Ceribell Instant EEG Headband

K171459 · Ceribell, Inc. · GXY · Aug 21, 2017 · Neurology

Device Facts

• Record ID: K171459
• Device Name: Ceribell Instant EEG Headband
• Applicant: Ceribell, Inc.
• Product Code: GXY · Neurology
• Decision Date: Aug 21, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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.

Device Story

Ceribell Instant EEG Headband is a single-use, disposable electrode array; designed exclusively for use with Ceribell Pocket EEG Device (K170363). Device consists of elastic fabric headband with 10 integrated passive Ag/AgCl electrodes; each electrode includes a reservoir of conductive electrolyte gel and scalp-contacting prongs to prepare skin. Device is applied to patient scalp by clinician or user; records EEG signals for transmission to the Pocket EEG Device. Provides EEG data for healthcare provider review; facilitates neurological monitoring in clinical or home environments. Benefits include rapid, simplified EEG setup compared to traditional electrode application.

Clinical Evidence

Bench testing only. Testing included electrode impedance, DC offset voltage, offset instability, internal noise, defibrillation overload recovery, bias current tolerance, gel delivery/skin prep, headband sizing, simulated use on mannequin heads, and packaging/shipping validation per ASTM D7386. Biocompatibility testing (cytotoxicity, irritation, sensitization) performed per ISO 10993-5 and ISO 10993-10.

Technological Characteristics

10 passive Ag/AgCl electrodes integrated on fabric substrate. Includes pre-filled conductive electrolyte gel reservoirs and scalp-contacting prongs. Single-cable connector for interface with Ceribell Pocket EEG Device. Non-sterile, disposable. Biocompatibility per ISO 10993-5/10. Electrical performance per ANSI/AAMI EC12.

Indications for Use

Indicated for EEG recording in patients 6 years and older. Intended for prescription use in home, healthcare facility, or clinical research settings.

Regulatory Classification

Identification

A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

Predicate Devices

• Hydrodot Statnet EEG Headpiece (K092828)

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 21, 2017

Ceribell, Inc. Josef Parvizi, MD, PhD Chairman 2483 Old Middlefield Wav. Suite 120 Mountain View, California 94043

Re: K171459

Trade/Device Name: Ceribell Instant EEG Headband Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: July 25, 2017 Received: July 27, 2017

Dear Dr. Parvizi:

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. 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

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Michael J. Hoffmann -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K171459

Device Name Ceribell Instant EEG Headband

Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------------------------------------------------------|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> |
| <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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# 510(K) SUMMARY

This summary of 510(k)- safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

# Applicant Information:

Ceribell, Inc. 2483 Old Middlefield Way Suite 120 Mountain View, California

## Contact Person:

Josef Parvizi, MD, PhD, Chairman Telephone: [phone] E-mail: [e-mail]

### Device Information:

| Trade Name: | Ceribell Instant EEG Headband |
|----------------------|--------------------------------------|
| Common Name: | Cutaneous electrode |
| Classification Name: | Cutaneous electrode (21CFR 882.1320) |
| Device Class: | II |
| Product Code: | GXY |

# Predicate Devices:

Hydrodot Statnet EEG Headpiece (K092828).

### Date Prepared:

August 17, 2017

### Device Description:

The Ceribell Instant EEG Headband is a 10 electrode EEG headband is non-sterile and disposable for single patient use and designed to be used exclusively with the Ceribell Pocket EEG Device (K170363) for EEG acquisition and recording.

The Ceribell Instant EEG Headband is comprised of the following components:

- An elastic fabric headband
- A cable attached to the headband to allow connection to an EEG acquisition/recording device
- 10 electrode assemblies, each consisting of the following: ●
- o Passive Silver/silver-chloride electrode
- o Reservoir filled with conductive electrolyte gel
- Mechanism for dispensing gel onto patient scalp O
- Scalp-contacting prongs to prepare scalp for electrode contact o

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## Indications for Use:

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.

### Comparison of Intended Use and Technological Characteristics with the Predicate Devices:

The subject and the predicate device share the same intended use: an integrated array of cutaneous electrodes intended for the recording of EEG signals. The characteristics of the subject device and the predicate device are summarized in the following table.

| Attribute | Predicate Device<br>Hydrodot StatNet EEG<br>Headpiece (K092828) | Subject Device<br>Ceribell Instant EEG<br>Headband | Substantially Equivalence |
|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | A single-use disposable<br>headpiece with an integrated<br>array of 17 passive<br>cutaneous electrodes that are<br>applied to the patient's head<br>to record EEG signals when<br>connected to an EEG<br>recording device. | A single-use disposable<br>headpiece with an integrated<br>array of 10 passive<br>cutaneous electrodes that are<br>applied to the patient's head<br>to record EEG signals when<br>connected to an EEG<br>recording device. | • The subject device and predicate<br>device all both intended for use as<br>single use, disposable, passive<br>cutaneous electrodes applied to the<br>patient's head to record EEG signals.<br>• The difference in number of electrodes<br>does not raise any new or different<br>questions of safety or effectiveness |
| Classification<br>Regulation | Class II per 21CFR882.1320,<br>cutaneous electrode | Class II per 21CFR882.1320,<br>cutaneous electrode | Same as predicate. |
| Product Code | GXY, Electrode, cutaneous | GXY, Electrode, cutaneous | Same as predicate. |
| Type of Patient<br>Contact | Contacts patient scalp | Contacts patient scalp | Same as predicate. |
| Type of use | Single use, non-sterile,<br>disposable. | Single use, non-sterile,<br>disposable. | Same as predicate. |
| System<br>Components,<br>Technological<br>Features, and<br>Materials | • 17 silver/silver-chloride<br>(Ag/AgCl) electrodes<br>• Foam gel reservoir<br>sponges pre-filled with<br>conductive electrolyte gel<br>• Electrodes integrated on a<br>plastic film substrate<br>• Integrated single-cable<br>connector to connect to an<br>EEG recording device | • 10 silver/silver-chloride<br>(Ag/AgCl) electrodes<br>• Packet gel reservoirs pre-<br>filled with conductive<br>electrolyte gel<br>• Electrodes integrated on a<br>fabric substrate<br>• Integrated single-cable<br>connector to connect to an<br>EEG recording device | • The technological features of the<br>subject device and predicate device<br>are substantially equivalent.<br>• Both devices include integrated pre-<br>filled containers of conductive<br>electrolyte gel.<br>• Both devices contain electrodes<br>integrated onto a substrate for<br>application onto the patient's head.<br>• Both devices include an integrated<br>single-cable connector to connect to<br>an EEG recording device.<br>• The differences in system<br>components, technological features,<br>and materials do not raise any new or<br>different questions of safety or<br>effectiveness. |
| Attribute | Predicate Device<br>Hydrodot StatNet EEG<br>Headpiece (K092828) | Subject Device<br>Ceribell Instant EEG<br>Headband | Substantially Equivalence |
| Electrodes | 17 passive Ag/AgCl<br>electrodes | 10 passive Ag/AgCl<br>electrodes | • Both the subject device and the<br>predicate device contain integrated<br>Ag/AgCl electrodes intended to be<br>applied to the patient's scalp and<br>provide coverage of both left and right<br>hemispheres of the patient's head<br>• The difference in number of electrodes<br>does not raise any new or different<br>questions of safety or effectiveness |
| Connector | Integrated single-cable<br>connector to connect to an<br>EEG recording device | Integrated single-cable<br>connector to connect to an<br>EEG recording device | Same as predicate. |
| Compatibility | Can connect to various EEG<br>devices using included<br>custom adapter cable. | Compatible with the Ceribell<br>Pocket EEG Device only. | • Both the subject device and the<br>predicate device are intended to be<br>connected to external EEG recording<br>devices.<br>• The difference in EEG recording<br>device compatibility does not raise any<br>new or different questions of safety or<br>effectiveness. |
| Available<br>Sizes and<br>Dimensions | Large (56 – 62 cm)<br>Medium (50 - 56 cm) | Small (48.4 – 53.6 cm)<br>Medium (53.3 - 56.5 cm)<br>Large (55.5 - 62 cm) | • The subject device and predicate<br>device are sized to encompass the<br>range of expected head sizes for their<br>intended patient population; and the<br>maximum head size for both devices<br>is the same.<br>• The differences in headband size<br>range do not raise any new or different<br>questions of safety or effectiveness. |
| Conductive<br>Electrolyte Gel | Electrodes are pre-filled with<br>an electrolyte gel filled<br>sponge adhered to each<br>electrode. | Conductive electrolyte gel is<br>included in a packet gel<br>reservoir integrated into each<br>electrode assembly. User is<br>also able to add additional<br>electrolyte gel when needed<br>using a syringe. | • The pre-filled conductive electrolyte<br>gel components in the subject device<br>and predicate device are substantially<br>equivalent.<br>• The differences in electrolyte gel<br>application do not raise any new or<br>different questions of safety or<br>effectiveness. |
| Bio-<br>compatibility | Biocompatibility of patient<br>contacting components<br>verified with Irritation,<br>Sensitization, and Cytotoxicity<br>testing per ISO 10993-5:2009<br>and ISO 10993-10:2010 | Biocompatibility of patient<br>contacting components<br>verified with Irritation,<br>Sensitization, and Cytotoxicity<br>testing per ISO 10993-5:2009<br>and ISO 10993-10:2010 | Same as predicate. |

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# Performance Data:

The following table summarizes test data that were provided to demonstrate safety and efficacy in support of a substantial equivalence determination. All of the performance testing described below was performed on the subject device.

| Test | Test Description | Test Results |
|---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Electrode<br>Impedance | AC impedance of electrode pairs of<br>subject device connected gel-to-gel<br>using the test methodology and<br>acceptance criteria of ANSI/AAMI EC12<br>5.2.2.1. | All samples passed. The test results do not<br>raise any new or different questions of<br>safety or effectiveness |
| Electrode DC<br>Offset Voltage | DC offset voltage of electrode pairs of<br>subject device connected gel-to-gel<br>following a 1 min stabilization period<br>using the test methodology and<br>acceptance criteria of ANSI/AAMI EC12<br>5.2.2.2. | All samples passed. The test results do not<br>raise any new or different questions of<br>safety or effectiveness |
| Combined<br>Offset<br>Instability and<br>Internal Noise | Peak-to-peak passband voltage<br>measured between electrode pairs of<br>subject device connected gel-to-gel<br>measured for a 5 min period following a<br>1 min stabilization using the test<br>methodology and acceptance criteria of<br>ANSI/AAMI EC12 5.2.2.3 | All samples passed. The test results do not<br>raise any new or different questions of<br>safety or effectiveness |
| Defibrillation<br>Overload<br>Recovery | DC offset voltage and AC impedance of<br>electrode pairs of subject device<br>connected gel-to-gel following 4<br>simulated defibrillation discharge events<br>using the test methodology and<br>acceptance criteria of ANSI/AAMI EC12<br>5.2.2.4 | All samples passed. The test results do not<br>raise any new or different questions of<br>safety or effectiveness |
| Bias Current<br>Tolerance | DC offset voltage of electrode pairs of<br>subject device connected gel-to-gel over<br>the course of 8 hours with an applied<br>bias current of 200 nA using the test<br>methodology and acceptance criteria of<br>ANSI/AAMI EC12 5.2.2.5. | All samples passed. The test results do not<br>raise any new or different questions of<br>safety or effectiveness |
| Conductive Gel<br>Delivery/Skin<br>Prep Testing | Subject devices are functionally tested<br>to verify that integrated conductive gel<br>can be dispensed, additional gel can be<br>added by the user, and aluminum oxide<br>powder is present on the scalp<br>contacting surfaces. | All samples passed. The test results do not<br>raise any new or different questions of<br>safety or effectiveness |
| Headband Size<br>Range Testing | Headband size ranges of subject<br>devices measured with calibrated ruler. | All samples passed. The test results do not<br>raise any new or different questions of<br>safety or effectiveness |
| Simulated Use<br>Testing | Small, medium, and large size subject<br>devices tested under simulated use<br>conditions using mannequin heads with<br>long hair. | All samples passed. The test results do not<br>raise any new or different questions of<br>safety or effectiveness |
| Test | Test Description | Test Results |
| Packaging<br>Performance<br>Testing | Subject devices packaging subjected to<br>environmental conditioning and shipping<br>test per ASTM D7386. After<br>environmental conditioning and<br>shipping, devices were visually<br>inspected, functionally tested under<br>simulated use conditions, and<br>electrically tested. | All samples passed. The test results do not<br>raise any new or different questions of<br>safety or effectiveness |
| Biocompatibility<br>Testing | Patient contacting materials used in<br>subject device subjected to<br>biocompatibility testing for devices that<br>contact surface/intact skin for limited<br>duration (< 24 hours). Cytotoxicity<br>testing conducted per ISO 10993-5;<br>Irritation and Sensitization testing<br>conducted per ISO 10993-10. | All samples passed. The test results do not<br>raise any new or different questions of<br>safety or effectiveness |

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## Summary:

The Ceribell Instant EEG Headband has the same intended use as the predicate device. In addition, it has similar technological characteristics; performance data demonstrates that any differences in technological characteristics do not raise different questions of safety or effectiveness. Therefore, the Ceribell Instant EEG Headband is substantially equivalent to the cleared predicate device.