
| Type of use | Reusable | Reusable | Same |
| Power source | Lithium polymer battery –
rechargeable with 100-240 V AC
power adapter (device does not work
when connected to AC to recharge) | Lithium ion batteries - rechargeable
with 100-240 V AC power adapter
(device does not work when
connected to AC to recharge) | Same |
| Charging | Micro-USB charging cable; if
connected to a computer, all EEG
acquisition functions are automatically
disabled | Micro-USB charging cable; if
connected to a computer, all EEG
acquisition functions are automatically
disabled | Same |
| Cutaneous electrode
specifications [GXY] | | | |
| Electrode type | Passive silver/silver-chloride
(Ag/AgCl) | Passive silver/silver-chloride
(Ag/AgCl) | Same |
| Number / locations
of electrodes | 3 (Locations: Fp1, Fpz, Fp2) | 10 (Locations: Fp1, Fp2, F7, F8, T3,
T4, T5, T6, O1, O2) | Substantially equivalent |
| Conductive
electrolyte gel | Semi-solid hydrogel is included in a
layer integrated into each electrode
assembly. | Liquid gel is included in a packet gel
reservoir integrated into each
electrode assembly. User can apply
additional gel if needed. | Substantially equivalent |
| Patient contact | Patient forehead (intact skin) | Patient scalp and forehead (intact
skin) | Same |
| Securing method | Integrated adhesive layer | Spandex blend fabric headband | Substantially equivalent |
| Available sizes and
dimensions | 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 to
connect to an EEG recording device | Integrated single-cable connector to
connect to an EEG recording device | Same |
| Compatibility | Compatible with the Neurosteer EEG
Recorder only | Compatible with the Ceribell Pocket
EEG Device only | Both the subject and
predicate device are
intended to connect to
external EEG recording
devices |
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6
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 | |
| and 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 the
acceptance criteria. The
subject device is as safe as
the predicates with respect to
biocompatibility. |
| Electrical Safety | Electrical safety testing was performed on the final finished
Electrode Strip, Sensor, and Brain Activity Monitor, including the
charger for the Sensor and the power adaptor for the Brain Activity
Monitor. Testing was performed in accordance with IEC 60601-1. | All samples passed the
acceptance criteria. The
subject device is as safe as
the predicates with respect to
electrical safety. |
| Electromagnetic
Compatibility
(EMC) | Electromagnetic compatibility, emissions and immunity testing was
performed on the final finished Electrode Strip and Sensor. Testing
was performed in accordance with IEC 60601-1-2. The test also
included conformance to ETSI EN 301 489-1. | All samples passed the
acceptance criteria for each
test. The subject device is as
safe as the predicates with
respect to EMC. |
| Battery Safety | The Sensor's rechargeable lithium-ion polymer battery was tested
in accordance with IEC 62133. The battery is not modified in any
way for the Neurosteer EEG Recorder, so the testing was
performed using samples from the original battery manufacturer. | All samples passed the
acceptance criteria. The
subject device is as safe as
the predicates with respect to
battery safety. |
| EEG Essential
Performance | The essential performance of the Neurosteer EEG Recorder's
EEG components (i.e., Sensor and Brain Activity Monitor) was
assessed via IEC 80601-2-26. | All samples passed the
acceptance criteria. The
subject device is as effective
as the predicates with respect
to EEG performance. |
| Electrode
Performance | The performance of the Electrode Strip was assessed via
ANSI/AAMI EC12 in accordance with the clauses and acceptance
criteria shown below. The test samples were final finished
Electrode Strips. An off-the-shelf, standard industry electrode was
used as a reference comparator. | All samples passed the
acceptance criteria. The
subject device is as effective
as the predicates with respect
to electrode performance. |
| | EC12 Clause / Test Description | Acceptance Criteria |
| | 5.2.2.1 (AC Impedance): AC impedance
of electrode pairs of Electrode Strip
connected hydrogel-to-hydrogel | ≤3,000 ohm |
| | 5.2.2.2 (DC Offset Voltage): DC offset
voltage of electrode pairs of Electrode
Strip connected hydrogel-to-hydrogel
following a 1 min stabilization period | ≤100 mV |
| | 5.2.2.3 (Combined Offset Instability and
Internal Noise): Peak-to-peak passband
voltage measured between electrode
pairs of Electrode Strip connected
hydrogel-to-hydrogel measured for a 5
min period following a 1 min stabilization | ≤150 uV |
| | 5.2.2.4 (Defibrillation Overload
Recovery): DC offset voltage and AC
impedance of electrode pairs of
Electrode Strip connected gel-to-gel
following 4 simulated defibrillation
discharge events | · Discharge time to 2V
≤2,000ms
· Recovery to