(91 days)
Not Found
No
The summary explicitly states the device does not provide diagnostic conclusions or automated alerts, and there is no mention of AI/ML terms, training/test sets, or performance metrics typically associated with AI/ML algorithms.
No
The device is used to record and present EEG signals for diagnostic purposes, not to treat a medical condition.
No
The device explicitly states that it "does not provide any diagnostic conclusion about the subject's condition". Its purpose is to record and present EEG signals, which then assist trained medical staff in making neurological diagnoses.
No
The device description explicitly lists hardware components such as the "Pocket EEG Device: a portable, battery powered, 8-channel EEG monitoring system," a power adapter, and a micro-USB cable. While it includes "EEG Recording Viewer Software," it is part of a larger hardware system.
Based on the provided information, the Ceribell Pocket EEG Device 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, tissue) to provide information about a person's health.
- Ceribell Pocket EEG Function: The Ceribell Pocket EEG Device records and presents electrical signals from the scalp (EEG). It does not analyze or test biological specimens.
- Intended Use: The intended use clearly states it records and presents EEG signals to assist trained medical staff in making neurological diagnoses. It does not perform any diagnostic testing on samples.
Therefore, the Ceribell Pocket EEG Device falls under the category of a medical device used for physiological monitoring and signal acquisition, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Ceribell Pocket EEG Device is intended to record and to present the EEG signals in visual and audible formats in real time. The visual and audible signals assist trained medical staff to make neurological diagnoses. The Pocket EEG Device does not provide any diagnostic conclusion about the subject's condition and does not provide any automated alerts of an adverse clinical event. The Pocket EEG Device is intended to be used in a professional healthcare facility environment.
Product codes
OMC
Device Description
The Ceribell Pocket EEG Device (subject) is a portable 8-channel EEG monitoring system. The device connects to 10 patient electrodes (5 left, 5 right), which are used to form the 8 channels, and may be used with any scalp EEG electrodes. The Device includes the following items:
- Pocket EEG Device: a portable, battery powered, 8-channel EEG monitoring system. .
- Power adapter: 100-240 V AC power adapter used to charge the Pocket EEG Device. ●
- . Micro-USB cable: cable used to connect Pocket EEG Device to power adapter for charging and to connect to a computer to transfer EEG recording files. When the Pocket EEG Device is connected to a power adapter of a computer, all EEG acquisition functions are automatically disabled.
- EEG Recording Viewer Software: EEG review software for viewing EEG recordings on a . computer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical staff / professional healthcare facility 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)
The following performance data were provided to demonstrate safety and efficacy in support of substantial equivalence determination:
- . Requirements for the basic safety and essential performance of electroencephalographs per IEC 60601-2-26
- Electromagnetic Compatibility and Electrical Safety Testing performed to applicable requirements . of IEC 60601-1 and IEC 60601-1-2
- Battery Safety Testing per IEC 62133 ●
- Bench testing to verify system performance ●
- . Shipping/distribution and vibration testing per ASTM D7386
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).
0
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 8, 2017
Ceribell, Inc. Josef Parvizi, MD, Ph.D. Chairman 2483 Old Middlefield Wav. Suite 120 Mountain View, California 94043
Re: K170363
Trade/Device Name: Ceribell Pocket EEG Device Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMC Dated: February 2, 2017 Received: February 6, 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 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 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
Carlos L. Peña, PhD, MS for 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) K170363
Device Name Ceribell Pocket EEG Device
Indications for Use (Describe)
The Ceribell Pocket EEG Device is intended to record and to present the EEG signals in visual and audible formats in real time. The visual and audible signals assist trained medical staff to make neurological diagnoses. The Pocket EEG Device does not provide any diagnostic conclusion about the subject's condition and does not provide any automated alerts of an adverse clinical event. The Pocket EEG Device is intended to be used in a professional healthcare facility 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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 Pocket EEG Device |
|---|---|
| Common Name: | Reduced-montage standard Electroencephalograph |
| Classification Name: | Electroencephalograph (21CFR 882.1400) |
| Device Class: | II |
| Product Code: | OMC |
Predicate Device:
Oxford Medilog 9000 EEG System, K830295
Date Prepared:
February 2nd, 2017
Device Description:
The Ceribell Pocket EEG Device (subject) is a portable 8-channel EEG monitoring system. The device connects to 10 patient electrodes (5 left, 5 right), which are used to form the 8 channels, and may be used with any scalp EEG electrodes. The Device includes the following items:
- Pocket EEG Device: a portable, battery powered, 8-channel EEG monitoring system. .
- Power adapter: 100-240 V AC power adapter used to charge the Pocket EEG Device. ●
- . Micro-USB cable: cable used to connect Pocket EEG Device to power adapter for charging and to connect to a computer to transfer EEG recording files. When the Pocket EEG Device is connected to a power adapter of a computer, all EEG acquisition functions are automatically disabled.
- EEG Recording Viewer Software: EEG review software for viewing EEG recordings on a . computer.
4
Indications for Use:
The Ceribell Pocket EEG Device is intended to record and store EEG signals, and to present the EEG signals in visual and audible formats in real time. The visual and audible signals assist trained medical staff to make neurological diagnoses. The Pocket EEG Device does not provide any diagnostic conclusion about the subject's condition and does not provide any automated alerts of an adverse clinical event. The Pocket EEG Device is intended to be used in a professional healthcare facility environment.
Comparison of Intended Use and Technological Characteristics with the Predicate Device:
The subject and the predicate devices share the same intended use as a portable EEG monitoring system that records, stores, and presents EEG signals in visual and audible formats. The recorded EEG signals assist trained medical staff to make neurological diagnoses. It does not provide any diagnostic conclusion about the subject's condition or any automated alerts of an adverse clinical event.
The subject and predicate device are based on the following same technological elements:
- . Portable, battery powered EEG acquisition and recording of 8 channels
- . EEG data presented in both visual and audible formats
- Review of EEG recordings on an external Replay Module or computer .
Whereas the predicate device uses analog technology for presentation, processing, storage and replay of data, the subject device utilizes digital technology. The predicate uses 16 electrodes to form 8 channels of EEG data; the subject uses 10 electrodes to form 8 channels of EEG data.
Performance Data:
The following performance data were provided to demonstrate safety and efficacy in support of substantial equivalence determination:
- . Requirements for the basic safety and essential performance of electroencephalographs per IEC 60601-2-26
- Electromagnetic Compatibility and Electrical Safety Testing performed to applicable requirements . of IEC 60601-1 and IEC 60601-1-2
- Battery Safety Testing per IEC 62133 ●
- Bench testing to verify system performance ●
- . Shipping/distribution and vibration testing per ASTM D7386
Summary:
The Ceribell Pocket EEG 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 Pocket EEG Device is substantially equivalent to the cleared predicate device.