Who is the manufacturer of Ceribell Instant EEG Headband?

Ceribell, Inc. filed the 510(k) submission for Ceribell Instant EEG Headband (K171459).

What is the FDA product code for Ceribell Instant EEG Headband?

GXY. It is classified under 21 CFR 882.1320 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Ceribell Instant EEG Headband?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Ceribell Instant EEG Headband?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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

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.

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)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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 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 {4}------------------------------------------------ ## 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 Hydrodot StatNet EEG Headpiece (K092828) | Subject Device Ceribell Instant EEG Headband | Substantially Equivalence | |----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | A single-use disposable headpiece with an integrated array of 17 passive cutaneous electrodes that are applied to the patient's head to record EEG signals when connected to an EEG recording device. | A single-use disposable headpiece with an integrated array of 10 passive cutaneous electrodes that are applied to the patient's head to record EEG signals when connected to an EEG recording device. | • The subject device and predicate device all both intended for use as single use, disposable, passive cutaneous electrodes applied to the patient's head to record EEG signals. • The difference in number of electrodes does not raise any new or different questions of safety or effectiveness | | Classification Regulation | 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 Patient Contact | 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. | | System Components, Technological Features, and Materials | • 17 silver/silver-chloride (Ag/AgCl) electrodes • Foam gel reservoir sponges pre-filled with conductive electrolyte gel • Electrodes integrated on a plastic film substrate • Integrated single-cable connector to connect to an EEG recording device | • 10 silver/silver-chloride (Ag/AgCl) electrodes • Packet gel reservoirs pre- filled with conductive electrolyte gel • Electrodes integrated on a fabric substrate • Integrated single-cable connector to connect to an EEG recording device | • The technological features of the subject device and predicate device are substantially equivalent. • Both devices include integrated pre- filled containers of conductive electrolyte gel. • Both devices contain electrodes integrated onto a substrate for application onto the patient's head. • Both devices include an integrated single-cable connector to connect to an EEG recording device. • The differences in system components, technological features, and materials do not raise any new or different questions of safety or effectiveness. | | Attribute | Predicate Device Hydrodot StatNet EEG Headpiece (K092828) | Subject Device Ceribell Instant EEG Headband | Substantially Equivalence | | Electrodes | 17 passive Ag/AgCl electrodes | 10 passive Ag/AgCl electrodes | • Both the subject device and the predicate device contain integrated Ag/AgCl electrodes intended to be applied to the patient's scalp and provide coverage of both left and right hemispheres of the patient's head • The difference in number of electrodes does not raise any new or different questions of safety or effectiveness | | Connector | Integrated single-cable connector to connect to an EEG recording device | Integrated single-cable connector to connect to an EEG recording device | Same as predicate. | | Compatibility | Can connect to various EEG devices using included custom adapter cable. | Compatible with the Ceribell Pocket EEG Device only. | • Both the subject device and the predicate device are intended to be connected to external EEG recording devices. • The difference in EEG recording device compatibility does not raise any new or different questions of safety or effectiveness. | | Available Sizes and Dimensions | 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 predicate device are sized to encompass the range of expected head sizes for their intended patient population; and the maximum head size for both devices is the same. • The differences in headband size range do not raise any new or different questions of safety or effectiveness. | | Conductive Electrolyte Gel | Electrodes are pre-filled with an electrolyte gel filled sponge adhered to each electrode. | Conductive electrolyte gel is included in a packet gel reservoir integrated into each electrode assembly. User is also able to add additional electrolyte gel when needed using a syringe. | • The pre-filled conductive electrolyte gel components in the subject device and predicate device are substantially equivalent. • The differences in electrolyte gel application do not raise any new or different questions of safety or effectiveness. | | Bio- compatibility | Biocompatibility of patient contacting components verified with Irritation, Sensitization, and Cytotoxicity testing per ISO 10993-5:2009 and ISO 10993-10:2010 | Biocompatibility of patient contacting components verified with Irritation, Sensitization, and Cytotoxicity testing per ISO 10993-5:2009 and ISO 10993-10:2010 | Same as predicate. | {5}------------------------------------------------ ______________________________________________________________________________________________________________________________________________________________________________ {6}------------------------------------------------ # 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 Impedance | AC impedance of electrode pairs of subject device connected gel-to-gel using the test methodology and acceptance criteria of ANSI/AAMI EC12 5.2.2.1. | All samples passed. The test results do not raise any new or different questions of safety or effectiveness | | Electrode DC Offset Voltage | DC offset voltage of electrode pairs of subject device connected gel-to-gel following a 1 min stabilization period using the test methodology and acceptance criteria of ANSI/AAMI EC12 5.2.2.2. | All samples passed. The test results do not raise any new or different questions of safety or effectiveness | | Combined Offset Instability and Internal Noise | Peak-to-peak passband voltage measured between electrode pairs of subject device connected gel-to-gel measured for a 5 min period following a 1 min stabilization using the test methodology and acceptance criteria of ANSI/AAMI EC12 5.2.2.3 | All samples passed. The test results do not raise any new or different questions of safety or effectiveness | | Defibrillation Overload Recovery | DC offset voltage and AC impedance of electrode pairs of subject device connected gel-to-gel following 4 simulated defibrillation discharge events using the test methodology and acceptance criteria of ANSI/AAMI EC12 5.2.2.4 | All samples passed. The test results do not raise any new or different questions of safety or effectiveness | | Bias Current Tolerance | DC offset voltage of electrode pairs of subject device connected gel-to-gel over the course of 8 hours with an applied bias current of 200 nA using the test methodology and acceptance criteria of ANSI/AAMI EC12 5.2.2.5. | All samples passed. The test results do not raise any new or different questions of safety or effectiveness | | Conductive Gel Delivery/Skin Prep Testing | Subject devices are functionally tested to verify that integrated conductive gel can be dispensed, additional gel can be added by the user, and aluminum oxide powder is present on the scalp contacting surfaces. | All samples passed. The test results do not raise any new or different questions of safety or effectiveness | | Headband Size Range Testing | Headband size ranges of subject devices measured with calibrated ruler. | All samples passed. The test results do not raise any new or different questions of safety or effectiveness | | Simulated Use Testing | Small, medium, and large size subject devices tested under simulated use conditions using mannequin heads with long hair. | All samples passed. The test results do not raise any new or different questions of safety or effectiveness | | Test | Test Description | Test Results | | Packaging Performance Testing | Subject devices packaging subjected to environmental conditioning and shipping test per ASTM D7386. After environmental conditioning and shipping, devices were visually inspected, functionally tested under simulated use conditions, and electrically tested. | All samples passed. The test results do not raise any new or different questions of safety or effectiveness | | Biocompatibility Testing | Patient contacting materials used in subject device subjected to biocompatibility testing for devices that contact surface/intact skin for limited duration (< 24 hours). Cytotoxicity testing conducted per ISO 10993-5; Irritation and Sensitization testing conducted per ISO 10993-10. | All samples passed. The test results do not raise any new or different questions of safety or effectiveness | {7}------------------------------------------------ ## 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.

Ceribell Instant EEG Headband

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

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Ceribell Instant EEG Headband

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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