The Ceribell Instant EEG Headcap is a single-use, non-sterile, disposable EEG electrode device that includes a minimum of 9 EEG electrodes that are placed on the subject's scalp. The Headcap is intended to collect and provide EEG signals to an EEG recording or monitoring device.

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

An elastic fabric headcap
An elastic chin strap
A minimum of 9 silver/silver chloride (Ag/AgCl) electrodes
A cable attached to the headcap to allow connection to an EEG acquisition/recording device

AI/ML Overview

The Ceribell Instant EEG Headcap is a cutaneous electrode device. The provided text outlines the acceptance criteria and performance data for this device, comparing it to a predicate device (Wuhan Greentek Disposable EEG Electrodes, K200162) to establish substantial equivalence.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Ceribell Instant EEG Headcap are based on the same requirements as its predicate device and defined by FDA-recognized consensus standards, primarily ANSI/AAMI EC12 Disposable ECG Electrodes and ISO 10993 series for biocompatibility.

Attribute	Acceptance Criteria (Standard)	Reported Device Performance
Electrical Performance
Average AC Impedance	≤ 2 kΩ (individual pairs ≤ 3kΩ) (ANSI/AAMI EC12)	Met the same requirements per FDA guidance document.
DC Offset Voltage	≤ 100 mV (ANSI/AAMI EC12)	Met the same requirements per FDA guidance document.
Combined Offset Instability and Internal Noise	≤ 150 μV (ANSI/AAMI EC12)	Met the same requirements per FDA guidance document.
Bias Current Tolerance (DC Voltage Offset)	≤ 100 mV (ANSI/AAMI EC12)	Met the same requirements per FDA guidance document.
Biocompatibility
Cytotoxicity	ISO 10993-5	Met the same requirements per FDA guidance document "Use of International Standard ISO 10993-1".
Sensitization, Irritation or Intracutaneous Reactivity	ISO 10993-10	Met the same requirements per FDA guidance document "Use of International Standard ISO 10993-1".
Electrical Connection Compliance	Conductive Connection Compliance per ES 60601-1, IEC 60601-1 clause 8.5.2.3, 21 CFR 898.12	Met the same requirements per FDA guidance document.
Shelf Life	ANSI/AAMI EC12 and IEC 60601-2-2	Testing completed (results not explicitly detailed, but implied compliance).

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample size for the test sets (e.g., number of EEG headcaps or subjects) used for each performance test. It only mentions that performance data was "provided" and "completed testing" was done.

Data provenance (e.g., country of origin, retrospective or prospective) is also not specified in the provided text.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable to this type of device and study. The Ceribell Instant EEG Headcap is a physical medical device (an electrode headcap), not an AI algorithm or diagnostic tool that requires expert interpretation for ground truth establishment. The performance criteria are objective measurements of electrical properties and biocompatibility.

4. Adjudication Method for the Test Set

This is not applicable as the tests performed are objective physical and electrical measurements, not interpretive clinical assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) use AI assistance to improve their diagnostic accuracy. The Ceribell Instant EEG Headcap is a hardware device for signal acquisition.

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

This is not applicable. The device is a physical electrode headcap, not an algorithm. Its performance is measured through objective electrical and biocompatibility testing, not algorithmic accuracy.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed on the Ceribell Instant EEG Headcap is based on established industry standards and objective measurable physical and electrical properties. For example:

Electrical Performance: The ground truth is defined by the limits set in ANSI/AAMI EC12.
Biocompatibility: The ground truth is defined by the pass/fail criteria of ISO 10993 tests (e.g., absence of cytotoxicity, sensitization, irritation).

8. The Sample Size for the Training Set

This is not applicable. The Ceribell Instant EEG Headcap is a physical medical device, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reason as above.

Summary

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March 21, 2023

Ceribell, Inc. Raymond Woo, PhD Chief Technical Officer 360 N Pastoria Ave Sunnyville, California 94085

Re: K223086

Trade/Device Name: Ceribell Instant EEG Headcap Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: January 24, 2023 Received: January 25, 2023

Dear Dr. Woo:

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.

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ivalence determination does not mean that FDA

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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-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.

Heather L. Dean -S

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) K223086

Device Name Ceribell Instant EEG Headband

Indications for Use (Describe)

The Ceribell Instant EEG Headcap is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired.

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 is being submitted in accordance with the requirements of 21 CFR 807.92.

Applicant Information:

Ceribell, Inc. 360 North Pastoria Avenue Sunnyvale, California 94085

Contact Person:

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

Device Information:

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

Predicate Device:

K200162, Wuhan Greentek Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP)

Date Prepared:

January 24, 2023

Device Description:

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

An elastic fabric headcap
An elastic chin strap
A minimum of 9 silver/silver chloride (Ag/AgCl) electrodes
A cable attached to the headcap to allow connection to an EEG acquisition/recording device ●

Indications for Use:

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The Ceribell Instant EEG Headcap is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired.

Comparison of Intended Use and Technological Characteristics with the Predicate Device:

Compared to the predicate device, the subject device has the same intended use, similar product design and the same product effectiveness as the predicate device as summarized in the following table.

Attribute	Subject DeviceCeribell Instant EEGHeadcap (Ceribell, Inc.)	Predicate DeviceDisposable EEGElectrodes, K200162(Wuhan Greentek PtyLtd.)	Comparison
ClassificationRegulation	Class II per 21 CFR882.1320, E Cutaneouselectrode	Class II per 21 CFR882.1320, ECutaneous electrode	Same
Product Code	GXY, Electrode, cutaneous	GXY, Electrode,cutaneous	Same
Indications forUse	The Ceribell Instant EEGHeadcap is intended foruse in routine clinicalsettings where rapidplacement of a number ofEEG electrodes is desired.	Disposable EEGElectrodes (MODEL:DL, E-CAP, FLEX-CAP)is intended for use inroutine clinicalsettings where rapidplacement of anumber of EEGelectrodes is desired.	Same
Intended Patientpopulation	Adults and children	Adults and children	Same
Environment ofUse	Electrophysiological	Electrophysiological	Same
Where Used	On the head	On the head	Same
DeviceDescription	Disposable EEG electrodearray with three sizesconsisting of:• Between 9 and 19silver/silver-chloride(Ag/AgCl) electrodes• Cable to connect to anEEG recording device• A spandex fabricheadcap to secure theelectrodes to thepatient	Disposable EEGelectrode array withthree models (DL, E-CAP, FLEX-CAP)consisting of:• Between 2 to 128silver/silver-chloride (Ag/AgCl)electrodes• Cable to connect toan EEG recordingdevice• A spandex fabricheadcap to securethe electrodes tothe patient	Same
Attribute	Subject DeviceCeribell Instant EEGHeadcap (Ceribell, Inc.)	Predicate DeviceDisposable EEGElectrodes, K200162(Wuhan Greentek PtyLtd.)	Comparison
Number ofElectrodes	9 -19	2 - 128 electrodes	Yes, the number of electrodes of thesubject device falls within thepossible customizable number ofelectrodes of the predicate device(between 2 to 128 electrodes).
ElectrodeLocations	The placement of theelectrodes is according tothe International 10-20system of electrodeplacement or theAmericanElectroencephalographicSociety positioning system(10-10). The number of theelectrodes in use isaccording to the needs ofclinical practice.	The placement of theelectrodes isaccording to theInternational 10-20system of electrodeplacement or theAmericanElectroencephalographic Society positioningsystem (10-10). Thenumber of theelectrodes in use isaccording to theneeds of clinicalpractice.	Same
Available Sizes	Various sizes (overall headsize range 26cm - 66cm)	Various sizes (babiesto large: overall headsize range 26cm -66cm)	Same
Cap Material	Spandex blend: BlackNylon Knitted Fabric, 82%Nylon and 18% Spandex	Spandex	The biocompatibility testing andelectrical performance testingcompleted are the same and followthe FDA guidance document"Cutaneous Electrodes for RecordingPurposes- Performance Criteriafor Safety and Performance BasedPathway," August 2020.
ElectrodeMounts	Soft thermoplasticelastomer (TPE)	Silicone	The electrical performance andbiocompatibility testing completedare the same and follow the FDAguidance document "CutaneousElectrodes for Recording Purposes-Performance Criteriafor Safety and Performance BasedPathway," August 2020.
Attribute	Subject DeviceCeribell Instant EEGHeadcap (Ceribell, Inc.)	Predicate DeviceDisposable EEGElectrodes, K200162(Wuhan Greentek PtyLtd.)	Comparison
ElectrodeMaterial	Silver/silver-chloride-coated photopolymer base	Silver/silver chlorideink printed on PET(polyethyleneterephthalate) orsilver/silver chloride-plated ABS base	The electrical performance andbiocompatibility testing completedare the same and follow the FDAguidance document "CutaneousElectrodes for Recording Purposes-Performance Criteriafor Safety and Performance BasedPathway," August 2020.
Type ofConnector	Touch-proof safety socketDIN 42-802 (ø1.5mm)	Touch-proof safetysocket DIN42-802(ø1.5mm)	The electrical performance testingcompleted met the samerequirements per FDA guidancedocument "Cutaneous Electrodes forRecording Purposes- PerformanceCriteriafor Safety and Performance BasedPathway," August 2020.
BiocompatibilityRequirements	ISO 10993-1ISO 10993-5 (Cytotoxicity)ISO 10993-10(Sensitization, Irritation orIntracutaneous Reactivity)	ISO 10993-1ISO 10993-5(Cytotoxicity)ISO 10993-10(Sensitization,Irritation orIntracutaneousReactivity)	The biocompatibility testing met thesame requirements per FDAguidance document "Use ofInternational Standard ISO 10993-1,"issued Sep 2020, for surface devicewith intact skin contact.
Cable	0.1m-3.0m integratedsingle cable	0.1m-3.0m standardribbon cable and leadwires	Both designed in conformance withAAMI/ ANSI ES60601-1:2005(R)2012and A1:2012, C1:2009/(R)2012 andA2:2010/(R)2012 (consolidated text)Medical electrical equipment- Part 1:General requirements for basicsafety and essential performance(IEC 60601-1:2005, mod). Theelectrical connection compliancemet the same requirements per FDAguidance document "CutaneousElectrodes for Recording Purposes-Performance Criteriafor Safety and Performance BasedPathway," August 2020.
Attribute	Subject DeviceCeribell Instant EEGHeadcap (Ceribell, Inc.)	Predicate DeviceDisposable EEGElectrodes, K200162(Wuhan Greentek PtyLtd.)	Comparison
ElectricalPerformanceRequirements	ANSI/AAMI EC12• Average AC Impedance:≤ 2 kΩ (individual pairs ≤3kΩ).• DC Offset Voltage: ≤ 100mV• Combined OffsetInstability and InternalNoise: ≤ 150 μV• Bias Current Tolerance: ≤100 mV	ANSI EC12• AC Impedance: < 2kΩ (at 10 Hz)• DC Offset Voltage: < 100 mV• Combined OffsetInstability andInternal Noise: < 150 μV• Bias CurrentTolerance: < 100 mV	The electrical performance testingmet the same requirements per FDAguidance document "CutaneousElectrodes for Recording Purposes-Performance Criteriafor Safety and Performance BasedPathway," August 2020.
ElectricalConnectionCompliance	• Conductive ConnectionCompliance (PatientLeads or Patient Cables)per ES 60601-1consensus standard• IEC 60601-1 clause8.5.2.3• 21 CFR 898.12	AAMI/ANSI ES60601-1 clause 8.5.2.3	The electrical connection compliancemet the same requirements per FDAguidance document "CutaneousElectrodes for Recording Purposes-Performance Criteriafor Safety and Performance BasedPathway," August 2020.

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The results of completed testing demonstrate that any differences in technology do not raise different questions of safety and effectiveness for the subject device compared to the predicate device.

Performance Data:

In accordance with FDA guidance document, "Cutaneous Electrodes for Recording Purposes- Performance Criteria for Safety and Performance Based Pathway", issued on August, 14, 202, the following performance data were provided to demonstrate safety and efficacy in substantial equivalence determination:

. Electrical Performance
- o AC Impedance per FDA-recognized consensus standard, ANSI/AAMI EC12 Disposable ECG Electrodes
- o Offset Voltage per FDA-recognized consensus standard, ANSI/AAMI EC12 Disposable ECG Electrodes
- Combined offset instability and internal noise per FDA-recognized consensus standard, ANSI/AAMI EC12 Disposable ECG Electrodes
- o Bias Current Voltage (DC Voltage Offset) per FDA-recognized consensus standard, ANSI/AAMI EC12 Disposable ECG Electrodes
Shelf life testing per FDA-recognized consensus standards, ANSI/AAMI EC12 Disposable ECG Electrodes and IEC 60601-2-2 Medical electrical equipment- Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

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. Biocompatibility testing per ISO 10993-1, ISO 10993-5, and ISO 10993-10

Summary:

The Ceribell Instant EEG Headcap 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 Headcap 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).