(166 days)
No
The summary describes a passive electrode array and cable for EEG acquisition, with no mention of data processing or analysis capabilities that would typically involve AI/ML.
No
The device is an EEG electrode array for recording EEGs, which is a diagnostic tool, not a therapeutic one. It is used to acquire and record data, not to treat a condition.
No
The device is described as an EEG electrode array intended for recording EEGs, not for interpreting or analyzing them to arrive at a diagnosis. It is indicated for use with the Ceribell Pocket EEG Device for "EEG acquisition and recording," implying it is a data collection tool.
No
The device description explicitly details physical hardware components including an elastic fabric headband, a cable, and electrode assemblies with passive electrodes, gel reservoirs, and scalp-contacting prongs. This is not a software-only device.
Based on the provided information, the Ceribell Instant EEG Headband is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Ceribell Instant EEG Headband is used to record electrical activity directly from the patient's scalp (in vivo), not to analyze a specimen taken from the body.
- The intended use describes recording EEGs in patients. This is a direct measurement of physiological activity, not an analysis of a biological sample.
- The device description details electrodes and gel for scalp contact. This further confirms its function as an in vivo measurement tool.
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 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.
Product codes (comma separated list FDA assigned to the subject device)
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
- Reservoir filled with conductive electrolyte gel
- Mechanism for dispensing gel onto patient scalp
- Scalp-contacting prongs to prepare scalp for electrode contact
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient scalp
Indicated Patient Age Range
2 years and older
Intended User / Care Setting
prescription use in the 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)
- 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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)
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.
| 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 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
4
●
- 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
- 10 electrode assemblies, each consisting of the following:
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 Instant | ||||
| EEG Headband | Ceribell Instant EEG Headband | |||
| (K171459) | Disposable EEG Electrodes | |||
| (K200162) | ||||
| Classification | ||||
| Regulation | Class II per 21 CFR | |||
| 882.1320, E Cutaneous | ||||
| electrode | Class II per 21 CFR 882.1320, E | |||
| Cutaneous electrode | Class II per 21 CFR 882.1320, E | |||
| Cutaneous electrode | Yes, the classification regulation is | |||
| the same as both predicates. | ||||
| Product | ||||
| Code | GXY, Electrode, cutaneous | GXY, Electrode, cutaneous | GXY, Electrode, cutaneous | Yes, the product code is the same as |
| both predicates. | ||||
| Attribute | Subject Device | Predicate Device #1 | Predicate Device #2 | Substantially equivalent? |
| Modified Ceribell Instant | ||||
| EEG Headband | Ceribell Instant EEG Headband | |||
| (K171459) | Disposable EEG Electrodes | |||
| (K200162) | ||||
| Intended | ||||
| Use | A single-use disposable | |||
| headpiece with an | ||||
| integrated array of 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 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 passive cutaneous | ||||
| electrodes that are applied to the | ||||
| patient's head to record EEG | ||||
| signals when connected to an | ||||
| EEG recording device. | Yes, the intended use is the same as | |||
| both predicates. | ||||
| 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 2 years and | ||||
| older. The Instant EEG | ||||
| Headband is intended for | ||||
| prescription use in the | ||||
| home, healthcare facility, or | ||||
| clinical research | ||||
| environment. | 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. | Disposable EEG Electrodes | |||
| (MODEL: DL, E-CAP, FLEX-CAP) is | ||||
| intended for use in routine | ||||
| clinical settings where rapid | ||||
| placement of a number of EEG | ||||
| electrodes is desired. | Yes, the Indications for Use is | |||
| substantially equivalent to both | ||||
| predicates. The Indications for Use for the | ||||
| Subject Device are identical to | ||||
| those of Predicate #1 with the | ||||
| exception of an expanded age | ||||
| range of 2 years and older, | ||||
| instead of 6 years and older. The Indications for Use of the | ||||
| Subject Device are equivalent to the | ||||
| Indications for Use of Predicate #2, | ||||
| which do not state any age limit for | ||||
| the patient population. | ||||
| Intended | ||||
| Patient | ||||
| population | 2 and older | 6 and older | Adults and children, no age range | |
| limitations. | Yes, both predicates have an | |||
| intended patient population that | ||||
| includes adults and children. The | ||||
| specific age range of 2 and older | ||||
| falls within the intended patient | ||||
| population of Predicate #2. | ||||
| Type of | ||||
| Patient | ||||
| Contact | Contacts patient scalp | Contacts patient scalp | Contacts patient scalp. | Yes, the type of patient contact is |
| the 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 as | ||
| both predicates. | ||||
| Device | ||||
| Description | Single use, non-sterile, | |||
| disposable EEG electrode | ||||
| array consisting of: 10 silver/silver-chloride | ||||
| (Ag/AgCl) electrodes Plastic packet gel | ||||
| reservoirs pre-filled with | ||||
| conductive electrolyte | ||||
| gel Integrated single-cable | ||||
| connector to connect to | ||||
| an EEG recording device A spandex blend fabric | ||||
| headband to secure the | ||||
| electrodes to the | ||||
| patient | Single use, non-sterile, disposable | |||
| EEG electrode array consisting of: 10 silver/silver-chloride | ||||
| (Ag/AgCl) electrodes Plastic packet gel reservoirs | ||||
| pre-filled with conductive | ||||
| electrolyte gel Integrated single-cable | ||||
| connector to connect to an | ||||
| EEG recording device A spandex blend fabric | ||||
| headband to secure the | ||||
| electrodes to the patient | Single use, non-sterile, disposable | |||
| EEG electrode array with three | ||||
| models (DL, E-CAP, FLEX-CAP) | ||||
| consisting of: Between 2 to 128 | ||||
| silver/silver-chloride | ||||
| (Ag/AgCl) electrodes (E-CAP | ||||
| and DL: coated Ag/AgCL | ||||
| electrodes; FLEX-CAP: printed | ||||
| Ag/AgCl electrodes) Integrated single-cable | ||||
| connector to connect to an | ||||
| EEG recording device A spandex blend fabric | ||||
| headcap to secure the | ||||
| electrodes to the patient | Yes. The device description is the | |||
| same as of Predicate #1 The Subject Device and both | ||||
| predicate devices contain an | ||||
| integrated array of silver/silver- | ||||
| chloride (Ag/AgCl) electrodes | ||||
| intended to acquire EEG signals. The Subject Device and both | ||||
| predicate devices include an | ||||
| integrated single cable | ||||
| connector for connection to EEG | ||||
| recording device. The Subject Device and both | ||||
| predicate devices affix the | ||||
| electrodes to a spandex blend | ||||
| fabric headpiece that is placed | ||||
| on the patient's head. | ||||
| Available | ||||
| Sizes | 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 size | |||
| range 26cm - 66cm) | Yes, the available sizes fall within | |||
| the available sizes of Predicate #2. | ||||
| Attribute | Subject Device | |||
| Modified Ceribell Instant | ||||
| EEG Headband | Predicate Device #1 | |||
| Ceribell Instant EEG Headband | ||||
| (K171459) | Predicate Device #2 | |||
| Disposable EEG Electrodes | ||||
| (K200162) | Substantially equivalent? | |||
| Number of | ||||
| Electrodes | 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 supporting | |||
| between 2 to 128 electrodes. | Yes. | |||
| • The number of electrodes is the | ||||
| same as Predicate #1. | ||||
| • The number of electrodes falls | ||||
| within the possible customizable | ||||
| number of electrodes of | ||||
| Predicate #2 (between 2 to 128 | ||||
| electrodes). | ||||
| Conductive | ||||
| Electrolyte | ||||
| Gel | Conductive electrolyte gel is | |||
| included in sealed gel | ||||
| packets integrated into each | ||||
| electrode assembly. User is | ||||
| also able to add additional | ||||
| electrolyte gel when needed | ||||
| using a syringe. | Conductive electrolyte gel is | |||
| included in sealed gel packets | ||||
| integrated into each electrode | ||||
| assembly. User is also able to add | ||||
| additional electrolyte gel when | ||||
| needed using a syringe. | Conductive electrolyte gel is not | |||
| included. User applies conductive | ||||
| gel with a syringe. | Yes, the Subject Device and both | |||
| predicates use conductive | ||||
| electrolyte gel to form an electrical | ||||
| connection between the patient | ||||
| scalp and the Ag/AgCl electrode. |
5
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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.