(95 days)
No
The summary describes a passive EEG electrode array and its physical and electrical performance characteristics. There is no mention of any software processing of the EEG signals, let alone AI/ML algorithms.
No
This device is an EEG electrode array, which is used for recording electrical activity from the brain, not for therapy or treatment.
Yes
The device is an electroencephalogram (EEG) electrode array intended for recording EEGs, which is a diagnostic procedure to measure electrical activity in the brain.
No
The device description explicitly details physical components like an elastic fabric headband, cables, electrodes, gel reservoirs, and scalp-contacting prongs. The performance studies also focus on the physical and electrical characteristics of these hardware components.
Based on the provided information, the Ceribell Instant EEG Headband is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to record EEGs in patients. This involves measuring electrical activity from the brain, which is a physiological process within the body.
- Device Description: The device is an electrode array designed to be placed on the patient's scalp to acquire electrical signals. It does not involve testing samples of biological material outside the body (in vitro).
- Performance Studies: The performance studies focus on the electrical and mechanical properties of the electrodes and headband, as well as biocompatibility. These are typical tests for devices that interact with the body to acquire physiological signals, not for analyzing biological samples.
IVD devices are typically used to examine specimens such as blood, urine, or tissue to provide information about a person's health status. The Ceribell Instant EEG Headband directly interacts with the patient's body to measure electrical activity, which falls under the category of a medical device used for physiological monitoring or diagnosis based on in vivo measurements.
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 6 years and older. 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 (K170363) 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: ●
- o Passive Silver/silver-chloride electrode
- o Reservoir filled with conductive electrolyte gel
- 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
patient's head
Indicated Patient Age Range
6 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)
- Electrode Impedance: AC impedance of electrode pairs of subject device connected gel-to-gel using the test methodology and acceptance criteria of ANSI/AAMI EC12 5.2.2.1. All samples passed. The test results do not raise any new or different questions of safety or effectiveness.
- Electrode DC Offset Voltage: DC offset voltage of electrode pairs of subject device connected gel-to-gel following a 1 min stabilization period using the test methodology and acceptance criteria of ANSI/AAMI EC12 5.2.2.2. All samples passed. The test results do not raise any new or different questions of safety or effectiveness.
- Combined Offset Instability and Internal Noise: Peak-to-peak passband voltage measured between electrode pairs of subject device connected gel-to-gel measured for a 5 min period following a 1 min stabilization using the test methodology and acceptance criteria of ANSI/AAMI EC12 5.2.2.3. All samples passed. The test results do not raise any new or different questions of safety or effectiveness.
- Defibrillation Overload Recovery: DC offset voltage and AC impedance of electrode pairs of subject device connected gel-to-gel following 4 simulated defibrillation discharge events using the test methodology and acceptance criteria of ANSI/AAMI EC12 5.2.2.4. All samples passed. The test results do not raise any new or different questions of safety or effectiveness.
- Bias Current Tolerance: DC offset voltage of electrode pairs of subject device connected gel-to-gel over the course of 8 hours with an applied bias current of 200 nA using the test methodology and acceptance criteria of ANSI/AAMI EC12 5.2.2.5. All samples passed. The test results do not raise any new or different questions of safety or effectiveness.
- Conductive Gel Delivery/Skin Prep Testing: Subject devices are functionally tested to verify that integrated conductive gel can be dispensed, additional gel can be added by the user, and aluminum oxide powder is present on the scalp contacting surfaces. All samples passed. The test results do not raise any new or different questions of safety or effectiveness.
- Headband Size Range Testing: Headband size ranges of subject devices measured with calibrated ruler. All samples passed. The test results do not raise any new or different questions of safety or effectiveness.
- Simulated Use Testing: Small, medium, and large size subject devices tested under simulated use conditions using mannequin heads with long hair. All samples passed. The test results do not raise any new or different questions of safety or effectiveness.
- Packaging Performance Testing: Subject devices packaging subjected to environmental conditioning and shipping test per ASTM D7386. After environmental conditioning and shipping, devices were visually inspected, functionally tested under simulated use conditions, and electrically tested. All samples passed. The test results do not raise any new or different questions of safety or effectiveness.
- Biocompatibility Testing: Patient contacting materials used in subject device subjected to biocompatibility testing for devices that contact surface/intact skin for limited duration (
§ 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
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 21, 2017
Ceribell, Inc. Josef Parvizi, MD, PhD Chairman 2483 Old Middlefield Wav. Suite 120 Mountain View, California 94043
Re: K171459
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 25, 2017 Received: July 27, 2017
Dear Dr. Parvizi:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Michael J. Hoffmann -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171459
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 6 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) |
|---|
| 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 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:
Josef Parvizi, MD, PhD, Chairman Telephone: (650) 521-7003 E-mail: josef@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:
Hydrodot Statnet EEG Headpiece (K092828).
Date Prepared:
August 17, 2017
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 (K170363) 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: ●
- o Passive Silver/silver-chloride electrode
- o Reservoir filled with conductive electrolyte gel
- 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 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.
Comparison of Intended Use and Technological Characteristics with the Predicate Devices:
The subject and the predicate device share the same intended use: an integrated array of cutaneous electrodes intended for the recording of EEG signals. The characteristics of the subject device and the predicate device are summarized in the following table.
| Attribute | Predicate Device
Hydrodot StatNet EEG
Headpiece (K092828) | Subject Device
Ceribell Instant EEG
Headband | Substantially Equivalence |
|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | A single-use disposable
headpiece with an integrated
array of 17 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 10 passive
cutaneous electrodes that are
applied to the patient's head
to record EEG signals when
connected to an EEG
recording device. | • The subject device and predicate
device all both intended for use as
single use, disposable, passive
cutaneous electrodes applied to the
patient's head to record EEG signals.
• The difference in number of electrodes
does not raise any new or different
questions of safety or effectiveness |
| Classification
Regulation | Class II per 21CFR882.1320,
cutaneous electrode | Class II per 21CFR882.1320,
cutaneous electrode | Same as predicate. |
| Product Code | GXY, Electrode, cutaneous | GXY, Electrode, cutaneous | Same as predicate. |
| Type of Patient
Contact | Contacts patient scalp | Contacts patient scalp | Same as predicate. |
| Type of use | Single use, non-sterile,
disposable. | Single use, non-sterile,
disposable. | Same as predicate. |
| System
Components,
Technological
Features, and
Materials | • 17 silver/silver-chloride
(Ag/AgCl) electrodes
• Foam gel reservoir
sponges pre-filled with
conductive electrolyte gel
• Electrodes integrated on a
plastic film substrate
• Integrated single-cable
connector to connect to an
EEG recording device | • 10 silver/silver-chloride
(Ag/AgCl) electrodes
• Packet gel reservoirs pre-
filled with conductive
electrolyte gel
• Electrodes integrated on a
fabric substrate
• Integrated single-cable
connector to connect to an
EEG recording device | • The technological features of the
subject device and predicate device
are substantially equivalent.
• Both devices include integrated pre-
filled containers of conductive
electrolyte gel.
• Both devices contain electrodes
integrated onto a substrate for
application onto the patient's head.
• Both devices include an integrated
single-cable connector to connect to
an EEG recording device.
• The differences in system
components, technological features,
and materials do not raise any new or
different questions of safety or
effectiveness. |
| Attribute | Predicate Device
Hydrodot StatNet EEG
Headpiece (K092828) | Subject Device
Ceribell Instant EEG
Headband | Substantially Equivalence |
| Electrodes | 17 passive Ag/AgCl
electrodes | 10 passive Ag/AgCl
electrodes | • Both the subject device and the
predicate device contain integrated
Ag/AgCl electrodes intended to be
applied to the patient's scalp and
provide coverage of both left and right
hemispheres of the patient's head
• The difference in number of electrodes
does not raise any new or different
questions of safety or effectiveness |
| Connector | Integrated single-cable
connector to connect to an
EEG recording device | Integrated single-cable
connector to connect to an
EEG recording device | Same as predicate. |
| Compatibility | Can connect to various EEG
devices using included
custom adapter cable. | Compatible with the Ceribell
Pocket EEG Device only. | • Both the subject device and the
predicate device are intended to be
connected to external EEG recording
devices.
• The difference in EEG recording
device compatibility does not raise any
new or different questions of safety or
effectiveness. |
| Available
Sizes and
Dimensions | Large (56 – 62 cm)
Medium (50 - 56 cm) | Small (48.4 – 53.6 cm)
Medium (53.3 - 56.5 cm)
Large (55.5 - 62 cm) | • The subject device and predicate
device are sized to encompass the
range of expected head sizes for their
intended patient population; and the
maximum head size for both devices
is the same.
• The differences in headband size
range do not raise any new or different
questions of safety or effectiveness. |
| Conductive
Electrolyte Gel | Electrodes are pre-filled with
an electrolyte gel filled
sponge adhered to each
electrode. | Conductive electrolyte gel is
included in a packet gel
reservoir integrated into each
electrode assembly. User is
also able to add additional
electrolyte gel when needed
using a syringe. | • The pre-filled conductive electrolyte
gel components in the subject device
and predicate device are substantially
equivalent.
• The differences in electrolyte gel
application do not raise any new or
different questions of safety or
effectiveness. |
| Bio-
compatibility | Biocompatibility of patient
contacting components
verified with Irritation,
Sensitization, and Cytotoxicity
testing per ISO 10993-5:2009
and ISO 10993-10:2010 | Biocompatibility of patient
contacting components
verified with Irritation,
Sensitization, and Cytotoxicity
testing per ISO 10993-5:2009
and ISO 10993-10:2010 | Same as predicate. |
5
6
Performance Data:
The following table summarizes test data that were provided to demonstrate safety and efficacy in support of a substantial equivalence determination. All of the performance testing described below was performed on the subject device.
| Test | Test Description | Test Results |
|---|---|---|
| Electrode | ||
| Impedance | AC impedance of electrode pairs of | |
| subject device connected gel-to-gel | ||
| using the test methodology and | ||
| acceptance criteria of ANSI/AAMI EC12 | ||
| 5.2.2.1. | All samples passed. The test results do not | |
| raise any new or different questions of | ||
| safety or effectiveness | ||
| Electrode DC | ||
| Offset Voltage | DC offset voltage of electrode pairs of | |
| subject device connected gel-to-gel | ||
| following a 1 min stabilization period | ||
| using the test methodology and | ||
| acceptance criteria of ANSI/AAMI EC12 | ||
| 5.2.2.2. | All samples passed. The test results do not | |
| raise any new or different questions of | ||
| safety or effectiveness | ||
| Combined | ||
| Offset | ||
| Instability and | ||
| Internal Noise | Peak-to-peak passband voltage | |
| measured between electrode pairs of | ||
| subject device connected gel-to-gel | ||
| measured for a 5 min period following a | ||
| 1 min stabilization using the test | ||
| methodology and acceptance criteria of | ||
| ANSI/AAMI EC12 5.2.2.3 | All samples passed. The test results do not | |
| raise any new or different questions of | ||
| safety or effectiveness | ||
| Defibrillation | ||
| Overload | ||
| Recovery | DC offset voltage and AC impedance of | |
| electrode pairs of subject device | ||
| connected gel-to-gel following 4 | ||
| simulated defibrillation discharge events | ||
| using the test methodology and | ||
| acceptance criteria of ANSI/AAMI EC12 | ||
| 5.2.2.4 | All samples passed. The test results do not | |
| raise any new or different questions of | ||
| safety or effectiveness | ||
| Bias Current | ||
| Tolerance | DC offset voltage of electrode pairs of | |
| subject device connected gel-to-gel over | ||
| the course of 8 hours with an applied | ||
| bias current of 200 nA using the test | ||
| methodology and acceptance criteria of | ||
| ANSI/AAMI EC12 5.2.2.5. | All samples passed. The test results do not | |
| raise any new or different questions of | ||
| safety or effectiveness | ||
| Conductive Gel | ||
| Delivery/Skin | ||
| Prep Testing | Subject devices are functionally tested | |
| to verify that integrated conductive gel | ||
| can be dispensed, additional gel can be | ||
| added by the user, and aluminum oxide | ||
| powder is present on the scalp | ||
| contacting surfaces. | All samples passed. The test results do not | |
| raise any new or different questions of | ||
| safety or effectiveness | ||
| Headband Size | ||
| Range Testing | Headband size ranges of subject | |
| devices measured with calibrated ruler. | All samples passed. The test results do not | |
| raise any new or different questions of | ||
| safety or effectiveness | ||
| Simulated Use | ||
| Testing | Small, medium, and large size subject | |
| devices tested under simulated use | ||
| conditions using mannequin heads with | ||
| long hair. | All samples passed. The test results do not | |
| raise any new or different questions of | ||
| safety or effectiveness | ||
| Test | Test Description | Test Results |
| Packaging | ||
| Performance | ||
| Testing | Subject devices packaging subjected to | |
| environmental conditioning and shipping | ||
| test per ASTM D7386. After | ||
| environmental conditioning and | ||
| shipping, devices were visually | ||
| inspected, functionally tested under | ||
| simulated use conditions, and | ||
| electrically tested. | All samples passed. The test results do not | |
| raise any new or different questions of | ||
| safety or effectiveness | ||
| Biocompatibility | ||
| Testing | Patient contacting materials used in | |
| subject device subjected to | ||
| biocompatibility testing for devices that | ||
| contact surface/intact skin for limited | ||
| duration ( |