(173 days)
Not Found
No
The summary describes a disposable EEG electrode headcap for signal acquisition, with no mention of AI/ML processing or analysis of the collected data.
No
The device is described as an EEG electrode device intended to collect and provide EEG signals to an EEG recording or monitoring device, which is a diagnostic function, not a therapeutic one.
No
The device is an EEG electrode device intended to collect and provide EEG signals to an EEG recording or monitoring device. It does not perform any analysis or interpretation of these signals to provide a diagnosis; it is a data collection tool.
No
The device description explicitly lists physical components like an elastic fabric headcap, chin strap, electrodes, and a cable, indicating it is a hardware device for collecting EEG signals.
Based on the provided information, the Ceribell Instant EEG Headcap is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Ceribell Headcap Function: The Ceribell Instant EEG Headcap is designed to be placed on the scalp to collect electrical signals from the brain (EEG signals). It is a device that interacts directly with the body's surface to acquire physiological data.
- Intended Use: The intended use is for "routine clinical settings where rapid placement of a number of EEG electrodes is desired," and it "collect[s] and provide[s] EEG signals to an EEG recording or monitoring device." This describes a device used for physiological monitoring, not for testing samples taken from the body.
Therefore, the Ceribell Instant EEG Headcap 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 Headcap is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired.
Product codes
GXY
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
On the head
Indicated Patient Age Range
Adults and children
Intended User / Care Setting
Not Found
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)
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
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.
Not Found
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
ivalence determination does not mean that FDA
Page 2
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
2
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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3
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 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 ●
Indications for Use:
4
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 Device
Ceribell Instant EEG
Headcap (Ceribell, Inc.) | Predicate Device
Disposable EEG
Electrodes, K200162
(Wuhan Greentek Pty
Ltd.) | Comparison |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification
Regulation | Class II per 21 CFR
882.1320, E Cutaneous
electrode | Class II per 21 CFR
882.1320, E
Cutaneous electrode | Same |
| Product Code | GXY, Electrode, cutaneous | GXY, Electrode,
cutaneous | Same |
| Indications for
Use | The Ceribell Instant EEG
Headcap is intended for
use in routine clinical
settings where rapid
placement of a number of
EEG electrodes is desired. | 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. | Same |
| Intended Patient
population | Adults and children | Adults and children | Same |
| Environment of
Use | Electrophysiological | Electrophysiological | Same |
| Where Used | On the head | On the head | Same |
| Device
Description | Disposable EEG electrode
array with three sizes
consisting of:
• Between 9 and 19
silver/silver-chloride
(Ag/AgCl) electrodes
• Cable to connect to an
EEG recording device
• A spandex fabric
headcap to secure the
electrodes to the
patient | Disposable EEG
electrode array with
three models (DL, E-
CAP, FLEX-CAP)
consisting of:
• Between 2 to 128
silver/silver-
chloride (Ag/AgCl)
electrodes
• Cable to connect to
an EEG recording
device
• A spandex fabric
headcap to secure
the electrodes to
the patient | Same |
| Attribute | Subject Device
Ceribell Instant EEG
Headcap (Ceribell, Inc.) | Predicate Device
Disposable EEG
Electrodes, K200162
(Wuhan Greentek Pty
Ltd.) | Comparison |
| Number of
Electrodes | 9 -19 | 2 - 128 electrodes | Yes, the number of electrodes of the
subject device falls within the
possible customizable number of
electrodes of the predicate device
(between 2 to 128 electrodes). |
| Electrode
Locations | The placement of the
electrodes is according to
the International 10-20
system of electrode
placement or the
American
Electroencephalographic
Society positioning system
(10-10). The number of the
electrodes in use is
according to the needs of
clinical practice. | The placement of the
electrodes is
according to the
International 10-20
system of electrode
placement or the
American
Electroencephalograp
hic Society positioning
system (10-10). The
number of the
electrodes in use is
according to the
needs of clinical
practice. | Same |
| Available Sizes | Various sizes (overall head
size range 26cm - 66cm) | Various sizes (babies
to large: overall head
size range 26cm -
66cm) | Same |
| Cap Material | Spandex blend: Black
Nylon Knitted Fabric, 82%
Nylon and 18% Spandex | Spandex | The biocompatibility testing and
electrical performance testing
completed are the same and follow
the FDA guidance document
"Cutaneous Electrodes for Recording
Purposes- Performance Criteria
for Safety and Performance Based
Pathway," August 2020. |
| Electrode
Mounts | Soft thermoplastic
elastomer (TPE) | Silicone | The electrical performance and
biocompatibility testing completed
are the same and follow the FDA
guidance document "Cutaneous
Electrodes for Recording Purposes-
Performance Criteria
for Safety and Performance Based
Pathway," August 2020. |
| Attribute | Subject Device
Ceribell Instant EEG
Headcap (Ceribell, Inc.) | Predicate Device
Disposable EEG
Electrodes, K200162
(Wuhan Greentek Pty
Ltd.) | Comparison |
| Electrode
Material | Silver/silver-chloride-
coated photopolymer base | Silver/silver chloride
ink printed on PET
(polyethylene
terephthalate) or
silver/silver chloride-
plated ABS base | The electrical performance and
biocompatibility testing completed
are the same and follow the FDA
guidance document "Cutaneous
Electrodes for Recording Purposes-
Performance Criteria
for Safety and Performance Based
Pathway," August 2020. |
| Type of
Connector | Touch-proof safety socket
DIN 42-802 (ø1.5mm) | Touch-proof safety
socket DIN42-802
(ø1.5mm) | The electrical performance testing
completed met the same
requirements per FDA guidance
document "Cutaneous Electrodes for
Recording Purposes- Performance
Criteria
for Safety and Performance Based
Pathway," August 2020. |
| Biocompatibility
Requirements | ISO 10993-1
ISO 10993-5 (Cytotoxicity)
ISO 10993-10
(Sensitization, Irritation or
Intracutaneous Reactivity) | ISO 10993-1
ISO 10993-5
(Cytotoxicity)
ISO 10993-10
(Sensitization,
Irritation or
Intracutaneous
Reactivity) | The biocompatibility testing met the
same requirements per FDA
guidance document "Use of
International Standard ISO 10993-1,"
issued Sep 2020, for surface device
with intact skin contact. |
| Cable | 0.1m-3.0m integrated
single cable | 0.1m-3.0m standard
ribbon cable and lead
wires | Both designed in conformance with
AAMI/ ANSI ES60601-1:2005(R)2012
and A1:2012, C1:2009/(R)2012 and
A2:2010/(R)2012 (consolidated text)
Medical electrical equipment- Part 1:
General requirements for basic
safety and essential performance
(IEC 60601-1:2005, mod). The
electrical connection compliance
met the same requirements per FDA
guidance document "Cutaneous
Electrodes for Recording Purposes-
Performance Criteria
for Safety and Performance Based
Pathway," August 2020. |
| Attribute | Subject Device
Ceribell Instant EEG
Headcap (Ceribell, Inc.) | Predicate Device
Disposable EEG
Electrodes, K200162
(Wuhan Greentek Pty
Ltd.) | Comparison |
| Electrical
Performance
Requirements | ANSI/AAMI EC12
• Average AC Impedance:
≤ 2 kΩ (individual pairs ≤
3kΩ).
• DC Offset Voltage: ≤ 100
mV
• Combined Offset
Instability and Internal
Noise: ≤ 150 μV
• Bias Current Tolerance: ≤
100 mV | ANSI EC12
• AC Impedance: