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 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:
- Passive Silver/silver-chloride electrode
- Reservoir filled with conductive electrolyte gel
- Mechanism for dispensing gel onto patient scalp
- Scalp-contacting prongs to prepare scalp for electrode contact

AI/ML Overview

The Ceribell Instant EEG Headband is a Class II medical device (product code GXY) intended for single-patient use in recording EEGs for patients aged 6 years and older. It is disposable, non-sterile, and designed to be used exclusively with the Ceribell Pocket EEG Device (K170363). The headband comprises an elastic fabric headband, a cable for connection to an EEG acquisition/recording device, and 10 electrode assemblies. Each electrode assembly contains a passive silver/silver-chloride electrode, a reservoir filled with conductive electrolyte gel, a mechanism for dispensing gel, and scalp-contacting prongs for scalp preparation.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (implied by standard)	Reported Device Performance
Electrode Impedance	Meets ANSI/AAMI EC12 5.2.2.1 requirements.	All samples passed.
Electrode DC Offset Voltage	Meets ANSI/AAMI EC12 5.2.2.2 requirements.	All samples passed.
Combined Offset Instability and Internal Noise	Meets ANSI/AAMI EC12 5.2.2.3 requirements. (Peak-to-peak passband voltage measured over 5 min after 1 min stabilization)	All samples passed.
Defibrillation Overload Recovery	Meets ANSI/AAMI EC12 5.2.2.4 requirements. (DC offset voltage and AC impedance after 4 simulated defibrillation discharge events)	All samples passed.
Bias Current Tolerance	Meets ANSI/AAMI EC12 5.2.2.5 requirements. (DC offset voltage over 8 hours with 200 nA bias current)	All samples passed.
Conductive Gel Delivery/Skin Prep Testing	• Integrated conductive gel can be properly dispensed. • Additional gel can be added by the user.• Aluminum oxide powder is present on scalp-contacting surfaces.	All samples passed.
Headband Size Range Testing	Measured headband sizes match specified ranges (Small, Medium, Large).	All samples passed.
Simulated Use Testing	Device functions correctly under simulated use conditions with mannequin heads (including long hair).	All samples passed.
Packaging Performance Testing	Device remains visually intact, functions, and performs electrically after environmental conditioning and shipping tests (per ASTM D7386).	All samples passed.
Biocompatibility Testing	• Cytotoxicity: Meets ISO 10993-5.• Irritation and Sensitization: Meets ISO 10993-10.	All samples passed.

2. Sample size used for the test set and the data provenance

The document does not explicitly state the specific sample sizes for each test in the performance data section. It consistently uses the phrase "All samples passed" for each test. The provenance of the data is that it was generated from performance testing conducted on the subject device (Ceribell Instant EEG Headband). The document does not specify the country of origin of the data or whether the studies were retrospective or prospective, though performance testing studies are typically prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable as the performance data presented primarily consists of engineering and biocompatibility testing against recognized standards (e.g., ANSI/AAMI EC12, ISO 10993) and functional verification tests. These tests do not involve expert interpretation or establishing ground truth in the way clinical studies with human assessors would.

4. Adjudication method for the test set

This section is not applicable for the same reasons above. The performance tests involve objective measurements against predefined criteria in established standards rather than subjective assessments requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The document does not indicate that an MRMC comparative effectiveness study was done. The device described is an EEG electrode array (cutaneous electrode), not an AI-powered diagnostic algorithm or analysis tool. Its purpose is for the recording of EEG signals, not their interpretation or analysis using AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable. The Ceribell Instant EEG Headband is a hardware device (electrode array) for signal acquisition, not a standalone algorithm.

7. The type of ground truth used

For the performance tests:

The "ground truth" or reference for the electrical performance tests (e.g., Impedance, DC Offset Voltage, Bias Current Tolerance, Defibrillation Overload Recovery, Combined Offset Instability and Internal Noise) was the specific requirements and methodologies outlined in the ANSI/AAMI EC12 standard.
For the biocompatibility tests, the ground truth was the specific requirements and methodologies outlined in ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization).
For functional tests (e.g., Conductive Gel Delivery/Skin Prep Testing, Headband Size Range Testing, Simulated Use Testing, Packaging Performance Testing), the ground truth was the pre-defined functional specifications and expected performance criteria established for the device.

8. The sample size for the training set

This section is not applicable. The Ceribell Instant EEG Headband is a hardware device (electrode array) and does not involve AI or machine learning algorithms that require a "training set" in the conventional sense.

9. How the ground truth for the training set was established

This section is not applicable as there is no training set mentioned for this hardware device.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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

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: (650) 521-7003 E-mail: josef@ceribell.com

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 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:

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 DeviceHydrodot StatNet EEGHeadpiece (K092828)	Subject DeviceCeribell Instant EEGHeadband	Substantially Equivalence
Intended Use	A single-use disposableheadpiece with an integratedarray of 17 passivecutaneous electrodes that areapplied to the patient's headto record EEG signals whenconnected to an EEGrecording device.	A single-use disposableheadpiece with an integratedarray of 10 passivecutaneous electrodes that areapplied to the patient's headto record EEG signals whenconnected to an EEGrecording device.	• The subject device and predicatedevice all both intended for use assingle use, disposable, passivecutaneous electrodes applied to thepatient's head to record EEG signals.• The difference in number of electrodesdoes not raise any new or differentquestions of safety or effectiveness
ClassificationRegulation	Class II per 21CFR882.1320,cutaneous electrode	Class II per 21CFR882.1320,cutaneous electrode	Same as predicate.
Product Code	GXY, Electrode, cutaneous	GXY, Electrode, cutaneous	Same as predicate.
Type of PatientContact	Contacts patient scalp	Contacts patient scalp	Same as predicate.
Type of use	Single use, non-sterile,disposable.	Single use, non-sterile,disposable.	Same as predicate.
SystemComponents,TechnologicalFeatures, andMaterials	• 17 silver/silver-chloride(Ag/AgCl) electrodes• Foam gel reservoirsponges pre-filled withconductive electrolyte gel• Electrodes integrated on aplastic film substrate• Integrated single-cableconnector to connect to anEEG recording device	• 10 silver/silver-chloride(Ag/AgCl) electrodes• Packet gel reservoirs pre-filled with conductiveelectrolyte gel• Electrodes integrated on afabric substrate• Integrated single-cableconnector to connect to anEEG recording device	• The technological features of thesubject device and predicate deviceare substantially equivalent.• Both devices include integrated pre-filled containers of conductiveelectrolyte gel.• Both devices contain electrodesintegrated onto a substrate forapplication onto the patient's head.• Both devices include an integratedsingle-cable connector to connect toan EEG recording device.• The differences in systemcomponents, technological features,and materials do not raise any new ordifferent questions of safety oreffectiveness.
Attribute	Predicate DeviceHydrodot StatNet EEGHeadpiece (K092828)	Subject DeviceCeribell Instant EEGHeadband	Substantially Equivalence
Electrodes	17 passive Ag/AgClelectrodes	10 passive Ag/AgClelectrodes	• Both the subject device and thepredicate device contain integratedAg/AgCl electrodes intended to beapplied to the patient's scalp andprovide coverage of both left and righthemispheres of the patient's head• The difference in number of electrodesdoes not raise any new or differentquestions of safety or effectiveness
Connector	Integrated single-cableconnector to connect to anEEG recording device	Integrated single-cableconnector to connect to anEEG recording device	Same as predicate.
Compatibility	Can connect to various EEGdevices using includedcustom adapter cable.	Compatible with the CeribellPocket EEG Device only.	• Both the subject device and thepredicate device are intended to beconnected to external EEG recordingdevices.• The difference in EEG recordingdevice compatibility does not raise anynew or different questions of safety oreffectiveness.
AvailableSizes andDimensions	Large (56 – 62 cm)Medium (50 - 56 cm)	Small (48.4 – 53.6 cm)Medium (53.3 - 56.5 cm)Large (55.5 - 62 cm)	• The subject device and predicatedevice are sized to encompass therange of expected head sizes for theirintended patient population; and themaximum head size for both devicesis the same.• The differences in headband sizerange do not raise any new or differentquestions of safety or effectiveness.
ConductiveElectrolyte Gel	Electrodes are pre-filled withan electrolyte gel filledsponge adhered to eachelectrode.	Conductive electrolyte gel isincluded in a packet gelreservoir integrated into eachelectrode assembly. User isalso able to add additionalelectrolyte gel when neededusing a syringe.	• The pre-filled conductive electrolytegel components in the subject deviceand predicate device are substantiallyequivalent.• The differences in electrolyte gelapplication do not raise any new ordifferent questions of safety oreffectiveness.
Bio-compatibility	Biocompatibility of patientcontacting componentsverified with Irritation,Sensitization, and Cytotoxicitytesting per ISO 10993-5:2009and ISO 10993-10:2010	Biocompatibility of patientcontacting componentsverified with Irritation,Sensitization, and Cytotoxicitytesting per ISO 10993-5:2009and 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
ElectrodeImpedance	AC impedance of electrode pairs ofsubject device connected gel-to-gelusing the test methodology andacceptance criteria of ANSI/AAMI EC125.2.2.1.	All samples passed. The test results do notraise any new or different questions ofsafety or effectiveness
Electrode DCOffset Voltage	DC offset voltage of electrode pairs ofsubject device connected gel-to-gelfollowing a 1 min stabilization periodusing the test methodology andacceptance criteria of ANSI/AAMI EC125.2.2.2.	All samples passed. The test results do notraise any new or different questions ofsafety or effectiveness
CombinedOffsetInstability andInternal Noise	Peak-to-peak passband voltagemeasured between electrode pairs ofsubject device connected gel-to-gelmeasured for a 5 min period following a1 min stabilization using the testmethodology and acceptance criteria ofANSI/AAMI EC12 5.2.2.3	All samples passed. The test results do notraise any new or different questions ofsafety or effectiveness
DefibrillationOverloadRecovery	DC offset voltage and AC impedance ofelectrode pairs of subject deviceconnected gel-to-gel following 4simulated defibrillation discharge eventsusing the test methodology andacceptance criteria of ANSI/AAMI EC125.2.2.4	All samples passed. The test results do notraise any new or different questions ofsafety or effectiveness
Bias CurrentTolerance	DC offset voltage of electrode pairs ofsubject device connected gel-to-gel overthe course of 8 hours with an appliedbias current of 200 nA using the testmethodology and acceptance criteria ofANSI/AAMI EC12 5.2.2.5.	All samples passed. The test results do notraise any new or different questions ofsafety or effectiveness
Conductive GelDelivery/SkinPrep Testing	Subject devices are functionally testedto verify that integrated conductive gelcan be dispensed, additional gel can beadded by the user, and aluminum oxidepowder is present on the scalpcontacting surfaces.	All samples passed. The test results do notraise any new or different questions ofsafety or effectiveness
Headband SizeRange Testing	Headband size ranges of subjectdevices measured with calibrated ruler.	All samples passed. The test results do notraise any new or different questions ofsafety or effectiveness
Simulated UseTesting	Small, medium, and large size subjectdevices tested under simulated useconditions using mannequin heads withlong hair.	All samples passed. The test results do notraise any new or different questions ofsafety or effectiveness
Test	Test Description	Test Results
PackagingPerformanceTesting	Subject devices packaging subjected toenvironmental conditioning and shippingtest per ASTM D7386. Afterenvironmental conditioning andshipping, devices were visuallyinspected, functionally tested undersimulated use conditions, andelectrically tested.	All samples passed. The test results do notraise any new or different questions ofsafety or effectiveness
BiocompatibilityTesting	Patient contacting materials used insubject device subjected tobiocompatibility testing for devices thatcontact surface/intact skin for limitedduration (< 24 hours). Cytotoxicitytesting conducted per ISO 10993-5;Irritation and Sensitization testingconducted per ISO 10993-10.	All samples passed. The test results do notraise any new or different questions ofsafety 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.

Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
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.(b)
Classification. Class II (performance standards).