The Ceribell Instant EEG Headband is an electroencephalogram (EEG) electrode array intended for single patient use in the recording of EEGs in patients of 2 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 (K191301) 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 provided document is a 510(k) premarket notification decision letter from the FDA to Ceribell, Inc. regarding their Instant EEG Headband. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study report of the device's diagnostic performance against established acceptance criteria.

The letter explicitly states:
"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..."

The "Performance Data" section within the 510(k) Summary lists the types of testing performed:

Biocompatibility testing per ISO 10993-1, ISO 10993-5, and ISO 10993-10
Bench testing and simulated use testing to verify system performance including testing and evaluation to ANSI EC12-2000 and IEC 60601-1 requirements.
Shelf life testing

These tests are related to the safety and functionality of the electrode array itself (biocompatibility, electrical safety, durability, and signal acquisition quality) and not to the diagnostic performance of an AI algorithm or human-in-the-loop performance related to interpreting EEG signals. The device described is a cutaneous electrode array, not an AI-powered diagnostic tool.

Therefore, the requested information regarding acceptance criteria for AI algorithm performance, sample size for test sets, expert adjudication, MRMC studies, or standalone algorithm performance is not present in this document because the device being cleared is an EEG headband (hardware), not a software algorithm for interpreting EEG.

To answer your request, if this were an AI/software as a medical device (SaMD) submission, the following sections would typically be present, but they are absent here due to the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance: This would typically define metrics (e.g., sensitivity, specificity, AUC) and their target values, along with the actual results from the study. (Not applicable/Not present)

2. Sample size used for the test set and data provenance:
* Sample Size: Not applicable.
* Data Provenance: Not applicable.

3. Number of experts used to establish ground truth and qualifications:
* Number of Experts/Qualifications: Not applicable, as there is no diagnostic AI component requiring ground truth for interpretation.

4. Adjudication method for the test set:
* Adjudication Method: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
* MRMC Study: No, this is a hardware device.

6. If a standalone (algorithm only) performance was done:
* Standalone Performance: No, this is a hardware device.

7. The type of ground truth used:
* Ground Truth: Not applicable.

8. The sample size for the training set:
* Training Set Sample Size: Not applicable.

9. How the ground truth for the training set was established:
* Training Set Ground Truth Establishment: Not applicable.

Summary

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August 30, 2021

Ceribell, Inc. Raymond Woo, PhD CTO 2483 Old Middlefield Way, Suite 120 Mountain View, California 94043

Re: K210805

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: August 18, 2021 Received: August 19, 2021

Dear Dr. Woo:

We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801): medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531 -542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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,

Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210805

Device Name Ceribell Instant EEG Headband

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X 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:

Raymond Woo, PhD CTO Telephone: (650) 556-4349 E-mail: ray@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:

K171459: Ceribell Instant EEG Headband (Predicate Device #1) K200162: Wuhan Greentek Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) (Predicate Device #2)

Date Prepared:

August 27, 2021

Device Description:

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

An elastic fabric headband

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●

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 O
  - Reservoir filled with conductive electrolyte gel O
  - Mechanism for dispensing gel onto patient scalp O
  - Scalp-contacting prongs to prepare scalp for electrode contact O

Indications for Use:

The Ceribell Instant EEG Headband is an electroencephalogram (EEG) electrode array intended for single patient use in the recording of EGGs in patients of 2 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, Indications for Use, and Technological Characteristics with the Predicate Devices:

The Subject Device and both predicate devices share the same intended use: an integrated array of cutaneous electrodes intended for the recording of EEG signals.

The Subject Device is a modified version of Predicate #1 (Ceribell Instant EEG Headband). The EEG Headband materials have been updated to allow the EEG Headband to accommodate an increased range of head sizes. This expands the intended patient population age range to include patients aged 2 and older. The number of sizes offered for the EEG Headband has been reduced from three sizes (Small, Medium, Large) to two sizes (Small, Medium/Large). The Indications for Use and labeling are updated accordingly for the modifications.

The Subject Device shares the same technological characteristics and intended use as Predicate #2 (Wuhan Greentek Disposable EEG Electrodes). Predicate #2 is available in various sizes and is intended for use on all patient ages. The Subject Device and both predicate devices use passive Ag/AgCl electrodes that are placed on a spandex blend fabric substrate.

The intended use, indications for use, and technological characteristics of the Subject Device and both predicate devices are summarized in the following table.

Attribute	Subject Device	Predicate Device #1	Predicate Device #2	Substantially equivalent?
	Modified Ceribell InstantEEG Headband	Ceribell Instant EEG Headband(K171459)	Disposable EEG Electrodes(K200162)
ClassificationRegulation	Class II per 21 CFR882.1320, E Cutaneouselectrode	Class II per 21 CFR 882.1320, ECutaneous electrode	Class II per 21 CFR 882.1320, ECutaneous electrode	Yes, the classification regulation isthe same as both predicates.
ProductCode	GXY, Electrode, cutaneous	GXY, Electrode, cutaneous	GXY, Electrode, cutaneous	Yes, the product code is the same asboth predicates.
Attribute	Subject Device	Predicate Device #1	Predicate Device #2	Substantially equivalent?
	Modified Ceribell InstantEEG Headband	Ceribell Instant EEG Headband(K171459)	Disposable EEG Electrodes(K200162)
IntendedUse	A single-use disposableheadpiece with anintegrated array of passivecutaneous electrodes thatare applied to the patient'shead to record EEG signalswhen connected to an EEGrecording device.	A single-use disposableheadpiece with an integratedarray of passive cutaneouselectrodes that are applied to thepatient's head to record EEGsignals when connected to anEEG recording device.	A single-use disposableheadpiece with an integratedarray of passive cutaneouselectrodes that are applied to thepatient's head to record EEGsignals when connected to anEEG recording device.	Yes, the intended use is the same asboth predicates.
Indicationsfor Use	The Ceribell Instant EEGHeadband is anelectroencephalogram(EEG) electrode arrayintended for single patientuse in the recording of EEGsin patients of 2 years andolder. The Instant EEGHeadband is intended forprescription use in thehome, healthcare facility, orclinical researchenvironment.	The Ceribell Instant EEGHeadband is anelectroencephalogram (EEG)electrode array intended forsingle patient use in the recordingof EEGs in patients of 6 years andolder. The Instant EEG Headbandis intended for prescription use inthe home, healthcare facility, orclinical research environment.	Disposable EEG Electrodes(MODEL: DL, E-CAP, FLEX-CAP) isintended for use in routineclinical settings where rapidplacement of a number of EEGelectrodes is desired.	Yes, the Indications for Use issubstantially equivalent to bothpredicates. The Indications for Use for theSubject Device are identical tothose of Predicate #1 with theexception of an expanded agerange of 2 years and older,instead of 6 years and older. The Indications for Use of theSubject Device are equivalent to theIndications for Use of Predicate #2,which do not state any age limit forthe patient population.
IntendedPatientpopulation	2 and older	6 and older	Adults and children, no age rangelimitations.	Yes, both predicates have anintended patient population thatincludes adults and children. Thespecific age range of 2 and olderfalls within the intended patientpopulation of Predicate #2.
Type ofPatientContact	Contacts patient scalp	Contacts patient scalp	Contacts patient scalp.	Yes, the type of patient contact isthe same as both predicates.
Type of Use	Single use, non-sterile,disposable.	Single use, non-sterile,disposable.	Non-sterile, disposable	Yes, the type of use is the same asboth predicates.
DeviceDescription	Single use, non-sterile,disposable EEG electrodearray consisting of: 10 silver/silver-chloride(Ag/AgCl) electrodes Plastic packet gelreservoirs pre-filled withconductive electrolytegel Integrated single-cableconnector to connect toan EEG recording device A spandex blend fabricheadband to secure theelectrodes to thepatient	Single use, non-sterile, disposableEEG electrode array consisting of: 10 silver/silver-chloride(Ag/AgCl) electrodes Plastic packet gel reservoirspre-filled with conductiveelectrolyte gel Integrated single-cableconnector to connect to anEEG recording device A spandex blend fabricheadband to secure theelectrodes to the patient	Single use, non-sterile, disposableEEG electrode array with threemodels (DL, E-CAP, FLEX-CAP)consisting of: Between 2 to 128silver/silver-chloride(Ag/AgCl) electrodes (E-CAPand DL: coated Ag/AgCLelectrodes; FLEX-CAP: printedAg/AgCl electrodes) Integrated single-cableconnector to connect to anEEG recording device A spandex blend fabricheadcap to secure theelectrodes to the patient	Yes. The device description is thesame as of Predicate #1 The Subject Device and bothpredicate devices contain anintegrated array of silver/silver-chloride (Ag/AgCl) electrodesintended to acquire EEG signals. The Subject Device and bothpredicate devices include anintegrated single cableconnector for connection to EEGrecording device. The Subject Device and bothpredicate devices affix theelectrodes to a spandex blendfabric headpiece that is placedon the patient's head.
AvailableSizes	Small (45.1 - 54.5cm)Medium/Large (53.3-62.0cm)	Small (48.4 - 53.6 cm)Medium (53.3 – 56.5 cm)Large (55.5 - 62 cm)	Various sizes (overall head sizerange 26cm - 66cm)	Yes, the available sizes fall withinthe available sizes of Predicate #2.
Attribute	Subject DeviceModified Ceribell InstantEEG Headband	Predicate Device #1Ceribell Instant EEG Headband(K171459)	Predicate Device #2Disposable EEG Electrodes(K200162)	Substantially equivalent?
Number ofElectrodes	10 (Locations: Fp1, F7, T3,T5, O1, Fp2, F8, T4, T6, O2)	10 (Locations: Fp1, F7, T3, T5, O1,Fp2, F8, T4, T6, O2)	Various configurations supportingbetween 2 to 128 electrodes.	Yes.• The number of electrodes is thesame as Predicate #1.• The number of electrodes fallswithin the possible customizablenumber of electrodes ofPredicate #2 (between 2 to 128electrodes).
ConductiveElectrolyteGel	Conductive electrolyte gel isincluded in sealed gelpackets integrated into eachelectrode assembly. User isalso able to add additionalelectrolyte gel when neededusing a syringe.	Conductive electrolyte gel isincluded in sealed gel packetsintegrated into each electrodeassembly. User is also able to addadditional electrolyte gel whenneeded using a syringe.	Conductive electrolyte gel is notincluded. User applies conductivegel with a syringe.	Yes, the Subject Device and bothpredicates use conductiveelectrolyte gel to form an electricalconnection between the patientscalp and the Ag/AgCl electrode.

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Ceribell, Inc.

Performance Data:

The following performance data were provided to demonstrate safety and efficacy in support of substantial equivalence determination:

Biocompatibility testing per ISO 10993-1, ISO 10993-5, and ISO 10993-10 ●
Bench testing and simulated use testing to verify system performance including testing and evaluation to ANSI EC12-2000 and IEC 60601-1 requirements.
Shelf life testing

Summary:

The modified Ceribell Instant EEG Headband has the same intended use as the predicate devices. 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 modified Ceribell Instant EEG Headband is substantially equivalent to the cleared predicate devices.

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).