(29 days)
No
The summary describes a passive electrode array and cable for EEG acquisition, with no mention of data processing or analysis capabilities, let alone AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
No
The device is described as an EEG electrode array intended for recording EEGs, not for treating conditions.
No
The device is an electrode array used for recording EEGs, which is an imaging modality for capturing brain activity. It does not analyze the data or provide a diagnosis.
No
The device description explicitly states it is a physical headband with electrodes, a cable, and gel, which are hardware components.
Based on the provided information, the Ceribell Instant EEG Headband is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Ceribell Instant EEG Headband Function: The description clearly states that the device is an "electroencephalogram (EEG) electrode array intended for single patient use in the recording of EEGs." It records electrical activity from the scalp, which is a measurement taken from the body, not a test performed on a specimen from the body.
- Lack of Specimen Handling: The device description focuses on electrodes, gel, and a headband for direct contact with the scalp. There is no mention of collecting or analyzing biological specimens.
Therefore, the Ceribell Instant EEG Headband falls under the category of a medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Ceribell Instant EEG Headband is an electroencephalogram (EEG) electrode array intended for single patient use in the recording of EEGs. The Instant EEG Headband is intended for prescription use in the home, healthcare facility, or clinical research environment.
Product codes
GXY
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 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Scalp
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home, healthcare facility, or clinical research environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
None required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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August 7, 2023
Ceribell, Inc. Raymond Woo CTO 360 North Pastoria Avenue Sunnyvale, California 94085
Re: K232052
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 10, 2023 Received: July 10, 2023
Dear Mr. 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.
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
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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 (OS) 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,
Tushar Bansal -S
for Heather Dean, PhD Assistant Director THT5B3: 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) K232052
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. 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K232052 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 Ave Sunnyvale, California 94085
Contact Person:
Raymond Woo, PhD CTO 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 Device:
K210805, Ceribell Instant EEG Headband (Ceribell, Inc.)
Date Prepared:
July 10, 2023
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 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
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. 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 device is identical to the predicate device with exception of the modified Indications for Use Statement and associated labeling.
Performance Data:
None required.
Summary:
The modified Ceribell Instant EEG Headband has the same intended use as the predicate devices. In addition, it has the same technological characteristic. Therefore, the modified Ceribell Instant EEG Headband is substantially equivalent to the cleared predicate device.